African Medicines Agency (AMA)
The African Medicines Agency (AMA) has been established under the African Union to contribute to the improvement of access to medicines within the continent.
Benefit of AMA
- Support the growth of local pharmaceutical production, a key objective of the Pharmaceutical Manufacturing Plan for Africa (PMPA).
- Catalyzing trade in support of the Africa Continental Free Trade Area (AfCFTA).
- Allow the collaborate with NMRA in the identification of substandard and falsified medical products (SFs) and facilitate information sharing across countries.
- Enable expanded and timely access to effective, safe, and quality medicines for the treatment of priority diseases
- Allow NMRA to participate in joint reviews of clinical trial applications for vaccines and assessment of "highly complex" product dossiers such as biosimilars
- Allow access to the database for Active Pharmaceutical Ingredients (API) manufacturing sites.
- Allow more focused resources for value adding activities and making evidence based scientific regulatory decisions
- Allow for increased reliance based on harmonized regulatory requirements across Africa enabling acceleration and simplification of access to medicines;
- Allow for technical backup, worksharing, synergies and collaboration ultimately ensuring overall optimization of the healthcare system.