Pick a country to access references related to it's FRPs
ACCESS New Active Substance Work-Sharing Initiative (NASWSI)
ACSS Consortium. Accessed on 26 July 2020., https://www.swissmedic.ch/swissmedic/en/home/about-us/international-collaboration/multilateral-co-operation-with-international-organisations---ini/multilateral-co-operation-with-international-organisations---ini.html#:~:text=The%20ACSS%20Consortium%20is%20a,Products%20(Swissmedic)%20of%20Switzerland, Sun Jul 26 2020
EU Regulatory Roundup: Swissmedic Authorizes First Drug Under International Work Sharing Initiative, https://www.raps.org/news-and-articles/news-articles/2020/2/eu-regulatory-roundup-swissmedic-authorizes-first, Sun Jul 26 2020
ACSS - NAS work sharing initiative, https://www.tga.gov.au/acss-nas-work-sharing-initiative#:~:text=ACSS%20NAS%20work%2Dsharing%20pilot,-The%20New%20Active&text=Initially%2C%20the%20ACSS%20NAS%20work,Canada%20and%20Therapeutic%20Goods%20Administration.&text=The%20work%2Dsharing%20pilot%20demonstrated,authorities%20and%20the%20pharmaceutical%20in, Sun Jul 26 2020
ACSS - NAS work sharing initiative: Q&A, https://www.tga.gov.au/acss-nas-work-sharing-initiative-qa, Sun Jul 26 2020
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium, https://www.tga.gov.au/australia-canada-singapore-switzerland-united-kingdom-access-consortium , Mon Mar 15 2021
Operational Procedures (OP) - Access Consortium New Active Substance Work-sharing Initiative (NASWSI). Version 1.2, https://assets.publishing.service.gov.uk/media/6842f47fe5a089417c8060e3/Access_NASWSI_-_Operational_Procedures_-_v1.2.pdf, Fri Aug 08 2025
Geraci, G., Smith, R., Hansford, A. et al. Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations. Ther Innov Regul Sci 58, 557–566 (2024)., https://link.springer.com/article/10.1007/s43441-024-00624-7, Tue Jan 14 2025
GOV.UK. Guidance: Access, new active substance and biosimilar work sharing initiatives., https://www.gov.uk/guidance/access-new-active-substance-nas-work-sharing-initiative, Fri Aug 08 2025
ACCESS - Generic Medicine Work-Sharing Initiative (GMWSI)
ACSS - Generic Medicine Work Sharing Trial., https://www.tga.gov.au/acss-generic-medicine-work-sharing-trial, Mon Mar 15 2021
Operational Procedures (OP) - ACSS Consortium Generic Medicines Work Sharing Trial (GMWST)., https://www.tga.gov.au/sites/default/files/acss-generic-medicine-work-sharing-trial-op.pdf, Mon Mar 15 2021
Questions and Answers (Q&A) Document - ACSS Consortium Generic Medicines Work Sharing Trial (GMWST)., https://www.tga.gov.au/sites/default/files/acss-generic-medicine-work-sharing-trial-qa.pdf, Mon Mar 15 2021
Mandate: ACSS Generic Medicines Working Group., https://www.tga.gov.au/mandate-acss-generic-medicines-working-group, Mon Mar 15 2021
Manan S, Nelson A. Access Consortium – A global collaborative pathway. RF Quarterly. 2023;3(2):39-45. Published online 28 June 2023., https://www.raps.org/News-and-Articles/News-Articles/2023/6/Consortium-%E2%80%93-A-global-collaborative-pathway, Sat Jul 15 2023
Operational Procedures (OP) Access Consortium Operational procedures for the Generic Medicines Work-Sharing Initiative (GMWSI)., https://www.hsa.gov.sg/docs/default-source/hprg-tpb/international/gmwsi---operational-procedures-eng.pdf, Sat Jul 15 2023
ACCESS Biosimilars Work-Sharing Initiative (BSWSI)
Access Consortium Biosimilars work-sharing initiative, https://www.tga.gov.au/access-consortium-biosimilars-work-sharing-initiative, Sat Jul 15 2023
Guidance for Industry - FACILITATING ACCESS WORK SHARING FOR BIOSIMILARS, https://www.hsa.gov.sg/docs/default-source/hprg-tpb/international/bswg-external-facing-rules-of-engagement_23july2021-final.pdf, Sat Jul 15 2023
GOV.UK. Guidance: Access, new active substance and biosimilar work sharing initiatives., https://www.gov.uk/guidance/access-new-active-substance-nas-work-sharing-initiative, Fri Aug 08 2025
Promise Pilot Pathway: ACCESS New Active Substance Work-Sharing Initiative (NASWSI)
Operational Procedures (OP) - Access Consortium New Active Substance Work-sharing Initiative (NASWSI). Version 1.2, https://assets.publishing.service.gov.uk/media/6842f47fe5a089417c8060e3/Access_NASWSI_-_Operational_Procedures_-_v1.2.pdf, Fri Aug 08 2025
Promise Pilot Pathway: Access work-sharing for priority prescription medicine applications, https://www.tga.gov.au/news/news/promise-pilot-pathway-access-work-sharing-priority-prescription-medicine-applications, Mon Jan 15 2024
GOV.UK. Guidance: Access, new active substance and biosimilar work sharing initiatives., https://www.gov.uk/guidance/access-new-active-substance-nas-work-sharing-initiative, Fri Aug 08 2025
ASEAN Joint Assessment Procedure for Pharmaceutical Products
ASEAN Joint Assessment Procedure for Pharmaceutical Products Information for applicants. Revision 3. 2024., https://www.fda.gov.ph/wp-content/uploads/2024/10/2.-Information-for-applicants_Revision-3_2024.pdf, Sat Jan 25 2025
Announcement || ASEAN Joint Assessment Procedure., https://www.fda.gov.ph/announcement-asean-joint-assessment-procedure-3/, Sat Jan 25 2025
Frequently Asked Questions. Revision 3. 2024., https://www.fda.gov.ph/wp-content/uploads/2024/10/3.-Frequently-Asked-Questions_Revision-3_2024.pdf, Sat Jan 25 2025
List of Priority Products for Joint Assessment Activities. Revision 2 (14 November 2022), https://www.fda.gov.ph/wp-content/uploads/2024/10/4.-List-of-Priority-Products-for-JA-Activities_Revision-2_14-November-2022.pdf, Sat Jan 25 2025
DIA Global: "Optimizing ASEAN Joint Assessment: Lessons from a Multistakeholder Pilot", https://globalforum.diaglobal.org/issue/april-2025/optimizing-asean-joint-assessment/, Tue Apr 15 2025
Expedited Joint Assessment Procedure
ASEAN Joint Assessment Procedure for Pharmaceutical Products, https://www.hsa.gov.sg/therapeutic-products/international-collaboration/ASEAN-JA, Tue May 09 2023
ASEAN Joint Assessment Procedure for Pharmaceutical Products Public Announcement, https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/asean/asean-ja-procedure-for-pharmaceutical-products---public-announcement.pdf, Tue May 09 2023
ASEAN Joint Assessment Procedure for Pharmaceutical Products Information for applicants. Revision 2. 14 November 2022. , https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/asean/information-for-applicants_revision-2_14-november-2022_final-clean-version31d44ffac37f42de92f83b87aec04063.pdf, Tue May 09 2023
LIST OF PRIORITY PRODUCTS FOR JA ACTIVITIES. REVISION 2., https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/asean/listof-1b76330e3338e48ec8d2b40957bb23b0a.pdf, Tue May 09 2023
FREQUENTLY ASKED QUESTIONS (FAQ) ON THE ASEAN JOINT ASSESSMENT (JA) PROCEDURE, https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/asean/faq_revision-2_14-november-2022_final-clean-versionbadf95f909fb4b81ae191f48f25cbe07.pdf, Tue May 09 2023
ASEAN Member States, https://asean.org/member-states/, Tue May 09 2023
DIA Global: "Optimizing ASEAN Joint Assessment: Lessons from a Multistakeholder Pilot", https://globalforum.diaglobal.org/issue/april-2025/optimizing-asean-joint-assessment/, Tue Apr 15 2025
Continental Listing of Medicinal Products (AMA)
Call for Industry Applications: Pilot of the Continental Listing of Medicinal Products, https://amrh.nepad.org/publication/call-industry-applications-pilot-of-continental-listing-of-medicinal-products, Thu Mar 14 2024
AMA Resources, https://www.nepad.org/microsite/african-medicines-agency-ama, Thu Mar 14 2024
Evaluation of Medicinal Products Technical Committee (EMP-TC) Continental Procedure, , Sun Apr 07 2024
African Medicines Agency Countdown - Health Policy Watch., https://healthpolicy-watch.news/african-medicines-agency-countdown/, Mon Jan 27 2025
Autorisation Temporaire d’Utilisation (ATU)
Regulatory, Pricing & Reimbursement Overview., https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-algeria/, Mon Mar 23 2020
PharmaBoard. Legal & Regulatory > Algeria > Updates on Authorization Fees in Algeria, https://pharmaboardroom.com/legal-articles/updates-on-authorization-fees-in-algeria/, Sat Feb 11 2023
Fast Track Proceedings: ‘Article 3’
Drug registration in Argentina., https://latampharmara.com/argentina/drug-registration-in-argentina/, Sat Feb 22 2020
Distribution and marketing of drugs in Argentina: overview., https://uk.practicallaw.thomsonreuters.com/w-014-7135?transitionType=Default&contextData=(sc.Default)&firstPage=true&bhcp=1#co_anchor_a447637, Sat Feb 22 2020
ANMAT Guideline 1000-MAN08: Good Reliance Practices, Mar-2022, https://www.argentina.gob.ar/sites/default/files/1000-man08-00_manual_de_buenas_practicas_de_reliance.pdf, Thu Jan 18 2024
Decreto Nº 150/1992 (con las modificaciones del Dec. N° 968/1992, Dec. N° 1890/1992, Dec. N° 177/1993, Dec. N° 1528/2004 y Res. Conj. N° 452/2014 y N° 1227/2014), http://www.anmat.gob.ar/webanmat/Legislacion/Medicamentos/Decreto150-1992.pdf, Sat Jun 22 2024
Fast Track Proceedings: ‘Article 4’
Drug registration in Argentina. , https://latampharmara.com/argentina/drug-registration-in-argentina/, Sat Feb 22 2020
Distribution and marketing of drugs in Argentina: overview. , https://uk.practicallaw.thomsonreuters.com/w-014-7135?transitionType=Default&contextData=(sc.Default)&firstPage=true&bhcp=1#co_anchor_a447637, Sat Feb 22 2020
ANMAT Guideline 1000-MAN08: Good Reliance Practices, Mar-2022, https://www.argentina.gob.ar/sites/default/files/1000-man08-00_manual_de_buenas_practicas_de_reliance.pdf, Thu Jan 18 2024
Decreto Nº 150/1992 (con las modificaciones del Dec. N° 968/1992, Dec. N° 1890/1992, Dec. N° 177/1993, Dec. N° 1528/2004 y Res. Conj. N° 452/2014 y N° 1227/2014), http://www.anmat.gob.ar/webanmat/Legislacion/Medicamentos/Decreto150-1992.pdf, Sat Jun 22 2024
Registrations Under Special Conditions
Tramitaciones correspondientes a la Disposición ANMAT N° 4622/12 (Registros Bajo Condiciones Especiales)., , Thu May 23 2024
National Administration of Drugs, Food and Medical Technology MEDICINAL SPECIALTIES Provision 4622/2012, https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-4622-2012-200533/texto, Thu May 23 2024
DISPOSICIÓN 4622/2012 ADMINISTRACIÓN NACIONAL DE MEDICAMENTOS, ALIMENTOS Y TECNOLOGÍA MÉDICA (A.N.M.A.T.) , https://e-legis-ar.msal.gov.ar/htdocs/legisalud/migration/pdf/19633.pdf, Thu May 23 2024
ANMAT signed a collaboration agreement with the European Medicines Agency (EMA)., https://www.argentina.gob.ar/noticias/la-anmat-firmo-acuerdo-de-colaboracion-con-la-agencia-europea-de-medicamentos-ema, Thu May 23 2024
National Administration of Drugs, Food and Medical Technology MEDICINAL SPECIALTIES Provision 705/2005., https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-705-2005-103738/actualizacion, Thu May 23 2024
TGA Comparative Overseas Regulator (COR)-A
Comparable overseas regulators (CORs): Submission requirements., https://www.tga.gov.au/comparable-overseas-regulators-cors-submission-requirements, Sun Apr 19 2020
TGA Comparative Overseas Regulator (COR)-B
Comparable overseas regulators (CORs): Submission requirements., https://www.tga.gov.au/comparable-overseas-regulators-cors-submission-requirements, Sun Apr 19 2020
Priority Registration Process
Fast track approval pathways., https://www.tga.gov.au/fast-track-approval-pathways, Sun Apr 19 2020
Priority review of prescription medicines., https://www.tga.gov.au/hubs/fast-track-approvals/priority-review-prescription-medicines, Sun Apr 19 2020
Priority determination. , https://www.tga.gov.au/publication/priority-determination#submitting, Sun Apr 19 2020
Hotaki, L.T., Shrestha, A., Bennett, M.P. et al. Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners. Ther Innov Regul Sci 57, 875–885 (2023). https://doi.org/10.1007/s43441-023-00522-4, https://link.springer.com/article/10.1007/s43441-023-00522-4#citeas, Wed Jul 05 2023
Provisional Approval Pathway
TGA. Provisional determination eligibility criteria., https://www.tga.gov.au/publication/provisional-determination-eligibility-criteria, Mon Jun 14 2021
TGA Provisional determination., https://www.tga.gov.au/publication/provisional-determination, Mon Jun 14 2021
TGA Fees and charges: summary from 1 July 2020., https://www.tga.gov.au/book-page/prescription-medicines-5, Mon Jun 14 2021
COVID-19 vaccine approval process
Provisional Determination. , https://www.tga.gov.au/resources/resource/guidance/provisional-determination, Mon May 06 2024
Provisional Registration Process. , https://www.tga.gov.au/resources/resource/guidance/provisional-registration-process, Mon May 06 2024
Fees and Payments., https://www.tga.gov.au/fees-and-payments, Mon May 06 2024
Fees and Charges: Summary. From 1 July 2023., https://www.tga.gov.au/sites/default/files/2023-12/fees-and-charges-summary-1-July-2023.pdf, Mon May 06 2024
COVID-19 vaccine: International Collaboration, https://www.tga.gov.au/products/covid-19/covid-19-vaccines/covid-19-vaccine-international-collaboration, Mon May 06 2024
COVID-19 vaccine: Information for consumers and health professionals., https://www.tga.gov.au/products/covid-19/covid-19-vaccines/covid-19-vaccine-information-consumers-and-health-professionals, Mon May 06 2024
COVID-19 vaccine approval process., https://www.tga.gov.au/products/covid-19/covid-19-vaccines/covid-19-vaccine-approval-process, Mon May 06 2024
Emergency Use Authorization of COVID-19 Vaccines
PQM+. 2021. Guideline on Emergency Use Authorization (EUA) of COVID-19 vaccines in Bangladesh. Submitted to the U.S. Agency for International Development by the PQM+ Program. Rockville, MD: U.S. Pharmacopeial Convention., http://www.dgdagov.info/index.php/information-center/guidance-documents/2449-guideline-on-emergency-use-authorization-eua-of-covid-19-vaccines-in-bangladesh/file, Mon May 06 2024
Guidelines for Registration of Human Vaccines. Version 01., http://www.dgdagov.info/index.php/information-center/guidance-documents/2287-guidelines-for-registration-of-human-vaccines/file, Mon May 06 2024
Procedure for Expedited Marketing Authorizatio of COVID-19 Vaccines in South-East Asia Region., http://www.dgdagov.info/index.php/information-center/guidance-documents/1625-procedure-for-expedited-marketing-authorizatio-of-covid-19-vaccines-in-south-east-asia-region/file, Mon May 06 2024
Fees, http://www.dgdagov.info/index.php/information-center/guidance-documents/1129-different-fee/file, Mon May 06 2024
Emergency Use Authorization., http://www.dgdagov.info/index.php/information-center/emergency-use-authorization, Mon May 06 2024
Abridged Registration
Guidelines for application for Registration of Medicinal Products 2006(DRA)., , Sat Apr 04 2020
Bhutan Medicines Rules and Regulation 2019, , Sat Apr 04 2020
GUIDELINE - Registration of Medicinal Products 2nd Edition, 2013., , Sat Apr 04 2020
Expedited Registration
Guidelines for application for Registration of Medicinal Products 2006(DRA)., , Sat Apr 04 2020
Bhutan Medicines Rules and Regulation 2019. , , Sat Apr 04 2020
GUIDELINE - Registration of Medicinal Products 2nd Edition, 2013., , Sat Apr 04 2020
Conditions for ER Registration & Documentary Requirements thereunder., https://drive.google.com/file/d/0Bzj2O5Bryu-LVnpZQ3lKLU5uYUhjRFk2ODFKSGp0cG9fQm1J/view, Sat Apr 04 2020
Sanitary Emergency Law
LEY N° 1359. LEY DE 17 DE FEBRERO DE 2021., https://www.agemed.gob.bo/resoluciones/Ley_1359.pdf, Sun Aug 29 2021
Bolivia LEY No. 1737. LEY DE 17 DE DICIEMBRE DE 1996., https://www.agemed.gob.bo/reg-far/doc_reg_far/T-N-1-RM050-LM1737.pdf, Sun Aug 29 2021
REGLAMENTO A LA LEY DEL MEDICAMENTO. DECRETO SUPREMO No. 25235. 30 DE NOVIEMBRE DE 1998., https://www.agemed.gob.bo/reg-far/doc_reg_far/T-N-2-DS-25235-REG_LM.pdf, Mon Aug 30 2021
Expedited/Fast-track procedure
Botswana Medicines Regulatory Authority (BoMRA). Guideline on Submission of Applications. Document Number: BOMRA/ER/MD/P04/G01. , https://www.bomra.co.bw/index.php/bomra-downloads/guidelines-manuals/file/34-guideline-on-submission-of-applications-and-bomra-timelines, Sun Aug 29 2021
Botswana Medicines Regulatory Authority (BoMRA). BoMRA Regulatory Fees 2019., https://www.bomra.co.bw/index.php/bomra-downloads/fees/file/29-bomra-fees-2019, Sun Aug 29 2021
Medicine Registration Exemption
Botswana Medicines Regulatory Authority. Application for Medicine Registration Exemption. Document No: BOMRA/ER/EX/P02/G01. Issue No. 5.0. Effective date: 05/12/2022. , https://bomra.co.bw/download/319/human-medicines/29759/gdln-application-for-medicine-registration-exemption-iss5-0-er-ex-p02-g01-2.pdf, Sat Feb 11 2023
Non-Routine Assessment of Products for Public Health Emergencies
Non-Routine Assessment of Products for Public Health Emergencies. Document No: BOMRA/ER/MD/P04/GO4. Issue No: 3.0. Effective date: 22-12-2023., https://www.bomra.co.bw/download/111/human-medicines/36603/guideline-non-routine-assessment-of-products-for-public-health-emergencies-bomra-er-md-p04-g04-iss3.pdf, Sat Feb 11 2023
Resolução de Diretoria Colegiada (RDC) 204/2017—Priority Review
Drugs., http://portal.anvisa.gov.br/drugs, Sat Feb 22 2020
ANVISA. RDC 204/2017., https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000204&seqAto=000&valorAno=2017&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=9434&cod_modulo=310&pesquisa=true, Fri May 23 2025
Hotaki, L.T., Shrestha, A., Bennett, M.P. et al. Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners. Ther Innov Regul Sci 57, 875–885 (2023). https://doi.org/10.1007/s43441-023-00522-4, https://link.springer.com/article/10.1007/s43441-023-00522-4#citeas, Wed Jul 05 2023
INSTRUÇÃO NORMA - IN N° 292, OF 2 MAY 2024., https://antigo.anvisa.gov.br/documents/10181/6531690/IN_292_2024_.pdf/33b87ce6-cb6b-4136-b7e8-9adc4d54285d, Mon May 27 2024
Resolution of the Collegiate Board of Directors - RDC No. 811, of 08/18/2023 , https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000811&seqAto=000&valorAno=2023&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=9434&cod_modulo=310&pesquisa=true, Fri May 23 2025
Biologics and Biosimilars Pathway (OS-45)
ANVISA. Service Guidance #45 of 2018. , https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/medicamentos/orientacoes-de-servico/orientacao-de-servico-no-45-de-2018.pdf/view, Tue Jun 07 2022
Biosimilars in Brazil, https://www.genengnews.com/news/biosimilars-in-brazil/, Thu Aug 31 2023
INSTRUÇÃO NORMA - IN N° 292, OF 2 MAY 2024., https://antigo.anvisa.gov.br/documents/10181/6531690/IN_292_2024_.pdf/33b87ce6-cb6b-4136-b7e8-9adc4d54285d, Mon May 27 2024
Temporary authorization for emergency use of medication for COVID-19
Guide 49/2021., http://antigo.anvisa.gov.br/documents/10181/6134216/Guia+AUE+Medicamentos.pdf/02e57b9b-ff1c-47ee-b82d-3141b7c5ec71,
Resolution 475., http://antigo.anvisa.gov.br/documents/10181/6134216/RDC_475_2021_.pdf/a9edad40-f6de-4d2d-891b-be84e4ee4171,
INSTRUÇÃO NORMA - IN N° 292, OF 2 MAY 2024., https://antigo.anvisa.gov.br/documents/10181/6531690/IN_292_2024_.pdf/33b87ce6-cb6b-4136-b7e8-9adc4d54285d, Mon May 27 2024
Orphan Drug Route
Global Regulatory Partners. Overview of the Registration Process of Orphan Drugs in Brazil., https://globalregulatorypartners.com/wp-content/uploads/Orphan-Drug-Registration-in-Brazil-_anvisa-global-regulatory-partners-_Final-pdf.pdf, Wed Mar 23 2022
Pharma Boardroom. Orphan Drugs & Rare Diseases: Brazil., https://pharmaboardroom.com/legal-articles/orphan-drugs-rare-diseases-brazil/, Wed Mar 23 2022
New Brazilian Regulatory Resolution Helps Rare Disease Research., https://communityresearch.com/media/86927/april-newsletter-new-brazilian-regulatory-resolution-helps-rare-disease-research.pdf, Tue Mar 22 2022
Ministério da Saúde - MS. Agência Nacional de Vigilância Sanitária - ANVISA. Este texto não substitui o(s) publicado(s) em Diário Oficial da União. RESOLUÇÃO DA DIRETORIA COLEGIADA – RDC Nº 205, DE 28 DE DEZEMBRO DE 2017., http://antigo.anvisa.gov.br/documents/10181/3113140/RDC_205_2017_COMP.pdf/0b34ff0b-e238-4925-bfc3-aba28f741329, Tue Jun 07 2022
INSTRUÇÃO NORMA - IN N° 292, OF 2 MAY 2024., https://antigo.anvisa.gov.br/documents/10181/6531690/IN_292_2024_.pdf/33b87ce6-cb6b-4136-b7e8-9adc4d54285d, Mon May 27 2024
Abridged Review for Small Molecules
ANVISA. ORIENTAÇÃO DE SERVIÇO Nº 70/DIRE2/ANVISA, DE 19 DE AGOSTO DE 2019., https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/medicamentos/orientacoes-de-servico/orientacao-de-servico-no-70-de-2019-gesef.pdf/view, Tue Jun 07 2022
INSTRUÇÃO NORMA - IN N° 292, OF 2 MAY 2024., https://antigo.anvisa.gov.br/documents/10181/6531690/IN_292_2024_.pdf/33b87ce6-cb6b-4136-b7e8-9adc4d54285d, Mon May 27 2024
Optimized Analysis Procedure
Public Consultation no. 1,108 of 18 August 2022 - Federal Official Gazette of 24 August 2022., https://antigo.anvisa.gov.br/documents/10181/6354042/Public+Consultation+no.+1108+of+18+August+2022++%281%29.pdf/6cc4cc3e-aafc-4aa6-a7b2-08055358137e, Wed Oct 04 2023
Ministério da Saúde - MS Agência Nacional de Vigilância Sanitária – ANVISA Este texto não substitui o(s) publicado(s) em Diário Oficial da União. RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC Nº 750, DE 6 DE SETEMBRO DE 2022 (Publicada no DOU nº 171, de 8 de setembro de 2022), https://antigo.anvisa.gov.br/documents/10181/6485985/RDC_750_2022_.pdf/f4ed579c-7536-4476-a788-749e3250285a, Wed Oct 04 2023
INSTRUÇÃO NORMA - IN N° 292, OF 2 MAY 2024., https://antigo.anvisa.gov.br/documents/10181/6531690/IN_292_2024_.pdf/33b87ce6-cb6b-4136-b7e8-9adc4d54285d, Mon May 27 2024
RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC Nº 741, DE 10 DE AGOSTO DE 2022 (Publicada no DOU nº 156, de 17 de agosto de 2022), https://antigo.anvisa.gov.br/documents/10181/6253937/RDC_741_2022_.pdf/8f28c953-a9ee-4979-a94c-18fea1bb2b83, Fri Aug 09 2024
Optimized Analysis Procedure (NORMATIVE INSTRUCTION - IN NO. 289, OF MARCH 20, 2024)
NORMATIVE INSTRUCTION - IN NO. 289, OF MARCH 20, 2024, https://antigo.anvisa.gov.br/documents/10181/6354042/IN_289_2024_.pdf/ec565fb0-e17e-4e0a-a8c0-a88935fb6cca, Sun Apr 07 2024
INSTRUÇÃO NORMA - IN N° 292, OF 2 MAY 2024., https://antigo.anvisa.gov.br/documents/10181/6531690/IN_292_2024_.pdf/33b87ce6-cb6b-4136-b7e8-9adc4d54285d, Mon May 27 2024
REGULATORY CONFIDENCE - Anvisa approves norm for the use of evaluations of equivalent foreign authorities., https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-aprova-norma-para-aproveitamento-de-avaliacoes-de-autoridades-estrangeiras-equivalentes, Tue Jun 18 2024
Reliance: Brazilian experience and Core Information for the decision. Fabrício Carneiro de Oliveira GGBIO, Agência Nacional de Vigilância Sanitária –ANVISA., , Fri Aug 09 2024
RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC Nº 741, DE 10 DE AGOSTO DE 2022 (Publicada no DOU nº 156, de 17 de agosto de 2022)., https://antigo.anvisa.gov.br/documents/10181/6253937/RDC_741_2022_.pdf/8f28c953-a9ee-4979-a94c-18fea1bb2b83, Fri Aug 09 2024
Verification Review of Medicines and Vaccines
Caribbean Public Health Agency – Caribbean Regulatory System (CRS). Technical Guidance No. 1: Requirements for Verification Review of Medicines and Vaccines., ,
An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology, https://link.springer.com/article/10.1186/s40545-020-00261-z?fromPaywallRec=true, Thu Sep 26 2024
Verification Review for Biotherapeutic Product Applications
Caribbean Regulatory System (CARPHA/CRS). Guidance Document: Submission of Biotherapeutic Product Applications for Verification Review. GD-ReqBTP001.1 , ,
An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology, https://link.springer.com/article/10.1186/s40545-020-00261-z?fromPaywallRec=true, Thu Sep 26 2024
Priority Review of Drug Submissions
Guidance for Industry - Priority Review of Drug Submissions., https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/priority-review/drug-submissions.html, Sun Apr 05 2020
FAQ – The Drug Regulatory and Approval Process in Canada., https://spharm-inc.com/frequently-asked-questions-on-the-drug-regulatory-approval-process-in-canada/, Sun Apr 05 2020
Guidance Document: Fees for the Review of Human and Disinfectant Drug Submissions and Applications., https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees/fees-review-drug-submissions-applications-2019/document.html#s2.4, Sun Apr 05 2020
Notice of compliance with conditions
Notice of Compliance with Conditions -NOC/c (Therapeutic Products)., https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/noccfs_accfd-eng.pdf, Sun Apr 05 2020
GUIDANCE DOCUMENT: Notice of Compliance with conditions (NOC/c) - Published by authority of the Minister of Health., https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/compli-conform/noccg_accd-eng.pdf, Sun Apr 05 2020
Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Explanatory note., https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-import-sale-advertising-drugs/note.html, Fri Mar 19 2021
Drug and vaccine authorizations for COVID-19: Overview., https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization.html, Fri Mar 19 2021
Extraordinary Use New Drugs (EUNDs)
Guidance Document - Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs), https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/submission-information-requirements-extraordinary-drugs-eunds.html, Wed Jul 05 2023
The Central American Mechanism for the Joint Evaluation of Medicines
Pan American Health Organization (PAHO). The Central American Mechanism for the Joint Evaluation of Medicines begins to receive dossiers for product registrations in the region., https://www.paho.org/en/news/28-7-2020-central-american-mechanism-joint-evaluation-medicines-begins-receive-dossiers#:~:text=%22The%20Central%20American%20Mechanism%20for,will%20be%20managed%20by%20PAHO, Thu May 05 2022
Pan American Health Organization (PAHO). PAHO presents the Central American Mechanism for the Joint Evaluation of Medicines to the pharmaceutical sector. , https://www.paho.org/en/news/25-6-2021-paho-presents-central-american-mechanism-joint-evaluation-medicines-pharmaceutical, Thu May 05 2022
Application Form, https://www.medicamentos.gob.sv/?wpdmpro=formulario-de-solicitud-para-la-evaluacion-conjunta-de-medicamentos-para-uso-humano, Fri Apr 21 2023
Simplified Procedure (Procedimiento Simplificado de Registro)
Decreto-54 21-AGO-2020 MINISTERIO DE SALUD, SUBSECRETARÍA DE SALUD PÚBLICA - Ley Chile - Biblioteca del Congreso Nacional (bcn.cl), ,
Priority Review: Short Registration Procedure
Regulatory, Pricing and Reimbursement. , https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-chile/, Sat Feb 22 2020
Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America, https://www.springer.com/home?SGWID=0-0-1003-00&aqId=4104966&download=1&checkval=3c915e2d99720318da3b6804d5849d1b&wt_mc=Internal.Event.1.SEM.ArticleAuthorOnlineFirst&utm_source=ArticleAuthorOnlineFirst&utm_medium=email&utm_content=AA_en_06082018&ArticleAuthorOnlineFirst_20200903, Mon Sep 14 2020
Regulatory, Pricing and Reimbursement. , https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-chile/, Sat Feb 22 2020
Sanitary Registration of Orphan Medicines
MODIFICA DECRETO Nº 3, DE 2010, QUE APRUEBA EL REGLAMENTO DEL SISTEMA NACIONAL DE CONTROL DE LOS PRODUCTOS FARMACÉUTICOS DE USO HUMANO , https://www.ispch.gob.cl/sites/default/files/modificacion_decreto3_isologo.pdf, Tue Oct 21 2025
Chile: Sanitary registration process for pharmaceutical products, https://www.productcomplianceinstitute.com/2020/09/10/chile-sanitary-registration-process-for-pharmaceutical-products/, Tue Oct 21 2025
Decree 54 Abbrv Reliance
MINISTERIO DE SALUD. Subsecretaría de Salud Pública. MODIFICA DECRETO Nº 3, DE 2010, DEL MINISTERIO DE SALUD, QUE APRUEBA REGLAMENTO DEL SISTEMA NACIONAL DE CONTROL DE LOS PRODUCTOS FARMACÉUTICOS DE USO HUMANO. , ,
Implementacion Decreto No 54 - Agencia Nacional de Medicamentos (Instituto de Salud Publica, Ministerio de Salud, Gobierno de Chile), https://www.ispch.gob.cl/sites/default/files/Taller%20implementaci%C3%B3n%20dto%2054%2014-9-2020%20(1).pdf, Thu Aug 31 2023
Respuestas a Preguntas de Participantes Realizados Durante Taller Decreto 54 - Instituto de Salud Publica, Ministerio de Salud, Gobierno de Chile, https://www.ispch.cl/sites/default/files/DocumentoDecreto54-29102020A.pdf, Thu Aug 31 2023
Conditional Approvals for New Drugs
ICON. Spotlight on regulatory reforms in China., https://www.iconplc.com/insights/regulatory/spotlight-on-regulatory-reforms-in-china/?creative=579175791014&keyword=china%20clinical%20trials%20regulations&matchtype=b&network=g&device=c&campaignid=16056730309&adgroupid=132415466763&feeditemid=&adposition=&gclid=Cj0KCQjwyMiTBhDKARIsAAJ-9VtN4nkO2dUAP7MsjOE2AfxM8eq_qptvF1G7AePBzQ-_Zd24hrFhpZMaAgvZEALw_wcB, Mon May 09 2022
Chinese Expedited Program Introduction. Yuanyuan (Irene) Diao, Senior Manager, Regulatory Affairs, Beigene., ,
Notice on the implementation of pre-acceptance services for innovative drugs and varieties that can be included in the priority review and approval procedures and conditional approval procedures after communication and exchange., https://www.cde.org.cn/main/news/viewInfoCommon/9eba0fc4a6b7a2fcea0a0922dcbb9426, Sat Jan 25 2025
State Council of the People’s Republic of China, Opinions on Deepening the Reform of the Review and Approval Processes to Encourage Innovation of Drugs and Medical Devices. 2017, https://www.gov.cn/zhengce/2017-10/08/content_5230105.htm, Fri Feb 07 2025
National Medical Products Administration, Measures for the Administration of Drug Registration. 2020. , https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html, Fri Feb 07 2025
National Medical Products Administration, Review and Approval Procedures for Conditional Approval of Drugs (Trial). 2020., https://www.nmpa.gov.cn/, Fri Feb 07 2025
National Medical Products Administration, Advisory draft of the procedures for review and approval of marketing applications for conditional approval of drugs.2023. , https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20230825104212129.html, Fri Feb 07 2025
Zou L, Qi Y, Jiang Y, et al. Criteria and regulatory considerations for the conditional approval of innovative antitumor drugs in China: from the perspective of clinical reviewers. Cancer Commun (Lond). 2023;43(2):171-176., https://pmc.ncbi.nlm.nih.gov/articles/PMC9926957/#:~:text=To%20make%20the%20process%20and%20standard%20of%20technical,Center%20for%20Drug%20Evaluation%20%28CDE%29%20with%20antitumor%20i, Fri Feb 07 2025
Impact of accelerated review policy on portfolio planning of vaccine companies, https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1339141, Sat Feb 22 2025
Prioritized Drug Review and Approval Pathway
How Is China’s Drug Approval Agency Outpacing International Counterparts? It’s Complicated., https://www.mercatus.org/bridge/commentary/how-chinas-drug-approval-agency-outpacing-international-counterparts, Mon Oct 26 2020
Provisions for Drug Registration (SFDA Order No. 28)., http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390595.htm, Mon Oct 26 2020
Fostering China Pharmaceutical Innovation System Series Report 4: Promoting Simultaneous R&D, Registration and Review of Innovative Drugs., http://enadmin.rdpac.org/upload/upload_file/1648213047.pdf, Mon Sep 05 2022
Impact of accelerated review policy on portfolio planning of vaccine companies, https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1339141, Sat Feb 22 2025
Breakthrough Therapy Designation (BTD)
Pharmaceutical Technology. (2021). New Chinese Breakthrough Therapy designation attracts foreign companies., https://www.pharmaceutical-technology.com/comment/china-breakthrough-therapy-designation/, Mon May 09 2022
Tigermed Insight. What’s New for Getting Breakthrough Therapy Designation for Drugs in China？, https://www.tigermed.net/whats-new-for-getting-breakthrough-therapy-designation-for-drugs-in-china/, Mon May 09 2022
