African leaders have called for full operationalisation of the African Medicines Agency (AMA), calling on remaining 24 Member States to ratify the AMA Treaty to secure quality, safe and efficacious medical products on the continent.
The call came 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 African Union (AU), the African Medicines Agency.
The breakfast by the AMA brought together Heads of State and Government, AU leadership, and senior representatives of the AMA, Africa Centres for Disease Control and Prevention (Africa CDC), and the African Continental Free Trade Area (AfCFTA) Secretariat to accelerate the Agency’s full operationalisation, universal ratification, and sustainable financing.
Leaders underscored the AMA’s role in strengthening continental regulation of medical products, bolstering health security, and supporting Africa’s industrialisation ambitions.
While progress has been made in establishing the Agency and operationalising its headquarters in Kigali, only 31 of the AU’s 55 Member States have ratified the AMA Treaty, and several still need to complete domestication measures.
This leaves gaps in protection against substandard and falsified medical products and limiting the benefits of a unified African regulatory system.
Several government leaders, Ministers of Health and representatives of AU agencies reiterated their commitment to the operationalisation of the AMA.
Doubling seed fund
On the occasion, Mr. Sebastien Pillay, Vice President of Seychelles reaffirmed his country’s political support and financial commitment of USD 200,000, doubling the seed fund contribution of USD 100,000 required of state parties, while urging larger nations to match this dedication.
Dr. Mustapha Ferjani, Minister of Health of Tunisia, reinforced the foundational importance of regulation, highlighting that “today, a single truth imposes itself: Africa’s health sovereignty depends on regulatory sovereignty.”
In his closing appeal, he added: “Let us all ratify, and equip AMA with the capacity to act—with resources, skills, clear procedures, and effective governance.
“Our people deserve it, our health security demands it, and our sovereignty depends on it.”
Presenting on priority actions for the AMA, Director General of the AMA, Dr. Delese Mimi Darko, updated leaders on the AMA’s ambition to be universally ratified, achieve WHO Listed Authority status and be financially self-reliant by 2030.
She stressed that “over the past five years, we have moved from a Treaty on paper to a living institution” and that the AMA is “already working hand‑in‑hand with Member States that have ratified to strengthen regulatory systems, streamline joint assessments and increase reliance on shared expertise.”
AMA’s centrality
In her closing remarks, the Commissioner for Health, Humanitarian Affairs and Social Development of the African Union Commission, Amb. Amma Twum‑Amoah, framed the AMA as central to the AU’s wider health and development agenda.
She affirmed that the Commission “firmly believes that universal ratification, full implementation and sustainable financing of the African Medicines Agency are achievable within this political cycle,”.
Twum‑Amoah described the AMA as “a shared continental asset integral to delivering on the African Health Strategy 2030 and Agenda 2063, and the commitments our Member States have made to protect the health and wellbeing of their people.”
The 39th AU Assembly thus served as a defining moment to move decisively toward a unified African medicines regulatory system that delivers quality medical products for all, advances regional industrialisation and trade, and contributes to a safer, more prosperous future for every African.
AMA’s centrality
The AMA Treaty was adopted by Heads of States and Government during their 32nd Ordinary Session of the Assembly on 11 February 2019 in Addis Ababa, Ethiopia.
The African Medicines Agency aspires to enhance capacity of State Parties and AU recognized Regional Economic Communities (RECs) to regulate medical products in order to improve access to quality, safe and efficacious medical products on the continent.
The AMA shall build on the efforts of the African Medicines Regulatory Harmonization (AMRH) initiative (2009), which is led by the Africa Union Development Agency – the New Partnership for Africa’s Development (AUDA-NEPAD).
The AMRH initiative provides guidance to AU recognized Regional Economic Communities (RECs) and Regional Health Organizations (RHOs), to facilitate harmonization of regulatory requirements and practice among the national medicines authorities (NMRAs) of the AU Member States.
It will be the second specialized health agency of the African Union after the Africa Centres for Disease Control and Prevention (Africa CDC).
