What happened?
Yesterday, 31st October 2023, the Tanzanian Parliament passed the decision to ratify the African Medicines Agency Treaty. This decision strengthens an agency that is expected to contribute to medical product regulatory harmonization.
What is the African Medicines Agency (AMA)?
The AMA is a specialized agency of the African Union whose main goal is to elevate regulatory capacity of member countries.
With this enhanced capacity, AMA has the intention to improve access to safe, quality and efficacious medicines in the continent. Earlier this year, the African Union chose Kigali, Rwanda as the Headquarters of the agency.
What are the functions of African Medicines Agency?
Among other core functions the AMA plans to:
- Coordinate and support harmonization of medical products regulation
- Help conduct clinical trial reviews particularly those involving different member states
- Build capacity of health product regulatory officers in the region
- Convene meetings (with international stakeholders) centered around regulatory system strengthening
- Provide guidance on traditional medicines regulation
- Conduct market surveillance to determine quality of medical products circulating in member countries
- Provide regulatory technical and resource support to member countries through pooling
- Optimize use of available quality control laboratories within national and regional regulatory authorities.
READ ALSO: Counterfeit medicines: 3 ways Africa can win the fight (africanpharmaceuticalreview.com)
How many countries have ratified so far?
With Tanzania as the new entrant, a total of 27 out of 55 AU member countries have now ratified the AMA treaty. In addition, 10 more countries have signed and are expected to ratify while 18 are yet to neither sign nor ratify.
Conclusion
The AMA train is steadily picking up pace and more and more AU countries are getting on board. This is a welcome move in a continent characterized by fragmented and largely weak regulatory systems. The Agency is expected to harmonize these systems and, in the process, enhance the safety, quality and efficacy of medical products in the continent.
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