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ACCESS New Active Substance Work-Sharing Initiative (NASWSI)
1. 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. ,2. 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 Accessed on 26 July 2020.,3. ACSS - NAS work sharing initiative. Accessed on 26 July 2020. 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 ,4. ACSS - NAS work sharing initiative: Q&A. https://www.tga.gov.au/acss-nas-work-sharing-initiative-qa Accessed on 26 July 2020. ,5. Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium. https://www.tga.gov.au/australia-canada-singapore-switzerland-united-kingdom-access-consortium Accessed on 15 March 2021.
ACCESS - Generic Medicine Work-Sharing Initiative (GMWSI)
1. ACSS - Generic Medicine Work Sharing Trial. https://www.tga.gov.au/acss-generic-medicine-work-sharing-trial Accessed on 15 March 2021. ,2. 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 Accessed on 15 March 2021. ,3. 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 Accessed on 15 March 2021. ,4. Mandate: ACSS Generic Medicines Working Group. https://www.tga.gov.au/mandate-acss-generic-medicines-working-group Accessed on 15 March 2021.
ACCESS Biosimilars Work-Sharing Initiative (BSWSI)
Promise Pilot Pathway: ACCESS New Active Substance Work-Sharing Initiative (NASWSI)
ASEAN Joint Assessment Procedure for Pharmaceutical Products
1. ASEAN JOINT ASSESSMENT PROCEDURE. https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=9&ved=2ahUKEwi1kqX0_O7mAhUZTxUIHeYxCnkQFjAIegQICBAH&url=https%3A%2F%2Fwww.npra.gov.my%2Fimages%2FAnnouncement%2F2016%2FASEAN-WHO-SIAHR_Joint%2520Assessments-information_for_applicants-Dec_2016_rev2.docx&usg=AOvVaw1DHh6Z2W7_-pN9NFFz3R72 Accessed on 6 January 2020
Expedited Joint Assessment Procedure
Continental Listing of Medicinal Products (AMA)
Autorisation Temporaire d’Utilisation (ATU)
Regulatory, Pricing & Reimbursement Overview. https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-algeria/ Accessed on 23 March 2020.
Fast Track Proceedings: ‘Article 3’
Drug registration in Argentina. https://latampharmara.com/argentina/drug-registration-in-argentina/,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 Accessed on 22 February 2020.,Drug registration in Argentina. https://latampharmara.com/argentina/drug-registration-in-argentina/
Fast Track Proceedings: ‘Article 4’
Drug registration in Argentina. https://latampharmara.com/argentina/drug-registration-in-argentina/,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 Accessed on 22 February 2020.,Drug registration in Argentina. https://latampharmara.com/argentina/drug-registration-in-argentina/
Registrations Under Special Conditions
TGA Comparative Overseas Regulator (COR)-A
Comparable overseas regulators (CORs): Submission requirements. https://www.tga.gov.au/comparable-overseas-regulators-cors-submission-requirements Accessed on 19 April 2020.
TGA Comparative Overseas Regulator (COR)-B
Comparable overseas regulators (CORs): Submission requirements. https://www.tga.gov.au/comparable-overseas-regulators-cors-submission-requirements Accessed on 19 April 2020.
Priority Registration Process
Fast track approval pathways. https://www.tga.gov.au/fast-track-approval-pathways Accessed on 19 April 2020. ,Priority review of prescription medicines. https://www.tga.gov.au/hubs/fast-track-approvals/priority-review-prescription-medicines Accessed on 19 April 2020. ,Priority determination. https://www.tga.gov.au/publication/priority-determination#submitting Accessed on 19 April 2020.
Provisional Approval Pathway
TGA. Provisional determination eligibility criteria. https://www.tga.gov.au/publication/provisional-determination-eligibility-criteria Accessed on 14 June 2021.,TGA. Provisional determination. https://www.tga.gov.au/publication/provisional-determination Accessed on 14 June 2021. ,TGA. Fees and charges: summary from 1 July 2020. https://www.tga.gov.au/book-page/prescription-medicines-5 Accessed on 14 June 2021.
COVID-19 vaccine approval process
Emergency Use Authorization of COVID-19 Vaccines
Abridged Registration
Guidelines for application for Registration of Medicinal Products 2006(DRA). Accessed on 4 April 2020. ,Bhutan Medicines Rules and Regulation 2019. Accessed on 4 April 2020. ,GUIDELINE - Registration of Medicinal Products 2nd Edition, 2013. DRUG REGULATORY AUTHORITY ROYAL GOVERNMENT OF BHUTAN. Accessed on 4 April 2020.
Expedited Registration
Guidelines for application for Registration of Medicinal Products 2006(DRA). Accessed on 4 April 2020. ,Bhutan Medicines Rules and Regulation 2019. Accessed on 4 April 2020. ,GUIDELINE - Registration of Medicinal Products 2nd Edition, 2013. DRUG REGULATORY AUTHORITY ROYAL GOVERNMENT OF BHUTAN. Accessed on 4 April 2020.,Conditions for ER Registration & Documentary Requirements thereunder. https://drive.google.com/file/d/0Bzj2O5Bryu-LVnpZQ3lKLU5uYUhjRFk2ODFKSGp0cG9fQm1J/view Accessed on 4 April 2020 "
Sanitary Emergency Law
1. LEY N° 1359. LEY DE 17 DE FEBRERO DE 2021. https://www.agemed.gob.bo/resoluciones/Ley_1359.pdf Accessed on 29 August 2021. ,2. 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 Accessed on 29 August 2021. ,3. 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 Accessed on 30 August 2021
Expedited/Fast-track procedure
1. 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 Accessed on 29 August 2021. ,2. Botswana Medicines Regulatory Authority (BoMRA). BoMRA Regulatory Fees 2019. https://www.bomra.co.bw/index.php/bomra-downloads/fees/file/29-bomra-fees-2019 Accessed on 29 August 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 Accessed on 11 February 2023.
Non-Routine Assessment of Products for Public Health Emergencies
Resolução de Diretoria Colegiada (RDC) 204/2017—Priority Review
1. Drugs. http://portal.anvisa.gov.br/drugs Accessed on 22 February 2020. 2. ANVISA. RDC 204/2017. http://antigo.anvisa.gov.br/documents/10181/2718376/RDC_204_2017_.pdf/b2d4ae64-2d91-44e9-ad67-b883c752c094 Accessed on 7 June 2022.
Biologics and Biosimilars Pathway (OS-45)
1. 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 Accessed on 7 June 2022.
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 ,Guide 42/2020. https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2020/anvisa-define-requisitos-para-pedidos-de-uso-emergencial-de-vacinas/guia-uso-emergencial.pdf ,Resolution 475. http://antigo.anvisa.gov.br/documents/10181/6134216/RDC_475_2021_.pdf/a9edad40-f6de-4d2d-891b-be84e4ee4171
Orphan Drug Route
1. 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 Accessed on 23 March 2022. 2. Pharma Boardroom. Orphan Drugs & Rare Diseases: Brazil. https://pharmaboardroom.com/legal-articles/orphan-drugs-rare-diseases-brazil/ Accessed on 23 March 2022. 3. New Brazilian Regulatory Resolution Helps Rare Disease Research. https://communityresearch.com/media/86927/april-newsletter-new-brazilian-regulatory-resolution-helps-rare-disease-research.pdf Accessed on 22 March 2022. 4. 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 Accessed on 7 June 2022.
