o support operationalization of the African Medicines Agency (AMA), the Evaluation of Medicinal Products Technical Committee (EMP-TC) has issued a Call for Industry Applications: Pilot of the Continental Listing of Medicinal Products. This pilot project has been designed to pressure test the continental procedures and processes for evaluating medicinal products developed and endorsed by the African Medicines Regulatory Harmonisation (AMRH) Steering Committee and the assembly of the 9th African Medicines Regulators Conference (AMRC).

In accordance with the AU Executive Council Decision, {EX.CL/Dec.857 (XXVI))} of January 2015, the African Medicines Regulatory Harmonisation (AMRH) initiative is a foundational pillar for the AMA. This continental listing of medicinal products pilot project has been developed to:

1. Validate the continental process and procedures, including models for work-sharing and reliance, proposed by the EMP and GMP (Good Manufacturing Practice) Technical Committees;
2. Inform review processes and procedures and develop proposals for operational modalities for AMA evaluation and approval of priority medicinal products;
3. Assist in identifying and proposing best operational models for continental GMP inspection activities;
4. Assist in identification of best and practical working relationship between AMRH or AMA with the Regional Economic Committees (RECs) and National Regulatory Agencies (NRAs) and other international organizations such as the World Health Organization (WHO), the European Medicines Agency (EMA), Pharmaceutical Inspection Co-operation Scheme (PICS), etc.;
5. Help identify and remediate gaps in the proposed continental procedures and pathways; and
6. Identify and propose any additional processes or procedures required for these proposed continental pathways to successfully strengthen the continent’s existing regulatory ecosystem.

The Call for Industry Applications was issued in November 2023 and will close on February 28, 2024. Upcoming key timelines for this pilot include:

• March 1, 2024: Window opens for submission of product dossiers
• March 7, 2024: Second Stakeholders Engagement Meeting
• Mid-March 2024: Begin continental dossier reviews and inspections
• April 30, 2024: Window closes for submission of product dossiers