The African Medicines Agency (AMA) is a specialised agency of the African Union. It aims to facilitate patient access to effective, safe and high-quality medicines in Africa.
It seeks to enable collaboration among African countries and regions, to help harmonise the regulation and oversight of medicines at Africa-wide level.
The African Medicines Agency builds on the work of the African Medicines Regulatory Harmonization (AMRH) Programme. This programme coordinated the harmonisation of medicine regulation across African regions from 2009 until 2025.
A continental regulatory model based on reliance between national authorities can create an environment that enables the development of the pharmaceutical industry in Africa.
Watch the video below featuring Emer Cooke, EMA's Executive Director, and Delese Mimi Darko, Director-General of AMA, sharing insights into their partnership:
For more information on its role and the countries that have ratified the African Medicines Agency treaty, see:
EMA and the European Commission's Directorate-General for International Partnerships signed a contribution agreement underpinning EMA's support for the establishment of the African Medicines Agency (AMA).
EMA received a grant of ten million euros to support the AMA project under this agreement. The funding is part of the Team Europe Initiative on manufacturing and access to vaccines, medicines, and health technologies (‘MAV+’), under the EU Global Gateway strategy.
The agreement entered into force on 1 May 2023. It was originally set to end in November 2027 but has since been extended until January 2029.
EMA provides both financial support and technical expertise through this contribution, working closely with European, African and international partners.
EMA’s support aims to make the African Medicines Agency fully operational and to strengthen regulatory and scientific capacity across the African continent.
EMA's work focuses on the following key priorities:
For more information, see:
2009
Creation of the African Medicines Regulatory Harmonization (AMRH) programme, under the African Union Development Agency (AUDA-NEPAD)
2012
African Union Council decides AMRH will serve as a foundation for the establishment of AMA
2020
Launch of the African Union - Smart Safety Surveillance (AU-3S) programme
November 2021
AMA treaty comes into force
May 2023
European Commission awards a 10 million euros grant to support the establishment of AMA
November 2024
Inauguration of AMA headquarters in Kigali, Rwanda
June 2025
Appointment of Delease Mimi Darko as AMA's Director-General
October 2025
Symbolic handover of the AMRH and AU-3S programmes to AMA
January 2026
Official handover at Lusaka, Zambia. It marks the end of the AMRH and AU-3S programmes
First Heads of National Regulatory Agencies and Regional Economic Communities Coordinators Forum held in Kigali
March 2026
EMA and AMA collaboration extended until January 2029
In July 2024, EMA awarded a grant to the African Medicines Regulatory Harmonization (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) to validate processes and procedures for the joint continental evaluation of medicines in Africa.
The pilot was co-funded with the Gates Foundation. It ran from November 2023 to October 2025.
During the pilot, AMRH technical committees evaluated the quality, safety and efficacy of priority medicinal products.
EMA supported the initiative by financing the assessment of 10 products and providing regulatory expertise, including experience from the European medicines regulatory model.
This initiative delivered a historic first for Africa:
The results of the evaluations will help to:
For more information, see:
EMA has awarded 11 grants to strengthen the scientific and regulatory expertise of African national authorities.
The following national competent authorities in the European medicines regulatory network have received these grants:
They will support training activities for regulatory professionals working for authorities in the following countries:
The training activities will be conducted by October 2027. They cover topics such as:
Assessors and inspectors active in the East African Community and at continental level can also benefit from these training activities.
EMA closed a call for proposals on August 2024. The answers to any questions received while the call was open are published in the following document:
The collaboration between the European medicines regulatory network and its African counterparts contributes to the development of regulatory systems in Africa. This ultimately helps establish the African Medicines Agency.
EMA has awarded a grant to the Council of Europe - European Directorate for the Quality of Medicines & HealthCare (EDQM) to help strengthen the testing capacity of national quality control laboratories across Sub-Saharan Africa. This includes laboratories at national, regional and continental level.
The agreement covers training activities to boost scientific and regulatory expertise of African laboratory control authorities. These activities aim to enhance the capacity of regulatory authorities to test for lot release, market surveillance, and the detection of falsified medicines.
The agreement also foresees a pilot in connection with the establishment of the Network of African Reliance Laboratories.
The network aims to facilitate mutual recognition of quality assurance and quality control data among the national quality control laboratories to improve regulatory cooperation, efficiency, and access to medical products across Africa.
EMA expects activities covered by the grant, including the pilot, to take place between Q3 2025 and Q3 2027.
For more information, see:
EMA launched an open procurement procedure for the design, development and delivery of e-learning training.
This call for tenders aims to strengthen the scientific and regulatory capacity of junior assessors in Africa. It covers the following fields:
This open procurement procedure is aimed at:
EMA closed this call on 26 May 2025.
For more information, see the call for tender on the EU Funding & Tenders Portal:
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in April 2026.
14 April 2026
Page's content fully revised, including a new timeline highlighting milestones in the establishment of AMA.
New video added featuring leaders from the EMA and AMA highlighting the collaboration between the two agencies and AMA’s first weeks of activity.