EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors.
The European Commission’s Directorate-General for International Partnerships has signed an agreement with EMA marking the official launch of the project.
AMA will be a specialised agency of the African Union (AU) dedicated to improving equitable access to quality, safe and effective medical products in Africa. To date, 27 countries have ratified the AMA treaty, and more AU members are expected to complete the process in the coming months. 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.
Cooperation and collaboration are in the DNA of the European medicines regulatory network (EMRN). The EMRN is the cornerstone of EMA's work and success. The Agency operates at the heart of the network, coordinating and supporting interactions between over fifty national competent authorities for human and veterinary medicines.
By sharing its unique expertise and regulatory model, the EMRN 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.
As African Medicines Regulatory Harmonisation (AMRH) lays the foundation for the AMA, our collaboration with EMA marks a crucial stride towards the realisation 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.
EMA has committed to mobilising experts to support AMA, its technical committees and African regulators in the set-up of AMA’s governance and scientific and administrative processes. EMA will also offer training to reinforce scientific and regulatory expertise in the evaluation and supervision of medicines together with experts from EU Member States.
EMA’s contribution is part of the ‘Team Europe’ initiative on manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+), launched by the Commission in May 2021. Under the EU’s Global Gateway strategy, the initiative has mobilised so far 1.3 billion euros including around 135 million euros in grants for regulatory strengthening. Working together with EU Member States, African partners such as the African Union Development Agency (AUDA-NEPAD) and the World Health Organization (WHO), the European Union will help to strengthen regulatory capacity in Africa with a comprehensive set of actions at continental, regional and national levels.