The decision was arrived at following a meeting of the Executive Council during the African Union Fourth Mid-Year Coordination Meeting in the Zambian capital Lusaka.
The AMA will be the second specialized health agency of the AU after the Africa Centres for Disease Control and Prevention (Africa CDC), which is headquartered in Addis Ababa, Ethiopia.
The AMA is expected to support the growth of local pharmaceutical production, evaluate medical products for the treatment of priority diseases as determined by the AU and regularly inspect, coordinate and share information about products that are authorised for marketing.
It is also expected to coordinate joint reviews of clinical trial applications for vaccines and assessment of “highly complex” product dossiers and coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites, among other functions.
In a statement, the AU said the AMA will enhance capacity of state parties and Regional Economic Communities (RECs) to “regulate medical products, to improve Africa’s access to quality safe, and efficacious medical products.”
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