Today in Brussels, during the high-level event on the European Union (EU) – African Union (AU) partnership on Global Health for equitable access, the European Commission, Belgian Presidency of the Council of the European Union, African Union Development Agency-NEPAD (AUDA-NEPAD) and European Medicines Agency (EMA) came together to fortify their support to the African Medicines Agency (AMA).
The European Commission announced a contribution of €10 million and Belgium a contribution of €4 million to AUDA-NEPAD, for the African Medicines Regulatory Harmonisation (AMRH) initiative to continue advancing the establishment of AMA. This support to 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 harmonisation 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, backed by a €10 million grant from the European Commission.
European Commissioner for International Partnerships Jutta Urpilainen said: “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. 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. We are boosting our strong cooperation between our Institutions and health agencies.”
“During our presidency, Belgium aims to strengthen the EU’s close cooperation with African partners on health. It is important we increase our support for Africa’s Global Health strategy for equitable access with tangible initiatives. That is why we support the African integration project with a focus on health and its formation of its African medicine agency. And therefore also a focus on social progress,” concluded Belgian Minister for Development Cooperation and Major Cities Caroline Gennez.
“The operationalisation 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. AUDA-NEPAD remains committed to providing technical leadership in the operationalization of the AMA through our AMRH programme, advancing our ongoing battle against substandard and falsified medical products,” stated the AUDA-NEPAD CEO, Nardos Bekele-Thomas.
Executive Director of the European Medicines Agency Emer Cooke said: ”EMA and the European medicines regulatory network are excited to support the strengthening of African regulatory systems. We are looking forward to sharing our unique experience and expertise in intra-continental medicines regulation to help the AMA build an effective regulatory model and practices for the benefit of public health in the African continent.”
AMA will be a specialised 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 euros 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.
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.
More information
Factsheet: Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies in Africa
African Medicines Agency Information