ICON. Spotlight on regulatory reforms in China., https://www.iconplc.com/insights/regulatory/spotlight-on-regulatory-reforms-in-china/?creative=579175791014&keyword=china%20clinical%20trials%20regulations&matchtype=b&network=g&device=c&campaignid=16056730309&adgroupid=132415466763&feeditemid=&adposition=&gclid=Cj0KCQjwyMiTBhDKARIsAAJ-9VtN4nkO2dUAP7MsjOE2AfxM8eq_qptvF1G7AePBzQ-_Zd24hrFhpZMaAgvZEALw_wcB, Mon May 09 2022
Impact of accelerated review policy on portfolio planning of vaccine companies, https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1339141, Sat Feb 22 2025
The Special Approval Pathway (SAP) for COVID-19 related products
Parexel International. The Special Approval Pathway (SAP) for COVID-19 related products in China., https://www.parexel.com/news-events-resources/blog/special-approval-pathway-sap-covid-19-related-products-china, Mon May 09 2022
ICON. Spotlight on regulatory reforms in China., https://www.iconplc.com/insights/regulatory/spotlight-on-regulatory-reforms-in-china/?creative=579175791014&keyword=china%20clinical%20trials%20regulations&matchtype=b&network=g&device=c&campaignid=16056730309&adgroupid=132415466763&feeditemid=&adposition=&gclid=Cj0KCQjwyMiTBhDKARIsAAJ-9VtN4nkO2dUAP7MsjOE2AfxM8eq_qptvF1G7AePBzQ-_Zd24hrFhpZMaAgvZEALw_wcB, Mon May 09 2022
Chinese Expedited Program Introduction. Yuanyuan (Irene) Diao, Senior Manager, Regulatory Affairs, Beigene. June 2022. | DIA., ,
Priority Review
ICON. Spotlight on regulatory reforms in China., https://www.iconplc.com/insights/regulatory/spotlight-on-regulatory-reforms-in-china/?creative=579175791014&keyword=china%20clinical%20trials%20regulations&matchtype=b&network=g&device=c&campaignid=16056730309&adgroupid=132415466763&feeditemid=&adposition=&gclid=Cj0KCQjwyMiTBhDKARIsAAJ-9VtN4nkO2dUAP7MsjOE2AfxM8eq_qptvF1G7AePBzQ-_Zd24hrFhpZMaAgvZEALw_wcB, Mon May 09 2022
Chinese Expedited Program Introduction. Yuanyuan (Irene) Diao, Senior Manager, Regulatory Affairs, Beigene. June 2022. | DIA., ,
Notice on the implementation of pre-acceptance services for innovative drugs and varieties that can be included in the priority review and approval procedures and conditional approval procedures after communication and exchange., https://www.cde.org.cn/main/news/viewInfoCommon/9eba0fc4a6b7a2fcea0a0922dcbb9426, Sat Jan 25 2025
Impact of accelerated review policy on portfolio planning of vaccine companies, https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1339141, Sat Feb 22 2025
INVIMA Abbreviated Procedure (Article 27)
Regulatory, Pricing and Reimbursement., https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-colombia/, Sat Feb 22 2020
Regulatory Systems Strengthening in the Americas., https://iris.paho.org/bitstream/handle/10665.2/53793/9789275123447_eng.pdf?sequence=5, Thu Aug 31 2023
Durán CE, Cañás M, Urtasun MA, Elseviers M, Andia T, Vander Stichele R, et al. Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries. Rev Panam Salud Publica. 2021;45:e10. https://doi.org/10.26633/ RPSP.2021.10, https://iris.paho.org/handle/10665.2/53563, Sun Jun 23 2024
Decree 677 of 1995 - Which partially regulates the Registration and Licensing Regime, Quality Control, as well as the Sanitary Surveillance Regime for Medicines, Cosmetics, Pharmaceutical Preparations based on Natural Resources, Cleaning, Hygiene and Cleaning Products and other products for domestic use and other provisions on the subject., https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=9751, Sun Jun 23 2024
INVIMA Exceptional Circumstances (Decree 481)
INVIMA Requirements for Registration of a Pharmaceutical Drug in Colombia. , https://www.bioaccessla.com/invima-requirements-for-registration-of-drugs-in-colombia, Sat Feb 22 2020
Regulatory, Pricing and Reimbursement., https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-colombia/, Sat Feb 22 2020
Life Sciences: product regulation and liability in Colombia., https://www.lexology.com/library/detail.aspx?g=0f52bfa1-a19a-4565-aecc-ac00ae143f82, Sat Feb 22 2020
Pharma & Medical Device Regulation., https://gettingthedealthrough.com/area/119/jurisdiction/8/pharma-medical-device-regulation-colombia/, Sat Feb 22 2020
Emergency Use Authorization (ASUE)
INVIMA, https://www.invima.gov.co/autorizacion-sanitaria-de-uso-de-emergencia-asue,
reglamento técnico de emergencia para el trámite de Autorización Sanitaria de Uso de Emergencia - ASUE, https://www.minsalud.gov.co/Normatividad_Nuevo/Decreto%20No.%201651%20de%202022.pdf, Mon May 20 2024
la vigencia del Decreto 1787 de 2020 que establece las condiciones sanitarias para el trámite y otorgamiento de la Autorización Sanitaria de Uso de Emergencia - ASUE para medicamentos de síntesis química y biológicos destinados al diagnóstico, la prevención y tratamiento de la COVID - 19, https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=174727, Mon May 20 2024
Procedure for Pharmacological and Pharmaceutical Evaluations of Biological Drugs in the Sanitary Registration Process (Decreee 1782 de 2014)
Procedure for Pharmacological and Pharmaceutical Evaluations of Biological Drugs in the Sanitary Registration Process (Decreee 1782 de 2014), https://www.invima.gov.co/sites/default/files/medicamentos-y-productos-biologicos/tecnico-medicamentos-2/Decreto_1782_de_2014.pdf, Sun Jun 23 2024
Decree 677 of 1995 - Which partially regulates the Registration and Licensing Regime, Quality Control, as well as the Sanitary Surveillance Regime for Medicines, Cosmetics, Pharmaceutical Preparations based on Natural Resources, Cleaning, Hygiene and Cleaning Products and other products for domestic use and other provisions on the subject., https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=9751, Sun Jun 23 2024
Padua, A., Partika, L., Bonamici, D. et al. Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America. J Public Health Pol 41, 481–495 (2020)., https://doi.org/10.1057/s41271-020-00245-y, Sun Jun 23 2024
Durán CE, Cañás M, Urtasun MA, Elseviers M, Andia T, Vander Stichele R, et al. Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries. Rev Panam Salud Publica. 2021;45:e10. https://doi.org/10.26633/ RPSP.2021.10, https://iris.paho.org/handle/10665.2/53563, Sun Jun 23 2024
Mutual Recognition of Sanitary Registration of Medicines for Human Use
Registration of Generic Drugs in Central America and Mexico., http://www.ijpacr.com/files/21-07-2017/29.pdf, Sun Mar 22 2020
Resolution No. 333-2013 (COMIECO-LXVI) of 12/12/2013 and annexes: Reg.RTCA 11.03.59:11 Pharmaceutical Products, Medicines for Human Use. Req. Sanitary Regulations annex 1. Procedure for Mutual Recognition of Sanitary Regulations medicines annex 2 N° 38414-COMEX-MEIC- S, http://www.pgrweb.go.cr/scij/Busqueda/Normativa/Normas/nrm_texto_completo.aspx?nValor1=1&nValor2=77461, Sat Jun 22 2024
Recognition of the evaluation and approval of final reports of reference regulatory authorities (Exec. Decree 39433-S)
Medication Registration., https://www.ministeriodesalud.go.cr/index.php/tramites/empresas/34-tramites/registros-2/160-registro-de-medicamentos, Sat Jun 22 2024
Health expands the list of Regulatory Reference Authorities to speed up evaluation for the registration of Medicines., https://www.ministeriodesalud.go.cr/index.php/prensa/60-noticias-2023/1743-salud-amplia-el-listado-de-autoridades-reguladoras-de-referencia-para-agilizar-evaluacion-para-registro-de-medicamentos, Sat Jun 22 2024
Recognition of the Evaluation and Approval of final reports of Clinical and Non-Clinical Studies by the Regulatory Authorities of reference as evidence for the Sanitary Registration of Medicines number 39433-S, http://www.pgrweb.go.cr/scij/Busqueda/Normativa/Normas/nrm_texto_completo.aspx?nValor1=1&nValor2=81006, Sat Jun 22 2024
List of Reference Regulatory Authorities., https://www.ministeriodesalud.go.cr/index.php/biblioteca-de-archivos-left/documentos-ministerio-de-salud/ministerio-de-salud/tramites-1/empresariales/registro-de-medicamentos/7176-ms-drpis-9043-2023-listado-de-autoridades-reguladoras-de-referencia-a-las-que-se-les-aplicara-el-reconocimiento-de-la-evaluacion-y-aprobacion-de-informes-finales-de-estudios-clinicos-y-no-clinicos-del-decreto-ejecutivo-no-39433-s-publicada-en-el-alcance-n/file, Sat Jun 22 2024
Conditional Marketing Authorization
Danay Mora Pascual. Regulatory functions for products to be introduced in Cuba., https://mediafra.admiralcloud.com/customer_609/067a4574-fd34-4c15-bc81-ec0918766e84?response-content-disposition=inline%3B%20filename%3D%22PPT%20CECMED%20%20German%20Forum%2014042021.pdf%22&Expires=1729339679&Key-Pair-Id=K3XAA2YI8CUDC&Signature=mGpssEcXvTRPtztES1QTu8q9kNCQ~z~Bo7OF1snn9gxCQpt3Ew2vkezKFUJgLeSqdPaYv3oC2Jnr2UznY5uxzNrxVNyy50hk-iN68IKizrUyLMjx4YbTWNF2CsD8EN9dyhb043yuYSoead4uKu0TE0~fmpV5wzlARiAJHTMIM2cCYx62QU~t2Wkt60vxsJoP7Q1au1YUmg~Q~GCax~pwFCMf60Ev3i2XjCBIpeacpsRCY71TiHbSouOakigcuNnwSpAkvWhFOpbjZSpeU721TH667~rVUqI6TOIamo4eSNokGQDWDcWKj3mVsBdLK8xavYnazTL0zstXewq9-1y4cg__, Sat Oct 19 2024
Sign of the Times: Updating CPP Practices around the Globe Experiences in Egypt, Hong Kong, and Cuba., https://globalforum.diaglobal.org/issue/october-2024/sign-of-the-times-updating-cpp-practices-around-the-globe/, Sat Oct 19 2024
REQUISITOS PARA EL REGISTRO SANITARIO CONDICIONAL DE MEDICAMENTOS DE USO HUMANO., https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/Reg_55-11.pdf , Tue Oct 21 2025
Simplified Procedure
Establishing Criteria for the Application of the Sanitary Registry through a Simplified Procedure and the Recognition of Certificates of Free Sale and Certificates of Good Practices of Establishments Issued by the Regional Reference Regulatory Authorities (rRNA) of the Parf/PAHO Network, dated January 27, 2016, https://www.msp.gob.do/web/Transparencia/documentos_oai/1404/2016/3206/resolucion-no-000004-2016.pdf, Sat Jun 22 2024
Durán CE, Cañás M, Urtasun MA, Elseviers M, Andia T, Vander Stichele R, et al. Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries. Rev Panam Salud Publica. 2021;45:e10. https://doi.org/10.26633/ RPSP.2021.10, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8040933/, Sat Jun 22 2024
Padua, A., Partika, L., Bonamici, D. et al. Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America. J Public Health Pol 41, 481–495 (2020)., https://rdcu.be/dLBbi, Sat Jun 22 2024
EEU Mutual Recognition Procedure
REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION. , https://www.regulatorypharmanet.com/eaeu/, Tue Feb 04 2020
Registration of medicines in the Eurasian Economic Union., https://gratanet.com/publications/registration-of-medicines-in-the-eurasian-economic-union, Tue Feb 04 2020
In the EAEU, a common medicines market is launched., http://www.eurasiancommission.org/en/nae/news/Pages/5-05-2017.aspx, Tue Feb 04 2020
Drug Registration in the Eurasian Economic Union (EAEU), https://www.biomapas.com/drug-registration-in-the-eurasian-economic-union-eaeu/, Thu May 04 2023
Keerthana, C., Sharma, S. Navigating the Evolving Eurasian Economic Union’s Pharmaceutical Landscape: Streamlining Drug Registration for Market Access. Ther Innov Regul Sci 59, 693–706 (2025). https://doi.org/10.1007/s43441-025-00782-2, https://link.springer.com/article/10.1007/s43441-025-00782-2, Sat Jul 05 2025
EEU Decentralized Procedure
REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION., https://www.regulatorypharmanet.com/eaeu/, Tue Feb 04 2020
Registration of medicines in the Eurasian Economic Union. , https://gratanet.com/publications/registration-of-medicines-in-the-eurasian-economic-union, Tue Feb 04 2020
In the EAEU, a common medicines market is launched., http://www.eurasiancommission.org/en/nae/news/Pages/5-05-2017.aspx, Tue Feb 04 2020
Keerthana, C., Sharma, S. Navigating the Evolving Eurasian Economic Union’s Pharmaceutical Landscape: Streamlining Drug Registration for Market Access. Ther Innov Regul Sci 59, 693–706 (2025). https://doi.org/10.1007/s43441-025-00782-2, https://link.springer.com/article/10.1007/s43441-025-00782-2, Sat Jul 05 2025
EU-M4all (formerly Article 58) - Standard Procedure
Medicines for Use Outside the European Union, https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/medicines-use-outside-european-union#applying-in-parallel-with-an-eu-marketing-authorisation-application-(new)-section,
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95. , https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Fees payable to the European Medicines Agency., https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Mon Jan 13 2025
PRIME (PRIority MEdicines)
Kondo H et al: The current status of Sakigake designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States., ,
Deuchar GA et al: Real world experience of PRIME and PIM applications. Reg Rapporteur 2017, https://www.topra.org/TOPRA_Member/TOPRA/TOPRA_Member/REGRAP/Public/Regulatory_Rapporteur_Issue_Summary.aspx?DocumentKey=5392F3E4-5594-4BCE-9CA2-07A6B0EA34DF,
Maurice Bancsi. A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP. RF Quarterly. Volume 2, Number 2. June 2022, ,
Fees payable to the European Medicines Agency., https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Mon Jan 13 2025
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95. , https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
EMA Accelerated Assessment
Pre-authorization guidance., https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance, Sat May 30 2020
Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004., https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-application-practical-arrangements-necessary-implement-procedure-accelerated/2004_en.pdf, Sat May 30 2020
Fees payable to the European Medicines Agency. , https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
EMA Adaptive Pathways
Guidance for companies considering the adaptive pathways approach., https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-companies-considering-adaptive-pathways-approach_en.pdf, Sun May 31 2020
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
Fees payable to the European Medicines Agency., https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Mon Jan 13 2025
EMA Advanced Therapy Medicinal Products
Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007., https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-evaluation-advanced-therapy-medicinal-product-accordance-article-8-regulation-ec/2007_en.pdf, Sat May 30 2020
Support for advanced therapy developers., https://www.ema.europa.eu/en/human-regulatory/research-development/advanced-therapies/support-advanced-therapy-developers, Sat May 30 2020
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Fees payable to the European Medicines Agency., https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Mon Jan 13 2025
EMA Marketing Authorisation under Exceptional Circumstances
Pre-authorisation guidance., https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance, Sat May 30 2020
GUIDELINE ON PROCEDURES FOR THE GRANTING OF A MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES, PURSUANT TO ARTICLE 14 (8) OF REGULATION (EC) NO 726/2004., https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-procedures-granting-marketing-authorisation-under-exceptional-circumstances-pursuant/2004_en.pdf, Sat May 30 2020
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
EMA Conditional Marketing Authorisation
Fees payable to the European Medicines Agency., https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Mon Jan 13 2025
Guideline on the scientific application and the practical arrangements necessary to implement Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No , https://www.ema.europa.eu/en/guideline-scientific-application-practical-arrangements-necessary-implement-regulation-ec-no-5072006, Sat May 30 2020
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
Opening procedures at EMA to non-EU authorities (OPEN) initiative
EMA COVID-19 assessments ‘OPEN’ to non-EU regulators., https://www.ema.europa.eu/en/news/ema-covid-19-assessments-open-non-eu-regulators#:~:text=EMA%20is%20piloting%20a%20new,pilot%20started%20in%20December%202020, Tue Mar 22 2022
Questions and Answers on the 'OPEN' Framework, https://www.ema.europa.eu/en/documents/other/questions-answers-open-framework_en.pdf, Thu Feb 06 2025
EMA’s governance during COVID-19 pandemic., https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/emas-governance-during-covid-19-pandemic#working-with-eu-and-international-partners-section, Tue Mar 22 2022
Opening procedures at EMA to non-EU authorities (OPEN) initiative, https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/opening-procedures-ema-non-eu-authorities-open-initiative, Wed Oct 04 2023
Questions and Answers on the 'OPEN' Framework Opening our Procedures at EMA to Non-EU authorities (Published 3 Jul 2023), https://www.ema.europa.eu/en/documents/other/questions-answers-open-framework_.pdf, Wed Oct 04 2023
OPEN Pilot: One-year review and recommendations (Published 17 Mar 2022), https://www.ema.europa.eu/en/documents/report/open-pilot-one-year-review-recommendations_en.pdf, Wed Oct 04 2023
Fees payable to the European Medicines Agency., https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Mon Jan 13 2025
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines
European Medicines Agency (EMA). EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines. EMA/638455/2022., https://www.ema.europa.eu/en/documents/other/ema-initiatives-acceleration-development-support-evaluation-procedures-covid-19-treatments-vaccines_en.pdf, Sat Nov 12 2022
Conditional marketing authorisation, https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation#use-during-covid-19-pandemic-section, Mon May 13 2024
COVID-19 vaccines: development, evaluation, approval and monitoring, https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-vaccines-development-evaluation-approval-and-monitoring#accelerated-evaluation, Mon May 13 2024
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Fees payable to the European Medicines Agency., https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Mon Jan 13 2025
EU-M4all (formerly Article 58) - Accelerated Assessment
Support for applications on Article 58, https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/support-applications-article-58_en.pdf, Sun Oct 15 2023
Fees payable to the European Medicines Agency, https://www.ema.europa.eu/en/human-regulatory/overview/fees-payable-european-medicines-agency, Mon Jan 13 2025
Advanced therapies Accelerated assessment Biosimilars Compliance Clinical data publication Conditional marketing authorisation Data on medicines (ISO IDMP standards) Evaluation of medicines, step-by-step Generic medicines Guidance documents Obtaining an EU marketing authorisation, step-by-step Orphan medicines Medicines for use outside EU (EU-M4all) Obtaining and maintaining an opinion Paediatric medicines Pharmacovigilance Pre-authorisation guidance Product information Submission dates Templates for assessors Medicines for use outside the European Union, https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/medicines-use-outside-european-union, Sun Oct 15 2023
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
EU-M4all (formerly Article 58) - Conditional Article 58 scientific opinion
Support for applications on Article 58, https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/support-applications-article-58_en.pdf, Sun Oct 15 2023
Fees payable to the European Medicines Agency , https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Sun Oct 15 2023
Medicines for use outside the European Union , https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/medicines-use-outside-european-union, Sun Oct 15 2023
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
EU-M4all (formerly Article 58) - Article 58 scientific opinion under exceptional circumstances
Medicines for use outside the European Union , https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/medicines-use-outside-european-union, Sun Oct 15 2023
Fees payable to the European Medicines Agency , https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency, Mon Jan 13 2025
Support for applications on Article 58, https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/support-applications-article-58_en.pdf, Sun Oct 15 2023
Document 32024R0568. Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95., https://eur-lex.europa.eu/eli/reg/2024/568/oj#tit_1, Mon Jan 13 2025
Annex IV to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_IV, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568., https://eur-lex.europa.eu/eli/reg/2024/568/oj#anx_I, Mon Jan 13 2025
Annex I to Regulation (EU) 2024/568 Questions & Answers (Q&As). EMA/528763/2024. , https://www.ema.europa.eu/en/documents/other/new-fee-regulation-annex-i-general-questions-answers-human-medicinal-products_en.pdf, Mon Jan 13 2025
Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency applicable from 1 January 2025. EMA/MB/183645/2024., https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf, Mon Jan 13 2025
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products, https://www.fda.gov/drugs/generic-drugs/fda-ema-parallel-scientific-advice-pilot-program-complex-generichybrid-products, Mon Mar 11 2024
PILOT PROGRAM: EMA-FDA PARALLEL SCIENTIFIC ADVICE FOR HYBRID/COMPLEX GENERIC PRODUCTS - GENERAL PRINCIPLES, https://www.fda.gov/media/152085/download?attachment, Mon Mar 11 2024
CDER’s OGD and EMA’s Parallel Scientific Advice Pilot Program for Complex Generics Works to Increase Harmonization and Bring Generic Drugs to Patients, https://www.fda.gov/drugs/our-perspective/cders-ogd-and-emas-parallel-scientific-advice-pilot-program-complex-generics-works-increase, Mon Mar 11 2024
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products. SBIA 2023—Advancing Generic Drug Development: Translating Science to Approval. Day 2, Session VIII: Global Collaboration to Support Efficient Generic Product Development & Regulatory Assessment., https://www.fda.gov/media/173402/download?attachment, Mon Mar 11 2024
EAC Medicines Regulatory Harmonization Program
Compendium of Medicines Evaluation and Registration for Medicine Regulation Harmonization in The East African Community, https://web.pharmacyboardkenya.org/download/compendium-of-medicines-evaluation-and-registration-for-medicine-regulation-harmonization-in-the-east-african-community/, Thu Dec 16 2021
EAC Medicines Regulatory Guidelines, https://www.eac.int/medicines-regulatory-guidelines, Thu Apr 27 2023
Joint assessments of applications for marketing authorization in the CEMAC zone
OCEAC. Joint evaluation: dossier new HPPN framework., https://www.oceac.org/evaluation-conjointe-dossier-nouveau-cadre-hppn/, Wed Nov 20 2024
ECCAS-MRH REC Project., https://amrh.nepad.org/amrh-recs/eccas-mrh-rec-project, Wed Nov 20 2024
Health Drug Registration for Homologation
Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America. Ana Padua, Livia Partika, Denise Bonamici. Journal of Public Health Policy, https://doi.org/10.1057/s41271-020-00245-y, Mon Sep 14 2020
REGLAMENTO SUSTITUTIVO DE REGISTRO SANITARIO PARA MEDICAMENTOS EN GENERAL., https://www.controlsanitario.gob.ec/wp-content/uploads/downloads/2014/08/A-0586-Reglamento-sustitutivo-de-registro-sanitario-para-medicamentos-en-general.pdf, Sun Jun 23 2024
Fast track procedure
Draft for the ministerial decree for the new registration process for human pharmaceutical products., http://www.eda.mohp.gov.eg/Files/86_website_draft3.pdf, Wed Nov 13 2019
Biologicals: Fast Track Guidelines., http://www.eda.mohp.gov.eg/images/News/F_39.pdf, Wed Nov 13 2019
Fast Track Announcement., http://www.eda.mohp.gov.eg/images/News/F_138.pdf, Wed Nov 13 2019
Ministerial Decree 425/2015 Registration of Human Pharmaceuticals, http://www.eda.mohp.gov.eg/Files/766_425_2015.pdf, Wed Nov 13 2019
Human Drug Registration, http://www.eda.mohp.gov.eg/Files/190_HumanRegWFlow.gif, Wed Nov 13 2019
Technical Committee Decisions for 2013., http://www.eda.mohp.gov.eg/Files/197_MinisterDec296.pdf, Wed Nov 13 2019
Technical Committee Decisions for 2013., http://www.eda.mohp.gov.eg/Files/154_Technical_Committee_Decisions_2013.pdf, Wed Nov 13 2019
EDA. GUIDELINES ON Reliance Practices During Registration of Medicinal Products. Year 2023. Version No: 3. Issue Date: 10-7-2023. Effective Date: 10-7-2023., https://www.edaegypt.gov.eg/media/d0gdk0uy/final-grelp-guideline-version-3.pdf, Thu Jan 18 2024
Guideline on Dossier Requirements of Human Pharmaceutical Products for Registration & Re-registration - Year 2023. Version 3.0 , https://www.edaegypt.gov.eg/media/ef3pm2sj/guideline-on-dossier-requirement-of-human-pharmaceutical-product_2.pdf, Sat Oct 19 2024
EDA. Workflow For Marketing Authorization Process - Year 2024. Version 1.0, https://edaegypt.gov.eg/media/q40bqwb5/notice-to-applicant-workflow-for-marketing-authorization-process.pdf, Mon Sep 08 2025
Biological Products Reliance Pathway (decree 343/2021)
Guidance to Applicants Submitting Marketing Authorization File for Biological Products Second Edition January - 2020, https://www.edaegypt.gov.eg/media/bkhdebl3/guidance-to-applicant-2nd-edition_biologicals-registra.pdf, Fri Nov 10 2023
Expediting access through Reliance Pathways: MENA region, https://www.biomapas.com/expediting-access-through-reliance-pathways-mena-region/, Fri Nov 10 2023
The Regulatory Reliance Review Model: Adoption in the Middle East, https://globalforum.diaglobal.org/issue/july-2019/the-regulatory-reliance-review-model-adoption-in-the-middle-east/, Fri Nov 10 2023
Flowcharts for Ministerial Decrees 425 for the year 2015, 645 for the year 2018, 820 for the year 2016, https://edaegypt.gov.eg/media/pyxhu3sk/flowcharts-for-ministerial-decrees-425-2015-_hdr-bioequivalence-e.pdf, Fri Nov 10 2023
Guideline On Reliance Practices for Pharmacovigilance in Egypt Year 2023, https://www.edaegypt.gov.eg/media/cajhz4s4/guideline-on-reliance.pdf, Fri Nov 10 2023
EDA. GUIDELINES ON Reliance Practices During Registration of Medicinal Products. Year 2023. Version No: 3. Issue Date: 10-7-2023. Effective Date: 10-7-2023., https://www.edaegypt.gov.eg/media/d0gdk0uy/final-grelp-guideline-version-3.pdf, Thu Jan 18 2024
Guideline on the regulation of Post-approval changes to a registered Biotherapeutic products in Egypt 2023. Code: EDREX.GL.Bioinn.008. Version No: 1.0. Issue date: 17/12/2023. Effective date: 01/01/2024., https://www.edaegypt.gov.eg/media/n4rjpc4y/guideline-on-the-regulation-of-post-approval-changes-to-a-registered-bio-therapeutic-products.pdf, Thu Jan 18 2024
Guideline for Content File of Biological Products for Registration & Re-registration File 2023, Version 3.0, 01-Jan-2023., https://www.edaegypt.gov.eg/media/c4whpzcw/registration-guidline-final-bio-tech-edaegypt-go-2845.pdf, Thu Jan 18 2024
Guideline for Registration of Biosimilar Products in Egypt 2023. Version No: 4.0. Issue Date: 11/9/2023. Effective date: 11/9/2023. Code: EDREX.GL.Bioinn.005., https://www.edaegypt.gov.eg/media/aztbeg2m/guideline-for-registration-of-biosimilar-products-in-egypt-version-4.pdf, Thu Jan 18 2024
Decree of the President of the Egyptian Drug Authority No. (343) of 2021 Concerning Issuing the Rules of Biological Products’ Registration Promulgating., https://www.edaegypt.gov.eg/media/tspglowd/minister-decree-no-343.pdf, Tue Jun 18 2024
Procedures for Registration of Biological products through Reliance pathways. 2022, https://www.edaegypt.gov.eg/media/a0ufl0eb/english-version-3_bio-tech-edaegypt-go.pdf, Wed Jun 19 2024
Guideline on Dossier Requirements of Human Pharmaceutical Products for Registration & Re-registration - Year 2023. Version 3.0 , https://www.edaegypt.gov.eg/media/ef3pm2sj/guideline-on-dossier-requirement-of-human-pharmaceutical-product_2.pdf, Sat Oct 19 2024
Emergency Use Application & Approval (EUA) - Medicinal Products
EDA. GUIDELINES ON Emergency Use Approval 2023. Code: EDREX: GL.BIOINN/CAPP.001. Version No: 4. Issue Date: 16/4/2023. Effective date: 16/4/2023., https://www.edaegypt.gov.eg/media/vv5n1w32/guidelines-on-emergency-use-approval-2023.pdf, Fri Jan 19 2024
EDA. GUIDELINES ON Reliance Practices During Registration of Medicinal Products. Year 2023. Version No: 3. Issue Date: 10-7-2023. Effective Date: 10-7-2023., https://www.edaegypt.gov.eg/media/d0gdk0uy/final-grelp-guideline-version-3.pdf, Fri Jan 19 2024
Guideline on Dossier Requirements of Human Pharmaceutical Products for Registration & Re-registration - Year 2023. Version 3.0 , https://www.edaegypt.gov.eg/media/ef3pm2sj/guideline-on-dossier-requirement-of-human-pharmaceutical-product_2.pdf, Sat Oct 19 2024
Emergency Use Application & Approval (EUA) - Biological Products
EDA. GUIDELINES ON Emergency Use Approval 2023. Code: EDREX: GL.BIOINN/CAPP.001. Version No: 4. Issue Date: 16/4/2023. Effective date: 16/4/2023., https://www.edaegypt.gov.eg/media/vv5n1w32/guidelines-on-emergency-use-approval-2023.pdf, Fri Jan 19 2024
EDA. GUIDELINES ON Reliance Practices During Registration of Medicinal Products. Year 2023. Version No: 3. Issue Date: 10-7-2023. Effective Date: 10-7-2023., https://www.edaegypt.gov.eg/media/d0gdk0uy/final-grelp-guideline-version-3.pdf, Fri Jan 19 2024
Guideline on Dossier Requirements of Human Pharmaceutical Products for Registration & Re-registration - Year 2023. Version 3.0 , https://www.edaegypt.gov.eg/media/ef3pm2sj/guideline-on-dossier-requirement-of-human-pharmaceutical-product_2.pdf, Sat Oct 19 2024
EDA. List of EDA Reference Countries. Year 2024. Code: EDREX: NP. CAPP.089. Version No: 1. Issue Date: 8/2024., https://edaegypt.gov.eg/media/cvjcvgaw/notice-to-applicant-list-of-eda-reference-countries-2024.pdf, Mon Sep 08 2025
Reliance pathway for post-approval changes to a registered biotherapeutic product
Guideline on the regulation of post-approval changes to a registered Biotherapeutic product in Egypt Code: EDREX.GL.Bioinn.008 Version/year: 1/2023, https://www.edaegypt.gov.eg/media/n4rjpc4y/guideline-on-the-regulation-of-post-approval-changes-to-a-registered-bio-therapeutic-products.pdf, Fri Aug 09 2024
GUIDELINE ON Reliance Practices During Registration of Medicinal Products Code: EDREX:GL.CAPP.025 Version /year: V3/2023, https://www.edaegypt.gov.eg/media/sy1bzptp/guidelines-on-reliance-practices-during-registration-of-medicinal-products-version-03.pdf, Fri Aug 09 2024
GUIDELINES ON Reliance Practices During Registration of Medicinal Products., https://www.edaegypt.gov.eg/media/d0gdk0uy/final-grelp-guideline-version-3.pdf, Fri Aug 09 2024
Guideline on Dossier Requirements of Human Pharmaceutical Products for Registration & Re-registration - Year 2023. Version 3.0 , https://www.edaegypt.gov.eg/media/ef3pm2sj/guideline-on-dossier-requirement-of-human-pharmaceutical-product_2.pdf, Sat Oct 19 2024
EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)
Concept Note of EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)., https://www.sahpra.org.za/wp-content/uploads/2024/10/WSI_Concept-Note_JTWG-Approved-NEW.pdf, Mon Oct 28 2024
Annex I: Application Form for EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)., https://www.sahpra.org.za/wp-content/uploads/2024/10/WSI_Annex-I_Application-Form_JTWG-Approved-NEW.pdf, Mon Oct 28 2024
Annex II - Operating Procedures of EDA SAHPRA Work Sharing Initiative (WSI) in Registration of Medical products (Pilot Phase)., https://www.sahpra.org.za/wp-content/uploads/2024/10/WSI_Annex-II_Operating-Procedures_JTWG-Approved-NEW.pdf, Mon Oct 28 2024
Lot Release of Biological Products in Egypt
Guideline for Lot Release of Biological Products in Egypt 2022. Version No: 1.0. Issue Date: 20/7/2022., https://www.edaegypt.gov.eg/media/vkzpwnjl/lot-release-guidline_1.pdf, Wed Nov 20 2024
Special Regulations for the Recognition of Foreign Health Registrations.
