Snapshot

The West African Health Organization (WAHO) Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products pathway has been developed by the WAHO of West African Health Organization (WAHO).

This pathway can be used where New chemical entities, biologicals, biosimilars, blood products, medical devices, generics..

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: Benin Burkina Faso Cape Verde Cote D'Ivoire Gambia Ghana Guinea Guinea-Bissau Liberia Mali Niger Nigeria Senegal Sierra Leone Togo

Currently, the West Africa has no Regional Medicines Regulatory Agency, which has legal mandate for marketing authorization of medicinal products. In view of this, and within the framework of the West African Medicines Regulatory Harmonization (WA-MRH) Initiative, selected medicines in the regional basket will be authorized through the national authorization procedure, after the joint assessment procedure. In the current operating model of the WA-MRH initiative, an NRA serves as a lead coordinator for a 2-year period and receives, validates and arranges for the assessment of the dossiers and additionally communicates with applicants and the WA-MRH Secretariat, which is based in the WAHO. There are 11 steps in the WA-MRH joint assessment procedure which include: expressions of interest; pre-submission meeting; submission and dossier validation (screening); dossier evaluation; technical evaluation (Phase I) - virtual; joint evaluation by EWG & technical partners: Face to Face/ Virtual (Phase I); Joint GMP inspection and quality control; technical evaluation virtual (Phase II); Joint Evaluation by EWG & Technical Partners (Phase II): Virtual ; Joint Evaluation by EWG & Technical Partners: Virtual; Validation by WA-MRH Steering Committee. The duration of the process from submission of the application to the Coordinating NRA until final WA-MRH Steering Committee recommendation under the Joint Assessment Procedure should take ~133 calendar days (for a complete dossier that receives no queries), and 196 calendar days with a single round of list of questions. Step 1: Expression of interest (EOI) - The WA-MRH (West Africa Medicines Regulatory Harmonization) EOI for products eligible for joint evaluation listed in this procedure is open all year round. - The invitation will be published on the WA-MRH Web-portal of WAHO website and other Partners websites. In situations of high public health concern as determined by ECOWAS Member States, the WA-MRH Secretariat at WAHO in consultation with ECOWAS Member States may directly invite relevant parties to submit specified products for assessment under this procedure without publication of an invitation for expressions of interest. - Product Dossiers are submitted to the Lead Coordinating NRA. The coordinating NRA (where the applications are submitted by the applicant) shall be stated in the EOI. Step 2: Pre-submission meeting - A pre-submission meeting (all interested applicants can attend) is compulsory for new chemical entities to the region while for existing chemical entities should be based on request. Step 3: Submission and Dossier validation (Screening) - A payment of $500 (dossier validation fee) must be paid to the coordinating NRA within 14 days of indication of interest. Applications without a paid-up fee (and evidence of payment provided to the coordinating NRA) in the specified timeframe will be considered non-compliant and will not be considered. Specific information on how to complete the payment (e.g. banking information) will be provided in the EOI. - The dossier is submitted to the Coordinating NRA by the applicant using the upload link provided by the lead NRA. - The dossier should be submitted in ECOWAS CTD format. - The Coordinating NRA screens the dossier for completeness to determine the acceptability of the dossier for evaluation and issues Letter of Acceptability or deferral within a maximum of thirty (30) days (from the date the payment is confirmed) to the applicant. (NB: the 30 days is not inclusive of the applicant’s response time, a maximum of 2 responses allowed after which a re-submission attracts a re-screening fee of $500). Step 4: Dossier Evaluation - The dossier evaluation fee payment must be made to WAHO’s account indicated in the letter of acceptance issued by the Coordinating NRA within fourteen (14) days. - Applicants are encouraged to make this payment at initial submission, or during the screening to ensure that assessment can proceed immediately after the Coordinating NRA has issued the Letter of Acceptability. Step 5: Technical Evaluation (Phase I) - Virtual - The assessors (NRA Assessors and the Expert Working Group (EWG) member) evaluate in-country the allocated dossier(s) using