Abridged Review for Small Molecules
1. 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 Accessed on 7 June 2022.
Optimized Analysis Procedure
Optimized Analysis Procedure (NORMATIVE INSTRUCTION - IN NO. 289, OF MARCH 20, 2024)
Abridged Route
Importation, Manufacture, Sale and Supply of Medicinal Products into Brunei Darussalam. Accessed on 27 October 2020.
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. CRS Guidance: GD-ReqDS004 ,,,,,
Verification Review for Biotherapeutic Product Applications
Caribbean Regulatory System (CARPHA/CRS). Guidance Document: Submission of Biotherapeutic Product Applications for Verification Review. GD-ReqBTP001.1
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 Accessed on 5 April 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/ Accessed on 5 April 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 Accessed on 5 April 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 Accessed on 5 April 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 Accessed on 5 April 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 Accessed on 19 March 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 Accessed on 19 March 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 Accessed on 05 July 2023.
The Central American Mechanism for the Joint Evaluation of Medicines
1. 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 Accessed on 5 May 2022. 2. 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 Accessed on 5 May 2022.
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/ Accessed on 22 February 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 Accessed on 14 September 2020. ,Regulatory, Pricing and Reimbursement. https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-chile/ Accessed on 22 February 2020.
Sanitary Registration of Orphan Medicines
Approves recommendations on sanitary registration of orphanic medicines. Accessed on 31 May 2020.
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. , , , , , , , , ,
Conditional Approvals for New Drugs
1. 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 Accessed on 9 May 2022. 2. Chinese Expedited Program Introduction. Yuanyuan (Irene) Diao, Senior Manager, Regulatory Affairs, Beigene. June 2022. | DIA. , , , , , , , , , , , , , , , , ,
Prioritized Drug Review and Approval Pathway
1. 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 Accessed on 26 October 2020. 2. Provisions for Drug Registration (SFDA Order No. 28). http://subsites.chinadaily.com.cn/nmpa/2019-07/25/c_390595.htm Accessed on 26 October 2020. 3. 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 Accessed on 5 September 2022.
Breakthrough Therapy Designation (BTD)
1. Pharmaceutical Technology. (2021). New Chinese Breakthrough Therapy designation attracts foreign companies. https://www.pharmaceutical-technology.com/comment/china-breakthrough-therapy-designation/ Accessed on 9 May 2022. 2. 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/ Accessed on 9 May 2022. 3. 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 Accessed on 9 May 2022.
The Special Approval Pathway (SAP) for COVID-19 related products
1. 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 Accessed on 9 May 2022. 2. 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 Accessed on 9 May 2022. 3. Chinese Expedited Program Introduction. Yuanyuan (Irene) Diao, Senior Manager, Regulatory Affairs, Beigene. June 2022. | DIA.
Priority Review
1. 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 Accessed on 9 May 2022. 2. Chinese Expedited Program Introduction. Yuanyuan (Irene) Diao, Senior Manager, Regulatory Affairs, Beigene. June 2022. | DIA.
INVIMA Abbreviated Procedure (Article 27)
Regulatory, Pricing and Reimbursement. https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-colombia/ Accessed on 22 February 2020. ,Life Sciences: product regulation and liability in Colombia. https://www.lexology.com/library/detail.aspx?g=0f52bfa1-a19a-4565-aecc-ac00ae143f82 Accessed on 22 February 2020.,Pharma & Medical Device Regulation. https://gettingthedealthrough.com/area/119/jurisdiction/8/pharma-medical-device-regulation-colombia/ Accessed on 22 February 2020.,Duran CE et al: Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries. Rev Panam Salud Publica. 2021;45:1-10
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 Accessed on 22 February 2020.,Regulatory, Pricing and Reimbursement. https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-colombia/ Accessed on 22 February 2020.,Life Sciences: product regulation and liability in Colombia. https://www.lexology.com/library/detail.aspx?g=0f52bfa1-a19a-4565-aecc-ac00ae143f82 Accessed on 22 February 2020. ,Pharma & Medical Device Regulation. https://gettingthedealthrough.com/area/119/jurisdiction/8/pharma-medical-device-regulation-colombia/ Accessed on 22 February 2020.
Emergency Use Authorization (ASUE)
http://pensamiento.unal.edu.co/fileadmin/recursos/focos/medicamentos/docs/Autorizacion_Sanitaria_de_Uso_de_Emergencia_-ASUE_para_medicamentos_de_diagnostico__prevencion_y_tratamiento_de_la_Covid_-19_1___4_.pdf,https://www.invima.gov.co/autorizacion-sanitaria-de-uso-de-emergencia-asue
Procedure for Pharmacological and Pharmaceutical Evaluations of Biological Drugs in the Sanitary Registration Process (Decreee 1782 de 2014)
Mutual Recognition of Sanitary Registration of Medicines for Human Use
Recognition of the evaluation and approval of final reports of reference regulatory authorities (Exec. Decree 39433-S)
Conditional Marketing Authorization
Simplified Procedure
https://www.paho.org/hq/dmdocuments/2012/CARICOM-Drug-Regulation-Assessment---Final-Report-Volume-2.pdf,http://www.incart.gob.do/transparencia/wp-content/uploads/2016/03/RESOLUCION-MSP-000004-ESTABLECE-CRITERIOS-PARA-LA-APLICACION-DEL-REGISTRO-SANITARIO-VENTA-LIBRE-Y-BUENAS-PRACTICAS-DE-ESTABLECIMIENTOS.pdf
EEU Mutual Recognition Procedure
REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION. https://www.regulatorypharmanet.com/eaeu/ Accessed on 4 February 2020. ,Registration of medicines in the Eurasian Economic Union. https://gratanet.com/publications/registration-of-medicines-in-the-eurasian-economic-union Accessed on 4 February 2020.,In the EAEU, a common medicines market is launched. http://www.eurasiancommission.org/en/nae/news/Pages/5-05-2017.aspx Accessed on 4 February 2020.
EEU Decentralized Procedure
REGISTRATION OF MEDICINES IN THE EURASIAN ECONOMIC UNION. https://www.regulatorypharmanet.com/eaeu/ Accessed on 4 February 2020. ,Registration of medicines in the Eurasian Economic Union. https://gratanet.com/publications/registration-of-medicines-in-the-eurasian-economic-union Accessed on 4 February 2020.,In the EAEU, a common medicines market is launched. http://www.eurasiancommission.org/en/nae/news/Pages/5-05-2017.aspx Accessed on 4 February 2020.
EU-M4all (formerly Article 58) - Standard Procedure
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
PRIME (PRIority MEdicines)
1. 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. TIRS 2017;51(1):51-54,Deuchar GA et al: Real world experience of PRIME and PIM applications. Reg Rapporteur 2017;14(10):4-7. 2. Maurice Bancsi. A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP. RF Quarterly. Volume 2, Number 2. June 2022. Accessed on 31 July 2022.
EMA Accelerated Assessment
Pre-authorization guidance. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance Accessed on 30 May 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 Accessed on 30 May 2020.,Fees payable to the European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/overview/fees-payable-european-medicines-agency#fees-for-marketing-authorisations-section Accessed on 30 May 2020.,Pre-authorization guidance. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance Accessed on 30 May 2020.
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 Accessed on 31 May 2020.
