EMA, Gates Foundation To Fund Pilot For Continental Evaluation Of Medicines In Africa

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The European Medicines Agency has come together with the Bill & Melinda Gates Foundation to co-fund a one-year pilot, whose goal is to test and validate procedures and processes for the joint continental evaluation of medical products in Africa.

The pilot, launched in November 2023, is set to be another building block that aims to ensure the smooth operationalization of the African Medicines Agency.

The African Union Development Agency (AUDA-NEPAD) has been working for more than a decade to resolve the fragmented nature of the continent’s regulatory systems.

And through this, the African Medicines Regulatory Harmonization (AMRH) initiative and African Medicines Agency were born. With these initiatives, the continent aims to create an enabling environment that facilitates access to high-quality, safe, and effective medical products and technologies.


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In a coordinated approach, AMRH established various technical committees expected to shape the processes and procedures of the African Medicines Agency. And one such committee is the Evaluation of Medicinal Products Technical Committee (EMP-TC), that many believe will play a critical role in harmonizing assessment, registration, and marketing authorization procedures on the continent.

In this pilot, the EMP-TC and the Good Manufacturing Practices Technical Committee (GMP-TC) will be closely collaborating to evaluate the quality, safety, and efficacy of medical products.

Consequently, the lessons learned from the evaluations will support the creation of continental policies and procedures, national authorization of suggested medications, and enhanced information exchange and trust.

Recently, EMP-TC launched its first continental dossier plenary session in Durban, South Africa, where more than 100 dossier assessors from Africa came together to discuss assessment reports of medical products that had been accepted during the pilot.

In the upcoming months, activities should pick up steam.

EMA and the European medicines regulatory network (EMRN) have committed to avail their “unique” experience and expertise in continental medicines regulation with the aim of supporting the operationalization of the African Medicines Agency.

Officially, EMA’s participation in the AMA project began in December 2023, when the agency was given funding by the European Commission to assist in establishing the AMA.


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