What happened?

Zambia reached a major milestone on January 21, 2024, when they deposited their instrument of ratification for the treaty establishing the African Medicines Agency (AMA).

This move by the Southern African nation represents yet another significant accomplishment for the continent, supporting an organization committed to promoting regional harmonization in the regulation of health products and technologies.

What is the African Medicines Agency?

As an African Union specialized agency, AMA is committed to strengthening its member countries' regulatory capabilities with the hope of increasing access to safe, quality, and effective health products and technologies throughout the continent.

It is safe to say the agency has gained considerable traction.

In November 2024, Rwanda and the African Union inaugurated the African Medicines Agency's headquarters in Kigali, paving the way for operations to kick on in earnest.

In addition, a number of important appointments were made with the aim of making AMA's operations both efficient and effective.

The African Union Development Agency-NEPAD's African Medicines Regulatory Harmonization (AMRH) created the first-ever Continental Heads of Medicines Registration and Marketing Authorization Forum.

Dr. Kariuki Gachoki from the Kenya Pharmacy and Poisons Board was appointed as the chair, with Dr. Chantel Noufionso from Benin as vice chairperson.

Senegal’s Mbagnick Diof, Nazalia Macuwele from Mozambique, and Bathusi Kgosietsile from Botswana fulfilled roles as rapporteurs.

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RELATED: New Nation Has Officially Ratified The African Medicines Agency Treaty

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Why the African Medicines Agency?

It is expected that AMA will play a crucial role in Africa’s pharmaceutical sector.

• AMA will support the advancement of local pharmaceutical production, aligning with a key objective of the Pharmaceutical Manufacturing Plan for Africa (PMPA). Additionally, it will play a vital role in fostering trade in alignment with the Africa Continental Free Trade Area (AfCFTA).

• AMA will assess medical products for treating priority diseases as designated by the African Union. It will also undertake routine inspections, coordination, and dissemination of information regarding authorized marketing products.

• AMA will coordinate collaborative assessments of clinical trial applications for vaccines and evaluations of “highly complex” product portfolios like biosimilars. Furthermore, it will organize collective inspections of Active Pharmaceutical Ingredients (API) manufacturing facilities.

• In collaboration with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs), AMA will aid in identifying substandard and falsified medical products (SFs) and facilitating cross-border information exchange.

• AMA will also be responsible for harmonizing legislation by establishing common standards and regulations.

How many countries have ratified so far?

After Zambia's recent accession, 29 of the 55 AU nations have officially ratified the AMA treaty. Over four countries have signed the pact. but have not yet ratified it, thus it is expected that more ratification instruments will follow.

Support from outside the continent

Key players in the global pharmaceutical industry have acknowledged the importance of what AMA can achieve in the broader context and have shown support.

The European Commission, for example, announced a contribution of €10 million and Belgium made a contribution of €4 million to AUDA-NEPAD for the African Medicines Regulatory Harmonization (AMRH) initiative to continue advancing the establishment of AMA.

Conclusion

An increasing number of AU countries are joining the AMA drive, a move that could benefit a continent where regulatory systems are often labelled weak and largely fragmented.
It is expected that AMA will improve the safety, efficacy, and quality of medical products throughout the continent by streamlining regulatory processes.

Which nation will lend its support to this cause next?

We’ll have to wait and see.

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