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 Accessed on 30 May 2020.,Support for advanced therapy developers. https://www.ema.europa.eu/en/human-regulatory/research-development/advanced-therapies/support-advanced-therapy-developers Accessed on 30 May 2020.
EMA Marketing Authorisation under Exceptional Circumstances
Pre-authorisation guidance. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance Accessed on 30 May 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 Accessed on 30 May 2020.
EMA Conditional Marketing Authorisation
Fees payable to the European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/overview/fees-payable-european-medicines-agency Accessed on 30 May 2020.,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 Accessed on 30 May 2020.
Opening procedures at EMA to non-EU authorities (OPEN) initiative
1. 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. Accessed on 22 March 2022. 2. Questions and Answers on the Pilot Project 'OPEN' | Opening our Procedures at EMA to Non-EU authorities. https://www.ema.europa.eu/en/documents/other/questions-answers-pilot-project-open_en.pdf Accessed on 22 March 2022. 3. 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 Accessed on 22 March 2022. 4. 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 Accessed on 04 October 2023. 5. 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 Accessed on 04 October 2023. 6. OPEN Pilot: One-year review and recommendations (Published 17 March 2022). https://www.ema.europa.eu/en/documents/report/open-pilot-one-year-review-recommendations_en.pdf Accessed on 04 October 2023.
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 Accessed on 12 November 2022.
EU-M4all (formerly Article 58) - Accelerated Assessment
EU-M4all (formerly Article 58) - Conditional Article 58 scientific opinion
EU-M4all (formerly Article 58) - Article 58 scientific opinion under exceptional circumstances
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
EAC Medicines Regulatory Harmonization Program
https://pharmacyboardkenya.org/files/?file=EAC_MER_Compendium.pdf EAC Medicines Regulatory Guidelines. https://www.eac.int/medicines-regulatory-guidelines Accessed on 27 April 2023.
Joint assessments of applications for marketing authorization in the CEMAC zone
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 Accessed on 14 September 2020.
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 Accessed on 13 November 2019.,Biologicals: Fast Track Guidelines. http://www.eda.mohp.gov.eg/images/News/F_39.pdf Accessed on 13 November 2019., Fast Track Announcement. http://www.eda.mohp.gov.eg/images/News/F_138.pdf Accessed on 13 November 2019. ,Ministerial Decree 425/2015 Registration of Human Pharmaceuticals http://www.eda.mohp.gov.eg/Files/766_425_2015.pdf,Human Drug Registration http://www.eda.mohp.gov.eg/Files/190_HumanRegWFlow.gif,Technical Committee Decisions for 2013. http://www.eda.mohp.gov.eg/Files/197_MinisterDec296.pdf AND http://www.eda.mohp.gov.eg/Files/154_Technical_Committee_Decisions_2013.pdf
Biological Products Reliance Pathway (decree 343/2021)
Emergency Use Application & Approval (EUA) - Medicinal Products
Emergency Use Application & Approval (EUA) - Biological Products
Reliance pathway for post-approval changes to a registered biotherapeutic product
EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)
Lot Release of Biological Products in Egypt
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 Accessed on 22 March 2020. , SPECIAL REGULATIONS FOR THE RECOGNITION OF FOREIGN HEALTH RECORDS. https://www.medicamentos.gob.sv/index.php/es/normativa-m/reglamentosdnm-m/reglamento-especial-para-el-reconocimiento-de-registros-sanitarios-extranjeros-dnm Accessed on 22 March 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 Accessed on 14 September 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/ Accessed on 10 November 2019. ,Rate of service fees regulation #370 of 2015. http://www.fmhaca.gov.et/wpcontent/plugins/downloadattachments/includes/download.php?id=3008 Accessed on 10 November 2019."
Conditional Approval of Medicines
1. 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 Accessed on 9 May 2022. 2. 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/ Accessed on 9 May 2022.
Emergency Use Authorization of COVID-19 Vaccine
1. 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 Accessed on 9 May 2022.
Registration of Low-Risk Medicines
1. 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 Accessed on 9 May 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 Accessed on 20 March 2021.,ATU regulations. https://ansm.sante.fr/documents/reference/reglementation-relative-aux-atu Accessed on 20 March 2021.
GHC Central Registration
1. Steps taken to streamline regulatory processes in the Middle East. https://clarivate.com/cortellis/blog/steps-taken-streamline-regulatory-processes-middle-east/ Accessed on 19 February 2020. 2. 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 Accessed on 19 February 2020. 3. Total fees for central registration and GCC. http://ghc.sa/en-us/Pages/crfees.aspx Accessed on 19 February 2020. 4. 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 Accessed on 19 February 2020. 5. Biomapas. Centralized Procedure in the GCC Region. https://www.biomapas.com/centralized-registration-procedure-gcc-region/ Accessed on 24 March 2022. 6. 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
Recognition of the state registration
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 Accessed on 10 November 2019,FDA Reliance Policy https://fdaghana.gov.gh/images/stories/pdfs/Quick%20link s/Policy/FDA%20RELIANCE%20POLICY.pdf Accessed on 10 November 2019
Abridged Review
Emergency Use Authorization (EUA) of Medical Products
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 Accessed on 26 April 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 Accessed on 26 April 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 Accessed on 26 April 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/index.php/legislacion-vigente/normas-tecnicas?download=285%3Anorma-tecnica-077-2018 Accessed on 26 April 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 Accessed on 14 September 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 Accessed on 26 April 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 Accessed on 26 April 2020.
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 Accessed on 26 April 2020. , Mutual Recognition of Sanitary Registry of Medicines for Human Use. https://arsa.gob.hn/descargas/Reconocimiento_Mutuo_PF.pdf Accessed on 26 April 2020.
Registration of Advanced Therapy Products
Regulation of Advanced Therapy Products. Accessed on 27 October 2020. https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/atp_regulation.html , Guidance on Application of Certificate of Drug/ Product Registration — Advanced Therapy Products Version 1.0.1 (Draft for comment). Accessed on 27 October 2020.https://www.drugoffice.gov.hk/eps/do/en/doc/atp_guidance/Draft_Guidance_Drug_Registration_ATP_v1.0.1.pdf , Pharmacy and Poisons (Amendment) Bill 2019 to regulate advanced therapy products. Accessed on 27 October 2020. https://www.info.gov.hk/gia/general/201910/18/P2019101800183.htm
1+ mechanism for approval of new drugs
New Chemical Entity approved & marketed in other countries not approved in India.
COVID-19 vaccine approval in India for restricted use in emergency situation
Quick and Expeditious Review Process
Accelerated Approval Process
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 Accessed on 6 February 2020. , Indonesia Pharmaceutical Regulatory Update. https://www.pacificbridgemedical.com/publication/indonesia-pharmaceutical-regulatory-update/ Accessed on 20 February 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 Accessed on 6 February 2020. , Indonesia Pharmaceutical Regulatory Update. https://www.pacificbridgemedical.com/publication/indonesia-pharmaceutical-regulatory-update/ Accessed on 20 February 2020.
Emergency Use Authorization
IGAD Joint Assessment Procedure
1. East Africa Regulatory Affairs Professional Association (EARAPA). Webinar on IGAD medicine harmonization procedures/process. https://www.youtube.com/watch?v=gZBSOl9grS4
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 Accessed on 4 February 2020.,Pharmaceutical drug Products registration/submission in Israel. https://bio-chem.co.il/en/blog/pharmaceutical-drug-products-registrationsubmission-in-israel/ Accessed on 4 February 2020.,State of Israel Ministry of Health, Pharmaceutical Division. https://www.health.gov.il/English/MinistryUnits/HealthDivision/MedicalTechnologies/Drugs/Pages/default.aspx Accessed on 4 February 2020.
