Snapshot

The IGAD Joint Assessment Procedure pathway has been developed by the Intergovernmental Authority on Development (IGAD) Region of Intergovernmental Authority on Development (IGAD) Region.

This pathway can be used where Medicines used for Reproductive Health (Oxytocin, Prostaglandins, Magnesium Sulphate, Tranexamic Acid); Medicines for Neonatal and Child Health (Antidiarrheals (Zinc sulphate products), products for treatment of upper and lower respiratory tract infection and pediatric formulations (Antimicrobials and Antimalarials)); Medicines used for management of Malaria (Antimalarial medicines based on Malaria Treatment Guidelines for each member state); Antimicrobial agents (Fixed dose combination products); Medicines used for management of cancer (Anti-cancer (Chemical and Biological) products); Medicines used for management of cardiovascular diseases (Medicines used for management of cardiovascular diseases); Medicines used for management of HIV/AIDs (Antiretrovirals); Medicines used for management of Tuberculosis (Anti-tuberculosis medicines); Medicines used for management of Neglected Tropical Diseases (NTDs) (Anti-leishmaniasis, Anti-pneumocystis, Anti-toxoplasmosis, Anti-filariasis, Anti-strongyloidiasis, Anti-leprosy medicines); Medicines used for management of Diabetes Mellitus (Insulin and oral hypoglycemics); Biologicals/immunising agents (Human vaccines).

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Djibouti Eritrea Ethiopia Kenya Somalia South Sudan Sudan Uganda

Target time assessment is For an application to qualify for the joint assessment, the applicant should officially express interest in the format provided in Annex 1, the duly completed form should be submitted to the IGAD MRH secretariat at Karim.Wanga@igad.int and the medicinal product dossier should be submitted electronically on the Accumulus platform, the details of the platform (access credentials and orientation on use of the platform) will be shared to the applicants that are eligible based on the screening outcome. JOINT ASSESSMENT PROCESS: The IGAD, in partnership with the NRAs, will coordinate the joint assessments of dossiers of the medicinal products received through this EOI. The dossier will be subjected to scientific review based on the CTD format to ascertain compliance of the medicinal product with the IGAD and international requirements for quality, safety, and efficacy. In addition, the manufacturing sites of the products will be inspected to check compliance with current Good Manufacturing Practices (cGMP). The assessment process will entail five critical steps as described below; (1) Step 1: Dossier selection: For purposes of joint assessments in the IGAD region, the IGAD secretariat, in collaboration with the EWG-MAR, will select the applications of medicinal product dossiers that are eligible for the joint assessments, taking into consideration the priority list of product categories and molecules. The applicant should commit to marketing the product in at least two or more member states of the IGAD region. (2) Step 2: Dossier Screening: Before a dossier is accepted for scientific review, the dossier will be subjected to screening to verify the completeness of the dossier and compliance with the technical document format (CTD) requirements using a screening checklist. The IGAD secretariat will screen dossiers in collaboration with NRAs and assigned experts. In case a dossier is incomplete or not CTD compliant, the applicant will be informed accordingly by the IGAD secretariat. (3) Step 3: Dossier Assessment: Experts from two NRAs will be involved in the assessment of one dossier. The NRAs are responsible for nominating experts who will be engaged in the joint assessments based on their own national processes and procedures. The first scientific review will be done by the primary assessor; the report from the primary assessor will then be re-assessed by the secondary assessor. Where additional data/information is required, queries will be raised to the applicant. The query responses will be evaluated by the primary and secondary assessor similarly. There will be two rounds/ cycles of assessments, where the applicant will have the opportunity to respond to the queries (allowable maximum time of 30 calendar days to respond; in each round). The regulatory clock will pause while waiting for applicant responses. (3a) GMP Verification and Inspections in the IGAD Joint Assessment Process: Where applicable, manufacturing sites associated with dossiers submitted for IGAD joint assessment will undergo verification to confirm compliance with the World Health Organization (WHO) current Good Manufacturing Practices (cGMP). The IGAD Secretariat, in collaboration with participating National Regulatory Authorities (NRAs), will coordinate joint GMP inspections for selected sites. These inspections will be conducted by designated GMP inspectors from IGAD member states, following WHO GMP standards and IGAD MRH inspection procedures. Applicants will be notified in advance of the inspection schedule and shall facilitate access to manufacturing sites, relevant documentation, and quality control records. Findings from the joint inspections will form part of the joint assessment report and will be shared with all participating NRAs for reliance and domestication (4) Step 4: Plenary Review and Recommendations: The final report will be subjected to peer review in plenary sessions, where experts from all seven NRAs participate in the scientific review before the final decision is made. The primary assessor or secondary assessor will present the report, taking into consideration comments from the secondary assessor, in the plenary session of the EWG-MAR, to provide an opportunity for all the experts in the EWG to provide their comments/ scientific reviews before the final decision is made. The outcome will be either RECOMMENDATION for registration of the product or REJECTION. The outcome of the joint assessment will be communicated to the respective applicant through an official letter. The outcome will also be communicated to all the NRAs of the IGAD member states. Standardized assessment templates will be applied to ensure compliance with international standards, as well as to ensure uniformity and quality assurance of the process. The World Health Organization, Africa Medicines Agency (AMA), or any other collaborating regulatory authority or international organizations may participate as observers as long as they agree to confidentiality terms and they have no conflict of interest. Observers shall not participate in the decision-making process. (5) National Registration / Domestication of regional outcome: If a positive recommendation is issued at the regional level, the applicant will submit an application to the relevant NRA for product registration. The NRA will rely on the decision of the IGAD EWG-MAR to issue market authorization/registration of the medicinal product within a period of 90 days. TARGET TIMELINES: 1. Dossier screening = 30 working days excluding paused-clock time; 2. Full Assessment = 210 regulatory decision days*; 3. Reliance Route = 90 working days; 4. National domestication = 90 working days. *NOTE: Target processing timelines are indicative timelines and do not necessarily represent the actual processing timelines. Working day means an eight-hour day. Regulatory decision day is counted from the date of receipt of an application to the date of approval or non-approval/withdrawal of an application and excludes paused-clock time. Paused-clock time means the time taken by an applicant to respond to any question asked. .