GENERAL REGULATION OF THE MEDICINES ACT., https://www.medicamentos.gob.sv/index.php/es/normativa-m/reglamentosdnm-m/reglamento-ley-de-medicamentos, Sun Mar 22 2020
SPECIAL REGULATIONS FOR THE RECOGNITION OF FOREIGN HEALTH RECORDS. Ministerio de Salud de El Salvador. Decreto n.34-Reglamento Especial para el Reconocimiento de Registros Sanitarios Extranjeros. Ministerio de Salud de El Salvador; 2013., https://elsalvador.law.pro/wp-content/uploads/2016/06/Reglamento_Especial_para_el_Reconocimiento_de_Registros_Sanitarios_Extranjeros.pdf, Sat Jun 22 2024
Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America. Ana Padua, Livia Partika, Denise Bonamici. Journal of Public Health Policy, https://doi.org/10.1057/s41271-020-00245-y, Mon Sep 14 2020
Fast track/priority registration
Fast track for locally manufactured and priority medicines
Guideline for registration of medicines 2014., http://www.fmhaca.gov.et/publication/guidelinefor-registration-of-medicines-2014/, Sun Nov 10 2019
Rate of service fees regulation #370 of 2015., http://www.fmhaca.gov.et/wpcontent/plugins/downloadattachments/includes/download.php?id=3008, Sun Nov 10 2019
Conditional Approval of Medicines
Food and Drug Authority of Ethiopia (EFDA). GUIDELINE FOR CONDITIONAL APPROVAL OF MEDICINES, January 2021., http://www.fmhaca.gov.et/wp-content/uploads/2021/01/Guideline-for-Conditional-Approval-of-Medicines.pdf, Mon May 09 2022
Food and Drug Authority of Ethiopia (EFDA). Rate of service fees regulation no 370 2015., http://www.fmhaca.gov.et/publication/rate-of-service-fees-regulation-no-370-2015/, Mon May 09 2022
Emergency Use Authorization of COVID-19 Vaccine
Food and Drug Authority of Ethiopia (EFDA). Guideline for Emergency Use Authorization of COVID-19 Vaccine. January 2021., http://www.fmhaca.gov.et/wp-content/uploads/2021/01/Guidance-for-Emergency-Use-Authorization-of-COVID-19-Vaccine.pdf, Mon May 09 2022
Registration of Low-Risk Medicines
Ethiopian Food and Drug Authority (EFDA). Guideline for Registration of Low-Risk Medicines. First Edition, June 2020., http://www.fmhaca.gov.et/wp-content/uploads/2020/10/Guideline-for-Registration-of-Low-risk-Medicines.pdf, Mon May 09 2022
Autorisation Temporaire d’Utilisation (Temporary Use Authorization)
Public Health Code. Sub-section 1: Temporary authorization of use requests (Articles R5121-68 to R5121-69). , https://www.legifrance.gouv.fr/codes/section_lc/LEGITEXT000006072665/LEGISCTA000006190666/2014-04-30/#LEGISCTA000026968493, Sat Mar 20 2021
ATU regulations., https://ansm.sante.fr/documents/reference/reglementation-relative-aux-atu, Sat Mar 20 2021
GHC Central Registration
Steps taken to streamline regulatory processes in the Middle East., https://clarivate.com/cortellis/blog/steps-taken-streamline-regulatory-processes-middle-east/, Wed Feb 19 2020
GCC Data Requirements for Human Drugs Submission. Content of the Dossier. Version 1.1., http://ghc.sa/ar-sa/Documents/التسجيل%20المركزي/مدونات%20وأدلة%20استرشادية/updated%20file/GCC%20Data%20Requirements%20for%20Human%20Drugs%20Submission%20version%201.1.pdf, Wed Feb 19 2020
Total fees for central registration and GCC., http://ghc.sa/en-us/Pages/crfees.aspx, Wed Feb 19 2020
Executive Board of the Health Ministers’ Council For GCC: Registration By-Laws of Pharmaceutical Companies and Their Products., http://ghc.sa/en-us/Documents/Central%20registration/Regulate%20and%20bylaws/Registration%20By-Laws%20of%20Pharmaceutical%20Companies%20and%20Their%20Products.pdf, Wed Feb 19 2020
Biomapas. Centralized Procedure in the GCC Region., https://www.biomapas.com/centralized-registration-procedure-gcc-region/, Thu Mar 24 2022
Hashan, H.M., Al-Muteb, S.K., Alismail, I.A. et al. Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality. Pharm Med (2022)., https://doi.org/10.1007/s40290-022-00432-0, Thu Mar 24 2022
About Central Registration, https://ghc.sa/en/central-registration/, Thu May 04 2023
Recognition of the state registration
Cratia. Registration of medicines., https://cratia.com/en/countries/gruziya/registracziya-lekarstvennyh-sredstv/, Wed May 10 2023
PWC. Pharmaceutical Product Regulation in Georgia. 2019., https://www.investingeorgia.org/en/ajax/downloadFile/1056/Pharmaceutical_product_regulation_in_Georgia.pdf, Wed May 10 2023
MKD. ADMISSION OF PHARMACEUTICAL PRODUCTS INTO THE GEORGIAN MARKET., https://www.mkd.ge/pdfLnews/special_edition.pdf, Wed May 10 2023
Alternative/non routine authorization application pathways – VERIFICATION ROUTE
Timelines for medical products registration., https://fdaghana.gov.gh/images/stories/pdfs/downloads/dr ugs%20guidelines/DER/2019/Timelines%20for%20Medicin al%20Product%20Registration.pdf, Sun Nov 10 2019
FDA Reliance Policy., https://fdaghana.gov.gh/images/stories/pdfs/Quick%20link s/Policy/FDA%20RELIANCE%20POLICY.pdf, Sun Nov 10 2019
Abridged Review
Owusu-Asante, M., Darko, D.M., Asamoah-Okyere, K.D. et al. Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities. Ther Innov Regul Sci 57, 372–385 (2023)., https://doi.org/10.1007/s43441-022-00478-x, Sat Feb 11 2023
Emergency Use Authorization (EUA) of Medical Products
FDA Fees, https://www.fdaghana.gov.gh/img/appfees.pdf, Sun Sep 24 2023
GUIDELINES FOR EMERGENCY USE AUTHORIZATION OF MEDICAL PRODUCTS Document No. :FDA/GEN/GL-EUA/2021/04, https://www.fdaghana.gov.gh/img/organisation/GUIDELINES%20FOR%20EMERGENCY%20USE%20AUTHORIZATION%20OF%20MEDICAL%20PRODUCTS%20IN%20GHANA%20(1).pdf, Sun Sep 24 2023
Procedure for the recognition of sanitary registration of medicines
Regulation for the Sanitary Control of Medicines and Related Products., https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/acuerdos?download=7%3Aag-712-99, Sun Apr 26 2020
Tariff for services provided by the departments of the General Directorate of Regulation, Surveillance and Health Control, June 8, 2006, Published in the Journal of Central America on June 19, 2006., https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/acuerdos?download=9%3Aag-297-2006, Sun Apr 26 2020
Annex 1 of resolution no. 93-2002 (COMIECO-XXIV) procedure for the mutual recognition of sanitary registration of medicines with sanitary registration prior to the entry into force of the customs union for member countries. , https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/acuerdos?download=231%3Aac-506-2002&start=20, Sun Apr 26 2020
Recognition of sanitary registration of drugs approved by regulatory agencies level IV according to the Pan American Health Organization (PAHO) as a basis for processing registration approval in Guatemala. 07-19-2018. , https://medicamentos.mspas.gob.gt/phocadownload/norma%20tecnica%20077-2018.pdf, Sat Jun 22 2024
Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America. Ana Padua, Livia Partika, Denise Bonamici. Journal of Public Health Policy., https://doi.org/10.1057/s41271-020-00245-y, Mon Sep 14 2020
Regulation for the Sanitary Control of Medicines and Related Products., https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/acuerdos?download=7%3Aag-712-99, Sun Apr 26 2020
Tariff for services provided by the departments of the General Directorate of Regulation, Surveillance and Health Control, June 8, 2006, Published in the Journal of Central America on June 19, 2006., https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/acuerdos?download=9%3Aag-297-2006, Sun Apr 26 2020
Reglamento especial para el registro sanitarios extarnjeros, https://medicamentos.mspas.gob.gt/phocadownload/norma%20tecnica%20077-2018.pdf, Tue Oct 21 2025
Mutual Recognition of Sanitary Registry of Medicines for Human Use.
Agreement No. 082-2019. Resolution Terms and Service Recovery Fees., https://arsa.gob.hn/descargas/documentos2020/Acuerdo082-2019.pdf, Sun Apr 26 2020
Mutual Recognition of Sanitary Registry of Medicines for Human Use., https://arsa.gob.hn/descargas/Reconocimiento_Mutuo_PF.pdf, Sun Apr 26 2020
Registration of Advanced Therapy Products
Regulation of Advanced Therapy Products., https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/atp_regulation.html, Sat Oct 19 2024
Guidance on Application of Certificate of Drug/Product Registration — Advanced Therapy Products. Version 3.0. , https://www.ppbhk.org.hk/eng/files/PPB_Guidance_Reg_ATP_en.pdf, Sat Oct 19 2024
Pharmacy and Poisons (Amendment) Bill 2019 to regulate advanced therapy products., https://www.info.gov.hk/gia/general/201910/18/P2019101800183.htm, Tue Oct 27 2020
1+ mechanism for approval of new drugs
"1+" mechanism for approval of new drugs to commence on November 1., https://www.info.gov.hk/gia/general/202310/26/P2023102600381.htm#:~:text=The%20%221%2B%22%20mechanism%20will%20facilitate%20the%20registration%20of,and%20allow%20patients%27%20early%20access%20to%20new%20drugs., Sat Sep 14 2024
New "1+" mechanism expedites approval of new drugs., https://www.info.gov.hk/gia/general/202312/08/P2023120800646.htm, Sat Sep 14 2024
Guidance Notes on Registration of Pharmaceutical Products/Substances. Version Nov 2022., https://www.ppbhk.org.hk/eng/files/Guidance_on_Reg_of_Pharm_Prod_Sub_en.pdf, Sat Sep 14 2024
Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity. Version July 2024., https://www.ppbhk.org.hk/eng/files/Guidance_on_Reg_of_Pharm_Prod_Containing_New_Chem_or_Bio_Entity_en.pdf, Sat Sep 14 2024
Enhancement of Evaluation Procedures for Applications for Registration of Pharmaceutical Products under “1+” Mechanism. , https://www.drugoffice.gov.hk/eps/upload/eps_news/53112/EN/1/PRC%20Letter%20to%20Trade_1+%20Enhancement_2024.03.25.pdf, Sat Sep 14 2024
Guidance Notes on Registration of Pharmaceutical Products/Substances. Version Aug 2021. , https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf.20220223, Sat Sep 14 2024
New Chemical Entity approved & marketed in other countries not approved in India.
DRAFT GUIDANCE ON APPROVAL OF CLINICAL TRIALS & NEW DRUGS. 2011. , https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI0Mw==, Sun Apr 07 2024
DCG(I) approval process for Drug Substance / Drug Product, https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/New-Drugs/Process/NDD_APPL_Organogram.pdf, Sun Apr 07 2024
The Evolving Regulatory Framework in India: Impact on the Pharmaceutical Industry (by Shagun Sharma, Vipul Kumar Gupta, and Helene Sou), https://globalforum.diaglobal.org/issue/december-2024/the-evolving-regulatory-framework-in-india-impact-on-the-pharmaceutical-industry/?utm_source=db&utm_medium=email&utm_campaign=global_forum&utm_content=PUB_GF_January_2025-01-18_nonmembers&mkt_tok=NjI3LVZKWS03ODUAAAGYGBklfa1aCqBwaGnr9Kqyqb_e18CIegUiToX5o8Q7h7sWz97cb1bBqMb7Q_sbiJQTSjphQLDaU4th_kaMoTzkEenVmwvE7a8dqfeW74Xuyw, Mon Jan 27 2025
THE NEW DRUGS AND CLINICAL TRIALS RULES, 2019., https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4OA==, Mon Jan 27 2025
COVID-19 vaccine approval in India for restricted use in emergency situation
Ministry of Health and Family Welfare. Union Health Ministry Issues Regulatory Pathways for foreign produced COVID-19 Vaccines., https://www.pib.gov.in/PressReleaseIframePage.aspx?PRID=1711979, Mon May 06 2024
Guidance for Approval COVID-19 Vaccines in India for Restricted Use in Emergency Situation which are already Approved for Restricted Use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL), 15-Apr-2021, https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzI4Mg==, Mon May 06 2024
CDSCO Guidance for Approval of COVID-19 Vaccines in India for restricted use in emergency situation., https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/notice15april21.pdf, Mon May 06 2024
X-11026/07/2020-PRO description, https://asiaactual.com/wp-content/uploads/2020/04/India-Regulatory-pathway-for-Vaccines-X-11026-07-2020-PRO.pdf, Mon May 20 2024
Mehrotra, N., Manchikanti, P. Emergency Approval Mechanisms for Human Vaccines in India. Pharm Med 38, 121–132 (2024)., https://doi.org/10.1007/s40290-023-00513-8, Mon Jan 13 2025
Policy on Vaccine Approval. , https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwNzA=, Mon Jan 27 2025
The Evolving Regulatory Framework in India: Impact on the Pharmaceutical Industry (by Shagun Sharma, Vipul Kumar Gupta, and Helene Sou), https://globalforum.diaglobal.org/issue/december-2024/the-evolving-regulatory-framework-in-india-impact-on-the-pharmaceutical-industry/?utm_source=db&utm_medium=email&utm_campaign=global_forum&utm_content=PUB_GF_January_2025-01-18_nonmembers&mkt_tok=NjI3LVZKWS03ODUAAAGYGBklfa1aCqBwaGnr9Kqyqb_e18CIegUiToX5o8Q7h7sWz97cb1bBqMb7Q_sbiJQTSjphQLDaU4th_kaMoTzkEenVmwvE7a8dqfeW74Xuyw, Mon Jan 27 2025
THE NEW DRUGS AND CLINICAL TRIALS RULES, 2019., https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4OA==, Mon Jan 27 2025
Quick and Expeditious Review Process
Mehrotra, N., Manchikanti, P. Emergency Approval Mechanisms for Human Vaccines in India. Pharm Med 38, 121–132 (2024)., https://doi.org/10.1007/s40290-023-00513-8, Mon Jan 13 2025
The Evolving Regulatory Framework in India: Impact on the Pharmaceutical Industry (by Shagun Sharma, Vipul Kumar Gupta, and Helene Sou), https://globalforum.diaglobal.org/issue/december-2024/the-evolving-regulatory-framework-in-india-impact-on-the-pharmaceutical-industry/?utm_source=db&utm_medium=email&utm_campaign=global_forum&utm_content=PUB_GF_January_2025-01-18_nonmembers&mkt_tok=NjI3LVZKWS03ODUAAAGYGBklfa1aCqBwaGnr9Kqyqb_e18CIegUiToX5o8Q7h7sWz97cb1bBqMb7Q_sbiJQTSjphQLDaU4th_kaMoTzkEenVmwvE7a8dqfeW74Xuyw, Mon Jan 27 2025
THE NEW DRUGS AND CLINICAL TRIALS RULES, 2019., https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4OA==, Mon Jan 27 2025
Accelerated Approval Process
Mehrotra, N., Manchikanti, P. Emergency Approval Mechanisms for Human Vaccines in India. Pharm Med 38, 121–132 (2024)., https://doi.org/10.1007/s40290-023-00513-8, Mon Jan 13 2025
Policy on Vaccine Approval. , https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwNzA=, Mon Jan 27 2025
The Evolving Regulatory Framework in India: Impact on the Pharmaceutical Industry (by Shagun Sharma, Vipul Kumar Gupta, and Helene Sou), https://globalforum.diaglobal.org/issue/december-2024/the-evolving-regulatory-framework-in-india-impact-on-the-pharmaceutical-industry/?utm_source=db&utm_medium=email&utm_campaign=global_forum&utm_content=PUB_GF_January_2025-01-18_nonmembers&mkt_tok=NjI3LVZKWS03ODUAAAGYGBklfa1aCqBwaGnr9Kqyqb_e18CIegUiToX5o8Q7h7sWz97cb1bBqMb7Q_sbiJQTSjphQLDaU4th_kaMoTzkEenVmwvE7a8dqfeW74Xuyw, Mon Jan 27 2025
THE NEW DRUGS AND CLINICAL TRIALS RULES, 2019., https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4OA==, Mon Jan 27 2025
Approval Process for Application received in hard copy with respect to In Vitro Diagnostics
CDSCO In-Vitro Website, https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/InVitro-Diagnostics/, Thu Sep 11 2025
Path IV (new life saving drugs)
AN OVERVIEW OF THE DRUG REGULATORY SYSTEM IN INDONESIA. , https://www.indianembassyjakarta.gov.in/pdf/AN_OVERVIEW_OF_THE_DRUG_REGULATORY_SYSTEM_IN_INDONESIA_jan31-19.pdf, Thu Feb 06 2020
Indonesia Pharmaceutical Regulatory Update., https://www.pacificbridgemedical.com/publication/indonesia-pharmaceutical-regulatory-update/, Thu Feb 20 2020
Path V (prior approved)
AN OVERVIEW OF THE DRUG REGULATORY SYSTEM IN INDONESIA. , https://www.indianembassyjakarta.gov.in/pdf/AN_OVERVIEW_OF_THE_DRUG_REGULATORY_SYSTEM_IN_INDONESIA_jan31-19.pdf, Thu Feb 06 2020
Indonesia Pharmaceutical Regulatory Update., https://www.pacificbridgemedical.com/publication/indonesia-pharmaceutical-regulatory-update/, Thu Feb 20 2020
Emergency Use Authorization
Regulations., https://jdih.pom.go.id/download/product/1292/HK.02.02.1.2.08.21.347/2021, Fri May 24 2024
IGAD Joint Assessment Procedure
East Africa Regulatory Affairs Professional Association (EARAPA). Webinar on IGAD medicine harmonization procedures/process., https://www.youtube.com/watch?v=gZBSOl9grS4, Thu May 20 2021
Abridged Procedure
Medicinal product regulation and product liability in Israel: overview., https://uk.practicallaw.thomsonreuters.com/w-016-6339?transitionType=Default&contextData=(sc.Default)&firstPage=true&bhcp=1, Tue Feb 04 2020
Pharmaceutical drug Products registration/submission in Israel., https://bio-chem.co.il/en/blog/pharmaceutical-drug-products-registrationsubmission-in-israel/, Tue Feb 04 2020
State of Israel Ministry of Health, Pharmaceutical Division., https://www.health.gov.il/English/MinistryUnits/HealthDivision/MedicalTechnologies/Drugs/Pages/default.aspx, Tue Feb 04 2020
Priority Review
Hotaki, L.T., Shrestha, A., Bennett, M.P. et al. Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners. Ther Innov Regul Sci 57, 875–885 (2023). , https://doi.org/10.1007/s43441-023-00522-4, Sat Jul 15 2023
Expedited Pathway
Reliance Procedure
AIRP. Decision No. 0015 AIRP/DG DU 04.06.2024 portant confiance reglementaire en des certificats, rapports ou decisions d'autres autorites nationales de reglementation pharmaceutique., , Sat Jul 06 2024
MODALITES DE DEMANDE D'AUTORISATION DE MISE SUR LE MARCHE (AMM) DES SPECIALITES PHARMACEUTIQUES (Conformément au Règlement no 04/2020/CM/UEMOA du 28 septembre 2020 et Décret no 2015-602 du 02 septembre 2015)., https://api.airpdigital.com/storage/prestations/modalites%20demande%20d'autorisation%20de%20mise%20sur%20le%20march%C3%A9%20des%20specialites%20pharmaceutiques.pdf, Sat Jul 06 2024
Loi no. 2017-541 du 5 aout 2017 relative a la regulation du secteur pharmaceutique., https://api.airpdigital.com/storage/documents/loi%202017-541%20airp%20jorci.pdf, Sat Jul 06 2024
MODALITES DE DEMANDE D'AUTORISATION DE MISE SUR LE MARCHE (AMM) DES MEDICAMENTS GENERIQUES (Conformément au Règlement no 04/2020/CM/UEMOA du 28 septembre 2020 et Décret no 2015-602 du 02/09/2015)., https://api.airpdigital.com/storage/prestations/modalites%20demande%20d'autorisation%20de%20mise%20sur%20le%20march%C3%A9%20des%20m%C3%A9dicaments%20generiques.pdf, Sat Jul 06 2024
MODALITES DE DEMANDE D'AUTORISATION DE MISE SUR LE MARCHE DES VACCINS., https://api.airpdigital.com/storage/prestations/modalites%20de%20demande%20d'autorisation%20de%20mise%20sur%20le%20marche%20des%20vaccins.pdf, Sat Jul 06 2024
The time-limited conditional approval system for regenerative medicines
Drugs Reviews., https://www.pmda.go.jp/english/review-services/reviews/0001.html, Thu Jan 23 2020
Outline of Reviews and Related Services., https://www.pmda.go.jp/english/review-services/outline/0001.html, Thu Jan 23 2020
PMDA’s Consultation Service., https://www.pmda.go.jp/files/000219654.pdf, Thu Jan 23 2020
Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time., https://www.pmda.go.jp/files/000153518.pdf, Fri Jan 24 2020
PMDA Annual Report 2018, https://www.pmda.go.jp/files/000232603.pdf, Thu Sep 05 2024
PMDA Conditional Early Approval
Drugs Reviews., https://www.pmda.go.jp/english/review-services/reviews/0001.html, Thu Jan 23 2020
Outline of Reviews and Related Services., https://www.pmda.go.jp/english/review-services/outline/0001.html, Thu Jan 23 2020
PMDA’s Consultation Service., https://www.pmda.go.jp/files/000219654.pdf, Thu Jan 23 2020
Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time. , https://www.pmda.go.jp/files/000153518.pdf, Fri Jan 24 2020
医薬品の条件付き承認の取扱いについて, https://www.mhlw.go.jp/content/11120000/000666236.pdf, Thu Aug 31 2023
Priority Review
Overview of Orphan Drug/Medical Device Designation System., https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/orphan_drug.html, Fri Jan 24 2020
Global Development and Approval by Cooperation of Key Regulatory Agencies., https://www.pmda.go.jp/files/000226656.pdf, Fri Jan 24 2020
Implementation of a Conditional Early Approval System for Pharmaceutical Products., https://www.pmda.go.jp/files/000227089.pdf, Fri Jan 24 2020
European Union - Japan orphan medicines cooperation., https://www.ema.europa.eu/en/documents/other/european-union-japan-orphan-medicines-cooperation_en.pdf, Fri Jan 24 2020
Outline of Reviews and Related Services., https://www.pmda.go.jp/english/review-services/outline/0001.html, Thu Jan 23 2020
Orphan Products Development Support Program., https://www.nibiohn.go.jp/en/activities/orphan-support.html, Fri Jan 24 2020
Outlook of Orphan and Pediatric Drug Development from Regulatory Perspectives., https://www.pmda.go.jp/files/000226869.pdf, Fri Jan 24 2020
Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time. , https://www.pmda.go.jp/files/000153518.pdf, Fri Jan 24 2020
PMDA’s Consultation Service., https://www.pmda.go.jp/files/000219654.pdf, Thu Jan 23 2020
先駆的医薬品の指定に関する取扱いについて, https://www.mhlw.go.jp/content/000731956.pdf, Thu Aug 31 2023
PMDA Sakigake (Pioneering Drug Designation)
Strategy of SAKIGAKE by MHLW., https://www.pmda.go.jp/english/reviewservices/reviews/advanced-efforts/0001.html, Thu Jan 23 2020
Drugs Reviews., https://www.pmda.go.jp/english/reviewservices/reviews/0001.html, Thu Jan 23 2020
Outline of Reviews and Related Services., https://www.pmda.go.jp/english/reviewservices/outline/0001.html, Thu Jan 23 2020
Strategy of Sakigake., https://www.mhlw.go.jp/english/policy/healthmedical/pharmaceuticals/dl/140729-01-01.pdf, Thu Jan 23 2020
Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time., https://www.pmda.go.jp/files/000153518.pdf, Fri Jan 24 2020
Maurice Bancsi. A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP. RF Quarterly. Volume 2, Number 2. June 2022., , Sun Jul 31 2022
PMDA’s Consultation Service., https://www.pmda.go.jp/files/000219654.pdf, Thu Jan 23 2020
Annual Reports FY 2018., https://www.pmda.go.jp/files/000232603.pdf, Fri Jan 24 2020
Summary of the Strategy of SAKIGAKE., https://www.mhlw.go.jp/english/policy/healthmedical/pharmaceuticals/dl/140729-01-02.pdf, Thu Jan 23 2020
Emergency Regulatory Approval System
Japan’s New Emergency Regulatory Approval System., https://pharmaboardroom.com/articles/japans-new-emergency-regulatory-approval-system/, Thu May 23 2024
Emergency Regulatory Approval System in Japan., https://globalforum.diaglobal.org/issue/september-2022/emergency-regulatory-approval-system-in-japan/, Thu May 23 2024
Regulations for Emergency Regulatory Approval System., https://www.mhlw.go.jp/content/11120000/000940766.pdf, Thu May 23 2024
Establishment of an emergency regulatory approval system in Japan in response to the COVID-19 pandemic and challenges in developing domestically produced vaccines., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9066468/, Thu May 23 2024
Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Act No. 145 of August 10, 1960., https://www.japaneselawtranslation.go.jp/ja/laws/view/3213/je, Thu May 23 2024
JFDA Verification Procedure
Jordan FDA Adopts Reliance Review Model., https://globalforum.diaglobal.org/issue/october-2019/jordan-fda-adopts-reliance-review-model/, Sat Jan 04 2020
Haqaish WSA, Obeidat H, Patel P, Walker S. The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore. Pharmaceut Med. 2017;31(1):21–30., doi:10.1007/s40290-016-0172-4, Sat Jan 04 2020
JFDA Abridged Procedure
Jordan FDA Adopts Reliance Review Model., https://globalforum.diaglobal.org/issue/october-2019/jordan-fda-adopts-reliance-review-model/, Sat Jan 04 2020
Haqaish WSA, Obeidat H, Patel P, Walker S. The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore. Pharmaceut Med. 2017;31(1):21–30., doi:10.1007/s40290-016-0172-4, Sat Jan 04 2020
Expedited Registration
Expertise of medicines., https://www.ndda.kz/category/ekspertiza_ls, Sun Jan 19 2020
Safety and quality evaluation., https://www.ndda.kz/category/about_sert, Sun Jan 19 2020
Expedited Registration
Fast track for locally manufactured and priority medicines
CAP 244 Laws of Kenya - Pharmacy and Poisons Board ACT., https://www.pharmacyboardkenya.org/files/?file=Pharma cyandPoisonsAct17of1956.pdf, Sun Nov 17 2019
Draft Importation of Orphan Medicinal Substances guideline., https://www.pharmacyboardkenya.org/files/?file=DraftIm portation-of-OrphanMedicinalSubstancesGuideline.pdf, Sun Nov 17 2019
PPB Drug Registration Guidelines., https://pharmacyboardkenya.org/files/?file=drug_reg_gui delines.pdf, Mon Nov 18 2019
Draft Pharmacy and Poisons (Parallel Importation of Medicinal Substances) Rules 2018., https://www.pharmacyboardkenya.org/files/?file=Draft%2 0Pharmacy%20and%20Poisons%20Parallel%20Importatio n%20of%20Medicinal%20Substances%20Rules%202018.pdf, Sun Nov 17 2019
Biotherapeutic Products Guidelines., https://www.pharmacyboardkenya.org/files/?file=Biother apeutic_Products_Guidelines.pdf, Sun Nov 17 2019
Pharmacy and Poisons Board. Good Manufacturing Practice Guidelines., https://web.pharmacyboardkenya.org/gmp-guidelines/, Thu Jan 18 2024
Reliance for Regulatory Decision Making in Kenya
Guidance on Reliance for Regulatory Decision Making in Kenya., https://web.pharmacyboardkenya.org/download/guidance-on-reliance-for-regulatory-decision-making-in-kenya/, Wed Mar 23 2022
PHARMACY AND POISONS BOARD. GUIDELINES ON MEDICINES EVALUATION AND REGISTRATION. JANUARY 2022. PPB/HPT/PER/GUD/016. Rev. No. 1. , https://web.pharmacyboardkenya.org/download/guidelines-on-medicines-evaluation-and-registration/?wpdmdl=4349&refresh=63e76b76398a71676110710, Mon Feb 13 2023
Pharmacy and Poisons Board. Marketing Authorization Pathways., https://web.pharmacyboardkenya.org/downloads/procedures/#, Mon Feb 13 2023
Pharmacy and Poisons Board. List of Stringent Regulatory Authorities. (HPT/PER/GUD/034 Rev No.0)., https://web.pharmacyboardkenya.org/download/list-of-stringent-regulatory-authorities/?wpdmdl=7250&refresh=63e9bd9ff20351676262815, Mon Feb 13 2023
Pharmacy and Poisons Board. Good Manufacturing Practice Guidelines., https://web.pharmacyboardkenya.org/gmp-guidelines/, Thu Jan 18 2024
Emergency Use Application (EUA)
Pharmacy and Poisons Board. Guidelines on submission of documentation for emergency use & compassionate use authorization (EUA/CUA) of health products and technologies. (January 2022)., https://web.pharmacyboardkenya.org/download/guideline-for-emergency-compassionate-use-application/#, Sat Apr 02 2022
Pharmacy and Poisons Board. Good Manufacturing Practice Guidelines., https://web.pharmacyboardkenya.org/gmp-guidelines/, Thu Jan 18 2024
Biological Product/Biosimilars Registration
Kuwait’s New Pharmaceutical Registration Guidelines., https://www.tamimi.com/news/kuwaitsnew-pharmaceutical-registration-guidelines/, Sun May 31 2020
KUWAIT: NEW GUIDELINES FOR PHARMACEUTICAL REGISTRATION., https://www.sabaip.com/news/kuwait-newregulations-for-pharmaceutical-registration/, Sun May 31 2020
Reliance Pathway
Kuwait: A Guide To Distribution Of Pharmaceutical Products In Kuwait., https://www.mondaq.com/Food-Drugs-Healthcare-Life-Sciences/873342/A-Guide-To-Distribution-Of-Pharmaceutical-Products-In-Kuwait, Thu Feb 20 2020
Market Overview 2016 Kuwait., https://www.tfhc.nl/wp-content/uploads/2017/08/KLSC-IMS-Kuwait-Health-Industry-Report-2016-vF2.pdf, Fri Feb 21 2020