Priority Review
Expedited Pathway
Reliance Procedure
The time-limited conditional approval system for regenerative medicines
Drugs Reviews. https://www.pmda.go.jp/english/review-services/reviews/0001.html Accessed on 23 January 2020. , Outline of Reviews and Related Services. https://www.pmda.go.jp/english/review-services/outline/0001.html Accessed on 23 January 2020. , PMDA’s Consultation Service. https://www.pmda.go.jp/files/000219654.pdf Accessed on 23 January 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 Accessed on 24 January 2020. , Annual Report FY 2018.
PMDA Conditional Early Approval
Drugs Reviews. https://www.pmda.go.jp/english/review-services/reviews/0001.html Accessed on 23 January 2020. , Outline of Reviews and Related Services. https://www.pmda.go.jp/english/review-services/outline/0001.html Accessed on 23 January 2020. , PMDA’s Consultation Service. https://www.pmda.go.jp/files/000219654.pdf Accessed on 23 January 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 Accessed on 24 January 2020.
Priority Review
Overview of Orphan Drug/Medical Device Designation System. https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/orphan_drug.html Accessed on 24 January 2020. , Global Development and Approval by Cooperation of Key Regulatory Agencies. https://www.pmda.go.jp/files/000226656.pdf Accessed on 24 January 2020. , Implementation of a Conditional Early Approval System for Pharmaceutical Products. https://www.pmda.go.jp/files/000227089.pdf Accessed on 24 January 2020. , European Union - Japan orphan medicines cooperation. https://www.ema.europa.eu/en/documents/other/european-union-japan-orphan-medicines-cooperation_en.pdf Accessed on 24 January 2020. , Outline of Reviews and Related Services. https://www.pmda.go.jp/english/review-services/outline/0001.html Accessed on 23 January 2020. , Orphan Products Development Support Program. https://www.nibiohn.go.jp/en/activities/orphan-support.html Accessed on 24 January 2020. , Outlook of Orphan and Pediatric Drug Development from Regulatory Perspectives. https://www.pmda.go.jp/files/000226869.pdf Accessed on 24 January 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 Accessed on 24 January 2020. , Annual Report FY 2018. , PMDA’s Consultation Service. https://www.pmda.go.jp/files/000219654.pdf Accessed on 23 January 2020.
PMDA Sakigake (Pioneering Drug Designation)
1. Strategy of SAKIGAKE by MHLW. https://www.pmda.go.jp/english/reviewservices/reviews/advanced-efforts/0001.html Accessed on 23 January 2020. 2. Drugs Reviews. https://www.pmda.go.jp/english/reviewservices/reviews/0001.html Accessed on 23 January 2020. 3. Outline of Reviews and Related Services. https://www.pmda.go.jp/english/reviewservices/outline/0001.html Accessed on 23 January 2020. 4. Strategy of Sakigake. https://www.mhlw.go.jp/english/policy/healthmedical/pharmaceuticals/dl/140729-01-01.pdf Accessed on 23 January 2020. 5. 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 Accessed on 24 January 2020. 6. Maurice Bancsi. A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP. RF Quarterly. Volume 2, Number 2. June 2022. Accessed on 31 July 2022. 7. PMDA’s Consultation Service. https://www.pmda.go.jp/files/000219654.pdf Accessed on 23 January 2020. 8. Annual Reports FY 2018. https://www.pmda.go.jp/files/000232603.pdf Accessed on 24 January 2020. 9. Summary of the Strategy of SAKIGAKE. https://www.mhlw.go.jp/english/policy/healthmedical/pharmaceuticals/dl/140729-01-02.pdf Accessed on 23 January 2020.
Emergency Regulatory Approval System
JFDA Verification Procedure
Jordan FDA Adopts Reliance Review Model. https://globalforum.diaglobal.org/issue/october-2019/jordan-fda-adopts-reliance-review-model/ Accessed on 4 January 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
JFDA Abridged Procedure
Jordan FDA Adopts Reliance Review Model. https://globalforum.diaglobal.org/issue/october-2019/jordan-fda-adopts-reliance-review-model/ Accessed on 4 January 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
Expedited Registration
Expertise of medicines. https://www.ndda.kz/category/ekspertiza_ls Accessed on 19 January 2020.,Safety and quality evaluation. https://www.ndda.kz/category/about_sert Accessed on 19 January 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 Accessed on 17 November 2019.,Draft Importation of Orphan Medicinal Substances guideline. https://www.pharmacyboardkenya.org/files/?file=DraftIm portation-of-OrphanMedicinalSubstancesGuideline.pdf Accessed on 17 November 2019. ,PPB Drug Registration Guidelines. https://pharmacyboardkenya.org/files/?file=drug_reg_gui delines.pdf Accessed on 18 November 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.p df Accessed on 17 November 2019. ,Biotherapeutic Products Guidelines. https://www.pharmacyboardkenya.org/files/?file=Biother apeutic_Products_Guidelines.pdf Accessed on 17 November 2019.
Reliance for Regulatory Decision Making in Kenya
1. Guidance on Reliance for Regulatory Decision Making in Kenya. https://web.pharmacyboardkenya.org/download/guidance-on-reliance-for-regulatory-decision-making-in-kenya/ Accessed on 23 March 2022. 2. 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 Accessed on 13 February 2023. 3. Pharmacy and Poisons Board. Marketing Authorization Pathways. https://web.pharmacyboardkenya.org/downloads/procedures/# Accessed on 13 February 2023. 4. 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 Accessed on 13 February 2023.
Emergency Use Application (EUA)
1. 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/# Accessed on 2 April 2022.
Biological Product/Biosimilars Registration
Kuwait’s New Pharmaceutical Registration Guidelines. https://www.tamimi.com/news/kuwaitsnew-pharmaceutical-registration-guidelines/ Accessed on 31 May 2020.,KUWAIT: NEW GUIDELINES FOR PHARMACEUTICAL REGISTRATION. https://www.sabaip.com/news/kuwait-newregulations-for-pharmaceutical-registration/ Accessed on 31 May 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 Accessed on 20 February 2020.,Market Overview 2016 Kuwait. https://www.tfhc.nl/wp-content/uploads/2017/08/KLSC-IMS-Kuwait-Health-Industry-Report-2016-vF2.pdf Accessed on 21 February 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- Accessed on 21 February 2020.
Biological Product/Biosimilars Registration
, , , , , , , , ,
Registration of Medicines
1. 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/ Accessed on 5 September 2022.
Import of New Drugs
FRP- Reliance (Verification)
1. FAQ : Generic Medicines. https://npra.gov.my/index.php/en/frequently-asked-questions-faqs-pharmacovigilance.html?highlight=WyJhYnJpZGdlZCIsImV2YWx1YXRpb24iLCJhYnJpZGdlZCBldmFsdWF0aW9uIl0= Accessed on 15 January 2020. 2. 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= Accessed on 15 January 2020. 3. FAQs: NCE. https://npra.gov.my/index.php/en/component/content/article/225-english/1527044-faq-nce.html?highlight=WyJ2ZXJpZmljYXRpb24iLCJyZXZpZXciLCJ2ZXJpZmljYXRpb24gcmV2aWV3Il0=&Itemid=1391 Accessed on 15 January 2020. 4. Drug Registration Guidance Document (DRGD) Third Edition, Third Revision July 2022. Appendix 9: Fees. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/APPENDIX-9--Fees.pdf Accessed on 23 August 2022.
