What is the African Medicines Agency?

Recommendation

4/5 December 2024
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

Under the umbrella of the African Union (AU), the African Medicines Agency (AMA) is currently being established. The African Medicines Regulatory Harmonization (AMRH) programme started already back in 2009 as a response to addressing challenges faced by National Medicine Regulatory Authorities (NMRAs) in Africa like non-coherent legislative frameworks, limited capacities and delayed approval decisions. It seeks to enable collaboration among African countries and regions, to help harmonise the regulation and oversight of medicines at Africa-wide level. To date, 27 countries have ratified the AMA treaty, and more AU members are expected to complete the process in the near future.

The AMA is also supported by the European Medicines Agency and the EU Commission. With the European medicines regulatory network (EMRN), support will be given in the following areas:

pooling resources and coordinating work to regulate medicines,
reducing administrative burden,
mobilising experts to support scientific and administrative processes,
training to reinforce scientific and regulatory expertise.

The EMA has now received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa.

Source: EMA press release