Guideline for Registration of Products. According to Ministerial Decree 302/80., https://www.yumpu.com/en/document/read/34914634/guidelines-for-registration-of-pharmaceutical-products-according-to-, Fri Feb 21 2020
Biological Product/Biosimilars Registration
Registration of Medicines
LIBERIA MEDICINES AND HEALTH PRODUCTS REGULATORY AUTHORITY. GUIDELINES FOR REGISTRATION OF MEDICINES AND HEALTH PRODUCTS IN LIBERIA. , https://lmhra.gov.lr/download/guidelines-for-registration-of-medicines-and-health-products-in-liberia/, Mon Sep 05 2022
Import of New Drugs
Application for Initial Registration of Pharmaceutical Products (Western Medicines) in Macao (Mar 27, 2024), https://www.gov.mo/zh-hant/services/ps-1568/ps-1568a/?utm_source=chatgpt.com, Sun Feb 23 2025
Director of the Health Bureau Order No. 12/SS/2022, https://www.isaf.gov.mo/wp-content/uploads/2022/12/%E7%AC%AC04%EF%BC%8FSS%EF%BC%8F2021%E8%99%9F%E8%A1%9B%E7%94%9F%E5%B1%80%E5%B1%80%E9%95%B7%E6%89%B9%E7%A4%BA.pdf, Sun Feb 23 2025
Regulations and Policies for the Registration of Traditional Chinese Medicine and Western Medicine in Macau, https://www.tsfbighealth.org/doc/seminar/03.pdf, Sun Feb 23 2025
ISAF promotes the marketing and use of new medicines in Macau, https://www.gcs.gov.mo/detail/zh-hans/N23JCw62uu?utm_source=chatgpt.com, Sun Feb 23 2025
FRP- Reliance (Verification)
FAQ : Generic Medicines., https://npra.gov.my/index.php/en/frequently-asked-questions-faqs-pharmacovigilance.html?highlight=WyJhYnJpZGdlZCIsImV2YWx1YXRpb24iLCJhYnJpZGdlZCBldmFsdWF0aW9uIl0=, Wed Jan 15 2020
Direktif untuk melaksanakan Guidelines on facilitated registration pathway: abbreviated and verification review. March 2019. , https://npra.gov.my/index.php/en/directive-general/2075-direktif-untuk-melaksanakan-guidelines-on-facilitated-registration-pathway-abbreviated-and-verification-review-2.html?highlight=WyJ2ZXJpZmljYXRpb24iLCJyZXZpZXciLCJ2ZXJpZmljYXRpb24gcmV2aWV3Il0=, Wed Jan 15 2020
FAQs: NCE., https://npra.gov.my/index.php/en/component/content/article/225-english/1527044-faq-nce.html?highlight=WyJ2ZXJpZmljYXRpb24iLCJyZXZpZXciLCJ2ZXJpZmljYXRpb24gcmV2aWV3Il0=&Itemid=1391, Wed Jan 15 2020
Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024. Appendix 9: Fees. , https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-9-Fees.pdf, Sun Sep 22 2024
Ministry of Health Malaysia. GUIDELINE FOR FACILITATED REGISTRATION PATHWAY. Revision 1 (November 2023)., https://www.npra.gov.my/easyarticles/images/users/1047/Direktif/Lampiran-A_FRP-Guidelines_Revision-1_2023.pdf, Thu Mar 14 2024
DRGD Appendix 14: Evaluation Routes., https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-14-Evaluation-Routes.pdf, Sun Sep 22 2024
Assessing the Malaysian Regulatory Process with OpERA Methodology – Mohd Sani 2025, https://cirsci.org/publications/assessing-the-malaysian-regulatory-process-with-opera-methodology-mohd-sani-2025/, Mon Sep 15 2025
FRP- Reliance (Abbreviated Review)
FAQ : Generic Medicines., https://npra.gov.my/index.php/en/frequently-asked-questions-faqs-pharmacovigilance.html?highlight=WyJhYnJpZGdlZCIsImV2YWx1YXRpb24iLCJhYnJpZGdlZCBldmFsdWF0aW9uIl0=, Wed Jan 15 2020
FAQs: NCE., https://npra.gov.my/index.php/en/component/content/article/225-english/1527044-faq-nce.html?highlight=WyJ2ZXJpZmljYXRpb24iLCJyZXZpZXciLCJ2ZXJpZmljYXRpb24gcmV2aWV3Il0=&Itemid=1391, Wed Jan 15 2020
Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024. Appendix 15: Requirements For Full Evaluation and Abridged Evaluation. APPENDIX 15, REQUIREMENTS FOR FULL EVALUATION AND ABRIDGED EVALUATION., https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-15-Requirements-for-Full-Evaluation-and-Abridged-Evaluation.pdf, Sun Sep 22 2024
Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024. Appendix 9: Fees. , https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-9-Fees.pdf, Sun Sep 22 2024
Ministry of Health Malaysia. GUIDELINE FOR FACILITATED REGISTRATION PATHWAY. Revision 1 (November 2023)., https://www.npra.gov.my/easyarticles/images/users/1047/Direktif/Lampiran-A_FRP-Guidelines_Revision-1_2023.pdf, Thu Mar 14 2024
DRGD Appendix 14: Evaluation Routes., https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-14-Evaluation-Routes.pdf, Sun Sep 22 2024
Assessing the Malaysian Regulatory Process with OpERA Methodology – Mohd Sani 2025, https://cirsci.org/publications/assessing-the-malaysian-regulatory-process-with-opera-methodology-mohd-sani-2025/, Mon Sep 15 2025
Priority Pathway
Appendix 12: Priority Review. Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024. , https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-12-Priority-Review.pdf, Sun Sep 22 2024
Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024. Appendix 9: Fees. , https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-9-Fees.pdf, Sun Sep 22 2024
Assessing the Malaysian Regulatory Process with OpERA Methodology – Mohd Sani 2025, https://cirsci.org/publications/assessing-the-malaysian-regulatory-process-with-opera-methodology-mohd-sani-2025/, Mon Sep 15 2025
Orphan Drug Route
Key Features of Orphan Drug Registration in Singapore, Malaysia, Philippines, and Vietnam., https://globalforum.diaglobal.org/issue/december-2021/key-features-of-orphan-drug-registration-in-singapore-malaysia-philippines-and-vietnam/, Sat Jul 30 2022
Malaysian Orphan Medicine Guidelines. , https://pharmacy.moh.gov.my/en/documents/malaysian-orphan-medicines-guideline-2020.html, Sun Sep 22 2024
Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024. , https://www.npra.gov.my/easyarticles/images/users/1153/DRGD%20July%202024/Complete-Drug-Registration-Guidance-Document-DRGD-3rd-Edition-8th-Revision-July-2024.pdf, Sun Sep 22 2024
Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024. Appendix 13: Designation and Registration of Orphan Medicines. APPENDIX 13 - DESIGNATION AND REGISTRATION OF ORPHAN MEDICINES., https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-13-Designation-and-Registration-of-Orphan-Medicines.pdf, Sun Sep 22 2024
Appendix 9: Fees, https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-9-Fees.pdf, Sun Sep 22 2024
Assessing the Malaysian Regulatory Process with OpERA Methodology – Mohd Sani 2025, https://cirsci.org/publications/assessing-the-malaysian-regulatory-process-with-opera-methodology-mohd-sani-2025/, Mon Sep 15 2025
Conditional Registration for Pharmaceutical Products During Disaster
Appendix 9: Fees., https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-9-Fees.pdf, Sun Sep 22 2024
Drug Registration Guidance Document (DRGD) Third Edition, Eighth revision - July 2024., https://www.npra.gov.my/easyarticles/images/users/1153/DRGD%20July%202024/Complete-Drug-Registration-Guidance-Document-DRGD-3rd-Edition-8th-Revision-July-2024.pdf, Sun Sep 22 2024
Guidelines on Conditional Registration for New Chemical Entities and Biologics - 2nd Edition. December 2020. , https://www.npra.gov.my/index.php/en/component/content/article/82-english/announcement-main/1527157-guidelines-on-conditional-registration.html?Itemid=1391, Tue Aug 23 2022
GUIDANCE AND REQUIREMENTS ON CONDITIONAL REGISTRATION OF PHARMACEUTICAL PRODUCTS DURING DISASTER. Revision 4 - June 2022. , https://www.npra.gov.my/index.php/en/guideline-bio/1527323-guidance-and-requirements-on-conditional-registration-of-pharmaceutical-products-during-disaster-march-2022.html, Sun Sep 22 2024
Direktif Bil 18/2020: “Pelaksanaan Pendaftaran Fast Track Bersyarat Untuk Produk Farmaseutikal Semasa Bencana"., https://www.npra.gov.my/index.php/en/directive-general/1527170-direktif-berkenaan-pelaksanaan-pendaftaran-fast-track-bersyarat-untuk-produk-farmaseutikal-semasa-bencana.html, Sun Sep 22 2024
Assessing the Malaysian Regulatory Process with OpERA Methodology – Mohd Sani 2025, https://cirsci.org/publications/assessing-the-malaysian-regulatory-process-with-opera-methodology-mohd-sani-2025/, Mon Sep 15 2025
Conditional Registration for New Chemical Entities and Biologics in Malaysia
Appendix 9: Fees., https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-9-Fees.pdf, Sun Sep 22 2024
Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision. July 2024., https://www.npra.gov.my/index.php/en/drug-registration-guidance-documents-drgd-e-book.html, Sun Sep 22 2024
Guidelines on Conditional Registration for New Chemical Entities and Biologics - 2nd Edition. December 2020. , https://www.npra.gov.my/index.php/en/component/content/article/82-english/announcement-main/1527157-guidelines-on-conditional-registration.html?Itemid=1391, Tue Aug 23 2022
GUIDANCE AND REQUIREMENTS ON CONDITIONAL REGISTRATION OF PHARMACEUTICAL PRODUCTS DURING DISASTER. Revision 2 – January 2022., https://www.npra.gov.my/easyarticles/images/users/1047/Lampiran-A-Guidance-and-Requirements-on-Conditional-Registration-of-Pharmaceutical-Products-During-Disaster-January-2022.pdf, Tue Aug 23 2022
Assessing the Malaysian Regulatory Process with OpERA Methodology – Mohd Sani 2025, https://cirsci.org/publications/assessing-the-malaysian-regulatory-process-with-opera-methodology-mohd-sani-2025/, Mon Sep 15 2025
Malaysia-Japan Cooperation on Simplifying Drug Review Procedure
Direktif Berkenaan Pengemaskinian dan Pelaksanaan Guideline for Facilitated Registration Pathway (FRP), Revision 1, 2023., https://www.npra.gov.my/index.php/en/directive-general/1527544-direktif-berkenaan-pengemaskinian-dan-pelaksanaan-guideline-for-facilitated-registration-pathway-frp-revision-1-2023.html, Mon Oct 28 2024
Malaysia-Japan Cooperation on Simplifying Drug Review Procedure., https://www.chemradar.com/news/detail/d6kvm2mx28e8, Mon Oct 28 2024
HSA-NPRA Generic Medicines Work Sharing Initiative
About the HSA-NPRA Generic Medicines Work Sharing Initiative., https://www.hsa.gov.sg/therapeutic-products/international-collaboration/npra#:~:text=The%20HSA-NPRA%20Generic%20Medicines%20Work%20Sharing%20Initiative%20is,the%20National%20Pharmaceutical%20Regulatory%20Agency%20%28NPRA%29%20of%20Malaysia., Mon Oct 28 2024
Request for Expressions of Interest (EOI) to Participate in the HSA-NPRA Generic Medicines Work-Sharing Initiative., https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/npra/1-notice-to-applicants-(npra).pdf?sfvrsn=b5c911d_0, Mon Oct 28 2024
Operational Procedures. , https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/npra/2-operational-procedures-(npra).pdf?sfvrsn=ad2cd4e0_0, Mon Oct 28 2024
Expression of Interest (EoI) Form., https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/npra/3-eoi-form-(npra).docx?sfvrsn=c0b505b5_0, Mon Oct 28 2024
Medical Device Regulatory Reliance Programme (Pilot)
Malaysia MDA Announces Second Reliance Pilot, https://www.emergobyul.com/news/malaysia-mda-announces-second-reliance-pilot, Tue Oct 28 2025
Malaysia and Singapore Sign Memorandum of Understanding and Launch Medical Device Regulatory Reliance Pilot to Fast Track Medical Device Market Access, https://www.hsa.gov.sg/announcements/press-release/HSA-MDAsignMOU, Tue Oct 28 2025
Article 170
DOF [Official Gazette of the Federation by its Spanish acronym]: 03/29/2019. , https://www.gob.mx/cms/uploads/attachment/file/459090/ACUERDO_DE_EQUIVALENCIAS_OMS-29032019__ENGLISH.pdf, Sat Apr 04 2020
Gobierno de Mexico. 062. COFEPRIS simplifies and expedites the authorization of clinical research protocols in Mexico., https://www.gob.mx/salud/prensa/062-la-cofepris-simplifica-y-agiliza-la-autorizacion-de-protocolos-de-investigacion-clinica-en-mexico?fbclid=IwZXh0bgNhZW0CMTEAAR0RSE8JkzVzRWvBV8A7oi0724KaDFY4BiucXSvoZ-QODkspy1GumwkewJ0_aem_D6DQU7w0UDSGfUo4Qi96hQ, Mon Apr 28 2025
Equivalence Agreement
Mexico - K. Healthcare Products & Services., https://www.export.gov/apex/article2?id=Mexico-Healthcare-Products-Services, Sun Mar 22 2020
Mexico: Medicinal Product Regulation And Product Liability In Mexico: Overview., https://www.mondaq.com/mexico/Food-Drugs-Healthcare-Life-Sciences/842550/Medicinal-Product-Regulation-And-Product-Liability-In-Mexico-Overview, Sun Mar 22 2020
Regulatory, Pricing & Reimbursement., https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-mexico/, Sun Mar 22 2020
Sanitary registry of allopathic medicines, vaccines and blood products of national manufacture, generic., https://www.gob.mx/tramites/ficha/registro-sanitario-de-medicamentos-alopaticos-vacunas-y-hemoderivados-de-fabricacion-nacional-generico/COFEPRIS395, Sun Mar 22 2020
Pharma & Medical Device Regulation: Mexico., https://gettingthedealthrough.com/area/119/jurisdiction/16/pharma-medical-device-regulation-mexico/, Sun Mar 22 2020
Gobierno de Mexico. 062. COFEPRIS simplifies and expedites the authorization of clinical research protocols in Mexico., https://www.gob.mx/salud/prensa/062-la-cofepris-simplifica-y-agiliza-la-autorizacion-de-protocolos-de-investigacion-clinica-en-mexico?fbclid=IwZXh0bgNhZW0CMTEAAR0RSE8JkzVzRWvBV8A7oi0724KaDFY4BiucXSvoZ-QODkspy1GumwkewJ0_aem_D6DQU7w0UDSGfUo4Qi96hQ, Mon Apr 28 2025
Recognition of MAs from Reference Authorities
AGREEMENT BY WHICH THE REQUIREMENTS ESTABLISHED IN ARTICLES 161 BIS, 167, 169, 170 AND 177 OF THE REGULATION OF HEALTH SUPPLIES AND THE TECHNICAL EVALUATION PROCEDURES CARRIED OUT BY THE FEDERAL COMMISSION FOR SANITARY PROTECTION AGAINST RACIAL PROTECTION GRANTING OF THE SANITARY REGISTRY OF HEALTH SUPPLIES REFERRED TO IN ARTICLES 2, SECTIONS XIV, XV, ITEMS BYCY 166, FRACTIONS I, II AND III OF THE REGULATION OF HEALTH SUPPLIES ; IN RELATION TO ARTICLES 222 AND 229 OF THE GENERAL HEALTH LAW, THE REQUIREMENTS REQUESTED AND EVALUATION PROCEDURES CARRIED OUT; AS WELL AS THE IMPORTATION OF MEDICINES WITH OR WITHOUT SANITARY REGISTRY IN MEXICO, DIRECTED TO ANY ILLNESS OR SUFFERING, WHICH ARE AUTHORIZED BY THE FOLLOWING REGULATORY AUTHORITIES: SWISS AGENCY FOR TERAP ÉU TICOS-SWISSMED PRODUCTS, EUROPEAN COMMISSION, FOOD AND DRUG ADMINISTRATION OF THE UNITED STATES OF AMERICA, MINISTRY OF DETAILS, MINISTRY OF DEUTS AUSTRALIA, PAHO / WHO REFERENCE EGULATORY AGENCIES PREQUALIFIED BY THE PRE-QUALIFICATION PROGRAM FOR DRUGS AND VACCINES OF THE WORLD HEALTH ORGANIZATION OR REGULATORY AGENCIES MEMBERS OF THE PHARMACEUTICAL INSPECTION COOPERATION SCHEME. DOF: 01/28/2020. , , Sat Apr 04 2020
Gobierno de Mexico. 062. COFEPRIS simplifies and expedites the authorization of clinical research protocols in Mexico., https://www.gob.mx/salud/prensa/062-la-cofepris-simplifica-y-agiliza-la-autorizacion-de-protocolos-de-investigacion-clinica-en-mexico?fbclid=IwZXh0bgNhZW0CMTEAAR0RSE8JkzVzRWvBV8A7oi0724KaDFY4BiucXSvoZ-QODkspy1GumwkewJ0_aem_D6DQU7w0UDSGfUo4Qi96hQ, Mon Apr 28 2025
Emergency Use Authorization
Perspectives for licensing vaccines in Mexico., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9272047/, Fri May 24 2024
DOF: 19/03/2021 AGREEMENT establishing the Guidelines for the issuance of temporary authorizations for health supplies for health care establishments and the temporary certification of good manufacturing practices for health supplies that contribute to the eradication and mitigation of the SARS-CoV2 virus (COVID-19).., https://www.dof.gob.mx/nota_detalle.php?codigo=5614001&fecha=19/03/2021#gsc.tab=0, Fri May 24 2024
Gobierno de Mexico. 062. COFEPRIS simplifies and expedites the authorization of clinical research protocols in Mexico., https://www.gob.mx/salud/prensa/062-la-cofepris-simplifica-y-agiliza-la-autorizacion-de-protocolos-de-investigacion-clinica-en-mexico?fbclid=IwZXh0bgNhZW0CMTEAAR0RSE8JkzVzRWvBV8A7oi0724KaDFY4BiucXSvoZ-QODkspy1GumwkewJ0_aem_D6DQU7w0UDSGfUo4Qi96hQ, Mon Apr 28 2025
Equivalencia 2025
Gobierno de Mexico. 062. COFEPRIS simplifies and expedites the authorization of clinical research protocols in Mexico., https://www.gob.mx/salud/prensa/062-la-cofepris-simplifica-y-agiliza-la-autorizacion-de-protocolos-de-investigacion-clinica-en-mexico?fbclid=IwZXh0bgNhZW0CMTEAAR0RSE8JkzVzRWvBV8A7oi0724KaDFY4BiucXSvoZ-QODkspy1GumwkewJ0_aem_D6DQU7w0UDSGfUo4Qi96hQ, Mon Apr 28 2025
Simplified Registration Procedure
Verification Review
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200. , 10.3389/fmed.2021.742200, Tue Sep 06 2022
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181., 10.3389/fmed.2021.742181, Tue Sep 06 2022
Abridged Review
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181., 10.3389/fmed.2021.742181, Tue Sep 06 2022
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200., 10.3389/fmed.2021.742200, Tue Sep 06 2022
Expedited “fast-track” registration procedure
Namibia Medicines Regulatory Council (NMRC). Medicines Evaluations and Registration. , https://nmrc.gov.na/medicine-registration-overview, Sun Aug 29 2021
SCHEDULE. ANNEXURE XXXVIII. MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003. FEES (Regulation 47)., , Mon Aug 09 2021
Namibia Medicines Regulatory Council (NMRC). Guidance for the preparation and submission of dossiers in Common Technical Document format., , Sun Aug 29 2021
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200., 10.3389/fmed.2021.742200, Sun Aug 29 2021
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181., 10.3389/fmed.2021.742181, Sun Aug 29 2021
Verification Review
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200., 10.3389/fmed.2021.742200, Mon Sep 05 2022
Namibia Medicines Regulatory Council (NMRC). Medicines Evaluations and Registration., https://nmrc.gov.na/medicine-registration-overview, Mon Sep 05 2022
Abridged Review
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200. , 10.3389/fmed.2021.742200, Mon Sep 05 2022
Namibia Medicines Regulatory Council (NMRC). Medicines Evaluations and Registration., https://nmrc.gov.na/medicine-registration-overview, Mon Sep 05 2022
Abbreviated Evaluation Process
Guideline on the Regulation of Therapeutic Products in New Zealand Part 2: Obtaining approval for new and changed medicines and related products Edition 1.1 October 2019. , https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part2.pdf , Tue Oct 27 2020
Priority Assessment of New Medicine Applications
Guideline on the Regulation of Therapeutic Products in New Zealand Part 2: Obtaining approval for new and changed medicines and related products Edition 1.1 October 2019., https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part2.pdf, Tue Oct 27 2020
Registration of Imported Drugs in Nigeria
National Agency for Food & Drug Administration & Control (NAFDAC). Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs). Doc. Ref. No: R&R-GDL-OO5-OO. , , Sun Aug 29 2021
GUIDELINES FOR REGISTRATION OF IMPORTED DRUGS, VACCINES AND IN-VITRO DIAGNOSTICS UNDER WHO COLLABORATIVE REGISTRATION PROCEDURE (CRP), "GUIDELINES FOR REGISTRATION OF IMPORTED DRUGS, VACCINES AND IN-VITRO DIAGNOSTICS UNDER WHO COLLABORATIVE REGISTRATION PROCEDURE (CRP)", Fri May 10 2024
Licensing or Access to COVID-19 Vaccines
National Agency for Food & Drug Administration & Control (NAFDAC). Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 Vaccines. Doc. Ref. No: DR&R-GDN-006-00. , https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/DR_And_R_Guidelines/Guidance-on-Regulatory-Preparedness-for-Licensing-or-Access-to-COVID-19-Vaccines.pdf, Mon Feb 13 2023
Joint Nordic HTA-Bodies (formerly FINOSE)
NORDIC PHARMACEUTICAL FORUM. STRATEGY FOR 2023-2025., https://amgros.dk/media/3790/nlf-strategy-final.pdf, Mon Aug 05 2024
Nordic collaboration through JNHB., https://fimea.fi/en/development/therapeutic_and_economic_value_of_medicines/nordic-collaboration-finose-, Mon Aug 05 2024
JNHB Submission. Dossier Template for Health Technology Assessment of Medicinal Products. Version 1 – June 2024., https://jnhtabodies.org/media/tlzfays5/submission-dossier-template-jnhb.pdf, Mon Aug 05 2024
Joint Nordic HTA-Bodies. Process Guideline - Steps and Responsibilities. Version 1 - June 2024., https://jnhtabodies.org/media/yn5fkfza/jnhb-process-guideline.pdf, Mon Aug 05 2024
FINOSE now includes all Nordic countries., https://fimea.fi/en/-/finose-now-includes-all-nordic-countries, Mon Aug 05 2024
FINOSE becomes Joint Nordic HTA-Bodies, JNHB., https://www.dmp.no/en/news/finose-becomes-joint-nordic-hta-bodies, Mon Aug 05 2024
Eriksson M, Andersson Galijatovic E, Schiel A, Brodtkorb T-H. The FINOSE collaboration – joint health technology assessment in the Nordics. Presented at the ISPOR Europe 2023; November 15, 2023. Copenhagen, Denmark., https://www.rtihs.org/publications/finose-collaboration-joint-health-technology-assessment-nordics, Mon Aug 05 2024
Nordic Pharmaceutical Forum., https://nordicpharmaceuticalforum.com/index.php/about-nordic-pharmaceutical-forum-nlf/, Mon Aug 05 2024
Project Orbis
Guidance on Project Orbis., https://www.gov.uk/guidance/guidance-on-project-orbis#products-eligible-for-project-orbis, Mon Mar 15 2021
Project Orbis: Strengthening International Collaboration for Oncology Product Reviews, Faster Patient Access to Innovative Therapies., https://www.fda.gov/news-events/fda-voices/project-orbis-strengthening-international-collaboration-oncology-product-reviews-faster-patient, Mon Mar 15 2021
Project Orbis: Global Collaborative Review Program. R. Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, et al. Clin Cancer Res, 10.1158/1078-0432.CCR-20-3292, Sun Apr 19 2020
Swissmedic participates in FDA Project Orbis., https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/fda-projekt-orbis.html, Sun Apr 19 2020
Guidance on Project Orbis., https://www.gov.uk/guidance/guidance-on-project-orbis#products-eligible-for-project-orbis, Mon Mar 15 2021
LinkedIn Posting by Emma Ungstrup, EMA, https://www.linkedin.com/posts/emma-ungstrup-8947817_in-2019fdas-project-orbis-started-to-provide-activity-7127243208673107968-l2DY?utm_source=share&utm_medium=member_desktop, Mon Nov 06 2023
Project Orbis Frequently Asked Questions, https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis-frequently-asked-questions, Thu Feb 06 2025
Project Orbis Types, https://www.fda.gov/media/165101/download?attachment, Thu Feb 06 2025
Priority Review of Submission
Policy Guidelines regarding Reference Regulatory Authorities for Registration of Drugs., http://www.dra.gov.pk/Home/Download?ImageName=Policy%20Guidelines%20Regarding%20Reference%20Regulatory%20Authorities%20for%20Registration%20of%20Drugs%20Dt_Up_05-01-2017.pdf, Wed Dec 18 2019
Draft Guideline for Priority Review and Accelerated Approval of Registration / Market Authorization. , http://www.dra.gov.pk/Home/Download?ImageName=MA%2001.12%20DRAFT%20Guideline%20on%20Non%20Rutine%20MA.pdf, Wed Dec 18 2019
Procedure for Registration of Drugs. , http://www.dra.gov.pk/Home/Download?ImageName=Procedure%20of%20Registration.pdf, Wed Dec 18 2019
Conditional Marketing Authorization
Procedure for Registration of Drugs., http://www.dra.gov.pk/Home/Download?ImageName=Procedure%20of%20Registration.pdf, Wed Dec 18 2019
Policy Guidelines regarding Reference Regulatory Authorities for Registration of Drugs., http://www.dra.gov.pk/Home/Download?ImageName=Policy%20Guidelines%20Regarding%20Reference%20Regulatory%20Authorities%20for%20Registration%20of%20Drugs%20Dt_Up_05-01-2017.pdf, Wed Dec 18 2019
Draft Guideline for Priority Review and Accelerated Approval of Registration / Market Authorization., http://www.dra.gov.pk/Home/Download?ImageName=MA%2001.12%20DRAFT%20Guideline%20on%20Non%20Rutine%20MA.pdf, Wed Dec 18 2019
Emergency Use Authorization for Drugs & Vaccines
EUA for Drugs & Vaccines., https://www.dra.gov.pk/therapeutic-goods/emergency-use-authorizations/eua-for-drugs/, Thu May 23 2024
Product Registration Process (Local Manufacturing / Finished Product Import of Biologicals) for human use., https://www.dra.gov.pk/wp-content/uploads/2022/12/human-biological-drug-registration.pdf, Thu May 23 2024
DRAP Consolidated Fees., https://www.dra.gov.pk/wp-content/uploads/2023/04/DRAP-Consolidated-Fee-17.04.2023.pdf, Thu May 23 2024
Revised registration fee for imported drugs., https://www.dra.gov.pk/wp-content/uploads/2024/01/Revised-Registration-Fee-for-Imported-Drugs-29.12.2023.pdf, Thu May 23 2024
Abbreviated Pathway
Decreto Ejecutivo N° 58 (De martes 28 de marzo de 2017) QUE ESTABLECE EL PROCEDIMIENTO ABREVIADO PARA EL REGISTRO SANITARIO DE MEDICAMENTOS, SU RENOVACIÓN Y MODIFICACIONES., http://gacetas.procuraduria-admon.gob.pa/28248_2017.pdf, Wed Jul 21 2021
LAW 97 (From 4 October 2019) Which modifies and adds articles to Law 1 of 2001, on Medicines and other Products for Human Health, and dictates other provisions , https://w3.css.gob.pa/wp-content/wdocs/LEY%2097%20DE%202019%20G.O.%2028875-A%20MODIFICA%20LEY%201%20DE%20MEDICAMENTOS.pdf, Sat Jun 22 2024
Padua, A., Partika, L., Bonamici, D. et al. Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America. J Public Health Pol 41, 481–495 (2020)., https://rdcu.be/dLBbi, Sat Jun 22 2024
Durán CE, Cañás M, Urtasun MA, Elseviers M, Andia T, Vander Stichele R, et al. Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries. Rev Panam Salud Publica. 2021;45:e10. https://doi.org/10.26633/ RPSP.2021.10, https://pubmed.ncbi.nlm.nih.gov/33859678/, Sat Jun 22 2024
Automatic recognition of sanitary registrations of medicines manufactured and registered in countries with WHO Listed Authorities (Executive Decree No. 2 of January 7, 2025)
Executive Decree 2 of January 7, 2025, https://www.minsa.gob.pa/sites/default/files/normatividad/decreto_ejecutivo_no_2_de_7_de_enero_de_2025_-_reconocimiento_de_registros_sanitarios_a_medicamentos_con_registros_de_la_oms.pdf, Thu Feb 06 2025
List of WHO Listed Authorities (WLAs), https://www.who.int/publications/m/item/list-of-who-listed-authorities-wlas, Thu Feb 06 2025
Evaluation Route 1 (Multi-Source Well-Established Products)
National Department of Health, Papua New Guinea. Registration Guideline for Medicines in Papua New Guinea. Version 1, January 2018., , Mon Apr 07 2025
Evaluation Route 2 (NCEs & Complex Biologicals)
National Department of Health, Papua New Guinea. Registration Guideline for Medicines in Papua New Guinea. Version 1, January 2018., , Mon Apr 07 2025
Priority Review Pathway
National Department of Health, Papua New Guinea. Registration Guideline for Medicines in Papua New Guinea. Version 1, January 2018., , Mon Apr 07 2025
Simplified procedure (Law 1119/97)
Durán CE, Cañás M, Urtasun MA, Elseviers M, Andia T, Vander Stichele R, et al. Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries. Rev Panam Salud Publica. 2021;45:e10. https://doi.org/10.26633/ RPSP.2021.10, https://iris.paho.org/handle/10665.2/53563, Sun Jun 23 2024
LEY 1119/97 DE PRODUCTOS PARA LA SALUD Y OTROS, https://www.mspbs.gov.py/dependencias/dnvs/adjunto/1d0e83-LEYN11191997DEPRODUCTOSPARALASALUDYOTROS.pdf, Sun Jun 23 2024
LAW N° 1.119 OF HEALTH PRODUCTS AND OTHERS, https://www.bacn.gov.py/leyes-paraguayas/4995/ley-n-1119-productos-para-la-salud-y-otros, Sun Jun 23 2024
