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The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
The European Medicines Agency (EMA) announced on Jan. 26, 2024 that the European Commission (EC) has given the agency a €10 million grant to support regulatory systems at a national and regional level in Africa. The agreement has been signed by the EC’s directorate-general for International Partnerships, marking the project’s official launch. The African Medicines Agency (AMA) treaty has been ratified by 27 countries with more African Union (AU) members expected to join.
EMA will collaborate with African, European, and international parties to set up the AMA. The AMA will be a specialized agency of the AU and will be dedicated to improving access to safe and effective medical products in Africa. Experts will be mobilized by EMA to support AMA, technical committees, and regulators. Training will also be provided by EMA to reinforce scientific and regulatory expertise.
“The creation of AMA is a unique opportunity to facilitate the regulation and oversight of key medicines at continental level, promoting collaboration among African countries and regions,” EMA stated in a press release. “By sharing its unique expertise and regulatory model, the EMRN [European medicines regulatory network] will share experience with AMA in pooling resources and coordinating work to regulate medicines efficiently and effectively, ensuring high-quality standards and use of the best available expertise, reducing administrative burden to allow medicines to reach patients faster and accelerating the exchange of information on critical issues such as medicines safety.”
“It will be exciting to see AMA build its own regulatory model and practices to increase availability of safe and affordable medicines in Africa. EMA will support this journey by sharing our learnings and experiences gained working together as a network of thousands of experts from across Europe,” said Emer Cooke, executive director of EMA, in the press release.
“As African Medicines Regulatory Harmonisation (AMRH) lays the foundation for the AMA, our collaboration with EMA marks a crucial stride towards the realization of AMA's mission. Together, AMRH and EMA will expedite the establishment of AMA, fostering greater collaboration among African nations. This partnership not only signifies a shared commitment but also accelerates AMA's journey to becoming a beacon for regulatory efficiency and healthcare advancement in Africa,” said Chimwemwe Chamdimba, head of the AMRH initiative at the African Union Development Agency-New Partnership for Africa’s Development, in the press release.