AFRICA – The African Union Development Agency-NEPAD (AUDA-NEPAD) has received €10 million (US$10.67m) from the European Commission and €4 million (US$4.27m) from Belgium for the African Medicines Regulatory Harmonisation (AMRH) initiative to continue advancing the establishment of African Medicines Agency (AMA). 

The European Commission, Belgian Presidency of the Council of the European Union, and European Medicines Agency (EMA) came together to fortify their support to the African Medicines Agency (AMA) during the high-level event on the European Union (EU) – African Union (AU) partnership on Global Health for equitable access.

This support for regulatory strengthening in Africa is part of the Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+).

AMRH supports the African Union Commission in setting up the governance of AMA, as well as strengthening national and regional policy and legal frameworks and supporting Regional Economic Communities with their harmonization process and joint regulatory activities. 

AMRH also seeks to increase the number of qualified regulatory science professionals and strengthen continental joint evaluation and safety monitoring of health products.  

The contributions to AMRH complement the recently announced cooperation with the European Medicines Agency to support the establishment of AMA.

“I am delighted to announce today further EU support to the establishment of the African Medicines Agency, the cornerstone of addressing Africa’s health needs,” European Commissioner for International Partnerships Jutta Urpilainen said.

“Safeguarding public health both on our continents and ensuring equitable access to safe and effective health products, including locally produced vaccines and medicines, remains at the forefront of our EU–AU Joint Vision and the EU’s Global Health Strategy.”

AMA will be a specialized Agency of the African Union. Its mandate will be to enhance the capacity of the State Parties and Regional Economic Communities to regulate health products and improve access to quality, safe and efficacious health products on the African continent. As of March 2024, 27 countries have ratified the AMA treaty.

The European Union and its Member States support regulatory strengthening across the African continent and the establishment of AMA through the Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+). 

Under the Global Gateway strategy, the initiative has mobilised so far around €157 million (US$167.59m) in grants for regulatory strengthening and possibly interventions at national and regional level, including from the European Commission to the World Health Organization,  the European Medicines Agency and AUDA-NEPAD.

“The operationalization of the African Medicines Agency represents a remarkable milestone for the African continent. Harmonized regulatory systems will unlock numerous opportunities for the local pharmaceutical industry,” stated the AUDA-NEPAD CEO, Nardos Bekele-Thomas.

“AUDA-NEPAD remains committed to providing technical leadership in the operationalization of the AMA through our AMRH program, advancing our ongoing battle against substandard and falsified medical products.” 

AUDA-NEPAD continues to play a pivotal role in advancing the establishment of the African Medicines Agency. It aligns its efforts and resources with international partners to strengthen regulatory capacity at continental, regional and national levels.

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