International treaty to establish the African Medicines Agency, to address availability and quality of medical products in Africa
Establishes a continent-wide regulatory body to coordinate pharmaceutical oversight and improve access to quality medicines across African Union member states.
Key Facts
- Treaty signed
- 11 February 2019
- Ratifications required
- At least 15 African Union member states
- Establishing body
- African Medicines Agency (AMA)
- Parent organization
- African Union (specialized agency)
- Scope
- Pharmaceuticals, medical devices, and other medical products
Cause → Event → Consequence
Africa has long faced challenges with the availability and quality of medical products, partly due to fragmented national regulatory systems that hamper coordinated oversight of pharmaceuticals, medical devices, and other health products across the continent's 55 African Union member states.
On 11 February 2019, the Treaty for the Establishment of the African Medicines Agency was concluded, requiring ratification or accession by at least 15 African Union member states before entry into force. It creates the AMA as a specialized agency of the African Union to harmonize regulatory frameworks governing the production and distribution of medical products.
Once ratified and operational, the AMA is expected to coordinate continental regulatory structures, reduce duplication of effort among national agencies, improve access to safe and effective medicines, and strengthen Africa's capacity to respond to public health challenges through unified pharmaceutical governance.
Political Outcome
Treaty concluded pending ratification by at least 15 African Union member states to bring the African Medicines Agency into force as a specialized AU body.
Fragmented national regulatory bodies with no continent-wide coordinating mechanism for medical products
Unified African Medicines Agency as a specialized African Union organ coordinating pharmaceutical regulation across the continent