Resolution 197/2024: APPROVING THE MANUAL OF GOOD PRACTICES FOR THE USE OF REGULATORY DECISIONS OF OTHER AUTHORITIES (RELIANCE) IN THE REGULATION OF MEDICINES, VACCINES, BLOOD AND BLOOD PRODUCTS, MEDICAL DEVICES, INCLUDING PRODUCTS FOR "IN VITRO" DIAGNOSTICS., https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:7cfb08f3-5043-4765-8059-fe7d88a9d7df, Sat Sep 14 2024
Reliance Pathway
Regulatory, Pricing and Reimbursement Overview., https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-peru/, Sun Mar 22 2020
Orphan Drugs & Rare Diseases: Peru., https://pharmaboardroom.com/legal-articles/orphan-drugs-rare-diseases-peru/, Sun Mar 22 2020
Biosimilars & Biologics: Peru., https://pharmaboardroom.com/legal-articles/biosimilars-biologics-peru/, Sun Mar 22 2020
Trade agreements and drug access: assessment of the impact of the 2009 Peruvian new drug policy on anti-infectives registration and availability. , https://link.springer.com/article/10.1186/s40545-018-0151-0, Sun Mar 22 2020
Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America. Ana Padua, Livia Partika, Denise Bonamici. Journal of Public Health Policy., https://doi.org/10.1057/s41271-020-00245-y, Mon Sep 14 2020
Conditional Sanitary Registration of Medicines and Biological Products
Supreme Decree that approves the Regulations for the Conditional Sanitary Registration of Medicines and Biological Products. SUPREME DECREE. N° 002-2021-SA., ,
Facilitated Access Law 32319
World Health Organization (WHO). List of WHO Listed Authorities (WLAs), as of May 2024., https://cdn.who.int/media/docs/default-source/medicines/regulatory-systems/wla/list_of_wla_may24.pdf?sfvrsn=1f6c2140_37&download=true, Fri May 23 2025
Congress of the Republic of Peru. Law No. 29459 - Law on Pharmaceuticals, Medical Devices and Medical Devices. November 25, 2009. , https://www.gob.pe/institucion/congreso-de-la-republica/normas-legales/2813441-29459, Fri May 23 2025
DIGEMID, Peru. Law No. 32319. , https://www.digemid.minsa.gob.pe/webDigemid/normas-legales/2025/ley-n-32319/#%3A~%3Atext=Descripci%C3%B3n%3A%2Chu%C3%A9rfanas%2C%20c%C3%A1ncer%20y%20dem%C3%A1s%20enfermedades, Fri May 23 2025
Diario Oficial del Bicentenario El Peruano. LAW NO. 32319. LAW ESTABLISHING MEASURES TO FACILITATE ACCESS TO MEDICINES AND BIOLOGICAL PRODUCTS REGISTERED IN COUNTRIES WITH HIGH HEALTH SURVEILLANCE FOR THE TREATMENT OF RARE DISEASES, ORPHANS, CANCER AND OTHER DISEASES., https://busquedas.elperuano.pe/dispositivo/NL/2395814-4, Fri May 23 2025
Ministry of Health Ministerial Resolution No. 403-2025-MINSA. June 14, 2025., https://www.gob.pe/institucion/minsa/normas-legales/6866023-403-2025-minsa, Tue Nov 04 2025
Collaborative Review Process (Accelerated registration of WHO-prequalified pharmaceutical products and vaccines
Regulatory Affairs Professionals Society (RAPS). Asia-Pacific Roundup: Philippine FDA consults on accelerated registration of WHO-prequalified products Posted 07 June 2022 | By Nick Paul Taylor., https://www.raps.org/news-and-articles/news-articles/2022/6/asia-pacific-roundup-philippine-fda-consults-on-ac?utm_source=MagnetMail&utm_medium=Email+&utm_campaign=RF+Today+%7c+7+June+2022, Fri Jun 17 2022
Philippines FDA. Draft for Comments || Implementing Guidelines on the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines. , https://www.fda.gov.ph/draft-for-comments-implementing-guidelines-on-the-collaborative-procedure-for-the-accelerated-registration-of-world-health-organization-who-prequalified-pharmaceutical-products-and-vacc/, Fri Jun 17 2022
ADMINISTRATIVE ORDER | No. 2020 - 004.4 SUBJECT: Adoption of the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO)- Prequalified Pharmaceutical Products and Vaccines., https://www.fda.gov.ph/wp-content/uploads/2020/09/Administrative-Order-2020-0044.pdf, Thu Aug 31 2023
Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration, https://www.fda.gov.ph/wp-content/uploads/2022/11/Guidelines-Prescribing-the-Principle-of-Reliance-for-Regulatory-Decisions-of-the-Food-and-Drug-Administration.pdf, Thu Jan 18 2024
Orphan Drug Route
Key Features of Orphan Drug Registration in Singapore, Malaysia, Philippines, and Vietnam., https://globalforum.diaglobal.org/issue/december-2021/key-features-of-orphan-drug-registration-in-singapore-malaysia-philippines-and-vietnam/, Sat Jul 30 2022
Government of Philippines. Rares Diseases Act., https://doh.gov.ph/sites/default/files/policies_and_laws/RA10747.pdf, Sat Jul 30 2022
FDA Philippines. FDA Circular No.2023-004 || Guidelines on Regulatory Reliance on the Conduct of Clinical Trials., https://www.fda.gov.ph/fda-circular-no-2023-004-guidelines-on-regulatory-reliance-on-the-conduct-of-clinical-trials/, Thu Jan 18 2024
Registration of Drug Products under Emergency Use for the Coronavirus Disease 2019 (COVID-19) (INITIAL-DEU)
Republic of the Philippines, Department of Health, FOOD AND DRUG ADMINISTRATION, CENTER FOR DRUG REGULATION AND RESEARCH. REGISTRATION OF DRUG PRODUCTS UNDER EMERGENCY USE FOR THE CORONAVIRUS DISEASE 2019 (COVID-19) (INITIAL-DEU)., https://www.fda.gov.ph/wp-content/uploads/2021/05/Registration-of-Drug-Products-under-Emergency-Use-for-the-COVID-19-Initial-DEU.pdf, Thu Aug 25 2022
FDA Circular No. 2020-012 || Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19). , https://www.fda.gov.ph/fda-circular-no-2020-012-guidelines-for-the-registration-of-drug-products-under-emergency-use-deu-for-the-coronavirus-disease-2019-covid-19/, Thu Aug 25 2022
FDA Philippines. FDA Circular No.2023-004 || Guidelines on Regulatory Reliance on the Conduct of Clinical Trials., https://www.fda.gov.ph/fda-circular-no-2023-004-guidelines-on-regulatory-reliance-on-the-conduct-of-clinical-trials/, Thu Jan 18 2024
Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration, https://www.fda.gov.ph/wp-content/uploads/2022/11/Guidelines-Prescribing-the-Principle-of-Reliance-for-Regulatory-Decisions-of-the-Food-and-Drug-Administration.pdf, Thu Jan 18 2024
Facilitated Review Pathway (Verification Review)
ADMINISTRATIVE ORDER No. II. Aono-OD4S SUBJECT: Establishing Facilitated Registration Pathways for Drug Products, including Vaccines and Biologicals., https://www.fda.gov.ph/wp-content/uploads/2020/10/Administrative-Order-2020-0045.pdf, Thu Aug 31 2023
FDA Circular No. 2022-004. Implementing guidelines on the abridged and verification review pathways for new drug applications in accordance with administrative order 2020-0045. , https://www.fda.gov.ph/wp-content/uploads/2022/06/FDA-Circular-No.2022-004.pdf, Thu Aug 31 2023
FDA Philippines. FDA Circular No.2023-004 || Guidelines on Regulatory Reliance on the Conduct of Clinical Trials., https://www.fda.gov.ph/fda-circular-no-2023-004-guidelines-on-regulatory-reliance-on-the-conduct-of-clinical-trials/, Thu Jan 18 2024
Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration, https://www.fda.gov.ph/wp-content/uploads/2022/11/Guidelines-Prescribing-the-Principle-of-Reliance-for-Regulatory-Decisions-of-the-Food-and-Drug-Administration.pdf, Thu Jan 18 2024
Facilitated Review Pathway (Abridged Review)
Republic of the Philippines, Department of Health, Food and Drug Administration. FDA Circular No. 2022-004. Subject: Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 "Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals". , https://www.fda.gov.ph/wp-content/uploads/2022/06/FDA-Circular-No.2022-004.pdf, Thu Aug 31 2023
ADMINISTRATIVE ORDER No. II. Aono-OD4S SUBJECT: Establishing Facilitated Registration Pathways for Drug Products, including Vaccines and Biologicals., https://www.fda.gov.ph/wp-content/uploads/2020/10/Administrative-Order-2020-0045.pdf, Thu Aug 31 2023
FDA Philippines. FDA Circular No.2023-004 || Guidelines on Regulatory Reliance on the Conduct of Clinical Trials., https://www.fda.gov.ph/fda-circular-no-2023-004-guidelines-on-regulatory-reliance-on-the-conduct-of-clinical-trials/, Thu Jan 18 2024
Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration, https://www.fda.gov.ph/wp-content/uploads/2022/11/Guidelines-Prescribing-the-Principle-of-Reliance-for-Regulatory-Decisions-of-the-Food-and-Drug-Administration.pdf, Thu Jan 18 2024
Centre for Innovation in Regulatory Science (2024) CIRS R&D Briefing 91: Approaches to Implementing Regulatory Reliance – Considerations for Agencies. Centre for Innovation in Regulatory Science (CIRS), London, UK., https://cirsci.org/publications/cirs-rd-briefing-91-approaches-to-implementing-regulatory-reliance-considerations-for-agencies/, Wed Mar 13 2024
Emergency Use Authorization for Drugs & Vaccines for COVID-19
FDA Circular No. 2020-036. Guidelines on the Issuance of EUA for Drugs & Vaccines for COVID-19, https://www.fda.gov.ph/wp-content/uploads/2020/12/FDA-Circular-No.2020-036.pdf, Fri Jan 19 2024
Accelerated Procedure for Expert Examination of Medicines
On Circulation of Medicines Adopted by the State Duma March 24, 2010 (as amended by Federal Laws of July, 27 2010, № 192-FZ; of October 11, 2010, No. 271-FZ, of November 29, No. 313-FZ, of December 06, 2011 No. 409-FZ, of June 25, 2012 No. 93-FZ)., https://www.unodc.org/res/cld/document/rus/federal-law-on-circulation-of-medicines_html/Russian_Federation_Federal_Law_On_Circulation_of_Medicines_61-FZ_EN.pdf, Wed Nov 25 2020
Accelerated Registration of Drugs
Medicines for the treatment of infected COVID-19 will be registered under the accelerated program., http://www.garant.ru/news/1361745/, Wed Nov 25 2020
On Circulation of Medicines. Adopted by the State Duma. March 24, 2010. (as amended by Federal Laws of July, 27 2010, № 192-FZ; of October 11, 2010, No. 271-FZ, of November 29, No. 313-FZ, of December 06, 2011 No. 409-FZ, of June 25, 2012 No. 93-FZ). , https://www.unodc.org/res/cld/document/rus/federal-law-on-circulation-of-medicines_html/Russian_Federation_Federal_Law_On_Circulation_of_Medicines_61-FZ_EN.pdf, Wed Nov 25 2020
Decree of the Government of the Russian Federation of April 3, 2020 No. 441 "On the peculiarities of the circulation of medicinal products for medical use, which are intended for use in conditions of the threat of occurrence, occurrence and elimination of an emergency situation and for organizing the provision of medical assistance to persons affected by emergencies, prevention emergency situations, prevention and treatment of diseases that pose a danger to others, diseases and injuries resulting from exposure to adverse chemical, biological, radiation factors "., https://www.garant.ru/products/ipo/prime/doc/73750814/, Wed Nov 25 2020
Authorization for Emergency Use for Medicinal Products, Medical Devices and IVDs
Rwanda FDA. GUIDELINES FOR AUTHORIZATION FOR EMERGENCY USE OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND IVDs., https://www.rwandafda.gov.rw/web/guidelines/Guidelines_for_Authorization_for_Emergency_Use_for_Medicinal_Products_Medical_devices_and_IVDs.pdf, Thu Aug 26 2021
Priority Review (Biological Products)
Rwanda FDA. Guidelines on submission of documentation for registration of human biological products., http://www.rwandafda.gov.rw/web/guidelines/Guidelines_Human_Biological_Products.pdf, Thu Aug 26 2021
Priority Review
Rwanda FDA. RWANDA FDA GUIDANCE ON PROCEDURAL ASPECTS FOR APPLICATIONS FOR MARKETING AUTHORIZATION OF HUMAN MEDICINES., https://www.rwandafda.gov.rw/web/guidelines/Guidance_on_Procedural_Aspects_for_Applications_for_Marketing_Authorization.pdf, Thu Aug 26 2021
Rwanda FDA. GUIDELINES ON RELIANCE FOR REGULATORY DECISION MAKING. , https://www.rwandafda.gov.rw/web/guidelines/GUIDELINES_ON_RELIANCE_FOR_REGULATORY_DECISION.pdf, Thu Aug 26 2021
Rwanda FDA. GUIDELINES ON ABRIDGED PROCEDURES FOR PHARMACEUTICAL PRODUCTS ASSESSMENT. , https://www.rwandafda.gov.rw/web/guidelines/Rwanda_FDA_Guidelines_on_Abridged_procedures_for_pharmaceutical_products_Assessment_April2020.pdf, Thu Aug 26 2021
Abridged Procedure
The Regulatory Reliance Review Model: Adoption in the Middle East., https://globalforum.diaglobal.org/issue/july-2019/the-regulatory-reliance-review-model-adoption-in-the-middle-east/, Thu Dec 12 2019
Registration according to Verification and Abridged Process. Version 2.2., https://www.sfda.gov.sa/sites/default/files/2024-05/VerificationAbridgedProcess22_0.pdf, Wed Jun 19 2024
Guidance for Priority Review of Product Registration. Version 5.3., https://www.sfda.gov.sa/sites/default/files/2024-02/ProrityReviewGuidanceV52_0.pdf, Wed Jun 19 2024
SFDA Fees: Details of all fees and amounts, https://pharmaknowl.com/sfda-fees/, Mon Jan 08 2024
Guideline: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products DS-REQ-074-V04/220404), Version 4, 04-Jun-2023, https://www.sfda.gov.sa/sites/default/files/2022-11/RegistrationRulesV3E.pdf, Thu Jan 18 2024
Guidance for Submission. Version 5.0., https://www.sfda.gov.sa/sites/default/files/2022-10/GuidanceSubmissionV5_0.pdf, Wed Jun 19 2024
Data Requirements for Human Drugs Submission - Content of the Dossier. Version 3.0. , https://www.sfda.gov.sa/sites/default/files/2022-10/Human-Drugs-SubV4.pdf, Wed Jun 19 2024
Guideline for Pharmaceutical Product Shelf Life Extension. Version 2.1., https://www.sfda.gov.sa/sites/default/files/2021-11/dr776-en.pdf, Wed Jun 19 2024
Verification Procedure
The Regulatory Reliance Review Model: Adoption in the Middle East., https://globalforum.diaglobal.org/issue/july-2019/the-regulatory-reliance-review-model-adoption-in-the-middle-east/, Thu Dec 12 2019
Registration according to Verification and Abridged Process. Version 2.2., https://www.sfda.gov.sa/sites/default/files/2024-05/VerificationAbridgedProcess22_0.pdf, Wed Jun 19 2024
Guidance for Priority Review of Product Registration. Version 5.3., https://www.sfda.gov.sa/sites/default/files/2024-02/ProrityReviewGuidanceV52_0.pdf, Wed Jun 19 2024
SFDA Fees: Details of all fees and amounts, https://pharmaknowl.com/sfda-fees/, Mon Jan 08 2024
Guideline: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products DS-REQ-074-V04/220404), Version 4, 04-Jun-2023, https://www.sfda.gov.sa/sites/default/files/2022-11/RegistrationRulesV3E.pdf, Thu Jan 18 2024
Guideline for Pharmaceutical Product Shelf Life Extension. Version 2.1., https://www.sfda.gov.sa/sites/default/files/2021-11/dr776-en.pdf, Wed Jun 19 2024
Data Requirements for Human Drugs Submission - Content of the Dossier. Version 3.0. , https://www.sfda.gov.sa/sites/default/files/2022-10/Human-Drugs-SubV4.pdf, Wed Jun 19 2024
Guidance for Submission. Version 5.0., https://www.sfda.gov.sa/sites/default/files/2022-10/GuidanceSubmissionV5_0.pdf, Wed Jun 19 2024
Priority Review
Guidance for Priority Review of Product Registration. Version 5.3., https://www.sfda.gov.sa/sites/default/files/2024-02/ProrityReviewGuidanceV52_0.pdf, Wed Jun 19 2024
Guideline: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products DS-REQ-074-V04/220404), Version 4, 04-Jun-2023, https://www.sfda.gov.sa/sites/default/files/2022-11/RegistrationRulesV3E.pdf, Thu Jan 18 2024
Guideline for Pharmaceutical Product Shelf Life Extension. Version 2.1., https://www.sfda.gov.sa/sites/default/files/2021-11/dr776-en.pdf, Wed Jun 19 2024
Data Requirements for Human Drugs Submission - Content of the Dossier. Version 3.0. , https://www.sfda.gov.sa/sites/default/files/2022-10/Human-Drugs-SubV4.pdf, Wed Jun 19 2024
Guidance for Submission. Version 5.0., https://www.sfda.gov.sa/sites/default/files/2022-10/GuidanceSubmissionV5_0.pdf, Wed Jun 19 2024
Breakthrough Medicine Program
SFDA. Breakthrough Medicine Program. Version 1.1. DS-G-109-V1.1/231025, https://www.sfda.gov.sa/sites/default/files/2024-05/SFDA-BMP_0.pdf, Wed Jun 19 2024
SFDA Fees: Details of all fees and amounts, https://pharmaknowl.com/sfda-fees/, Mon Jan 08 2024
Guideline: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products DS-REQ-074-V04/220404), Version 4, 04-Jun-2023, https://www.sfda.gov.sa/sites/default/files/2022-11/RegistrationRulesV3E.pdf, Thu Jan 18 2024
Guideline for Pharmaceutical Product Shelf Life Extension. Version 2.1., https://www.sfda.gov.sa/sites/default/files/2021-11/dr776-en.pdf, Wed Jun 19 2024
Data Requirements for Human Drugs Submission - Content of the Dossier. Version 3.0. , https://www.sfda.gov.sa/sites/default/files/2022-10/Human-Drugs-SubV4.pdf, Wed Jun 19 2024
Guidance for Submission. Version 5.0., https://www.sfda.gov.sa/sites/default/files/2022-10/GuidanceSubmissionV5_0.pdf, Wed Jun 19 2024
Conditional Approval for Medicinal Products for Human Use
SFDA. Conditional approval for medicinal products for human use. v1. DS-G-107-V01/231018 , https://www.sfda.gov.sa/sites/default/files/2023-10/CAMPv01_2.pdf, Wed Jun 19 2024
SFDA Fees: Details of all fees and amounts, https://pharmaknowl.com/sfda-fees/, Mon Jan 08 2024
Guideline: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products DS-REQ-074-V04/220404), Version 4, 04-Jun-2023, https://www.sfda.gov.sa/sites/default/files/2022-11/RegistrationRulesV3E.pdf, Thu Jan 18 2024
Guideline for Pharmaceutical Product Shelf Life Extension. Version 2.1., https://www.sfda.gov.sa/sites/default/files/2021-11/dr776-en.pdf, Wed Jun 19 2024
Data Requirements for Human Drugs Submission - Content of the Dossier. Version 3.0. , https://www.sfda.gov.sa/sites/default/files/2022-10/Human-Drugs-SubV4.pdf, Wed Jun 19 2024
Orphan Drug Designation
SFDA. Guidance for Orphan Drug Designation. v1.1. DS-G-101-V1.1/230604, https://www.sfda.gov.sa/sites/default/files/2024-05/SFDA-OrphanDrugDesignation_0.pdf, Wed Jun 19 2024
Guideline: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products DS-REQ-074-V04/220404), Version 4, 04-Jun-2023, https://www.sfda.gov.sa/sites/default/files/2022-11/RegistrationRulesV3E.pdf, Thu Jan 18 2024
Guideline for Pharmaceutical Product Shelf Life Extension. Version 2.1., https://www.sfda.gov.sa/sites/default/files/2021-11/dr776-en.pdf, Wed Jun 19 2024
Data Requirements for Human Drugs Submission - Content of the Dossier. Version 3.0. , https://www.sfda.gov.sa/sites/default/files/2022-10/Human-Drugs-SubV4.pdf, Wed Jun 19 2024
Guidance for Submission. Version 5.0., https://www.sfda.gov.sa/sites/default/files/2022-10/GuidanceSubmissionV5_0.pdf, Wed Jun 19 2024
Marketing Authorization Issuance according to the Accelerated Procedure
PRICELIST (“Official Gazette of the Republic of Serbia”, No. 95/2017). , https://www.alims.gov.rs/eng/files/2019/02/Cenovnik_Pricelist.pdf, Fri Jan 17 2020
Law on medicines and medical devices (“The Official Gazette of the Republic of Serbia”, 30/2010; 107/2012-other law and 113/2017-other law). , https://www.alims.gov.rs/eng/files/2013/04/Law-on-Medicines-and-Medical-Devices-2010.doc, Fri Jan 17 2020
Expedited/Fast-Track Review Process
Registration Fees, http://www.pharmacyboard.gov.sl/RegistrationFees.php, Mon May 06 2024
Guideline for registration of allopathic/medicinal products (Common Technical Document) - Quality Part. Doc No: PBSL/GL/037. Version No. 2. , https://pharmacyboard.gov.sl/admin/gallery/e33e3d132e121b3b7ddd99741bb2ee9b.pdf, Mon May 06 2024
Guidelines for the expedited registration of medical products. Doc No: PBSL/GL/024. Version No 2., https://clinregs.niaid.nih.gov/sites/default/files/documents/sierra_leone/G-FastReg_v2.pdf, Mon May 06 2024
Listing of specialized or orphan products for importation in Sierra Leone
Registration Fees, http://www.pharmacyboard.gov.sl/RegistrationFees.php, Mon May 06 2024
GUIDELINES FOR THE LISTING OF SPECIALISED OR ORPHAN PRODUCTS FOR IMPORTATION IN SIERRA LEONE. Doc No: PBSL/GL/028. Version No. 2. , https://pharmacyboard.gov.sl/admin/gallery/e02103f30ccd2444a1640c73fd59392d.pdf, Mon May 06 2024
Emergency Use Authorization
Approval of COVID-19 vaccines in Sierra Leone., https://pharmacyboard.gov.sl/admin/gallery/f26b937f23658d145161c96a78849cd8.pdf, Mon May 06 2024
Verification - CECA Route
Health Sciences Authority. Fees and turnaround time for therapeutic products., https://www.hsa.gov.sg/therapeutic-products/fees, Sat Apr 02 2022
Health Sciences Authority. Guidance on Therapeutic Product Registration in Singapore (August 2021). TPB-GN-005-007., https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/guidance-on-therapeutic-product-registration-in-singapore_aug21.pdf, Sat Apr 02 2022
ECTD submissions, https://www.hsa.gov.sg/therapeutic-products/register/ectd-submissions, Wed Jun 19 2024
GDA Verification Route
Health Sciences Authority. Fees and turnaround time for therapeutic products., https://www.hsa.gov.sg/therapeutic-products/fees, Sat Apr 02 2022
Health Sciences Authority. Guidance on Therapeutic Product Registration in Singapore (August 2021). TPB-GN-005-007. , https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/guidance-on-therapeutic-product-registration-in-singapore_aug21.pdf, Sat Apr 02 2022
ECTD submissions, https://www.hsa.gov.sg/therapeutic-products/register/ectd-submissions, Wed Jun 19 2024
GDA Abridged Route
Health Sciences Authority. Fees and turnaround time for therapeutic products., https://www.hsa.gov.sg/therapeutic-products/fees, Sat Apr 02 2022
Health Sciences Authority. Guidance on Therapeutic Product Registration in Singapore (August 2021). TPB-GN-005-007., https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/guidance-on-therapeutic-product-registration-in-singapore_aug21.pdf, Sat Apr 02 2022
ECTD submissions, https://www.hsa.gov.sg/therapeutic-products/register/ectd-submissions, Wed Jun 19 2024
NDA Abridged Route
Health Sciences Authority. Fees and turnaround time for therapeutic products. , https://www.hsa.gov.sg/therapeutic-products/fees, Sat Apr 02 2022
Health Sciences Authority. Guidance on Therapeutic Product Registration in Singapore (August 2021). TPB-GN-005-007., https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/guidance-on-therapeutic-product-registration-in-singapore_aug21.pdf, Sat Apr 02 2022
ECTD submissions, https://www.hsa.gov.sg/therapeutic-products/register/ectd-submissions, Wed Jun 19 2024
NDA Verification Evaluation Route
Health Sciences Authority. Verification evaluation route for new drug application., https://www.hsa.gov.sg/therapeutic-products/register/guides/new-drug/verification-evaluation, Sat Apr 02 2022
Health Sciences Authority. Fees and turnaround time for therapeutic products., https://www.hsa.gov.sg/therapeutic-products/fees, Sat Apr 02 2022
Health Sciences Authority. Guidance on Therapeutic Product Registration in Singapore (August 2021). TPB-GN-005-007., https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/guidance-on-therapeutic-product-registration-in-singapore_aug21.pdf, Sat Apr 02 2022
ECTD submissions, https://www.hsa.gov.sg/therapeutic-products/register/ectd-submissions, Wed Jun 19 2024
Pandemic Special Access Route (PSAR)
Pandemic Special Access Route (PSAR) for Supply of Emergency Therapeutic Products, https://www.hsa.gov.sg/therapeutic-products/register/special-access-routes/psar-emergency-therapeutic-product, Thu May 23 2024
Minimum Data Requirement for Application via the Pandemic Special Access Route [PSAR] for Supply of Emergency Therapeutic Products, https://www.hsa.gov.sg/docs/default-source/hprg-tpb/psar/annex-a-to-guidance-note-on-psar-for-emergency-tp_jun22_final.pdf?sfvrsn=dab3a124_15, Thu May 23 2024
Pandemic Special Access Route (PSAR) , https://www.hsa.gov.sg/hsa-psar, Thu May 23 2024
ECTD submissions, https://www.hsa.gov.sg/therapeutic-products/register/ectd-submissions, Wed Jun 19 2024
HSA-NPRA Generic Medicines Work Sharing Initiative
About the HSA-NPRA Generic Medicines Work Sharing Initiative., https://www.hsa.gov.sg/therapeutic-products/international-collaboration/npra#:~:text=The%20HSA-NPRA%20Generic%20Medicines%20Work%20Sharing%20Initiative%20is,the%20National%20Pharmaceutical%20Regulatory%20Agency%20%28NPRA%29%20of%20Malaysia., Mon Oct 28 2024
Request for Expressions of Interest (EOI) to Participate in the HSA-NPRA Generic Medicines Work-Sharing Initiative., https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/npra/1-notice-to-applicants-(npra).pdf?sfvrsn=b5c911d_0, Mon Oct 28 2024
Operational Procedures. , https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/npra/2-operational-procedures-(npra).pdf?sfvrsn=ad2cd4e0_0, Mon Oct 28 2024
Expression of Interest (EoI) Form., https://www.hsa.gov.sg/docs/default-source/gdo/international-collaboration/npra/3-eoi-form-(npra).docx?sfvrsn=c0b505b5_0, Mon Oct 28 2024
Reliance-based Evaluation Pathways – ABRIDGED REVIEW
QUALITY AND BIOEQUIVALENCE GUIDELINE., https://www.sahpra.org.za/wpcontent/uploads/2020/02/2.02_Quality-and-BioequivalenceGuideline_Jul19_v7-1.pdf, Sun May 10 2020
CLINICAL GUIDELINE. , https://www.sahpra.org.za/wpcontent/uploads/2020/02/2.09_Clinical-Guideline_Jul19_v2- 1.pdf, Sun May 10 2020
GUIDANCE FOR THE SUBMISSION OF THE SOUTH AFRICAN CTD /eCTD - GENERAL & MODULE., https://www.sahpra.org.za/wpcontent/uploads/2020/02/2.01- Guidance_General_Module_1_May19_v6-1.pdf, Sun May 10 2020
The Regulatory Review Process in South Africa. , https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6047299/,
Updated – General Information., https://sahivsoc.org/Files/2.01_general%20information_%20 jul19_v10%20(1).pdf,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181, 10.3389/fmed.2021.742181,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200., 10.3389/fmed.2021.742200,
Reliance Guidance. 15 May 2024. SAHPGL-BAU-01_v4. , https://www.sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-BAU-01_v4-Reliance-Guideline.pdf, Sat Jun 15 2024
SAHPRA. GENERAL INFORMATION GUIDELINE. 17 April 2023. SAHPGL-HPA-07_v11 , https://www.sahpra.org.za/wp-content/uploads/2023/04/SAHPGL-HPA-07_v11-General-Information-Guideline.pdf, Wed May 10 2023
Agreements/MOUs With Other Regulators Or Similar Organisations., https://www.sahpra.org.za/agreements-mous-with-other-regulators-or-similar-organisations/, Sat Jun 15 2024
Agreements/MOUs With Other Regulators Or Similar Organisations., https://www.sahpra.org.za/agreements-mous-with-other-regulators-or-similar-organisations/, Sat Jun 15 2024
Reliance-based Evaluation Pathways - RECOGNITION
QUALITY AND BIOEQUIVALENCE GUIDELINE., https://www.sahpra.org.za/wpcontent/uploads/2020/02/2.02_Quality-and-Bioequivalence-Guideline_Jul19_v7-1.pdf, Sun May 10 2020
CLINICAL GUIDELINE., https://www.sahpra.org.za/wpcontent/uploads/2020/02/2.09_Clinical-Guideline_Jul19_v2-1.pdf, Sun May 10 2020
GUIDANCE FOR THE SUBMISSION OF THE SOUTH AFRICAN CTD /eCTD - GENERAL & MODULE., https://www.sahpra.org.za/wpcontent/uploads/2020/02/2.01-Guidance_General_Module_1_May19_v6-1.pdf, Sun May 10 2020
The Regulatory Review Process in South Africa., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6047299/,
6. Updated – General Information., https://sahivsoc.org/Files/2.01_general%20information_%20jul19_v10%20(1).pdf,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200., 10.3389/fmed.2021.742200,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181. , 10.3389/fmed.2021.742181,
