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By Alfred Ajayi
African leaders have renewed calls for the full operationalisation of the African Medicines Agency (AMA), urging the remaining 24 Member States of the African Union (AU) to ratify the AMA Treaty to guarantee access to quality, safe and efficacious medical products across the continent.
The call was made during a High-Level Presidential Breakfast held on the margins of the 39th Ordinary Session of the Assembly of Heads of State and Government of the AU.
The meeting convened Heads of State, AU leaders and senior representatives of key continental institutions to accelerate universal ratification, sustainable financing and the agency’s full functionality.
Participants included representatives of the Africa Centres for Disease Control and Prevention and the African Continental Free Trade Area Secretariat, reflecting the link between medicines regulation, health security and economic integration.
Leaders stressed that a strong AMA would harmonise regulatory standards, curb substandard and falsified medical products, and advance Africa’s industrialisation ambitions.
Although the agency’s headquarters in Kigali is operational, only 31 of the AU’s 55 Member States have ratified the treaty, with several yet to complete domestication processes — gaps that weaken the benefits of a unified continental regulatory system.
Demonstrating commitment, Seychelles’ Vice President, Sebastien Pillay, doubled his country’s seed fund contribution to 200,000 dollars, exceeding the 100,000 dollars required of State Parties, and challenged larger economies to follow suit.
Tunisia’s Health Minister, Mustapha Ferjani, emphasised that Africa’s health sovereignty depends on regulatory sovereignty, urging countries to equip the AMA with adequate resources, skills and governance structures.
Director-General of the AMA, Dr Delese Mimi Darko, said the agency aims for universal ratification, WHO Listed Authority status and financial self-reliance by 2030. “We have moved from a treaty on paper to a living institution,” she noted, highlighting ongoing collaboration with ratifying states to strengthen regulatory systems and joint assessments.
In her closing remarks, AU Commissioner for Health, Humanitarian Affairs and Social Development, Amb. Amma Twum Amoah, described the AMA as central to delivering the African Health Strategy 2030 and Agenda 2063.
She expressed confidence that universal ratification and full implementation are achievable within the current political cycle.
Adopted on 11 February 2019 in Addis Ababa, the AMA Treaty builds on the African Medicines Regulatory Harmonization initiative led by the Africa Union Development Agency–NEPAD.
Once fully operational, the AMA will become the AU’s second specialised health agency after the Africa CDC, strengthening regulatory capacity and ensuring safer medicines for all Africans.
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