FRP- Reliance (Abbreviated Review)
1. FAQ : Generic Medicines. https://npra.gov.my/index.php/en/frequently-asked-questions-faqs-pharmacovigilance.html?highlight=WyJhYnJpZGdlZCIsImV2YWx1YXRpb24iLCJhYnJpZGdlZCBldmFsdWF0aW9uIl0= Accessed on 15 January 2020. 2. 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= Accessed on 15 January 2020. 3. FAQs: NCE. https://npra.gov.my/index.php/en/component/content/article/225-english/1527044-faq-nce.html?highlight=WyJ2ZXJpZmljYXRpb24iLCJyZXZpZXciLCJ2ZXJpZmljYXRpb24gcmV2aWV3Il0=&Itemid=1391 Accessed on 15 January 2020. 4. Drug Registration Guidance Document (DRGD) Third Edition, Third Revision July 2022. 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/1047/drgd/APPENDIX-15--Requirements-for-Full-Evaluation-and-Abridged-Evaluation.pdf Accessed on 23 August 2022. 5. Drug Registration Guidance Document (DRGD) Third Edition, Third Revision July 2022. Appendix 9: Fees. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/APPENDIX-9--Fees.pdf Accessed on 23 August 2022.
Priority Pathway
1. Appendix 12: Priority Review. Drug Registration Guidance Document (DRGD) Third Edition, Third Revision July 2022. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/APPENDIX-12--Priority-Review.pdf Accessed on 23 August 2022. 2. Drug Registration Guidance Document (DRGD) Third Edition, Third Revision July 2022. Appendix 9: Fees. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/APPENDIX-9--Fees.pdf Accessed on 23 August 2022. , , , , , , , , , , , , ,
Orphan Drug Route
1. 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/ Accessed on 30 July 2022. 2. Malaysian Orphan Medicine Guidelines. MOH/S/FAR/24.20(GU)-e. https://www.pharmacy.gov.my/v2/sites/default/files/document-upload/malaysian-orphan-medicines-guideline-2020_0.pdf Accessed on 30 July 2022. 3. Drug Registration Guidance Document (DRGD) Third Edition, Third Revision July 2022. Appendix 9: Fees. APPENDIX 9 - FEES. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/APPENDIX-9--Fees.pdf Accessed on 30 July 2022. 4. Drug Registration Guidance Document (DRGD) Third Edition, Third Revision July 2022. Appendix 13: Designation and Registration of Orphan Medicines. APPENDIX 13 - DESIGNATION AND REGISTRATION OF ORPHAN MEDICINES. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/APPENDIX-13--Designation-and-Registration-of-Orphan-Medicines.pdf Accessed on 30 July 2022.
Conditional Registration for Pharmaceutical Products During Disaster
1. Appendix 9: Fees. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/APPENDIX-9--Fees.pdf Accessed on 23 August 2022. 2. Drug Registration Guidance Document (DRGD) Third Edition, January 2021. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/Main-Body-Drug-Registration-Guidance-Document-DRGD-3rd-Edition-January-2021_final.pdf Accessed on 23 August 2022. 3. 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 Accessed on 23 August 2022. 4. 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 Accessed on 23 August 2022.
Conditional Registration for New Chemical Entities and Biologics in Malaysia
1. Appendix 9: Fees. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/APPENDIX-9--Fees.pdf Accessed on 23 August 2022. 2. Drug Registration Guidance Document (DRGD) Third Edition, January 2021. https://www.npra.gov.my/easyarticles/images/users/1047/drgd/Main-Body-Drug-Registration-Guidance-Document-DRGD-3rd-Edition-January-2021_final.pdf Accessed on 23 August 2022. 3. 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 Accessed on 23 August 2022. 4. 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 Accessed on 23 August 2022.
Malaysia-Japan Cooperation on Simplifying Drug Review Procedure
HSA-NPRA Generic Medicines Work Sharing Initiative
Article 170
1. 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 Accessed on 4 April 2020. , , , , , , , , , , , , ,
Equivalence Agreement
Mexico - K. Healthcare Products & Services. https://www.export.gov/apex/article2?id=Mexico-Healthcare-Products-Services Accessed on 22 March 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 Accessed on 22 March 2020. ,Regulatory, Pricing & Reimbursement. https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-mexico/ Accessed on 22 March 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 Accessed on 22 March 2020.,Pharma & Medical Device Regulation: Mexico. https://gettingthedealthrough.com/area/119/jurisdiction/16/pharma-medical-device-regulation-mexico/ Accessed on 22 March 2020.,Mexico - K. Healthcare Products & Services. https://www.export.gov/apex/article2?id=Mexico-Healthcare-Products-Services Accessed on 22 March 2020.
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. Accessed on 4 April 2020.
Emergency Use Authorization
Equivalencia 2025 - Proposed in Public Consultation
Simplified Registration Procedure
Verification Review
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 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 2. 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
Abridged Review
1. 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 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 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
Expedited “fast-track” registration procedure
Namibia Medicines Regulatory Council (NMRC). Medicines Evaluations and Registration. https://nmrc.gov.na/medicine-registration-overview Accessed on 29 August 2021. ,SCHEDULE. ANNEXURE XXXVIII. MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003. FEES (Regulation 47). ,Namibia Medicines Regulatory Council (NMRC). Guidance for the preparation and submission of dossiers in Common Technical Document format. Accessed on 29 August 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. doi: 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
Verification Review
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 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 2. Namibia Medicines Regulatory Council (NMRC). Medicines Evaluations and Registration. https://nmrc.gov.na/medicine-registration-overview Accessed on 5 September 2022.
Abridged Review
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 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 2. Namibia Medicines Regulatory Council (NMRC). Medicines Evaluations and Registration. https://nmrc.gov.na/medicine-registration-overview Accessed on 5 September 2022.
Abbreviated Evaluation Process
1. 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
Priority Assessment of New Medicine Applications
1. 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
Registration of Imported Drugs in Nigeria
1. 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. Accessed on 29 August 2021
Licensing or Access to COVID-19 Vaccines
Joint Nordic HTA-Bodies (formerly FINOSE)
Project Orbis
Guidance on Project Orbis. https://www.gov.uk/guidance/guidance-on-project-orbis#products-eligible-for-project-orbis Accessed on 15 March 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 Accessed on 15 March 2021.,Project Orbis: Global Collaborative Review Program. R. Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, et al. Clin Cancer Res Published OnlineFirst October 9, 2020. doi:10.1158/1078-0432.CCR-20-3292,Swissmedic participates in FDA Project Orbis. Accessed on 19 April 2020. https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/fda-projekt-orbis.html,Guidance on Project Orbis. https://www.gov.uk/guidance/guidance-on-project-orbis#products-eligible-for-project-orbis Accessed on 15 March 2021.
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 Accessed on 18 December 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 Accessed on 18 December 2019. ,Procedure for Registration of Drugs. http://www.dra.gov.pk/Home/Download?ImageName=Procedure%20of%20Registration.pdf Accessed on 18 December 2019.