Reliance Guidance. 15 May 2024. SAHPGL-BAU-01_v4. , https://www.sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-BAU-01_v4-Reliance-Guideline.pdf, Sat Jun 15 2024
SAHPRA. GENERAL INFORMATION GUIDELINE. 17 April 2023. SAHPGL-HPA-07_v11, https://www.sahpra.org.za/wp-content/uploads/2023/04/SAHPGL-HPA-07_v11-General-Information-Guideline.pdf, Wed May 10 2023
Agreements/MOUs With Other Regulators Or Similar Organisations., https://www.sahpra.org.za/agreements-mous-with-other-regulators-or-similar-organisations/, Sat Jun 15 2024
Reliance-based Evaluation Pathways – VERIFIED REVIEW
QUALITY AND BIOEQUIVALENCE GUIDELINE., https://www.sahpra.org.za/wpcontent/uploads/2020/02/2.02_Quality-and-BioequivalenceGuideline_Jul19_v7-1.pdf, Sun May 10 2020
CLINICAL GUIDELINE., https://www.sahpra.org.za/wpcontent/uploads/2020/02/2.09_Clinical-Guideline_Jul19_v2- 1.pdf, Sun May 10 2020
GUIDANCE FOR THE SUBMISSION OF THE SOUTH AFRICAN CTD /eCTD - GENERAL & MODULE., https://www.sahpra.org.za/wpcontent/uploads/2020/02/2.01-Guidance_General_Module_1_May19_v6-1.pdf, Sun May 10 2020
The Regulatory Review Process in South Africa., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6047299/,
Updated – General Information. , https://sahivsoc.org/Files/2.01_general%20information_%20j ul19_v10%20(1).pdf,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181., 10.3389/fmed.2021.742181,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200., 10.3389/fmed.2021.742200,
Reliance Guidance. 15 May 2024. SAHPGL-BAU-01_v4. , https://www.sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-BAU-01_v4-Reliance-Guideline.pdf, Sat Jun 15 2024
SAHPRA. GENERAL INFORMATION GUIDELINE. 17 April 2023. SAHPGL-HPA-07_v11, https://www.sahpra.org.za/wp-content/uploads/2023/04/SAHPGL-HPA-07_v11-General-Information-Guideline.pdf, Wed May 10 2023
Agreements/MOUs With Other Regulators Or Similar Organisations., https://www.sahpra.org.za/agreements-mous-with-other-regulators-or-similar-organisations/, Sat Jun 15 2024
Registration of Candidate COVID-19 vaccines
SAHPRA Fees, https://www.sahpra.org.za/document/regulations-regarding-fees-payable-in-terms-of-the-provisions-of-the-medicines-and-related-substances-act-1965-act-no-101-of-1965/, Sun Sep 24 2023
INFORMATION AND GUIDANCE ON APPLICATION FOR REGISTRATION OF CANDIDATE COVID-19 VACCINE - COMMUNICATION TO INDUSTRY. v1 Nov 2020, https://www.sahpra.org.za/wp-content/uploads/2020/12/INFORMATION-AND-GUIDANCE-ON-APPLICATION-FOR-REGISTRATION-OF-CANDIDATE-COVID-19-VACCINE.pdf, Sun Sep 24 2023
COVID-19 Related Priority Process Guidance for New Medicine Registration Applications, https://www.sahpra.org.za/wp-content/uploads/2020/03/Priority-Process-Guidance-for-COVID-19.pdf, Mon May 13 2024
EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)
Concept Note of EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)., https://www.sahpra.org.za/wp-content/uploads/2024/10/WSI_Concept-Note_JTWG-Approved-NEW.pdf, Mon Oct 28 2024
Annex I: Application Form for EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)., https://www.sahpra.org.za/wp-content/uploads/2024/10/WSI_Annex-I_Application-Form_JTWG-Approved-NEW.pdf, Mon Oct 28 2024
Annex II - Operating Procedures of EDA SAHPRA Work Sharing Initiative (WSI) in Registration of Medical products (Pilot Phase)., https://www.sahpra.org.za/wp-content/uploads/2024/10/WSI_Annex-II_Operating-Procedures_JTWG-Approved-NEW.pdf, Mon Oct 28 2024
Prior Review
Regulation on Fees for Pharmaceutical Approval, etc., https://www.mfds.go.kr/eng/brd/m_18/view.do?seq=71456&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1, Wed Jan 15 2020
Regulation for Pharmaceutical Approvals, Notifications and Reviews., https://www.mfds.go.kr/eng/brd/m_18/view.do?seq=71448&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=2, Wed Jan 15 2020
Regulation on Prior Review of Pharmaceuticals. , https://www.mfds.go.kr/eng/brd/m_18/view.do?seq=70099&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=3, Wed Jan 15 2020
Guide to Drug Approval System in Korea. , https://www.mfds.go.kr/eng/brd/m_52/down.do?brd_id=eng0013&seq=71608&data_tp=A&file_seq=1, Wed Jan 15 2020
Prime Minister Ordinance No. 1985: Regulation on Safety of Pharmaceutical Drugs., https://www.law.go.kr/LSW/lsInfoP.do?lsiSeq=265711&ancYd=20241004&ancNo=01985&efYd=20250405&nwJoYnInfo=N&efGubun=Y&chrClsCd=010202&ancYnChk=0#AJAX, Sat Jan 25 2025
Global Innovative products on Fast Track (GIFT)
Global Innovative products on Fast Track(GIFT), https://www.mfds.go.kr/eng/wpge/m_1176/de011009l001.do, Thu May 23 2024
Visual Guide for GIFT, https://www.mfds.go.kr/com/file/down.do?dnCd=eng&fileNm=visual%20guide%20of%20GIFT.pdf&filePath=contents/, Thu May 23 2024
Regulation on Fees for Pharmaceutical Approval, etc., https://www.mfds.go.kr/eng/brd/m_18/down.do?brd_id=eng0003&seq=71529&data_tp=A&file_seq=1, Thu May 23 2024
GIFT Designation Products., https://www.mfds.go.kr/com/file/down.do?dnCd=eng&fileNm=List%20of%20GIFT%20designation%20products_240716.xlsx&filePath=contents/, Mon Nov 18 2024
Prime Minister Ordinance No. 1985: Regulation on Safety of Pharmaceutical Drugs., https://www.law.go.kr/LSW/lsInfoP.do?lsiSeq=265711&ancYd=20241004&ancNo=01985&efYd=20250405&nwJoYnInfo=N&efGubun=Y&chrClsCd=010202&ancYnChk=0#AJAX, Sat Jan 25 2025
Fast Track (Priority) Review
Guideline on Registration of Medicines., https://nmra.gov.lk/images/PDF/draft_guidelines/Guideline-on-registration-of-medicine.pdf, Sun May 31 2020
TBD
Swissmedic Article 13 Therapeutic Product Act (TPA)
Guidance on applications according to Article 13 TPA for eCTD applications., , Mon Sep 05 2022
Swissmedic. Questions and answers Art. 13 TPA Version dated 13 June 2022. , ,
Questions and answers Art. 13 TPA Version dated 1 November 2019., https://www.swissmedic.ch/swissmedic/en/home/legal/legal-basis/administrative-ordinances/questions-and-answers-regarding-the-application-of-the-administr.html, Sun Jun 13 2021
Swissmedic. Directory List countries with comparable control of human medicinal products HMV4., , Sun Jun 13 2021
Swissmedic. Guidance document Authorisation human medicinal product under Art. 13 TPA. Version 4.1, https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_019d_vvanleitungzulassungimauslandbereitszugelassenerhu.pdf.download.pdf/ZL000_00_019e_WL%20Guidance%20document%20Authorisation%20human%20medicine%20under%20Art%2013%20ATP.pdf, Thu Aug 31 2023
Swissmedic. Time Limits for Authorisation Applications. Version 9.0, Effective 1 June 2025., https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_014d_wlfristenzulassungsgesuche.pdf.download.pdf/zl000_00_014e_wltimelimitsforauthorizationapplications.pdf, Fri Aug 08 2025
Swissmedic Marketing Authorisation for Global Health Products (MAGHP) Procedure
SwissMedic Guidance document MAGHP Procedure., , Mon Apr 20 2020
Presentation at the 2023 Global Health and Regulatory Team Convening (April 2023) Lisbon: L Paganini, Swissmedic, , Wed Apr 26 2023
Swissmedic. Time Limits for Authorisation Applications. Version 9.0, Effective 1 June 2025., https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_014d_wlfristenzulassungsgesuche.pdf.download.pdf/zl000_00_014e_wltimelimitsforauthorizationapplications.pdf, Fri Aug 08 2025
Procedure with prior notification (PPN)
Swissmedic. Guidance document - Procedure with prior notification HMV4. , https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl101_00_013d_wlerlaeuterungenzumverfahrenmitvoranmeldungvmva.pdf.download.pdf/zl101_00_013e_mbexplanationoftheprocedurewithpriornotificationpp.pdf, Sat Jun 12 2021
Swissmedic. Time Limits for Authorisation Applications. Effective 1 June 2025., https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_014d_wlfristenzulassungsgesuche.pdf.download.pdf/zl000_00_014e_wltimelimitsforauthorizationapplications.pdf, Fri Aug 08 2025
Fast-track authorisation procedure (FTP)
Swissmedic. Guidance document - Fast-track authorisation procedure. Identification number: ZL104_00_002. Version: 10.0 (Valid from: 15.01.2024), https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl104_00_002d_wl_beschleunigtes_zlverfahren_hmv4_ab_010121.pdf.download.pdf/ZL104_00_002e_WL_Fast_track_authorisation_procedure.pdf, Thu Jan 18 2024
Swissmedic. Changes to the Guidance document Fast-track authorisation procedure: Optimisation of the application procedure for the implementation of a fast-track authorisation procedure (FTP)., https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-beschleunigtes-zulassungsverfahren.html, Thu Jan 18 2024
Swissmedic. Time Limits for Authorisation Applications. Effective 1 June 2025., https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_014d_wlfristenzulassungsgesuche.pdf.download.pdf/zl000_00_014e_wltimelimitsforauthorizationapplications.pdf, Fri Aug 08 2025
Temporary authorisation for human medicinal products
Swissmedic. Guidance document Temporary authorisation for human medicinal products. Identification number: ZL109_00_001. Version 14.0 (Valid from: 15.01.2024), https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl109_00_001d_wl_befristete_zl_ham_hmv4_ab_010121.pdf.download.pdf/ZL109_00_001e_WL_Temporary_authorisation_for_human_medicinal_products.pdf, Wed Jan 17 2024
Swissmedic. Guidance document - Time limits for authorisation applications. Version 9.0, Effective 1 June 2025. , https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_014d_wlfristenzulassungsgesuche.pdf.download.pdf/zl000_00_014e_wltimelimitsforauthorizationapplications.pdf, Fri Aug 08 2025
Simplified Authorization Procedure (Art. 14)
Guidance document Authorisation in accordance with Art. 14para.1 abis-quater TPA, https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_022d_wlzulassungart14abs1bstabis-quaterhmg.pdf.download.pdf/zl000_00_022e_wlauthorisationart14para1abis-quatertpa.pdf, Thu Jul 06 2023
Questions and answers on Art. 14 para. 1 letter abis-quater TPA HMV4, https://www.swissmedic.ch/swissmedic/en/home/services/documents/faq_art14abs_1bst_abis-quater_hmg.html, Thu Jul 06 2023
Guidance document. Time limits for authorisation applications. Version 9.0, effective 1 June 2025., https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_014d_wlfristenzulassungsgesuche.pdf.download.pdf/zl000_00_014e_wltimelimitsforauthorizationapplications.pdf, Fri Aug 08 2025
Fees, https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/clinical-trials/gebuehren.html, Thu Jul 06 2023
Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 updated, https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-zl-art-14.html, Thu Jul 06 2023
Marketing Authorisation for Global Health Products (MAGHP) Light Procedure
Swissmedic Fees, https://www.fedlex.admin.ch/eli/cc/2018/593/de, Mon Sep 25 2023
Swissmedic extends the MAGHP procedure, https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/maghp_light.html, Mon Sep 25 2023
Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP), https://www.swissmedic.ch/swissmedic/en/home/about-us/development-cooperation/marketing-authorisation-for-global-health-products.html, Mon Sep 25 2023
Leaflet “Swissmedic – MAGHP Procedure” (PDF, 344 kB, 21.01.2021), https://www.swissmedic.ch/dam/swissmedic/en/dokumente/stab/networking/Swissmedic_MAGHP_Procedure.pdf.download.pdf/Swissmedic_MAGHP_Procedure.pdf, Mon Sep 25 2023
ZL000_00_047e_WL Guidance document MAGHP Procedure (PDF, 446 kB, 25.05.2023), https://www.swissmedic.ch/dam/swissmedic/en/dokumente/stab/networking/maghp_procedure.pdf.download.pdf/maghp_procedure.pdf, Mon Sep 25 2023
Draft Procedure for Scientific advice meetings during the developmental phase of a medicinal product intended for submission under the Swissmedic Marketing Authorisation for Global Health Products (MAGHP) ZL105_00_002e_WL Guidance document Scientific Advice MAGHP (PDF, 345 kB, 01.05.2023), https://www.swissmedic.ch/dam/swissmedic/en/dokumente/stab/networking/scientific_advicemeetingsmaghpprocedure.pdf.download.pdf/scientific_advicemeetingsmaghpprocedure.pdf, Mon Sep 25 2023
Swissmedic. Time Limits for Authorisation Applications. Version 9.0, Effective 1 June 2025., https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_014d_wlfristenzulassungsgesuche.pdf.download.pdf/zl000_00_014e_wltimelimitsforauthorizationapplications.pdf, Fri Aug 08 2025
Priority Review
Fee-Charging Standards for the Review of Medicament and Cosmetic Advertisements., , Mon Jan 06 2020
Taiwan Drug Approval Process., https://www.fda.gov.tw/eng/newsContent.aspx?id=22247, Mon Jan 06 2020
Priority review mechanism for new drug inspection and registration., https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637097695048103910&type=1, Mon Nov 18 2024
Key Explanations and Comparisons of Various Review Mechanisms for New Drug Inspection and Registration (pdf), https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637100308229586539&type=1, Mon Nov 18 2024
Accelerated Approval
Fee-Charging Standards for the Review of Medicament and Cosmetic Advertisements., , Mon Jan 06 2020
Taiwan Drug Approval Process. , https://www.fda.gov.tw/eng/newsContent.aspx?id=22247, Mon Jan 06 2020
Accelerated approval mechanism for new drug inspection and registration., https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637097695048203883&type=1, Mon Nov 18 2024
Key Explanations and Comparisons of Various Review Mechanisms for New Drug Inspection and Registration (pdf)., https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637100308229586539&type=1, Mon Nov 18 2024
Abbreviated Review
Fee-Charging Standards for the Review of Medicament and Cosmetic Advertisements., , Mon Jan 06 2020
Taiwan Drug Approval Process., https://www.fda.gov.tw/eng/newsContent.aspx?id=22247, Mon Jan 06 2020
Streamlining the review mechanism for new drug inspection and registration, https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637097695047973843&type=1, Mon Nov 18 2024
Key Explanations and Comparisons of Various Review Mechanisms for New Drug Inspection and Registration (pdf)., https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637100308229586539&type=1, Mon Nov 18 2024
Taiwan Orphan Drug Pathway
REGULATION OF ORPHAN DRUGS IN TAIWAN. Yin-Hsiu Chien, M.D., PhD. Department of Medical Genetics and Pediatrics. National Taiwan University Hospital. , https://www.pmda.go.jp/files/000243140.pdf, Fri Jul 15 2022
Ministry of Health & Welfare. The Rare Disease and Orphan Drug Act. , https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030003, Fri Jul 15 2022
Rare diseases, orphan drugs, and their regulation in Asia: Current status and future perspectives. Peipei Song, Jianjun Gao, Yoshinori Inagaki, Norihiro Kokudo, Wei Tang. Intractable & Rare Diseases Research. 2012; 1(1):3-9. DOI: 10.5582/irdr.2012.v1.1.3, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4204590/pdf/irdr-1-3.pdf, Fri Jul 15 2022
Breakthrough Therapy Designation
Key points for Breakthrough Therapy Designation., https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637097695048303869&type=1, Mon Nov 18 2024
Key Explanations and Comparisons of Various Review Mechanisms for New Drug Inspection and Registration (pdf)., https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637100308229586539&type=1, Mon Nov 18 2024
Fast Track Evaluation
TFDA Registration Medicines., https://www.tmda.go.tz/uploads/publications/en1573544130- GN%20314%20-%20Registration%20medicines.pdf, Wed Nov 13 2019
Guidelines of submission of documentation for registration of human pharmaceutical products., https://www.tmda.go.tz/uploads/publications/en1558078061- Guidelines%20on%20Submission%20of%20Documentation %20for%20Registration%20of%20Human%20Pharmaceutic al%20Products_0.pdf, Wed Nov 13 2019
Quality Assurance Tanzania. , http://origin.who.int/hiv/amds/QualityAssuranceTanzania.ppt, Wed Nov 13 2019
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181. , 10.3389/fmed.2021.742181,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200., 10.3389/fmed.2021.742200,
Abridged Review
TMDA. Compendium Guidelines for Marketing Authorization of Medicinal Products. , https://www.tmda.go.tz/uploads/documents/en1628081967-en1599042165-en1597226062-COMPENDIUM%20GUIDELINES%20FOR%20MARKETING%20AUTHORIZATION%20OF%20MEDICINAL%20PRODUCTS%20JULY%202020.pdf, Mon Sep 05 2022
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200., 10.3389/fmed.2021.742200, Mon Sep 05 2022
TMDA. GUIDELINES ON REGULATORY RELIANCE FOR MARKETING AUTHORISATION OF HUMAN MEDICINAL PRODUCTS. July 2025. Doc No. TMDA/DMC/MRE/G/022; Rev. #00 , https://www.tmda.go.tz/uploads/publications/en1754936171-en1753251628-The%20Guidelines%20on%20Regulatory%20Reliance%20for%20Marketing%20Authorisation%20of%20Human%20Medicinal%20Products%20July,%202025.pdf, Sun Nov 02 2025
TMDA. Application Forms for Medicines Registration., https://www.tmda.go.tz/publications/23, Sun Nov 02 2025
Emergency Use Authorization of Medicinal Products
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY. GUIDELINES FOR EMERGENCY USE AUTHORIZATION OF MEDICINAL PRODUCTS. Doc No. TMDA/DMC/MRE/G/018 Rev.#00. , https://www.tmda.go.tz/uploads/documents/en1663061902-FINAL%20GUIDELINES%20FOR%20EMMERGENCE%20USE%20AUTHORIZATION%20OF%20MEDICINAL%20PRODUCTS_12_09_2022.pdf, Mon Feb 13 2023
Tanzania announcements on Covid-19 vaccines authorisations, https://www.tmda.go.tz/announcements/tmda-authorizes-five-types-of-covid-19-vaccines-fo, Thu May 09 2024
Orphan Medicines
Tanzania Medicines & Medical Devices Authority. Orphan Medicines., https://www.tmda.go.tz/pages/orphan-medicines, Mon Feb 13 2023
Recognition
TMDA. GUIDELINES ON REGULATORY RELIANCE FOR MARKETING AUTHORISATION OF HUMAN MEDICINAL PRODUCTS. July 2025. Doc No. TMDA/DMC/MRE/G/022; Rev. #00 , https://www.tmda.go.tz/uploads/publications/en1754936171-en1753251628-The%20Guidelines%20on%20Regulatory%20Reliance%20for%20Marketing%20Authorisation%20of%20Human%20Medicinal%20Products%20July,%202025.pdf, Sun Nov 02 2025
TMDA. Compendium Guidelines for Marketing Authorization of Medicinal Products, July, 2020., https://www.tmda.go.tz/uploads/publications/en1755005202-en1599042165-en1597226062-COMPENDIUM%20GUIDELINES%20FOR%20MARKETING%20AUTHORIZATION%20OF%20MEDICINAL%20PRODUCTS%20JULY%202020.pdf, Sun Nov 02 2025
TMDA. Application Forms for Medicines Registration., https://www.tmda.go.tz/publications/23, Sun Nov 02 2025
Verification of the sameness
TMDA. GUIDELINES ON REGULATORY RELIANCE FOR MARKETING AUTHORISATION OF HUMAN MEDICINAL PRODUCTS. July 2025. Doc No. TMDA/DMC/MRE/G/022; Rev. #00 , https://www.tmda.go.tz/uploads/publications/en1754936171-en1753251628-The%20Guidelines%20on%20Regulatory%20Reliance%20for%20Marketing%20Authorisation%20of%20Human%20Medicinal%20Products%20July,%202025.pdf, Sun Nov 02 2025
TMDA. Compendium Guidelines for Marketing Authorization of Medicinal Products, July, 2020., https://www.tmda.go.tz/uploads/publications/en1755005202-en1599042165-en1597226062-COMPENDIUM%20GUIDELINES%20FOR%20MARKETING%20AUTHORIZATION%20OF%20MEDICINAL%20PRODUCTS%20JULY%202020.pdf, Sun Nov 02 2025
TMDA. Application Forms for Medicines Registration., https://www.tmda.go.tz/publications/23, Sun Nov 02 2025
Abridged Evaluation of New Drugs
Drug Regulation in Thailand. , https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source =web&cd=15&cad=rja&uact=8&ved=2ahUKEwiN5evvsLrnAh VRalAKHfnmCB8QFjAOegQIBBAB&url=https%3A%2F%2Fw ww.fda.gov.tw%2Ftc%2Fincludes%2FGetFile.ashx%3Fid%3 Df636695447955896008&usg=AOvVaw2AUNvUr_Cw5kPc0dtmEIF, Wed Feb 05 2020
Drug Registration in Malaysia, Thailand, other Asia markets. , https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source =web&cd=16&cad=rja&uact=8&ved=2ahUKEwiN5evvsLrnAh VRalAKHfnmCB8QFjAPegQICBAB&url=https%3A%2F%2Fw ww.pacificbridgemedical.com%2Fregulatoryservices%2Fpharmaceutical%2Fproductregistration%2Fothers%2F&usg=AOvVaw37yYIlUvGQw0jqy 1aN8v1y, Wed Feb 05 2020
Regulatory, Pricing and Reimbursement Overview: Thailand., https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source =web&cd=17&cad=rja&uact=8&ved=2ahUKEwiN5evvsLrnAh VRalAKHfnmCB8QFjAQegQIBxAB&url=https%3A%2F%2Fp harmaboardroom.com%2Flegal-articles%2Fregulatorypricing-and-reimbursement-overview-thailand%2F&usg=AOvVaw2yxKFKzqBwHglR0D5aGghZ, Wed Feb 05 2020
Drug act B.E.2510 and its amendments., http://www.fda.moph.go.th/sites/drug/EN/Shared%20Docu ments/law/DrugAct2510.pdf, Sat Jan 18 2020
Conditional Approval for Emergency Use of Medical Products
Regulatory Regime for Approval of COVID-19 Vaccines by the Thai FDA, https://www.tilleke.com/insights/regulatory-regime-for-approval-of-covid-19-vaccines-by-the-thai-fda/, Thu May 23 2024
Thailand Updates Rules on Conditional Approval for Emergency Use of Medicinal Products, https://www.tilleke.com/insights/thailand-updates-rules-on-conditional-approval-for-emergency-use-of-medicinal-products/, Thu May 23 2024
Guideline on procedural aspects regarding MA of vaccines in Thailand, https://drug.fda.moph.go.th/media.php?id=504244657690124288&name=Procedural_%20GL_Vaccine_final_sep_08.pdf, Thu May 23 2024
Conditional approval for emergency use of medical products., https://en.fda.moph.go.th/media.php?id=504122968562081792&name=7.%20Condition%20for%20emergency%20use%20No.1%20FDA-20200725.pdf, Thu May 23 2024
Conditional approval for emergency use of medical products., https://old.fda.moph.go.th/sites/drug/Shared%20Documents/Law04-Notification-ThFDA/FDA-20210217.pdf, Thu May 23 2024
Abridged Review
MCA Gambia. Guideline for registration of medicines. Document number and version: MCA-GL-102, version 3., http://www.mca.gm/wp-content/uploads/2018/01/MCA-GL-102_v3_Registration-Meds_15Apr20-1.pdf, Thu Aug 26 2021
Homologation procedure
Agency descriptor, https://amrh.nepad.org/amrh-countries/togo, Thu Nov 09 2023
WHO Announcement, https://extranet.who.int/prequal/news/togo-joins-collaborative-registration-procedure, Thu Nov 09 2023
Prioritization Request
ANMPS. GUIDE DE L’ENREGISTREMENT DES MEDICAMENTS A USAGE HUMAIN EN TUNISIE T-OP2-003-FR-000. Juin 2025. Date d’entrée en vigueur : Septembre 2025, https://drive.google.com/file/d/1aKYDxwoAnov3yyNu1E5wkrUUalnFD2wK/view, Sun Jul 20 2025
Abbreviated Assessment
ANMPS. GUIDE DE L’ENREGISTREMENT DES MEDICAMENTS A USAGE HUMAIN EN TUNISIE T-OP2-003-FR-000. Juin 2025. Date d’entrée en vigueur : Septembre 2025, https://drive.google.com/file/d/1aKYDxwoAnov3yyNu1E5wkrUUalnFD2wK/view, Sun Jul 20 2025
ANMPS. Guide de l’Enregistrement des Médicaments à usage Humain via la Procédure de confiance réglementaire « Reliance » Juin 2025. Version pour commentaires., https://drive.google.com/file/d/1-OOEeANi9yuA1MZpdHRUXVVzSzf7nC8-/view, Sun Jul 20 2025
ANMPS. GUIDE DE L’ENREGISTREMENT DES MEDICAMENTS A USAGE HUMAIN EN TUNISIE VIA LES PROCEDURES DE CONFIANCE REGLEMENTAIRES « RELIANCE ». AOUT 2025. « Mise en application: Septembre 2025 ». Document ID: T-OP2-010-FR. Version: 000-19.08.2025., https://media.licdn.com/dms/document/media/v2/D4D1FAQEBYtc9ZDY6Vg/feedshare-document-pdf-analyzed/B4DZj06RI7IYAs-/0/1756455583088?e=1758758400&v=beta&t=3AuEiRCequPlzYa5hgHjPbqnwBMGgcp1BjTkasjASbU, Mon Sep 15 2025
Verification Procedure
ANMPS. GUIDE DE L’ENREGISTREMENT DES MEDICAMENTS A USAGE HUMAIN EN TUNISIE T-OP2-003-FR-000. Juin 2025. Date d’entrée en vigueur : Septembre 2025, https://drive.google.com/file/d/1aKYDxwoAnov3yyNu1E5wkrUUalnFD2wK/view, Sun Jul 20 2025
ANMPS. Guide de l’Enregistrement des Médicaments à usage Humain via la Procédure de confiance réglementaire « Reliance » Juin 2025. Version pour commentaires., https://drive.google.com/file/d/1-OOEeANi9yuA1MZpdHRUXVVzSzf7nC8-/view, Sun Jul 20 2025
ANMPS. GUIDE DE L’ENREGISTREMENT DES MEDICAMENTS A USAGE HUMAIN EN TUNISIE VIA LES PROCEDURES DE CONFIANCE REGLEMENTAIRES « RELIANCE ». AOUT 2025. « Mise en application: Septembre 2025 ». Document ID: T-OP2-010-FR. Version: 000-19.08.2025., https://media.licdn.com/dms/document/media/v2/D4D1FAQEBYtc9ZDY6Vg/feedshare-document-pdf-analyzed/B4DZj06RI7IYAs-/0/1756455583088?e=1758758400&v=beta&t=3AuEiRCequPlzYa5hgHjPbqnwBMGgcp1BjTkasjASbU, Mon Sep 15 2025
Continuous Assessment
ANMPS. GUIDE DE L’ENREGISTREMENT DES MEDICAMENTS A USAGE HUMAIN EN TUNISIE T-OP2-003-FR-000. Juin 2025. Date d’entrée en vigueur : Septembre 2025, https://drive.google.com/file/d/1aKYDxwoAnov3yyNu1E5wkrUUalnFD2wK/view, Sun Jul 20 2025
TITCK Priority Assessments
Mashaki Ceyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore. Front Pharmacol. 2018;9:9. Published 2018 Jan 25., 10.3389/fphar.2018.00009,
TURKISH MEDICINES AND MEDICAL DEVICES AGENCY GUIDELINE FOR WORKING PRINCIPLES AND PROCEDURES OF HUMAN MEDICINAL PRODUCTS PRIORITY ASSESSMENT COMMISSION., https://titck.gov.tr/storage/legislation/QgR2Se2X.pdf, Sat Jan 04 2020
Turkish Medicines and Medical Devices Agency Marketing Authorization Procedure.,DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use. , https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF, Sat Jan 04 2020
Emergency Use Authorization
REGULATION ON LICENSING OF MEDICINAL PRODUCTS FOR HUMAN USE REGULATION ON AMENDMENTS (Regulation 31338), https://www.resmigazete.gov.tr/eskiler/2020/12/20201218-2.htm, Thu May 23 2024
Turkey adopts regulation on ‘emergency use authorization’ for COVID-19 vaccine., https://bianet.org/haber/turkey-adopts-regulation-on-emergency-use-authorization-for-covid-19-vaccine-236222, Thu May 23 2024
NDA Abridged Evaluation Process
Drug Registration Regulation., https://www.nda.or.ug/?ddownload=2215,
Drug Fees Regulation., https://www.nda.or.ug/?ddownload=2220,
Guidelines Marketing Authorization of SRO Approved Medicinal Products., https://www.nda.or.ug/?ddownload=1575,
Guidelines on Submission of documentation for marketing authorization of a pharmaceutical product for human use., https://www.nda.or.ug/?ddownload=1622,
Guideline on submission of documentation for a marketing authorization of a pharmaceutical product for human use that is prequalified by the WHO or a stringent regulatory authority., https://www.nda.or.ug/nda/files/downloads/DAR%20GDL%20027%20Guidelines_Marketing%20Authorization%20of%20SRO-Approved%20Medicinal%20Products.pdf,
Monitored Emergency Use of Unregistered Investigational Interventional Products (MEURI)
Guidelines on the Review and Consideration of Applications for Monitored Emergency Use of Unregistered and Experimental Interventions and Off-Label Products Use in Uganda., https://www.nda.or.ug/wp-content/uploads/2023/07/DPS-GDL-045-Guidelines-on-the-Review-and-Consideration-of-Applications-for-Monitored-Emergency-Use-of-Unregistered-and-Experimental-Interventions-and-Off-Label-Products-for-Use-in-Uganda_Rev0.pdf, Sat Jun 15 2024
