What is AMA's role?
-
AMA will support the growth of local pharmaceutical production, a key objective of the Pharmaceutical Manufucaturing Plan for Africa (PMPA). It will further play a critical role in catalyzing trade in support of the Africa Continental Free Trade Area (AfCFTA).
-
AMA will evaluate medical products for the treatment of priority diseases as determined by the African Union.
-
It will also regularly inspect, coordinate and share information about products that are authorised for marketing.
-
AMA will coordinate joint reviews of clinical trial applications for vaccines and assessment of "highly complex" product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites.
-
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.