Conditional Marketing Authorization
Procedure for Registration of Drugs. http://www.dra.gov.pk/Home/Download?ImageName=Procedure%20of%20Registration.pdf Accessed on 18 December 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 Accessed on 18 December 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 Accessed on 18 December 2019.
Emergency Use Authorization for Drugs & Vaccines
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
Automatic recognition of sanitary registrations of medicines manufactured and registered in countries with WHO Listed Authorities (Executive Decree No. 2 of January 7, 2025)
Evaluation Route 1 (Multi-Source Well-Established Products)
Evaluation Route 2 (NCEs & Complex Biologicals)
Priority Review Pathway
Simplified procedure (Law 1119/97)
Reliance Pathway
Regulatory, Pricing and Reimbursement Overview. https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-peru/ Accessed on 22 March 2020. ,Orphan Drugs & Rare Diseases: Peru. https://pharmaboardroom.com/legal-articles/orphan-drugs-rare-diseases-peru/ Accessed on 22 March 2020. ,Biosimilars & Biologics: Peru. https://pharmaboardroom.com/legal-articles/biosimilars-biologics-peru/ Accessed on 22 March 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 Accessed on 22 March 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 Accessed on 14 September 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. , , , , , , , , ,
Collaborative Review Process (Accelerated registration of WHO-prequalified pharmaceutical products and vaccines
1. 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 Accessed on 17 June 2022. 2. 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/ Accessed on 17 June 2022.
Orphan Drug Route
1. 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/ Accessed on 30 July 2022. 2. Government of Philippines. Rares Diseases Act. https://doh.gov.ph/sites/default/files/policies_and_laws/RA10747.pdf Accessed on 30 July 2022.
Registration of Drug Products under Emergency Use for the Coronavirus Disease 2019 (COVID-19) (INITIAL-DEU)
1. 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 Accessed on 25 August 2022. 2. 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/ Accessed on 25 August 2022.
Facilitated Review Pathway (Verification Review)
1. 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".
Facilitated Review Pathway (Abridged Review)
1. 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".
Emergency Use Authorization for Drugs & Vaccines for COVID-19
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 Accessed on 25 November 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/ Accessed on 25 November 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 Accessed on 25 November 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/ Accessed on 25 November 2020.
Authorization for Emergency Use for Medicinal Products, Medical Devices and IVDs
1. Rwanda FDA. GUIDELINES FOR AUTHORIZATION FOR EMERGENCY USE OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND IVDs. Accessed on 26 August 2021. https://www.rwandafda.gov.rw/web/guidelines/Guidelines_for_Authorization_for_Emergency_Use_for_Medicinal_Products_Medical_devices_and_IVDs.pdf
Priority Review (Biological Products)
1. 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 Accessed on 26 August 2021.
Priority Review
1. 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 Accessed on 26 August 2021. ,2. Rwanda FDA. GUIDELINES ON RELIANCE FOR REGULATORY DECISION MAKING. https://www.rwandafda.gov.rw/web/guidelines/GUIDELINES_ON_RELIANCE_FOR_REGULATORY_DECISION.pdf Accessed on 26 August 2021. ,3. 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 Accessed on 26 August 2021.
Abridged Procedure
"1. 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/ Accessed on 12 December 2019.,2.Registration according to Verification and Abridged Process. https://www.sfda.gov.sa/en/drug/drug_reg/Regulations/VerificationAbridgedProcess.pdf Accessed on 12 December 2019.,Guidance for Priority Review of Product Registration. https://www.sfda.gov.sa/en/drug/drug_reg/Regulations/PriorityReviewProductRegistration.pdf Accessed on 12 December 2019.
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/ Accessed on 12 December 2019.,Registration according to Verification and Abridged Process. https://www.sfda.gov.sa/en/drug/drug_reg/Regulations/VerificationAbridgedProcess.pdf Accessed on 12 December 2019.,Guidance for Priority Review of Product Registration. https://www.sfda.gov.sa/en/drug/drug_reg/Regulations/PriorityReviewProductRegistration.pdf Accessed on 12 December 2019.,Draft of Regulatory Framework for Drug Approvals. https://www.sfda.gov.sa/en/drug/drug_reg/Regulations/RegulatoryFrameworkFinalV6.pdf Accessed on 19 December 2019.,Drug Master File: Guidance for Submission. https://www.sfda.gov.sa/en/drug/drug_reg/Regulations/DMF-GuidanceV3.pdf Accessed on 19 December 2019.
Priority Review
Breakthrough Medicine Program
Conditional Approval for Medicinal Products for Human Use
Orphan Drug Designation
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 Accessed on 17 January 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 Accessed on 17 January 2020.
Expedited/Fast-Track Review Process
Listing of specialized or orphan products for importation in Sierra Leone
Emergency Use Authorization
Verification - CECA Route
1. Health Sciences Authority. Fees and turnaround time for therapeutic products. https://www.hsa.gov.sg/therapeutic-products/fees Accessed on 2 April 2022. 2. 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 Accessed on 2 April 2022.
GDA Verification Route
1. Health Sciences Authority. Fees and turnaround time for therapeutic products. https://www.hsa.gov.sg/therapeutic-products/fees Accessed on 2 April 2022. 2. 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 Accessed on 2 April 2022.
GDA Abridged Route
1. Health Sciences Authority. Fees and turnaround time for therapeutic products. https://www.hsa.gov.sg/therapeutic-products/fees Accessed on 2 April 2022. 2. 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 Accessed on 2 April 2022.
NDA Abridged Route
1. Health Sciences Authority. Fees and turnaround time for therapeutic products. https://www.hsa.gov.sg/therapeutic-products/fees Accessed on 2 April 2022. 2. 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 Accessed on 2 April 2022.
NDA Verification Evaluation Route
1. Health Sciences Authority. Verification evaluation route for new drug application. https://www.hsa.gov.sg/therapeutic-products/register/guides/new-drug/verification-evaluation Accessed on 2 April 2022. 2. Health Sciences Authority. Fees and turnaround time for therapeutic products. https://www.hsa.gov.sg/therapeutic-products/fees Accessed on 2 April 2022. 3. 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 Accessed on 2 April 2022.
Pandemic Special Access Route (PSAR)
HSA-NPRA Generic Medicines Work Sharing Initiative
Reliance-based Evaluation Pathways – ABRIDGED REVIEW
Reliance-based Evaluation Pathways - RECOGNITION
Reliance-based Evaluation Pathways – VERIFIED REVIEW
Registration of Candidate COVID-19 vaccines
EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)
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 Accessed on 15 January 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 Accessed on 15 January 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 Accessed on 15 January 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 Accessed on 15 January 2020.
Global Innovative products on Fast Track (GIFT)
Fast Track (Priority) Review
Guideline on Registration of Medicines. https://nmra.gov.lk/images/PDF/draft_guidelines/Guideline-on-registration-of-medicine.pdf Accessed on 31 May 2020. , , , , , , , , ,
TBD
, , , , , , , , ,
Swissmedic Article 13 Therapeutic Product Act (TPA)
1. Guidance on applications according to Article 13 TPA for eCTD applications. Accessed on 5 September 2022. 2. Swissmedic. Questions and answers Art. 13 TPA Version dated 13 June 2022. 3. Swissmedic. Guidance document Authorisation human medicinal product under Art. 13 TPA HMV4. Accessed on 13 June 2021. 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 4. 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 Accessed on 13 June 2021, 5. Swissmedic. Directory List countries with comparable control of human medicinal products HMV4. Accessed on 13 June 2021.
