The European Medicines Agency (EMA) is set to enhance pharmaceutical regulation across Africa, backed by a significant €10 million grant from the European Commission. This funding is earmarked to bolster regulatory systems at both national and regional levels on the continent, specifically targeting the development of the African Medicines Agency (AMA).

The European Commission’s Directorate-General for International Partnerships has formalized an agreement with EMA, signaling the official start of this ambitious project. The funding supports the African Union’s initiative to establish the AMA as a specialised agency responsible for improving access to quality, safe and effective medical products across the continent.

At the time of the announcement, 27 African countries had ratified the treaty establishing the AMA. The agency is intended to promote cooperation between national regulatory authorities and regional organisations, helping to improve the consistency and efficiency of medicines regulation across Africa.

The EMA and the European medicines regulatory network will contribute technical expertise and share experience from the European regulatory model. This includes supporting the development of the AMA’s governance structures, scientific and administrative processes, and technical committees. Training will also be provided to strengthen regulatory and scientific expertise among African regulators.

Emer Cooke, Executive Director of EMA, welcomed the collaboration and emphasised the importance of supporting the AMA in developing its own regulatory model and practices. The aim is to improve the availability of safe and affordable medicines through stronger regulatory cooperation and the exchange of expertise.

The project forms part of the European Union’s Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+), launched in 2021 under the Global Gateway strategy. It reflects broader EU efforts to strengthen healthcare systems and regulatory capacity across the continent.

The €10 million contribution is intended to support the AMA’s development and strengthen the wider African regulatory network. The initiative does not transfer regulatory authority to EMA; the AMA is an African Union institution whose role is to support regulatory cooperation and capacity across its member states.

For further information, visit the EMA website: European Medicines Agency – News (https://www.ema.europa.eu/en/news/ema-support-establishment-african-medicines-agency).