EMA, Gates Foundation back pilot for African continental drug evaluations
The European Medicines Agency (EMA) is co-funding a one-year pilot program with the Bill & Melinda Gates Foundation to support the establishment of continental medicines review procedures in the African Union (AU). The program builds on work done over the past decade toward establishing an African Medicines Agency (AMA).On 30 July EMA announced it plans to co-fund the African Medicines Regulatory Harmonization (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) to evaluate joint continental regulatory oversight of drugs in Africa.
"AUDA-NEPAD has been working on harmonization activities for a decade, paving the way for the creation of the African Medicines Agency (AMA)," EMA noted. "The launch of the continental pilot is one of these activities that aim to validate procedures and processes ahead of the establishment of the AMA."
The agency noted that the AMRH Evaluation of Medicinal Products Technical Committee (EMP-TC) will act as a pre-regulatory agency to evaluate the quality, safety, and efficacy of priority drugs in the pilot program with the support of the continental Good Manufacturing Practices Technical Committee (GMP-TC). The pilot outcomes will ultimately be used to develop regulatory policies to help national authorities authorize products for their markets while strengthening information sharing across borders.
EMA noted that AMRH's technical committees met with their European counterparts in June to learn about how European regulations are implemented and how it could serve as a model for the AMA regulatory system.
"EMA and the European medicines regulatory network (EMRN) will continue making available their unique experience and expertise in continental medicines regulation to support the establishment of the AMA by providing technical expertise and training both online and in person," said the agency.
While work under the AMRH has been ongoing for more than a decade, EMA noted that it officially began its involvement in December 2023, when it received funding from the European Commission to help set up AMA. The agency also noted that the overall project is part of the European Union (EU) Global Gateway strategy and Team Europe Initiative on Manufacturing and Access to Vaccines, Medicines and Health Technologies (MAV+) to help African countries develop and strengthen their local pharmaceutical industries and manufacturing capacity.
EMA statement
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