What happened?
On May 15th, 2024, the Republic of Cote d’Ivoire achieved a significant milestone by depositing their instrument of ratification for the Treaty establishing the African Medicines Agency (AMA).
This development marks another significant achievement for the continent, reinforcing an agency that is dedicated to advancing harmonization in the regulation of health products and technologies within the region.
Ultimately, this strengthens the foundation for success in the sector.
What is the African Medicines Agency?
The AMA, as a specialized agency of the African Union, is dedicated to bolstering the regulatory capacities of its member nations. Through this strengthened capacity, the AMA endeavors to improve access to safe, high-quality, and effective medicines across the continent.
The agency is gaining momentum.
In a significant move last year, the African Union designated Kigali, Rwanda, as the headquarters for the agency. This year, several key appointments have been made, expected to drive the operations of the AMA.
The inaugural Continental Heads of Medicines Registration and Marketing Authorization Forum was established earlier this year by the African Union Development Agency-NEPAD’s African Medicines Regulatory Harmonization (AMRH).
Dr. Kariuki Gachoki from the Kenya Pharmacy and Poisons Board was appointed as the Chair, with Dr. Chantel Noufionso from Benin as Vice Chairperson.
Senegal’s Mbagnick Diof, Nazalia Macuwele from Mozambique, and Bathusi Kgosietsile from Botswana will fulfill roles as Rapporteurs.
RELATED: New Country Ratifies The African Medicines Agency Treaty (africanpharmaceuticalreview.com)
Why African Medicines Agency?
It is expected that AMA will play a crucial role in Africa’s pharmaceutical sector.
- AMA will support the advancement of local pharmaceutical production, aligning with a key objective of the Pharmaceutical Manufacturing Plan for Africa (PMPA). Additionally, it will play a vital role in fostering trade in alignment with the Africa Continental Free Trade Area (AfCFTA).
- AMA will assess medical products for treating priority diseases as designated by the African Union. It will also undertake routine inspections, coordination, and dissemination of information regarding authorized marketing products.
- AMA will coordinate collaborative assessments of clinical trial applications for vaccines and evaluations of “highly complex” product portfolios like bio-similars. Furthermore, it will organize collective inspections of Active Pharmaceutical Ingredients (API) manufacturing facilities.
- In collaboration with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs), AMA will aid in identifying substandard and falsified medical products (SFs) and facilitating cross-border information exchange.
- AMA will also be responsible for harmonizing legislation by establishing common standards and regulations.
How many countries have ratified so far?
With Cote d’Ivoire being the latest to join, a total of 29 out of 55 AU countries have now ratified the AMA treaty. It is anticipated that more nations will follow suit, considering that over 5 countries have signed but have yet to ratify the agreement.
Support from outside the continent
Earlier this year, the European Medicines Agency (EMA) was awarded a grant of ten million euros by the European Commission to bolster regulatory systems at both national and regional levels in Africa.
This funding is specifically designated to assist in the establishment of the African Medicines Agency (AMA), in cooperation with African, European, and international stakeholders.
Conclusion
The momentum of the AMA initiative is steadily increasing, with an increasing number of AU countries participating.
This development is particularly encouraging in a continent dominated by fragmented and generally weak regulatory frameworks.
This Agency is anticipated to streamline these systems, thereby improving the safety, quality and efficacy of medical products across the continent.
Which country will be next to support this cause?
Let’s wait and see.
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About the author
Bevin Likuyani is a Pharmacist with a MPharm (Pharmacoepidemiology & Pharmacovigilance) and MBA (Strategic Management) from School of Business, University of Nairobi). He is a Certified Supply Chain Pharmacist. (American Association of Supply Chain Management) and content writer on pharmaceutical related topics. Email: bevin@africanpharmaceuticalreview.com LinkedIn
