The inequitable distribution of vaccines during the COVID-19 pandemic was the final proof of the need for more home-grown manufacturing and regulatory capacity across Africa.
People in African countries waited longer to receive COVID-19 vaccines than did people in high-income countries.Credit: Robert Bonet/NurPhoto/Getty
Who would have thought that the proverbial red carpet would be rolled out for a regulatory agency? That is what happened — and rightly so — with today’s launch of the African Medicines Agency (AMA), which is headquartered in Kigali.
As Nature Africa’s news team reports, the AMA is the most important development for health and science in Africa in years. Medicines regulators are the hidden stars of public health. It is their job to ensure that the pills we consume and the vaccines we receive are quality products, safe to use and do what they say on the label. The AMA has been a decade in the making (B. M. Ncube et al. J. Pharm. Policy Pract. 14, 29; 2021). Now that it has become reality, it must succeed.
Africa finally has its own drug-regulation agency — and it could transform the continent’s health
The idea of a single medicines regulator for the African continent comes some 30 years after the creation of the European Medicines Agency (EMA), the European Union’s one-stop regulator, now based in Amsterdam. The EMA, which has been advising and funding the AMA during this initial phase, has a number of roles. High on the list is providing scientific advice on proposals for new medicines, vaccines and other medical products. This is often guidance on improving the design of studies so that they are as robust as possible.
However, the EMA is arguably best known for evaluating the safety and efficacy of products after laboratory tests and clinical trials. It can recommend authorization of a drug or vaccine so that it can be sold across the EU, but the actual decision to make it available rests with the European Commission and national regulatory bodies.
The AMA will draw on this experience, but its operating environment couldn’t be more different from that of European countries. The EU is home to some of the world’s largest pharmaceutical companies and some of the best-funded research groups in the areas that it regulates. African countries, by contrast, import more than 70% of medicines and 99% of vaccines. Each EU country has its own national regulatory body for medicines that takes care of authorizing clinical trials, another important part of the regulatory chain. Only 9 of 55 African Union member states have national regulators that have achieved the necessary quality threshold to be allowed to do this, as determined by the World Health Organization (N. Wairagkar et al. PLOS Glob. Public Health 5, e0004276; 2025). They are not authorized to approve vaccines and drugs — another reason why so many countries rely on imported products.
What the launch of the African Medicines Agency means for drug and health regulation
This means that, compared with its European counterpart, the AMA will need to do a lot more training and capacity building so that national authorities have the expertise needed to authorize medicines. It will need to work with universities, funding agencies and industry to build and establish research partnerships.
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