Last updated: 5 February 2024
See updates at the end of the post.
The African Medicines Agency’s (AMA) long journey towards harmonization started in 2009 with the establishment of the African Medicines Regulatory Harmonisation Initiative (AMRH) and the involvement of many key partners across governments, civil society, and industry.
In 2019 the African Union Assembly adopted a treaty to establish the AMA to enhance regulatory oversight across the continent and meet the challenges of access to quality, safe, and efficacious medicines in the continent.
What is AMAs vision?
AMAs vision is for the People of Africa to have access to essential Medical Products and Technologies.
What will be the structure of the AMA?
AMA will consist of the the following:
- The Conference of parties
- Governing Board
- The Secretariat
- Technical Committees
What will be the AMAs role?
- AMA will support the growth of local pharmaceutical production, a key objective of the Pharmaceutical Manufacturing Plan for Africa (PMPA). It will further play a critical role in catalyzing trade in support of the Africa Continental Free Trade Area (AfCFTA).
- AMA will evaluate medical products for the treatment of priority diseases as determined by the African Union.
- It will also regularly inspect, coordinate and share information about products that are authorised for marketing.
- AMA will coordinate joint reviews of clinical trial applications for vaccines and assessment of “highly complex” product dossiers such as biosimilars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites.
- AMA will collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) in the identification of substandard and falsified medical products (SFs) and facilitate information sharing across countries.
- By developing common standards and regulations, AMA will also be responsible for harmonising legislation.
Progress so far towards the establishment of the AMA
2024
January
The European Medicines Agency will harness its unique experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network.
EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors.
EMA has committed to mobilising experts to support AMA, its technical committees and African regulators in the set-up of AMA’s governance and scientific and administrative processes. EMA will also offer training to reinforce scientific and regulatory expertise in the evaluation and supervision of medicines together with experts from EU Member States.
More on this topic here.
2023
January
This article from Devex suggests that the appointment of a Director General could be the next step in the coming months. This article is quite comprehensive and covers various topics including challenges for the new agency.
June
The Rwandan government and the African Union Commission (AUC) finalised the arrangement for the establishment of the headquarters of the first ever African Medicines Agency in Kigali.
On 19 June, the country also signed an agreement with the African Union to host the headquarters of the African Medicines Agency (AMA) in Kigali.
Source: Vanguard
December 2023
EMA and the European Commission’s Directorate-General for International Partnerships signed an agreement in December 2023 underpinning EMA’s support for setting up the African Medicines Agency through to November 2027.
EMA has received a grant of ten million euros from the European Commission to support the project.
EMA provides funding and technical expertise, working with European, African and international partners.
EMA’s support will focus on:
- Regulatory harmonisation, adoption of common standards and guidelines
- Capacity building
- Training
- Technical assistance
- Making the African Medicines Agency operational
Source: EMA
2022
April
This status list (up to 27 April 2022) shows the countries that have signed, ratified and deposited the instrument of ratification for the Treaty for the establishment of the AMA. A simpler list is available at tend of this page.
June
During the first meeting of the Conference of the States Parties (Ministers of Health from AMA-ratified countries) held in June 2022 in Addis Ababa, the African Union Commission reaffirmed its commitment to providing all necessary support toward the earliest operationalization of the AMA, and highlighted the importance of AMA operationalization to enhancing regional capacity to regulate medicines, medical products, and healthcare technology. The AU press release provides further details about this meeting.
July
Formal assessment of the eight host country candidates was completed, and the Executive Council of the AU met in July 2022 to decide on this host. The council voted for Rwanda to host the AMA, during its midyear coordination meetings held in Zambia.
October
In a major step forward for the new regulatory alliance, Africa’s third-largest economy, South Africa is now moving to join the African Medicines Agency.
South Africa’s Cabinet has approved the signing of the African Union treaty establishing the African Medicines Agency (AMA) and submitted it to Parliament for ratification, according to a government statement on 23 September.
Source: Health Policy Watch
2021
October
The minimum number of 15 ratifications (of the treaty) by African Union (AU) countries was reached in October 2021.
November – AMA established
Following ratification, the AMA was established establish in November 2021. The African Union has since stepped up efforts, through the African Union Commission and the African Union Development Agency, to prepare for the opening of the AMA Secretariat. They have developed a joint workplan, with elements including:
- a continued push for further ratification by additional countries,
- developing an AMA roadmap for the first year and subsequent years,
- setting up AMA’s core activities and detailed procedures, and
- developing AMA business processes (including enterprise resource planning).
They also agreed on the division of labour between their respective organizations and have started to engage with multiple partners around this workplan, including the European Medicines Agency (EMA), national regulators in Europe and elsewhere, and funding partners, among others, to explore how they can leverage others’ experiences in support of setting up the AMA.
Which country will host the AMA?
Rwanda will host the AMA.
Is AMA the first cross-continental health agency of the African Union?
AMA is the second cross-continental health agency of the African Union, following the Africa Centres for Disease Control and Prevention, which is hosted in Ethiopia.
Countdown
Here, you can see which countries have signed/ratified/deposited The African Medicines Agency Treaty.
Sources:
African Medicines Agency (AMA)
African Medicines Regulatory Harmonisation
Treaty for the Establishment of the African Medicines Agency
The Pharmaceutical Manufacturing Plan for Africa (PMPA)
Updates
| Date | Update |
|---|---|
| 5 Feb 2024 | Added new section 2024, subsection January on the EMA harnessing its unique experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network. |
| 21 June 2023 | Section entitled Progress so far towards the establishment of the AMA updated to to add news of establishment of the headquarters of the agency and hosting in Kigali, Rwanda. |
| 17 Jan 2023 | Addition of a link to an article from Devex under the heading Progress so far towards the establishment of the AMA. |
| 20 Oct 2022 | Section entitled Countdown added. |
| 13 Oct 2022 | October 2022 updated added on South Africa moving to join the African Medicines Agency. |
Photo by James Wiseman on Unsplash