Swissmedic Marketing Authorisation for Global Health Products (MAGHP) Procedure
SwissMedic Guidance document MAGHP Procedure. Accessed on 20 April 2020.
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 Accessed on 12 June 2021.
Fast-track authorisation procedure (FTP)
Temporary authorisation for human medicinal products
Simplified Authorization Procedure (Art. 14)
Marketing Authorisation for Global Health Products (MAGHP) Light Procedure
Priority Review
Fee-Charging Standards for the Review of Medicament and Cosmetic Advertisements. Accessed on 6 January 2020. , Taiwan Drug Approval Process. https://www.fda.gov.tw/eng/newsContent.aspx?id=22247 Accessed on 6 January 2020.
Accelerated Approval
Fee-Charging Standards for the Review of Medicament and Cosmetic Advertisements. Accessed on 6 January 2020. ,Taiwan Drug Approval Process. https://www.fda.gov.tw/eng/newsContent.aspx?id=22247 Accessed on 6 January 2020.
Abbreviated Review
Fee-Charging Standards for the Review of Medicament and Cosmetic Advertisements. Accessed on 6 January 2020. , Taiwan Drug Approval Process. https://www.fda.gov.tw/eng/newsContent.aspx?id=22247 Accessed on 6 January 2020.
Taiwan Orphan Drug Pathway
1. 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 Accessed on 15 June 2022. 2. Ministry of Health & Welfare. The Rare Disease and Orphan Drug Act. https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030003 Accessed on 15 June 2022. 3. 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 Accessed on 15 June 2022.
Breakthrough Therapy Designation
Fast Track Evaluation
TFDA Registration Medicines. https://www.tmda.go.tz/uploads/publications/en1573544130- GN%20314%20-%20Registration%20medicines.pdf Accessed on 13 November 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 Accessed on 13 November 2019. ,Quality Assurance Tanzania. http://origin.who.int/hiv/amds/QualityAssuranceTanzania.ppt Accessed on 13 November 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
Abridged Review
1. 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 Accessed on 5 September 2022. 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 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
Emergency Use Authorization of Medicinal Products
Orphan Medicines
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 Accessed on 5 February 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 Accessed on 5 February 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 Accessed on 5 February 2020.,Drug act B.E.2510 and its amendments. http://www.fda.moph.go.th/sites/drug/EN/Shared%20Docu ments/law/DrugAct2510.pdf Accessed on 18 January 2020.
Conditional Approval for Emergency Use of Medical Products
Abridged Review
1. 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 Accessed on 26 August 2021.
Homologation procedure
Prioritization Request
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. doi: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 Accessed on 4 January 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 Accessed on 4 January 2020.
Emergency Use Authorization
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)
Fast-track assessment of CTD dossier applications
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 Accessed on 18 January 2020.,Abridged registration procedures. https://cratia.ua/en/state-registration-medicines-and-active-pharmaceutical-ingredients/abridgedregistration-procedures Accessed on 18 January 2020.
Authenticity Procedure
Abridged registration procedures. https://cratia.ua/en/state-registration-medicines-and-active-pharmaceutical-ingredients/abridged-registration-procedures Accessed on 18 January 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/ Accessed on 19 January 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 Accessed on 19 January 2020.
Innovative Licensing and Access Pathway (ILAP)
1. 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 Accessed on 16 March 2021. 2. 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 Accessed on 31 July 2022. 3. Guidance - About the pathway. https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap-for-medicines/about-the-pathway Accessed on 16 March 2021. 4. Guidance - Innovative Licensing and Access Pathway (ILAP) for medicines. https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap-for-medicines Accessed on 16 March 2021.
European Commission Decision Reliance Procedure (ECDRP)
1. GOV.UK. Guidance: European Commission (EC) Decision Reliance Procedure. https://www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure Accessed on 31 March 2022. Updated on 03 July 2023.
Decentralised and mutual recognition reliance procedure for marketing authorisations (MRDCRP)
1. 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 Accessed on 31 March 2022.
Conditional Marketing Authorisation Applications (CMA)
1. 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 Accessed on 27 May 2022
Great Britain Marketing Authorisations under exceptional circumstances
1. 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 Accessed on 27 May 2022. 2. 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 Accessed on 27 May 2022.
150-day assessment for national applications for medicines
1. 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 Accessed on 31 May 2022
Orphan medicinal products
1. GOV.UK. Guidance | Orphan medicinal products. https://www.gov.uk/guidance/orphan-medicinal-products-in-great-britain Accessed on 31 May 2022.
Early Access to Medicines Scheme (EAMS)
Unfettered Access Procedure (UAP)
International Recognition Procedure - Recognition A
International Recognition Procedure - Recognition B
FDA Breakthrough Therapy
1. Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics. https://www.fda.gov/media/86377/download Accessed on 17 June 2022. 2. Conrad R et al: Breakthrough Therapy Designation: CDER analysis of requests 4 years into the program. TIRS 2017:51(4);509-515, 3. Damle N et al: FDA’s expedited programs and their impact on the availability of new therapies. TIRS 2017:51(1):24-28 4. Bennie Johnson. How does FDA rescind a Breakthrough Therapy Designation? New guidance heads to White House for review. AgencyIQ. FDA Today | June 10, 2022. 5. 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 Accessed on 17 June 2022. 6. 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 Accessed on 17 June 2022. 7. Maurice Bancsi. A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP. RF Quarterly. Volume 2, Number 2. June 2022. Accessed on 31 July 2022.
FDA Accelerated Approval
Accelerated Approval. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval Accessed on 11 April 2020.,Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics. https://www.fda.gov/media/86377/download Accessed on 11 April 2020.
FDA CPP for Unapproved Products
CDER CPP – Unapproved Drug. https://www.fda.gov/media/97627/download Accessed on 13 April 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 Accessed on 13 April 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 Accessed on 13 April 2020.
FDA Fast Track
Fast Track. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track Accessed on 11 April 2020.,Fast Track Designation Requests. https://www.fda.gov/drugs/ind-activity/fast-track-designation-requests Accessed on 11 April 2020. ,Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics. https://www.fda.gov/media/86377/download Page 9 accessed on 11 April 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 Accessed on 12 April 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 Accessed on 12 April 2020.,Electronic Code of Federal Regulations. e-CFR data is current as of April 9, 2020. Accessed on 12 April 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 Accessed on 12 April 2020.,Orphan Drugs: Understanding the FDA Approval Process. Academic Entrepreneurship for Academic and Health Scientists. Vol. 1, Issue 3, Article 13. Accessed on 12 April 2020.
FDA Priority Review
Priority Review. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review Accessed on 11 April 2020. ,Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics. https://www.fda.gov/media/86377/download Accessed on 11 April 2020.
FDA Real Time Oncology Review-RTOR
1. "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 Accessed on 13 April 2020. 2. Real-Time Oncology Review Pilot Program. https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program Accessed on 13 April 2020. 3. 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. 4. 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 Accessed on 31 July 2022. 5. US Food and Drug Administration. Real-Time Oncology Review (RTOR) - Guidance for Industry. DRAFT GUIDANCE. July 2022. https://www.fda.gov/media/160186/download Accessed on 31 July 2022.