Fast-track assessment of CTD dossier applications
The National Drug Policy and Authority (Fees) Regulations, 2022., https://www.nda.or.ug/wp-content/uploads/2022/03/NDA-FEES-REGULATIONS-2022-1.pdf, Sat Jun 15 2024
Guidelines on Submission of Documentation for Registration of a Pharmaceutical Product for Human Use in Uganda., https://www.nda.or.ug/wp-content/uploads/2023/02/PAR-GDL-004-Guidelines-on-Submission-of-Documentation-for-Registration-of-a-Pharmaceutical-Product-for-Human-Use_Rev-3.pdf, Sat Jun 15 2024
Fast-Track Assessment of CTD dossier applications., https://www.nda.or.ug/wp-content/uploads/2024/02/Circular_FAST-TRACK-ASSESSMENT-OF-CTD-DOSSIER-APPLICATIONS.pdf, Sat Jun 15 2024
Expedited Review
Ukrainian Ministry of Healthcare changes authorization process for medicinal products., https://epam.ru/eng/legal-updates/view/ukrainianministry-of-healthcare-changes-authorizationprocess-for-medicinal-products, Sat Jan 18 2020
Abridged registration procedures., https://cratia.ua/en/state-registration-medicines-and-active-pharmaceutical-ingredients/abridgedregistration-procedures, Sat Jan 18 2020
Authenticity Procedure
Abridged registration procedures., https://cratia.ua/en/state-registration-medicines-and-active-pharmaceutical-ingredients/abridged-registration-procedures, Sat Jan 18 2020
Fast-track Registration
UAE: A World Leader for Early Access to Innovation., https://pharmaboardroom.com/articles/uae-a-world-leader-for-early-access-to-innovation/, Sun Jan 19 2020
Minister of Health and Prevention issues ministerial decree for the registration of innovative medicines and rare drugs. , https://www.mohap.gov.ae/en/MediaCenter/News/Pages/1950.aspx, Sun Jan 19 2020
Innovative Licensing and Access Pathway (ILAP)
Guidance - Innovation Passport for ILAP eligibility., https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap-for-medicines/innovation-passport-for-ilap-eligibility, Tue Mar 16 2021
Bancsi M. A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP. RF Quarterly. 2022;2(2):54-59. Published online 27 June 2022. , https://bit.ly/3R3tcoL, Wed Jul 13 2022
Guidance - About the pathway., https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap-for-medicines/about-the-pathway, Tue Mar 16 2021
Guidance - Innovative Licensing and Access Pathway (ILAP) for medicines. , https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap-for-medicines, Tue Mar 16 2021
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
European Commission Decision Reliance Procedure (ECDRP)
GOV.UK. Guidance: European Commission (EC) Decision Reliance Procedure. , https://www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure, Thu Mar 31 2022
European Commission Decision Reliance Procedure (ECDRP) extension., https://www.gov.uk/government/news/european-commission-decision-reliance-procedure-ecdrp-extension, Mon Jul 03 2023
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
Decentralised and mutual recognition reliance procedure for marketing authorisations (MRDCRP)
GOV.UK. Guidance: Decentralised and mutual recognition reliance procedure for marketing authorisations. , https://www.gov.uk/guidance/decentralised-and-mutual-recognition-reliance-procedure-for-marketing-authorisations, Thu Mar 31 2022
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
Conditional Marketing Authorisation Applications (CMA)
GOV.UK. Guidance | Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice. , https://www.gov.uk/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-authorisations-and-national-scientific-advice, Fri May 27 2022
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
Great Britain Marketing Authorisations under exceptional circumstances
GOV.UK. Guidance | Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice. , https://www.gov.uk/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-authorisations-and-national-scientific-advice, Fri May 27 2022
legislation.gov.uk. The Human Medicines Regulations 2012. UK Statutory Instruments 2012, No. 1916, PART 5 Consideration of application, Regulation 60. , https://www.legislation.gov.uk/uksi/2012/1916/regulation/60, Fri May 27 2022
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
150-day assessment for national applications for medicines
GOV.UK. 150-day assessment for national applications for medicines. , https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines, Tue May 31 2022
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
Orphan medicinal products
GOV.UK. Guidance | Orphan medicinal products. , https://www.gov.uk/guidance/orphan-medicinal-products-in-great-britain, Tue May 31 2022
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
Early Access to Medicines Scheme (EAMS)
GOV.UK. Guidance - Apply for the early access to medicines scheme (EAMS)., https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams, Wed Jul 05 2023
Promising Innovative Medicine (PIM) Designation - Step I of Early Access to Medicines Scheme (EAMS) , https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/375327/PIM_designation_guidance.pdf, Wed Jul 05 2023
Guidance for Applicants for the Early Access to Medicines Scheme (EAMS) - Step II, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/375408/guidance_on_applying_for_a_scientific_opinion__including_the_pre-submission_meeting.pdf, Wed Jul 05 2023
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
Unfettered Access Procedure (UAP)
Guidance - Unfettered Access Procedure for marketing authorisations approved in Northern Ireland, https://www.gov.uk/guidance/unfettered-access-procedure-for-marketing-authorisations-approved-in-northern-ireland, Thu Jul 06 2023
Guidance - Moving qualifying goods from Northern Ireland to the rest of the UK, https://www.gov.uk/guidance/moving-qualifying-goods-from-northern-ireland-to-the-rest-of-the-uk, Thu Jul 06 2023
Statutory guidance - Current MHRA fees, https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees, Thu Jul 06 2023
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
International Recognition Procedure - Recognition A
Medicines & Healthcare products Regulatory Agency - Guidance International Recognition Procedure. Published 30 August 2023., https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure, Thu Sep 07 2023
Statutory guidance - MHRA fees, https://www.gov.uk/government/publications/mhra-fees, Thu Sep 07 2023
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
International Recognition Procedure - Recognition B
Statutory guidance - MHRA fees, https://www.gov.uk/government/publications/mhra-fees, Thu Sep 07 2023
Medicines & Healthcare products Regulatory Agency - Guidance: International Recognition Procedure. Published 30 August 2023., https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure#overview, Thu Sep 07 2023
GOV.UK. Guidance: Types of application for marketing authorisations (legal basis of applications). , https://www.gov.uk/guidance/types-of-application-legal-basis, Fri Aug 08 2025
FDA Breakthrough Therapy
Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics., https://www.fda.gov/media/86377/download, Fri Jun 17 2022
Conrad R et al: Breakthrough Therapy Designation: CDER analysis of requests 4 years into the program. TIRS 2017:51(4);509-515, ,
Damle N et al: FDA’s expedited programs and their impact on the availability of new therapies. TIRS 2017:51(1):24-28, ,
Bennie Johnson. How does FDA rescind a Breakthrough Therapy Designation? New guidance heads to White House for review. AgencyIQ. FDA Today | June 10, 2022. , ,
CENTER FOR DRUG EVALUATION AND RESEARCH. MAPP 6025.6. POLICY AND PROCEDURES. OFFICE OF NEW DRUGS. Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics., https://www.fda.gov/media/89155/download, Fri Jun 17 2022
Center for Biologics Evaluation and Research. SOPP 8212: Management of Breakthrough Therapy-Designated Products: Sponsor Interactions and Status Assessment Including Rescinding. Version: 3. Effective Date: February 3, 2022., https://www.fda.gov/media/98351/download, Fri Jun 17 2022
Maurice Bancsi. A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP. RF Quarterly. Volume 2, Number 2. June 2022. , , Sun Jul 31 2022
FDA Accelerated Approval
Accelerated Approval., https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program, Wed Mar 13 2024
Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics., https://www.fda.gov/media/86377/download, Sat Apr 11 2020
Project Confirm: An Initiative to Promote Transparency of the Accelerated Approval Program for Oncology Indications, https://ascopost.com/issues/march-10-2022/project-confirm-an-initiative-to-promote-transparency-of-the-accelerated-approval-program-for-oncology-indications/, Wed Mar 13 2024
Project Confirm, https://www.fda.gov/about-fda/oncology-center-excellence/project-confirm#:~:text=Project%20Confirm%20is%20an%20initiative%20of%20the%20FDA,outcomes%20related%20to%20Accelerated%20Approvals%20for%20oncology%20indications, Wed Mar 13 2024
McGuireWoods. Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies. January 29, 2025. , https://www.mcguirewoods.com/client-resources/alerts/2025/1/rethinking-fdas-accelerated-approval-pathway-new-draft-guidances-and-implications-for-drug-companies/, Wed May 14 2025
USFDA. Draft Guidance: Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics - Guidance for Industry. December 2024., https://www.fda.gov/media/184120/download, Wed May 14 2025
USFDA. Draft Guidance: Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway - Guidance for Industry. January 2025., https://www.fda.gov/media/184831/download, Wed May 14 2025
USFDA. Accelerated Approval Council Activities Report CY 2024. (Required by Section 3210 of FDORA), https://www.fda.gov/media/174154/download, Sat Jul 05 2025
FDA CPP for Unapproved Products
CDER CPP – Unapproved Drug., https://www.fda.gov/media/97627/download, Mon Apr 13 2020
CDER Office of Compliance. Office of Drug Security, Integrity & Recalls. Division of Import Operations & Recalls. Imports Exports Compliance Branch (IECB) FDA compliance focal point for imports & exports of CDER regulated drugs., https://www.fda.gov/media/91749/download, Mon Apr 13 2020
IFPMA US Certificate of Pharmaceutical Product Questions and Answers (Q&A). , https://www.ifpma.org/wp-content/uploads/2018/05/US_CPPs_paper_final_-4May2017.pdf, Mon Apr 13 2020
FDA Fast Track
Fast Track., https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track, Sat Apr 11 2020
Fast Track Designation Requests. , https://www.fda.gov/drugs/ind-activity/fast-track-designation-requests, Sat Apr 11 2020
Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics. , https://www.fda.gov/media/86377/download, Sat Apr 11 2020
FDA Orphan Designation
Designating an Orphan Product: Drugs and Biological Products., https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products, Sun Apr 12 2020
Frequently Asked Questions (FAQ) About Designating an Orphan Product. , https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/frequently-asked-questions-faq-about-designating-orphan-product, Sun Apr 12 2020
Electronic Code of Federal Regulations. e-CFR data is current as of April 9, 2020., , Sun Apr 12 2020
Recommended Tips for Creating an Orphan Drug Designation Application. A Webinar by the Office of Orphan Products Development (OOPD) 2018., https://www.fda.gov/media/111762/download, Sun Apr 12 2020
Orphan Drugs: Understanding the FDA Approval Process. Academic Entrepreneurship for Academic and Health Scientists. Vol. 1, Issue 3, Article 13., , Sun Apr 12 2020
FDA Priority Review
Priority Review. , https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review, Sat Apr 11 2020
Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics. , https://www.fda.gov/media/86377/download, Sat Apr 11 2020
FDA Real Time Oncology Review-RTOR
"Real-Time Review of Drug Applications is Now a Reality" September 20, 2018 Issue. , https://www.fda.gov/drugs/real-time-review-drug-applications-now-reality-september-20-2018-issue, Mon Apr 13 2020
de Claro RA, Gao JJ, Kim T, Kluetz PG, Theoret MR, Beaver JA, Pazdur R. U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program. Clin Cancer Res. 2021 Jan 1;27(1):11-14. doi: 10.1158/1078-0432.CCR-20-2220. Epub 2020 Aug 19. PMID: 32816899. , ,
FDA explains the ins and outs of real-time oncology review program in new guidance. Regulatory News | 26 July 2022 | By Ferdous Al-Faruque., https://www.raps.org/news-and-articles/news-articles/2022/7/fda-explains-the-ins-and-outs-of-real-time-oncolog?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2026%20July%202022, Sun Jul 31 2022
USFDA. Real-Time Oncology Review (RTOR), Guidance for Industry, November 2023, https://www.fda.gov/media/173641/download, Tue Apr 22 2025
USFDA. GUIDANCE DOCUMENT: Real-Time Oncology Review (RTOR) Guidance for Industry, November 2023, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-time-oncology-review-rtor, Tue Apr 22 2025
USFDA. Assessment Aid (AAid)., https://www.fda.gov/about-fda/oncology-center-excellence/assessment-aid, Tue Apr 22 2025
USFDA. Real-Time Oncology Review. , https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review, Tue Apr 22 2025
FDA Regenerative Medicine Advanced Therapy Designation
Regenerative Medicine Advanced Therapy Designation. , https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation, Sun Apr 12 2020
Programs for Regenerative Medicine Therapies for Serious Conditions. Guidance for Industry. , https://www.fda.gov/media/120267/download, Sun Apr 12 2020
Limited Population Pathway for Antibacterial and Antifungal Drugs
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry. , https://www.fda.gov/media/113729/download, Mon May 17 2021
Limited Population Pathway for Antibacterial and Antifungal Drugs; Guidance for Industry; Availability., https://www.federalregister.gov/documents/2020/08/06/2020-17109/limited-population-pathway-for-antibacterial-and-antifungal-drugs-guidance-for-industry-availability, Mon May 17 2021
Split Real-Time Application Review (STAR) Program
Prescription Drug User Fee Act (PDUFA) Reauthorization FDA and Industry Pre-market subgroup | Meeting Summary (January 6, 2021). , https://www.fda.gov/media/147587/download, Tue Mar 22 2022
PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2023 THROUGH 2027., https://www.fda.gov/media/151712/download, Tue Mar 22 2022
The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments., https://www.thefdalawblog.com/2021/09/the-fda-pdufa-vii-goals-letter-fy-2023-2027-a-review-of-our-top-10-commitments/, Tue Mar 22 2022
Coronavirus Treatment Acceleration Program (CTAP)
US Food and Drug Administration. Coronavirus Treatment Acceleration Program (CTAP). , https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap, Thu May 05 2022
US Food and Drug Administration. COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products. Guidance for Industry and Investigators. May 2020., https://www.fda.gov/media/137927/download, Thu May 05 2022
US Food and Drug Administration. An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program., https://www.fda.gov/news-events/fda-voices/update-and-behind-scenes-fdas-coronavirus-treatment-acceleration-program, Thu May 05 2022
Accelerating Rare disease Cures (ARC) Program
US Food & Drug Administration. CDER's ARC Program. Accelerating Rare disease Cures (ARC) Program | Center for Drug Evaluation and Research (CDER). , https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cders-arc-program?utm_medium=email&utm_source=govdelivery, Wed May 11 2022
US Food & Drug Administration. CDER Launches New Accelerating Rare disease Cures (ARC) Program., https://www.fda.gov/drugs/drug-safety-and-availability/cder-launches-new-accelerating-rare-disease-cures-arc-program?utm_medium=email&utm_source=govdelivery, Wed May 11 2022
Innovative Science and Technology Approaches for New Drugs (ISTAND) Program
USFDA. CDER and CBER accept first submission to ISTAND Pilot Program., https://www.fda.gov/drugs/drug-safety-and-availability/cder-and-cber-accept-first-submission-istand-pilot-program?utm_medium=email&utm_source=govdelivery, Thu Sep 08 2022
USFDA. Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program Submission Process., https://www.fda.gov/drugs/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program-submission-process, Thu Sep 08 2022
USFDA. Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program., https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program, Thu Sep 08 2022
USFDA. CDER Focuses on Novel Drug Development Tools to Help Speed Creation of New Therapies., https://www.fda.gov/drugs/news-events-human-drugs/cder-focuses-novel-drug-development-tools-help-speed-creation-new-therapies, Thu Sep 08 2022
USFDA. Drug Development Tool (DDT) Qualification Programs., https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-programs, Thu Sep 08 2022
CEDR: FDA's ISTAND Pilot Program Accepts Submission of First Artificial Intelligence-based and Digital Health Technology for Neuroscience, fdadruginfo@public.govdelivery.com, Fri Jan 26 2024
FDA Launches Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program to Support Use of Novel Drug Development Tools - Drug Information Update, https://content.govdelivery.com/accounts/USFDA/bulletins/2aeef1a#:~:text=Today,%20the%20U.S.%20Food%20and%20Drug%20Administration%20launched%20the%20Innovative, Thu Sep 26 2024
Database: CDER & CBER Drug Development Tool Qualification Project Search, https://force-dsc.my.site.com/ddt/s/, Fri Aug 08 2025
USFDA. FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program., https://www.fda.gov/news-events/fda-voices/fda-advances-drug-development-innovation-establishing-istand-permanent-qualification-program?utm_medium=email&utm_source=govdelivery, Fri Aug 08 2025
Emergency Use Authorization (EUA)
Emergency Use Authorization, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, Thu Oct 13 2022
Emergency Use Authorization of Medical Products and Related Authorities. Guidance for Industry and Other Stakeholders, JANUARY 2017., https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities, Thu Oct 13 2022
Emergency Use Authorization for Vaccines to Prevent COVID-19
US Food and Drug Administration. Emergency Use Authorization for Vaccines to Prevent COVID-19 - Guidance for Industry. Document issued on March 31, 2022., https://www.fda.gov/media/142749/download, Sat Nov 12 2022
Robinson SA, et al. Expedited regulatory pathway options and utility: Pandemic to endemic. Regulatory Focus. Published 7 April 2022., https://www.raps.org/news-and-articles/news-articles/2022/4/expedited-regulatory-pathway-options-and-utility-p, Sat Nov 12 2022
The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization, https://www.fda.gov/media/143890/download, Mon May 13 2024
Project FrontRunner
Project FrontRunner, https://www.fda.gov/about-fda/oncology-center-excellence/project-frontrunner, Mon Jul 03 2023
US FDA Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval, https://pink.pharmaintelligence.informa.com/PS147946/US-FDA-Formalizes-One-Trial-Approach-For-Oncology-Accelerated-Approval, Mon Jul 03 2023
Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics Guidance for Industry, https://pink.pharmaintelligence.informa.com/-/media/supporting-documents/pink-sheet/2023/03/oncology-aa-one-trial-approach-draft-guidance-3-24-23.pdf?rev=f6c227003896488d8ec48586474ac357&hash=B84F4E8365FFC5A8993A73F552E6A58D, Mon Jul 03 2023
Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program
Federal Register. Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program; Program Announcement A Notice by the Food and Drug Administration on 10/02/2023, https://www.federalregister.gov/documents/2023/10/02/2023-21235/support-for-clinical-trials-advancing-rare-disease-therapeutics-pilot-program-program-announcement, Mon Oct 09 2023
Gov Info. 88 FR 67763 - Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program; Program Announcement, https://www.govinfo.gov/app/details/FR-2023-10-02/2023-21235, Mon Oct 09 2023
Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program, https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/support-clinical-trials-advancing-rare-disease-therapeutics-start-pilot-program, Sat Jun 15 2024
Tropical Disease Priority Review Voucher Program
Tropical Disease Priority Review Voucher Program, https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program, Thu Oct 19 2023
Federal Register - Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2018, https://www.federalregister.gov/documents/2017/09/28/2017-20799/fee-for-using-a-tropical-disease-priority-review-voucher-in-fiscal-year-2018, Thu Oct 19 2023
USFDA Tropical Disease Priority Review Vouchers - Guidance for Industry , https://www.fda.gov/media/72569/download, Thu Oct 19 2023
Mukherjee S (2023) The United States Food and Drug Administration (FDA) regulatory response to combat neglected tropical diseases (NTDs): A review. PLoS Negl Trop Dis 17(1): e0011010., https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0011010, Thu Oct 19 2023
Generating Antibiotic Incentives Now (GAIN)
GENERATING ANTIBIOTIC INCENTIVES NOW. Required by Section 805 of the Food and Drug Administration Safety and Innovation Act Public Law 112-144. Department of Health and Human Services. , https://www.fda.gov/files/about%20fda/published/Report-to-Congress-on-Generating-Antibiotic-Incentives-Now-%28GAIN%29.pdf, Thu Oct 26 2023
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products, https://www.fda.gov/drugs/generic-drugs/fda-ema-parallel-scientific-advice-pilot-program-complex-generichybrid-products, Mon Mar 11 2024
PILOT PROGRAM: EMA-FDA PARALLEL SCIENTIFIC ADVICE FOR HYBRID/COMPLEX GENERIC PRODUCTS - GENERAL PRINCIPLES, https://www.fda.gov/media/152085/download?attachment, Mon Mar 11 2024
CDER’s OGD and EMA’s Parallel Scientific Advice Pilot Program for Complex Generics Works to Increase Harmonization and Bring Generic Drugs to Patients, https://www.fda.gov/drugs/our-perspective/cders-ogd-and-emas-parallel-scientific-advice-pilot-program-complex-generics-works-increase, Mon Mar 11 2024
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products. SBIA 2023—Advancing Generic Drug Development: Translating Science to Approval. Day 2, Session VIII: Global Collaboration to Support Efficient Generic Product Development & Regulatory Assessment., https://www.fda.gov/media/173402/download?attachment, Mon Mar 11 2024
Animal Rule Approvals
Product Development Under the Animal Rule. Guidance for Industry. October 2015., https://www.fda.gov/media/88625/download, Mon Mar 11 2024
Product Development Under FDA’s Animal Rule: Understanding FDA’s Expectations and Potential Implications for Traditional Development Programs, https://link.springer.com/article/10.1177/2168479016641717, Mon Mar 11 2024
CDER DRUG AND BIOLOGIC ANIMAL RULE APPROVALS, https://www.fda.gov/media/150191/download?attachment, Mon Mar 11 2024
Animal Rule Approvals, https://www.fda.gov/drugs/nda-and-bla-approvals/animal-rule-approvals, Mon Mar 11 2024
Animal Rule Summary, https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/animal-rule-summary, Mon Mar 11 2024
GUIDANCE DOCUMENT - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. SEPTEMBER 2023., https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-pdufa-products, Mon Mar 11 2024
Animal Rule Information, https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/animal-rule-information, Mon Mar 11 2024
USFDA-EMA Mutual Recognition Agreement for GMP Inspections
What the Historic FDA and EMA Mutual Recognition Agreement Means for Drug Companies, https://www.pearlpathways.com/fda-ema-mutual-recognition-agreement/#:~:text=The%20Mutual%20Recognition%20Agreement%20allows%20EMA%20and%20FDA,are%20manufactured%20or%20which%20agency%20inspected%20the%20manufacturer., Thu Mar 14 2024
Mutual Recognition Agreement / Frequently Asked Questions and Answers January 2021, https://www.fda.gov/media/103391/download, Thu Mar 14 2024
European Union (EU) Mutual Recognition Agreement, https://www.fda.gov/international-programs/international-arrangements/european-union-eu-mutual-recognition-agreement, Thu Mar 14 2024
Model-Informed Drug Development Paired Meeting Program
Model-Informed Drug Development Paired Meeting Program., https://www.fda.gov/drugs/development-resources/model-informed-drug-development-paired-meeting-program, Mon Sep 23 2024
The US Food and Drug Administration's Model-Informed Drug Development Meeting Program: From Pilot to Pathway., https://doi.org/10.1002/cpt.3228, Mon Sep 23 2024
PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2018 THROUGH 2022., https://www.fda.gov/media/99140/download?attachment, Mon Sep 23 2024
Advanced Manufacturing Technologies Designation Program
Advanced Manufacturing Technologies Designation Program Guidance for Industry. Draft Guidance - December 2023., https://www.fda.gov/media/174651/download, Wed Sep 25 2024
Collaboration on Gene Therapies Global Pilot (CoGenT)
FDA eyes collaborative review pilot for gene therapies., https://www.raps.org/news-and-articles/news-articles/2024/1/fda-eyes-collaborative-review-pilot-for-gene-thera, Wed Sep 25 2024
FDA Takes First Step Toward International Regulation of Gene Therapies to Treat Rare Diseases., https://natlawreview.com/article/fda-takes-first-step-toward-international-regulation-gene-therapies-treat-rare, Wed Sep 25 2024
Biosimilar Regulatory Review and Approval
Biosimilar Regulatory Review and Approval., https://www.fda.gov/media/151061/download?attachment, Mon Jan 27 2025
Biologics Price Competition and Innovation Act., https://www.dpc.senate.gov/healthreformbill/healthbill70.pdf, Mon Jan 27 2025
Biosimilar Product Regulatory Review and Approval., https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf#:~:text=FDA%20evaluates%20each%20biosimilar%20product%20on%20a%20case-specific,is%20already%20publicly%20known%20about%20the%20reference%20product., Mon Jan 27 2025
Review and Approval., https://www.fda.gov/drugs/biosimilars/review-and-approval, Mon Jan 27 2025
Industry Information and Guidance., https://www.fda.gov/drugs/biosimilars/industry-information-and-guidance, Mon Jan 27 2025
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3). Guidance for Industry - DRAFT GUIDANCE., https://www.fda.gov/media/119278/download, Mon Jan 27 2025
Questions and Answers on Biosimilar Development and the BPCI Act - Guidance for Industry. September 2021. Revision 2., https://www.fda.gov/media/119258/download, Mon Jan 27 2025
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1). September 2023., https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biosimilarity-and-interchangeability-additional-draft-qas-biosimilar-development-and-bpci-act, Mon Jan 27 2025