the WA-MRH Technical Assessment Guide and generate a draft report (dossier comments and list of questions) within forty-five (45) days post confirmation of payment and assignment of dossier to the selected NRA. The report is uploaded on the WA-MRH Platform. Step 6: Joint Evaluation by EWG & Technical Partners: Face to Face/ Virtual (Phase I) - The WA-MRH Secretariat organises joint assessment meeting within twenty-one (21) days of the upload of the technical report for peer review comments and finalise the list of questions to be sent to the applicant as applicable. - The Coordinating NRA would notify the applicant(s) on the outcome of the joint evaluation within seven (7) days after the meeting. - The applicant has a maximum of ninety (90) days to provide responses to the List of Questions that would be raised during the first Joint Assessment. The response should be sent to coordinating agency (to the contact specified in the EOI). The applicant can request for additional time in writing to the Coordinating NRA with justification for the extension. Step 7: Joint GMP Inspection and Quality Control - The WA-MRH Secretariat organises the Joint GMP Inspection and Quality Control of medicines in collaboration with the Coordinating NRA after completion of the joint evaluation report (if recommended). - Samples are to be submitted immediately after the acceptance of the dossier(s) by the coordinating NRA. Step 8: Technical Evaluation Virtual (Phase II) - The responses to the list of questions (LOQs) from the applicant are sent to the Coordinating NRA for evaluation by the selected NRA, after confirmation of availability. - The assessor will generate a draft report (technical report #2 addressing LOQs) within twenty (20) days from the date of the assignment of the additional data. The report is uploaded within three (3) days of completion of the report. Step 9: Joint Evaluation by EWG & Technical Partners (Phase II): Virtual - The WA-MRH Secretariat organizes joint assessment to review technical report #2 submitted by the assessor within thirty (30) days of upload of completed technical report (TR2). - The EWG will prepare LOQs (if any) to be sent to the applicant by the lead NRA within 7 days of the completion of the EWG joint evaluation meeting. - The responses to the LOQs #2 from the applicant are sent to the assessor(s) for further review. - If dossier is found unacceptable after the third round of assessment (after second LOQ response), any re-submission will attract 50% of the original charge. Step 10: Joint Evaluation by EWG & Technical Partners: Virtual - If dossier is satisfactory, the EWG will prepare final report for consideration by the steering committee and inform the WA-MRH Secretariat of same within fourteen (14) days after the EWG meeting. Step 11: Validation by WA-MRH Steering Committee - The report is presented to the WA-MRH Project Steering Committee by the Chair of the EWG-MRH for validation/ratification within thirty (30) days of submission to the secretariat by EWG Chair. - The applicant is notified of the regional decision not more than fourteen (14) days after the meeting of the steering committee. The notification is valid for 2 years. - The Coordinating NRA would make available final report, Quality Information Summary (QIS) and notification of approval to all member countries through the WAHO portal for ease of access and reference. Once the WA-MRH Steering Committee is satisfied that the assessment process is complete for the relevant product, and that the WA-MRH harmonized requirements and standards are met, the product, as produced at the specified manufacturing site(s), a notification letter on completion of assessment of the dossier will be issued by the WAHO Secretariat to the applicant/manufacturer. The letter shall state that the final recommendation for registration outcome will be communicated by WAHO Secretariat, subject to compliance to all the requirements. National Authorizations: - Based on the notification, the applicant has a maximum period of 2 years to apply for Marketing Authorisation (MA) across the ECOWAS countries. - The competent authority (Director General, NRA or Minister of Health) delivers the Marketing Authorization (MA) within a maximum period of 60 days after the applicant has filed with the NRA the specific product, the accompanying WAHO notification of recommendation, and the relevant local requirements including national fees. - This procedure will give marketing authorization in ECOWAS Member State(s). - The Marketing Authorization Holder (MAH) can begin to make the medicine available to patients and healthcare professionals in ECOWAS Member States where marketing authorization has been granted.