Snapshot

The Continental Listing of Medicinal Products (AMA) pathway has been developed by the of African Medicines Agency (AMA).

This pathway can be used where Priority Medicinal Products Category 1 and/or 2 as per the Guidance on Eligibility Criteria for Priority Products..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Austria Belgium Brazil Bulgaria Canada China Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Japan Latvia Liechtenstein Lithuania Luxembourg Malta Mexico Netherlands Norway Poland Portugal Romania Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States WHO

The EMP TC will undertake a comprehensive evaluation of the quality, safety, and efficacy of priority medicinal products, based on medicinal products dossiers submitted by the applicants and on an assessment of the GMP/GCP/GLP compliance through relevant continental technical committees under AMRH. The EMP-TC Secretariat will screen each product dossier submitted by an applicant according to an internal Standard Operating Procedure (SOP) before the evaluation can start, for completeness of dossiers, selected pathway, and eligibility as part of priority products for continental assessment. The EMP-TC secretariat will have 15 calendar days (CD) to screen the dossiers. Dossiers submitted for products not meeting the eligibility criteria for the priority product list will not be accepted for continental assessment. Once the AMA is fully operational, other products, on a case-by-case basis, may be accepted and assessed for the AMA to issue an independent opinion like the EU-M4All pathway. Similarly, the EMP-TC Secretariat will not consider incomplete dossiers. The EMP-TC Secretariat will inform the applicant that an incomplete dossier has been received and will be requested to complete the dossier within 15 calendar days. In the event of non-compliance, the dossier may be rejected for incompleteness and returned to the applicant. Dossiers considered complete as the results of the screening done by the EMP-TC Secretariat will be retained by the EMP-TC Secretariat for assessment. After screening, if the dossier is accepted for assessment, the applicant will be informed of this and will receive a letter including a dossier reference number. This letter will serve as an agreement between the EMP-TC and the applicant for participation in the continental procedure and a commitment to comply with the provisions of the EMP-TC procedure. The initial evaluation of a product dossier by assessors should take a maximum of 80 calendar days. Following this initial assessment, a report on each part of the dossier will be consolidated by the EMP-TC Secretariat for quality assurance and consolidation of the final list of queries to the applicant. The applicant will then have a maximum of 60 calendar days to respond to queries from the assessors (two times) and to send the additional information to the EMP-TC Secretariat. The assessors should assess the applicants’ responses within 60 additional days. If necessary, a second round of questions may be sent to the applicants with similar timelines. When the applicant has provided the final responses, the assessors and rapporteur/co-rapporteur will have 60 additional calendar days to give a final opinion. The total timeline for an EMP-TC process will be 260 calendar days maximum (not considering the stop clock of evaluation pending additional information from applicants). A fast-track evaluation process with shorter timelines may be applied for medicinal products needed for emergencies, orphan medicines, or WHO/SRA/WLA-approved products. Applicants may request longer timelines for responding to assessor queries, providing strong justifications to the AMRH Secretariat/AMA. This will be done through a negotiation between applicants and the EMP-TC Secretariat. If necessary, each applicant may also request a meeting with EMP-TC experts involved in the assessment to clarify issues identified by assessors. If evaluation demonstrates that a product and its corresponding manufacturing and clinical site(s) meet the continental standards acceptable by the Technical Committees (i.e., internationally acceptable standards), the medicinal product will be issued with an INDEPENDENT SCIENTIFIC OPINION or RECOMMENDATION which will then allow the product to be included in the continental list (listing) of medicinal products recommended by the EMP-TC (if positive). The assessment as well as inspection reports will be shared with concerned National Regulatory Agencies (NRAs) in Africa to support and facilitate registration and marketing authorization of Africa’s priority medicinal products. The EMP TC may also publish negative opinion if deemed appropriate in the interest of public health. Most countries in Africa commit to 90 working days to process country level evaluation and decide on the product for products recommended through recognized regulatory and quality assurance mechanisms, however with the nature of the EMP TC where the process is fully inclusive and involves review some of the country-specific data (such as stability data etc.,), the adoption is expected to be within 60 days.