Biosimilar User Fee Amendments., https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments, Mon Jan 27 2025
USFDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, Guidance for Industry. DRAFT GUIDANCE. October 2025., https://www.fda.gov/media/189366/download, Sun Nov 02 2025
USFDA. FACT SHEET: Bringing Lower-Cost Biosimilar Drugs to American Patients., https://www.fda.gov/media/189382/download?attachment, Sun Nov 02 2025
Importation Program under Section 804 of the FD&C Act
USFDA. Importation Program under Section 804 of the FD&C Act., https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act, Sun May 25 2025
Federal Register. Importation of Prescription Drugs - A Rule by the Food and Drug Administration on 10/01/2020, https://www.federalregister.gov/documents/2020/10/01/2020-21522/importation-of-prescription-drugs, Sun May 25 2025
USFDA. GUIDANCE DOCUMENT - Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide. May 2022., https://www.fda.gov/regulatory-information/search-fda-guidance-documents/importation-prescription-drugs-final-rule-questions-and-answers-small-entity-compliance-guide, Sun May 25 2025
Federal Register. Lowering Drug Prices by Once Again Putting Americans First - A Presidential Document by the Executive Office of the President on 04/18/2025., https://www.federalregister.gov/documents/2025/04/18/2025-06837/lowering-drug-prices-by-once-again-putting-americans-first, Sun May 25 2025
Code of Federal Regulations. PART 251—SECTION 804 IMPORTATION PROGRAM., https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-251, Sun May 25 2025
USFDA. Tips for SIPs., https://www.fda.gov/about-fda/reports/tips-sips, Sun May 25 2025
21 USC 384: Importation of prescription drugs, https://uscode.house.gov/view.xhtml?req=(title:21%20section:384%20edition:prelim), Sun May 25 2025
Commissioner’s National Priority Voucher (CNPV) Program
USFDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. For Immediate Release: June 17, 2025., https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests, Tue Jun 24 2025
USFDA. FAQs: Commissioner’s National Priority Voucher Program., https://www.fda.gov/news-events/press-announcements/faqs-commissioners-national-priority-voucher-program, Tue Jun 24 2025
CNBC. FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says., https://www.cnbc.com/2025/07/11/fda-to-consider-drug-affordability-when-speeding-up-approvals-makary.html?msockid=3dd776f32e096ca815df63082fdc6d77, Tue Jul 15 2025
Regulatory Focus. Questions remain as FDA opens submissions for new priority voucher program., https://www.raps.org/news-and-articles/news-articles/2025/7/questions-remain-as-fda-opens-submissions-for-new, Mon Jul 28 2025
Daniel Carpenter, Ph.D. et al. Flaws in the FDA’s New Priority Voucher Program. Published October 25, 2025 N Engl J Med 2025;393:1662-1664, https://www.nejm.org/doi/full/10.1056/NEJMp2509215, Sun Nov 02 2025
ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing
USFDA. FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing., https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-new-anda-prioritization-pilot-support-us-generic-drug-manufacturing-and-testing#:~:text=%5B10%2F3%2F2025%5D%20Today%2C%20the%20U.S.%20Food%20and%20Drug%20Administration,test%20and%20manufacture%20their%20products%20in%20the%20U.S., Sun Oct 19 2025
USFDA. MANUAL OF POLICIES AND PROCEDURES. CENTER FOR DRUG EVALUATION AND RESEARCH. Prioritization of the Review of Original ANDAs, Amendments, and Supplements. (MAPP 5240.3 Rev. 6.) , https://www.fda.gov/media/89061/download?attachment, Sun Oct 19 2025
USFDA. FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing. , https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing, Sun Oct 19 2025
Rare Disease Evidence Principles (RDEP)
USFDA. CDER/CBER Rare Disease Evidence Principles (RDEP)., https://www.fda.gov/industry/fda-rare-disease-innovation-hub/cdercber-rare-disease-evidence-principles-rdep, Sun Oct 19 2025
USFDA. Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (September 2023). , https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-one-adequate-and-well-controlled-clinical, Sun Oct 19 2025
RAPS. FDA launches program for rare diseases targeting ‘significant’ unmet need., https://www.raps.org/news-and-articles/news-articles/2025/9/fda-launches-program-for-rare-diseases-targeting-%E2%80%98, Sun Oct 19 2025
Rare Pediatric Disease Designation and Priority Review Voucher Programs
USFDA. Rare Pediatric Disease Designation and Priority Review Voucher Programs: Information for product sponsors., https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs, Sun Oct 19 2025
USFDA. Rare Pediatric Disease Priority Review Vouchers Guidance for Industry - DRAFT GUIDANCE. Jul 2019, Revision 1., https://www.fda.gov/media/90014/download, Sun Oct 19 2025
Federal Register. Fee Rate for Using a Priority Review Voucher in Fiscal Year 2024., https://www.federalregister.gov/documents/2023/09/29/2023-21513/fee-rate-for-using-a-priority-review-voucher-in-fiscal-year-2024, Sun Oct 19 2025
Expedited Procedure
Regulatory, Pricing and Reimbursement. 06/11/2018. FERRERE / Uruguay. , https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-uruguay/, Sun Apr 26 2020
Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America. Ana Padua, Livia Partika, Denise Bonamici. Journal of Public Health Policy, https://doi.org/10.1057/s41271-020-00245-y, Mon Sep 14 2020
Decree No. 324/999 MEDICINES AND RELATED PRODUCTS FOR HUMAN USE, https://www.impo.com.uy/bases/decretos/324-1999, Sun Jun 23 2024
Decree No. 28/014 AMENDMENT OF ARTICLE 7 OF DECREE 324/999 ON MEDICINES AND RELATED PRODUCTS FOR HUMAN USE, https://www.impo.com.uy/bases/decretos/28-2014, Sun Jun 23 2024
REGULATIONS FOR THE REGISTRATION, PRODUCTION, EXPORT, IMPORT AND MARKETING OF MEDICINAL PRODUCTS FOR HUMAN USE. Aprobado/a por: Decreto Nº 18/020 de 13/01/2020, https://www.impo.com.uy/bases/decretos-reglamento/18-2020, Wed Feb 12 2025
Urgent Procedure for biotechnological medicinal products
Ordinance No. 2.128/023 Urgent Procedure for Biotechnological Medicines, https://www.gub.uy/ministerio-salud-publica/institucional/normativa/ordenanza-n-2128023-procedimiento-tramite-urgente-para-medicamentos, Wed Feb 12 2025
Reliance Review Pathway
Change in Drug Registration in Vietnam., https://www.tilleke.com/resources/change-drugregistration-vietnam, Wed Feb 05 2020
Vietnam's Ministry of Health Issues a New Circular Regulating the Registration of Drugs and Drug Materials. , https://www.bakermckenzie.com/en/insight/publications/ 2019/04/vietnams-ministry-of-health-issues-a-newcircular, Wed Feb 05 2020
Medicinal product regulation and product liability in Vietnam: overview. , https://ca.practicallaw.thomsonreuters.com/6-518- 6504?transitionType=Default&contextData=(sc.Default)& firstPage=true&bhcp=1, Wed Feb 05 2020
APAC Med. Regulatory Reliance Pathways Tracker., https://apacmed.org/regulatory-reliance-pathways-tracker/, Tue Nov 04 2025
Asia Partnership Conference of Pharmaceutical Associations (APAC). Pharmaceutical Market & Regulatory Environment in Asia (PMRE); ver. 2025. Volume 1: Regulatory Environment Identification and Clarification of the Differences in Regulatory Environment between Asian Economies. April 22, 2025. Tokyo, Japan., https://apac-asia.com/images/ra/pdf/report2025.pdf, Tue Nov 04 2025
Pacific Bridge Medical. Vietnam Promulgates New Regulations to Streamline Drug Approval., https://www.pacificbridgemedical.com/news-brief/vietnam-promulgates-new-regulations-to-streamline-drug-approval/#:~:text=On%20May%2016%2C%202025%2C%20the%20Ministry%20of%20Health,the%20current%20fixed%20listing%20of%20over-the-counter%20%28OTC%29%20drugs., Tue Nov 04 2025
Decision 2546/QD-BYT 2025 announcing new administrative procedures for promulgating the pharmaceutical sector under the management of the Ministry of Health, https://luatvietnam.vn/hanh-chinh/quyet-dinh-2546-qd-byt-408175-d1.html, Tue Nov 04 2025
Decree 163/2025/ND-CP detailling the Law on Pharmacy, https://english.luatvietnam.vn/decreeno163-2025-nd-cpdatedjune292025ofthegovernmentdetailinganumberofarticlesandprescribingmeasuresfororganizingandguidingth-404439-doc1.html, Tue Nov 04 2025
Orphan Drug Route
Key Features of Orphan Drug Registration in Singapore, Malaysia, Philippines, and Vietnam., https://globalforum.diaglobal.org/issue/december-2021/key-features-of-orphan-drug-registration-in-singapore-malaysia-philippines-and-vietnam/, Sun Jul 31 2022
Pharma Boardroom. Regulatory, Pricing and Reimbursement Overview. 30/05/2020. Tilleke & Gibbins / Vietnam., https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-vietnam/, Sun Jul 31 2022
Asia Partnership Conference of Pharmaceutical Associations (APAC). Pharmaceutical Market & Regulatory Environment in Asia (PMRE); ver. 2025. Volume 1: Regulatory Environment Identification and Clarification of the Differences in Regulatory Environment between Asian Economies. April 22, 2025. Tokyo, Japan., https://apac-asia.com/images/ra/pdf/report2025.pdf, Tue Nov 04 2025
WHO Accelerated registration of FPPs approved by SRA
Annex 11: Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities., https://extranet.who.int/prequal/sites/default/files/documents/TRS_1010-2018_Annex11.pdf, Wed Jan 01 2020
WHO Collaborative Registration Process: Accelerated Registration of Prequalified FPPs
Accelerated Registration of Prequalified FPPs., https://extranet.who.int/prequal/content/collaborative-registration-faster-registration, Wed Jan 01 2020
WHO Collaborative Procedure between WHO and National Medicines Regulatory Authorities in Assessment and Accelerated National Registration. , https://extranet.who.int/prequal/key-resources/documents/faq-who-collaborative-procedure-between-who-and-national-medicines, Wed Jan 01 2020
World Health Organization (2025). WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-eight report. Appendix 7: Good practices of NRAs in implementing collaborative registration procedures.World Health Organization. https://iris.who.int/handle/10665/381072. License: CC BY-NC-SA 3.0 IGO, https://iris.who.int/handle/10665/381072, Tue Oct 07 2025
WHO. Countries participating in the WHO Collaborative Registration Procedure (CRP) for Prequalified medicines and vaccines., https://cdn.who.int/media/docs/default-source/medicines/regulatory-updates/fpi/pq-crp---medicines-and-vaccines_-partcipating-countries_june-2024.pdf?sfvrsn=ff47ffb8_3, Tue Oct 07 2025
WHO Prequalification of Medicines Programme (PQP) – Abridged Assessments
Fee Schedule. , http://who.int/medicines/news/finance-arrangements-prequal-med/en/, Wed Dec 18 2019
WHO Prequalification Fees. , http://who.int/medicines/news/finance-arrangements-prequal-med/en/, Wed Dec 18 2019
Overview: History & Mission., https://extranet.who.int/prequal/content/overview-history-mission, Wed Dec 18 2019
Technical Report Series (TRS) documents approved by the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) , , Thu Dec 19 2019
Guidance documents drafted by the WHO Prequalification Team Accessed on 19 December 2019.,Procedure for Prequalification of Pharmaceutical Products (2011). , http://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS961_Annex10.pdf, Thu Dec 19 2019
Guidelines on APIMF Submission Procedure. , http://www.who.int/entity/medicines/areas/quality_safety/quality_assurance/GuidelinesActivePharmaceuticalIngredientTRS948Annex4.pdf?ua=1, Sun Dec 29 2019
WHO Prequalification of Medicines Programme (PQP) – Full Assessments
Fee Schedule. , http://who.int/medicines/news/finance-arrangements-prequal-med/en/, Wed Dec 18 2019
WHO Prequalification Fees. , http://who.int/medicines/news/finance-arrangements-prequal-med/en/, Wed Dec 18 2019
Overview: History & Mission. , https://extranet.who.int/prequal/content/overview-history-mission, Wed Dec 18 2019
Technical Report Series (TRS) documents approved by the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), , Thu Dec 19 2019
Guidance documents drafted by the WHO Prequalification Team Accessed on 19 December 2019.,Procedure for Prequalification of Pharmaceutical Products (2011)., http://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS961_Annex10.pdf, Thu Dec 19 2019
Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities (2014)., , Thu Dec 19 2019
Guidelines on APIMF Submission Procedure. , http://www.who.int/entity/medicines/areas/quality_safety/quality_assurance/GuidelinesActivePharmaceuticalIngredientTRS948Annex4.pdf?ua=1, Sun Dec 29 2019
WHO Collaborative Registration Procedure: Finished Pharmaceutical Products assessed and approved by SRAs
World Health Organization (WHO). Accelerated Registration of FPPs Approved by SRAs. , https://extranet.who.int/pqweb/medicines/faster-registration-fpps-approved-sras, Fri Mar 25 2022
Vaz A, Roldão Santos M, Gwaza L, Mezquita González E, Pajewska Lewandowska M, Azatyan S, Saint-Raymond A. WHO collaborative registration procedure using stringent regulatory authorities' medicine evaluation: reliance in action? Expert Rev Clin Pharmacol. 2022 Jan;15(1):11-17. doi: 10.1080/17512433.2022.2037419. Epub 2022 Feb 12. PMID: 35130803. , ,
WHO. Countries participating in the WHO Collaborative Registration Procedure for products approved by Stringent Regulatory Authorities (SRA CRP). Version: 8 April 2025., https://cdn.who.int/media/docs/default-source/medicines/regulatory-updates/fpi/sra-crp-participating-countries.pdf?sfvrsn=c247bee4_2, Tue Oct 07 2025
World Health Organization (2025). WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-eight report. Appendix 7: Good practices of NRAs in implementing collaborative registration procedures.World Health Organization. https://iris.who.int/handle/10665/381072. License: CC BY-NC-SA 3.0 IGO, https://iris.who.int/handle/10665/381072, Tue Oct 07 2025
COVID-19 Technology Access Pool (C-TAP)
World Health Organization (WHO). WHO COVID-19 Technology Access Pool., https://www.who.int/initiatives/covid-19-technology-access-pool, Wed Jun 15 2022
World Health Organization (WHO). How WHO C-TAP Works?., https://www.who.int/initiatives/covid-19-technology-access-pool/what-is-c-tap, Wed Jun 15 2022
Parallel recommendation and regulatory pathway
Application of parallel, coordinated, and independent evaluation procedures for health products that are eligible for prequalification and require WHO recommendations on their use., https://extranet.who.int/prequal/sites/default/files/document_files/WG%20Alignment%20of%20normative%20and%20PQ%20processes%20interim%20report.pdf, Sat Oct 19 2024
WHO to begin development of parallel recommendation and regulatory pathways; shortening the time taken for people to access health products., https://www.who.int/news/item/20-03-2024-who-to-begin-development-of-parallel-recommendation-and-regulatory-pathways--shortening-the-time-taken-for-people-to-access-health-products, Sat Oct 19 2024
WHO to begin development of parallel recommendation and regulatory pathways; shortening the time taken for people to access health products., https://extranet.who.int/prequal/news/who-begin-development-parallel-recommendation-and-regulatory-pathways-shortening-time-taken, Sat Oct 19 2024
FPPs & APIs Eligible for Prequalification ("EOIs")., https://extranet.who.int/prequal/medicines/fpps-apis-eligible-prequalification-eois, Sat Oct 19 2024
Coordinated Scientific Advice (CSA) for Health Product R&D
WHO Coordinated Scientific Advice for health product R&D., https://www.who.int/our-work/science-division/research-for-health/who-coordinated-scientific-advice-for-health-product-r-d, Sat Oct 19 2024
Coordinated Scientific Advice for Health Product R&D., https://cdn.who.int/media/docs/default-source/research-for-health/coordinated-scientific-advice-for-health-product-research-and-dev.pdf?sfvrsn=9ce1dd86_3&download=true, Sat Oct 19 2024
WHO Coordinated Scientific Advice Procedure for health product research and development. July 2021., https://www.who.int/publications/i/item/9789240031043, Sat Oct 19 2024
Frequently asked questions on the WHO Coordinated Scientific Advice Procedure., https://www.who.int/our-work/science-division/research-for-health/frequently-asked-questions-on-the-who-coordinated-scientific-advice-procedure, Sat Oct 19 2024
Mercedes Perez Gonzalez. Presentation on "WHO Coordinated Scientific Advice Procedure"., https://extranet.who.int/prequal/sites/default/files/document_files/2023-jm-day1-session2_csa.pdf, Sat Oct 19 2024
Emergency Use Listing (EUL) Procedure for Vaccines
Emergency Use Listing Procedure for vaccines., https://www.who.int/teams/regulation-prequalification/eul/eul-vaccines, Wed Nov 20 2024
Q&A for guidelines on emergency use listing procedure - 15 July 2020, https://www.who.int/publications/m/item/q-a-for-guidelines-on-emergency-use-listing-procedure, Wed Nov 20 2024
Emergency use listing procedure Version 9 August 2022., https://www.who.int/publications/m/item/emergency-use-listing-procedure, Wed Nov 20 2024
Expert Review Panel (ERP)
Expert Review Panel, https://extranet.who.int/prequal/medicines/expert-review-panel, Wed Apr 30 2025
The Expert Review Panel (ERP). Guidance Document, 08 February 2019 , https://extranet.who.int/prequal/sites/default/files/document_files/73_ERP_Feb2019_new%20templ.pdf, Wed Apr 30 2025
Market Information, https://extranet.who.int/prequal/medicines/market-information, Wed Apr 30 2025
The Global Fund. Expert Review Panel., https://www.theglobalfund.org/en/sourcing-management/quality-assurance/expert-review-panel/, Wed Apr 30 2025
The Global Fund. Timeline of the Expert Review Panel Process for Pharmaceutical Products. February 2017., https://www.theglobalfund.org/media/5587/psm_2017-02-selectedmedicinesmanufacturersexpressionofinterest_timeline_en.pdf, Wed Apr 30 2025
Global Fund Quality Assurance Policy for Pharmaceutical Products. Expert Review Panel, Indicative Terms of Reference. , https://www.theglobalfund.org/media/7188/psm_expertreviewpanelforpharmaceuticalproducts_tor_en.pdf, Wed Apr 30 2025
Licensing of Pharmaceuticals for Human Use in WAEMU Member States
THE ANNEXES TO THE REGULATION ON APPROVAL PROCEDURES FOR PHARMACEUTICAL PRODUCTS FOR HUMAN USE IN WAEMU MEMBER STATES. , https://arp.sn/wp-content/uploads/2023/12/Annexe_reglement-revise-procedure-d-homologation-des-medicaments-VF-13012021_2-1.pdf, Sat Jun 15 2024
Regulations for the Licensing of Pharmaceuticals in WAEMU, https://arp.sn/wp-content/uploads/2023/05/REGLEMENT-PROCEDURES-DHOMOLOGATION-DES-PRODUITS-PHARMACEUTIQUES.pdf, Sat Jun 15 2024
Owusu-Asante M, Darko DM, Seaneke S, Nacoulma A, Traore OIO, Adeyeye CM, Akinyemi A, Assane C, Clamoungou CÉKM, Ndao OK, Kande RN, Komeh J, Mansaray S, Lamboni D, Agba M, Walker S and Salek S (2025) Comparison of good review practices of seven countries participating in the ECOWAS medicines regulatory harmonisation initiative: identifying opportunities for improvement. Front. Med. 11:1520892., https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1520892/full, Mon Jan 13 2025
West African Health Organization (WAHO) Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products
WEST AFRICAN HEALTH ORGANIZATION (WAHO). REGIONAL JOINT ASSESSMENT PROCEDURE FOR MEDICINE REGISTRATION AND MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS., https://data.wahooas.org/tenders/uploads/attachment/document/319/ECOWAS_Joint_Assessment_Procedure_Edited_22072022.pdf, Mon Oct 14 2024
Owusu-Asante M, Darko DM, Walker S and Salek S (2022), Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries. Front. Pharmacol. 13:1069345. doi: 10.3389/fphar.2022.1069345, https://doi.org/10.3389/fphar.2022.1069345, Thu Apr 27 2023
IFPMA Infographic - Navigating the ECOWAS Joint Assessment Procedure, https://www.ifpma.org/resources/navigating-the-ecowas-joint-assessment-procedure/, Thu Aug 31 2023
Guidance for preparation of applications., https://data.wahooas.org/tenders/uploads/attachment/document/357/CTD_En_Guidance_for_the_Preparation_of_Applications.pdf, Mon Oct 14 2024
Guidelines for the preparation and submission of dossiers., https://data.wahooas.org/tenders/uploads/attachment/document/358/CTD_Fr__Lignes_Directrices_pour_la_preparation_et_la_soumission_des_Dossiers.pdf, Mon Oct 14 2024
Owusu-Asante M, Darko DM, Seaneke S, Nacoulma A, Traore OIO, Adeyeye CM, Akinyemi A, Assane C, Clamoungou CÉKM, Ndao OK, Kande RN, Komeh J, Mansaray S, Lamboni D, Agba M, Walker S and Salek S (2025) Comparison of good review practices of seven countries participating in the ECOWAS medicines regulatory harmonisation initiative: identifying opportunities for improvement. Front. Med. 11:1520892., https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1520892/full, Mon Jan 13 2025
TRIPS Compulsory Licensing during public health crisis
Li Z and Guo P (2025) Compulsory licensing of pharmaceuticals during public health crisis: a TRIPS framework analysis. Front. Public Health 13:1630586. doi: 10.3389/fpubh.2025.1630586, https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1630586/full, Tue Oct 07 2025
Manisha A. Desai. Compulsory licensing: Procedural requirements under the TRIPS agreement. Pharmaceuticals Policy and Law 18 (2016) 31–44. , https://www.ifpma.org/wp-content/uploads/2023/01/i2023_4.-Compulsory-Licensing-Procedural-Requirements-under-the-TRIPS-Agreement.pdf, Tue Oct 07 2025
WTO. Declaration on the TRIPS agreement and public health. , https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm, Tue Oct 07 2025
WTO. Marrakesh Agreement Establishing the World Trade Organization. , https://www.wto.org/english/docs_e/legal_e/marag_e.htm#fnt-4, Tue Oct 07 2025
Verification Review (Type 1)
Sithole, T., Mahlangu, G., Capote, V., Sitoie, T., Shifotoka, S., Gaeseb, J., Danks, L., Nkambule, P., Juma, A., Fimbo, A., Munkombwe, Z., Mwale, B., Salek, S., & Walker, S. (2021). Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Frontiers in medicine, 8, 742200. , https://doi.org/10.3389/fmed.2021.742200,
ithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181. doi: 10.3389/fmed.2021.742181, ,
Chisha CS, Siyanga M, Leigh S, Kermad A, Walker S. Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities. Ther Innov Regul Sci. Published online December 27, 2024., https://link.springer.com/article/10.1007/s43441-024-00730-6, Tue Feb 25 2025
Abridged review (Type 2)
Sithole, T., Mahlangu, G., Capote, V., Sitoie, T., Shifotoka, S., Gaeseb, J., Danks, L., Nkambule, P., Juma, A., Fimbo, A., Munkombwe, Z., Mwale, B., Salek, S., & Walker, S. (2021). Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Frontiers in medicine, 8, 742200., https://doi.org/10.3389/fmed.2021.742200,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181. doi: 10.3389/fmed.2021.742181, ,
Chisha CS, Siyanga M, Leigh S, Kermad A, Walker S. Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities. Ther Innov Regul Sci. Published online December 27, 2024., https://link.springer.com/article/10.1007/s43441-024-00730-6, Tue Feb 25 2025
Fast-track/priority review
Sithole, T., Mahlangu, G., Capote, V., Sitoie, T., Shifotoka, S., Gaeseb, J., Danks, L., Nkambule, P., Juma, A., Fimbo, A., Munkombwe, Z., Mwale, B., Salek, S., & Walker, S. (2021). Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Frontiers in medicine, 8, 742200., https://doi.org/10.3389/fmed.2021.742200,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181. doi: 10.3389/fmed.2021.742181 , ,
Chisha CS, Siyanga M, Leigh S, Kermad A, Walker S. Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities. Ther Innov Regul Sci. Published online December 27, 2024., https://link.springer.com/article/10.1007/s43441-024-00730-6, Tue Feb 25 2025
ZAZIBONA Centralized Joint Assessment Pathway for Pharmaceutical Products (ZAZIBONA CP) [July 2025 to December 2026]
Sithole T, Mahlangu G, Salek S, Walker S. Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration Initiative. Ther Innov Regul Sci [Internet]. 2020;54(6):1319–29., https://doi.org/10.1007/s43441-020-00154-y,
ZAZIBONA STAKEHOLDERS’ ENGAGEMENT MEETING, 18 JULY 2023 QUESTION & ANSWER, , Thu Oct 05 2023
REQUEST FOR EXPRESSIONS OF INTEREST IN THE SUBMISSION OF PRODUCT APPLICATIONS FOR THE CENTRALIZED ZAZIBONA JOINT ASSESSMENT PATHWAY FOR PHARMACEUTICAL PRODUCTS , https://media.licdn.com/dms/document/media/v2/D4D1FAQH8c8Vw2drgEA/feedshare-document-pdf-analyzed/B4DZcs77EcGgAY-/0/1748805600086?e=1751500800&v=beta&t=rrLDy-EyUcxLicEd0JQAmz2qFQVPx3xX9Hqg3kpfLJ8, Tue Jun 24 2025
Expedited or “Fast-track” Registration Procedure
How to Register Conventional Medicines., https://www.mcaz.co.zw/index.php/how-to-register, Sun Nov 10 2019
Expedited/Fast-track application process Circular 08/2019, https://www.mcaz.co.zw/images/evr/Circula-8-of-2019- Opening-of-Expedited-Review-Channel-for-Assessment-ofApplications-for-Registration-of-Human-AllopathicMedicines-in-2019.pdf,
MCAZ Quotation Form., https://www.mcaz.co.zw/images/evr/Quotation_confirmatio n_form.doc, Sun Nov 10 2019
MCAZ CTD Guidelines. , http://www.mcaz.co.zw/index.php/downloads/category/11- guidelines?download=74:mcaz-ctd-guidelines, Sun Nov 10 2019
MCAZ Guideline Complementary Medicines – Approved by Registration Committee., http://www.mcaz.co.zw/index.php/downloads/category/11- guidelines?download=127:guideline-complementarymedicines-approved-by-registration-committee, Sun Nov 10 2019
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Padayachee S, Sehloho T, Khea A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742181. doi: 10.3389/fmed.2021.742181, ,
Sithole T, Mahlangu G, Capote V, Sitoie T, Shifotoka S, Gaeseb J, Danks L, Nkambule P, Juma A, Fimbo A, Munkombwe Z, Mwale B, Salek S and Walker S (2021) Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward. Front. Med. 8:742200. doi: 10.3389/fmed.2021.742200, ,
Medicines Control Authority of Zimbabwe (MCAZ). Alternative Submission Pathways., https://www.mcaz.co.zw/alternative-submission-pathways/, Mon Feb 13 2023
Medicines Control Authority of Zimbabwe (MCAZ). Reliance Guidelines for Regulation of Medicines., https://www.mcaz.co.zw/wp-content/uploads/2022/12/Reliance-Guidelines-for-Regulation-of-Medicines.pdf, Mon Feb 13 2023
MCAZ Reliance Policy., https://www.mcaz.co.zw/wp-content/uploads/2024/04/QPM-09-Rev2_April-2024-MCAZ-Reliance-Policy.pdf, Sat Jun 15 2024
Emergency Use Authorization of Medical Products
MCAZ. Guidelines for Emergency Use Authorization of Medical Products. Effective Date: 29 November 2022. Document: MCAZ/EVR/GL-01. Rev2_November 2022. , https://portal.mcaz.co.zw/wp-content/uploads/2025/07/Guideline-for-Emergency-Use-Authorisation-of-Medical-Products.pdf, Sun Oct 12 2025
MCAZ. Circular No. 12 of 2025. Fee Schedule. , https://www.mcaz.co.zw/wp-content/uploads/2025/05/Circular-12-of-2025.pdf, Sun Oct 12 2025