The Treaty For The Establishment Of The African Medicines Agency (AMA) Treaty was adopted by the Assembly of Heads of State and Government of the African Union at its 32nd Ordinary Session on 11 February 2019 in Addis Ababa (Assembly/AU/Dec.735(XXXII)).
In accordance with the Treaty provisions, it entered into force on 5 November 2021 after the deposit of the fifteenth instrument of ratification. Currently, 31 countries out of 55 have ratified the AMA Treaty and are State Parties of AMA. The objective of AMA is to enhance the capacity of State Parties and Regional Economic Communities, to regulate medical products in order to improve access to quality, safe and efficacious medical products on the continent.
In a context of recurrent health emergencies, circulation of substandard and falsified medical products, and continued dependence on imports, AMA is a key pillar of Africa’s health security architecture, the Pharmaceutical Manufacturing Plan for Africa (PMPA), the AU Health Strategy 2030 and Agenda 2063.
AMA builds on the African Medicines Regulatory Harmonisation (AMRH) Initiative, the African Vaccines Regulatory Forum (AVAREF) and AU decisions on health, industrialisation and pharmaceutical manufacturing.
AMA became operational in October 2025 when the inaugural Director General, Dr Delese Mimi Darko assumed office at the AMA Heaquarters in Kigali, Rwanda.
“The AMA’s value lies in partnership, performance and Trust.
We do not seek to replace national authorities but rather to complement and empower them. Every assessment, inspection, substandard or falsified medical product or safety report at the national or REC level will find amplified impact through AMA’s coordination and mutual recognition.”
The AMA has the following organs:
“Our focus is clear: protect patients, strengthen national regulators, and build a regulatory system that works for Africa.”
The AMA has the following organs:
The scope of products for the African Medicines Agency (AMA) according to the AMA Treaty are “selected medical products including complex molecules for the treatment of priority diseases/conditions as determined by the African Union, and WHO”.
In addition, the African Medicines Regulatory Harmonization (AMRH) initiative which served as the foundation for AMA has published a list of 24 Priority Medical Products for AMA along with a roadmap for regional pharmaceutical manufacturing in Africa. These products were selected based on, disease burden in Africa, public health impact, feasibility for local manufacturing, and alignment with WHO Essential Medicines List.