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 Accessed on 12 April 2020.,Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. Guidance for Industry. https://www.fda.gov/media/120267/download Accessed on 12 April 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 Accessed on 17 May 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 Accessed on 17 May 2021.
Split Real-Time Application Review (STAR) Program
1. 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 Accessed on 22 March 2022. 2. PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2023 THROUGH 2027. https://www.fda.gov/media/151712/download Accessed on 22 March 2022. 3. 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/ Accessed on 22 March 2022.
Coronavirus Treatment Acceleration Program (CTAP)
1. US Food and Drug Administration. Coronavirus Treatment Acceleration Program (CTAP). https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap Accessed on 5 May 2022. 2. 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 Accessed on 5 May 2022. 3. 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 Accessed on 5 May 2022.
Accelerating Rare disease Cures (ARC) Program
1. 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 Accessed on 11 May 2022. 2. 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 Accessed on 11 May 2022.
Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program
1. 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 Accessed on 8 September 2022. 2. 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 Accessed on 8 September 2022. 3. 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 Accessed on 8 September 2022. 4. 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 Accessed on 8 September 2022. 5. USFDA. Drug Development Tool (DDT) Qualification Programs. https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-programs Accessed on 8 September 2022.
Emergency Use Authorization (EUA)
1. US Food and Drug Administration. Emergency Use Authorization. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization Accessed on 13 October 2022. 2. US Food and Drug Administration. 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 Accessed on 13 October 2022.
Emergency Use Authorization for Vaccines to Prevent COVID-19
1. 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 Accessed on 12 November 2022. 2. 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/newsarticles/2022/4/expedited-regulatory-pathway-options-and-utility-p Accessed on 12 November 2022.
Project FrontRunner
Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program
Tropical Disease Priority Review Voucher Program
Generating Antibiotic Incentives Now (GAIN)
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
Animal Rule Approvals
USFDA-EMA Mutual Recognition Agreement for GMP Inspections
Model-Informed Drug Development Paired Meeting Program
Advanced Manufacturing Technologies Designation Program
Collaboration on Gene Therapies Global Pilot (CoGenT)
Biosimilar Regulatory Review and Approval
Expedited Procedure
Regulatory, Pricing and Reimbursement. 06/11/2018. FERRERE / Uruguay. https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-uruguay/ Accessed on 26 April 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 Accessed on 14 September 2020.
Urgent Procedure for biotechnological medicinal products
Abridged Procedure
Change in Drug Registration in Vietnam. https://www.tilleke.com/resources/change-drugregistration-vietnam Accessed on 5 February 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 Accessed on 5 February 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 Accessed on 5 February 2020.
Orphan Drug Route
1. 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/ Accessed on 31 July 2022. 2. Pharma Boardroom. Regulatory, Pricing and Reimbursement Overview. 30/05/2020. Tilleke & Gibbins / Vietnam. https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-vietnam/ Accessed on 31 July 2022.
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 Accessed on 1 January 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 Accessed on 1 January 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 Accessed on 1 January 2020.
WHO Prequalification of Medicines Programme (PQP) – Abridged Assessments
Fee Schedule. http://who.int/medicines/news/finance-arrangements-prequal-med/en/ Accessed on 18 December 2019.,WHO Prequalification Fees. http://who.int/medicines/news/finance-arrangements-prequal-med/en/ Accessed on 18 December 2019. ,Overview: History & Mission. https://extranet.who.int/prequal/content/overview-history-mission Accessed on 18 December 2019. ,Technical Report Series (TRS) documents approved by the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) Accessed on 19 December 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 Accessed on 19 December 2019.,Guidelines on APIMF Submission Procedure http://www.who.int/entity/medicines/areas/quality_safety/quality_assurance/GuidelinesActivePharmaceuticalIngredientTRS948Annex4.pdf?ua=1 Accessed on 29 December 2019.
WHO Prequalification of Medicines Programme (PQP) – Full Assessments
Fee Schedule. http://who.int/medicines/news/finance-arrangements-prequal-med/en/ Accessed on 18 December 2019. ,WHO Prequalification Fees. http://who.int/medicines/news/finance-arrangements-prequal-med/en/ Accessed on 18 December 2019.,Overview: History & Mission. https://extranet.who.int/prequal/content/overview-history-mission Accessed on 18 December 2019. ,Technical Report Series (TRS) documents approved by the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) Accessed on 19 December 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 Accessed on 19 December 2019.,Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities (2014) Accessed on 19 December 2019. ,Guidelines on APIMF Submission Procedure http://www.who.int/entity/medicines/areas/quality_safety/quality_assurance/GuidelinesActivePharmaceuticalIngredientTRS948Annex4.pdf?ua=1 Accessed on 29 December 2019.
WHO Collaborative Registration Procedure: Finished Pharmaceutical Products assessed and approved by SRAs
1. World Health Organization (WHO). Accelerated Registration of FPPs Approved by SRAs. https://extranet.who.int/pqweb/medicines/faster-registration-fpps-approved-sras Accessed on 25 March 2022. 2. 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.
COVID-19 Technology Access Pool (C-TAP)
1. World Health Organization (WHO). WHO COVID-19 Technology Access Pool. https://www.who.int/initiatives/covid-19-technology-access-pool Accessed on 15 June 2022. 2. World Health Organization (WHO). How WHO C-TAP Works?. https://www.who.int/initiatives/covid-19-technology-access-pool/what-is-c-tap Accessed on 15 June 2022.
Parallel recommendation and regulatory pathway
Coordinated Scientific Advice (CSA) for Health Product R&D
Emergency Use Listing (EUL) Procedure for Vaccines
Licensing of Pharmaceuticals for Human Use in WAEMU Member States
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://www.wahooas.org/webooas/sites/default/files/publications/1993/wa-mrhregional-joint-medicines-assessmentprocedure.pdf Accessed on 20 February 2020.
Verification Review (Type 1)
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 2. 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
Abridged review (Type 2)
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 2. 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
Fast-track/priority review
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 2. 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
ZAZIBONA Collaborative Medicines Registration Process - Cost Recovery Pilot
SADC Collaborative Medicines Registration Initiative (Zazibona). https://www.saapi.org.za/download/presentation/davismahlatji.pdf Accessed on 19 February 2020.,Zazibona Request Form. http://www.mcaz.co.zw/index.php/downloads/category/21- forms?download=231:zazibona-request-form Accessed on 19 February 2020.,Zazibona Registration Pathway. http://www.mcaz.co.zw/index.php/downloads/category/13- zazibona?download=1:zazibona-registration-pathway-v01- 09062015 Accessed on 19 February 2020., Annex I documents. http://www.mcaz.co.zw/index.php/downloads/category/13- zazibona?download=4:annex-i-documents Accessed on 19 February 2020. 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. Available from: https://doi.org/10.1007/s43441-020-00154-y ZAZIBONA STAKEHOLDERS’ ENGAGEMENT MEETING, 18 JULY 2023 QUESTION & ANSWER.
Expedited or “Fast-track” Registration Procedure
How to Register Conventional Medicines https://www.mcaz.co.zw/index.php/how-to-register Accessed on 10 November 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 Accessed on 10 November 2019,MCAZ CTD Guidelines http://www.mcaz.co.zw/index.php/downloads/category/11- guidelines?download=74:mcaz-ctd-guidelines Accessed on 10 November 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 Accessed on 10 November 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/ Accessed on 13 February 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 Accessed on 13 February 2023.