ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country spotlighted on the cover of Market Pathways' print issue. The June 2025 cover features the African Union's headquarters in Addis Ababa, Ethiopia.
Regulation
Authority: African Medicines Agency (AMA)
Leader: Delese Mimi Darko, Director General, AMA
Points of Interest:
- Darko was selected in June to lead the new AMA, charged with harmonizing regulations across the African Union’s 55 member states.
- The African Union Development Agency is drafting a framework to support “regulatory reliance” between national authorities.
- Nine national regulators from AU countries are affiliate members of the International Medical Device Regulators Forum (IMDRF).
Procurement
Authority: Africa Centres for Disease Control and Prevention (CDC)
Leader: Jean Kaseya, Director General, CDC
Points of Interest:
- AU countries rely heavily on imported devices procured by international donors or non-governmental organizations.
- Africa CDC oversees pooled procurement mechanisms for priority products, including diagnostics.
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17 African countries have national lists of devices approved for procurement or reimbursement, according to the World Health Organization.
More Resources
- Market Pathways interviewed Paulyne Wairimu, African Medicine Device Forum chair, about the AMA and efforts to harmonize device regulations in Africa.
- The African Union Development Agency’s (AUDA-NEPAD) draft “Continental Regulatory Reliance Framework,” published in May.
- A 2023 review article in BMJ Global Health on “Medical Device Regulation and Oversight in African Countries: A Scoping Review of Literature and Development of a Conceptual Framework.”
