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Africa finally has its own drug-regulation agency — and it could transform the continent’s health

If it gets things right, the first major regulator of medicines to launch for 30 years could empower Africa to tackle African challenges around health and disease.
By
  1. Mwila Mulubwa

    1. Mwila Mulubwa is an investigator in the drug metabolism and pharmacokinetics team at the Holistic Drug Discovery and Development (H3D) Centre, University of Cape Town, South Africa.

  2. Leon Mutesa

    1. Leon Mutesa is a professor of human genetics at the Center for Human Genetics and Genomics, College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.

  3. Kelly Chibale

    1. Kelly Chibale is a professor of organic chemistry and the founder and director of the H3D Centre at the University of Cape Town, South Africa.

Two researchers in protecteive clothing using a centrifuge in a medical research laboratory.

Biomedical researchers at a laboratory in Yaoundé, Cameroon. Credit: Daniel Beloumou Olomo/AFP via Getty

After more than a decade of planning, the launch of the African Medicines Agency (AMA) is being celebrated in Mombasa, Kenya, this week at the Seventh Biennial Scientific Conference on Medical Products Regulation in Africa. The agency’s establishment marks a pivotal moment in Africa’s public health, at a time when the need for biomedical research conducted in Africa, focused on African health problems, has never been greater.

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Nature 647, 313-316 (2025)

doi: https://doi.org/10.1038/d41586-025-03637-w

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Supplementary Information

  1. Supplementary information AMA
  2. WHO trials data sorted by continent

Competing Interests

The authors declare no competing interests.

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