Jun 22, 2022 | Basic page

What is AMA's role?

  1. AMA will support the growth of local pharmaceutical production, a key objective of the Pharmaceutical Manufacturing Plan for Africa (PMPA). It will further play a critical role in catalyzing trade in support of the Africa Continental Free Trade Area (AfCFTA).

  2. AMA will evaluate medical products for the treatment of priority diseases as determined by the African Union.

  3. It will also regularly inspect, coordinate and share information about products that are authorised for marketing.

  4. AMA will coordinate joint reviews of clinical trial applications for vaccines and assessment of "highly complex" product dossiers such as bio-similar. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites.

  5. AMA will collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) in the identification of substandard and falsified medical products (SFs) and facilitate information sharing across countries. By developing common standards and regulations, AMA will also be responsible for harmonising legislation.