African Medicines Agency (African Union)

The African Medicines Agency 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 Harmonisation (AMRH) Programme. This programme coordinates the harmonisation of medicine regulation across African regions.

A continental regulatory model based on reliance between national authorities can create an environment that enables the development of the pharmaceutical industry in Africa.

For more information on its role and the countries involved, see:

• African Medicines Agency
• Treaty for the Establishment of the African Medicines Agency

EMA and the European Commission's Directorate-General for International Partnerships signed an agreement underpinning EMA's support to set up the African Medicines Agency through to November 2027. 

The agreement was signed in December 2023.

EMA has received a grant of ten million euros from the European Commission to support the project.

This includes EMA providing funding and technical expertise, and working with European, African and international partners.

EMA has extensive experience in continent-wide medicines regulation. It coordinates and supports over fifty European national competent authorities for human and veterinary medicines. 

EMA's support for AMA focuses on:

• Regulatory harmonisation, adoption of common standards and guidelines
• Capacity building
• Training
• Technical assistance
• Making the African Medicines Agency operational

EMA's contribution is part of the Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies (‘MAV+’).

EMA's work focuses on three key priorities:

• Providing expertise needed to make the African Medicines Agency operational, strengthening cooperation between European, African and international partners
• Helping develop the capabilities of the African regulatory network (institutional, regulatory and scientific)
• Coordinating efforts across the European medicines regulatory network and with African and international partners

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:

• Pharmaceutical quality assessment
• Clinical assessment
• Non-clinical assessment

This open procurement procedure is aimed at:

• persons who reside in, and companies registered in, any European Union (EU) Member State or European Economic Area (EEA) country;
• persons who are nationals of, and companies that are established in, any of the countries in Sub-Saharan Africa.

The deadline for receipt of tenders is 26 May, 12:00 Amsterdam time (CEST).

For more information, see the call for tender on the EU Funding & Tenders Portal:

• EU Funding & Tenders Portal: Services to design, develop, and deliver e-learning in the field of pharmaceutical quality assessment, clinical and non clinical assessment (ref. EMA/2024/OP/0013)

EMA has awarded a grant to support a one-year pilot programme to test and validate processes and procedures for the joint continental evaluation of medicines in Africa. This is ahead of the establishment of the African Medicines Agency.

The African Medicines Regulatory Harmonisation (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) is responsible for running the pilot. 

During the pilot, AMRH technical committees will evaluate the quality, safety and efficacy of priority medicinal products.

The results of the evaluations will help to:

• develop continental processes and procedures;
• facilitate national authorisations of recommended medicines;
• strengthen information sharing and reliance.

The pilot is co-funded with the Bill & Melinda Gates Foundation.

For more information, see:

• African Medicines Regulatory Harmonisation (AMRH) Programme

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:

• Germany (Paul Ehrlich Institute)
• Ireland (Health Products Regulatory Authority, HPRA)
• Italy (Italian Medicines Agency, IMA)
• Malta (Malta Medicines Authority, MMA)
• Poland (Office for Registration of Medicinal Devices and Biocidal Products, URPL)
• Portugal (National Authority of Medicines and Health Products, INFARMED)
• Spain (Spanish Agency of Medicines and Medical Devices, AEMPS)
• Sweden (Swedish Medical Products Agency, SMPA)

They will support training activities for regulatory professionals working for Sub-Saharian authorities in the following countries:

• Botswana
• Cape Verde
• Ethiopia
• Ghana
• Lesotho
• Mozambique
• Tanzania
• Uganda
• Zimbabwe

The training activities will be conducted by October 2027. They cover topics such as:

• Quality, non-clinical and clinical aspects of medicine assessment
• Pharmacovigilance
• Inspection procedures

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.