"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."
Inequitable vaccine distribution during the COVID-19 pandemic demonstrated the need for more home-grown manufacturing and regulatory capacity across Africa. The African Medicines Agency (AMA) launched in Kigali to serve as a continental medicines regulator after a decade of preparation. Medicines regulators ensure that pharmaceuticals and vaccines are quality products, safe to use and effective as labelled. The EMA advised and funded the AMA during its initial phase and provides scientific advice, study-design guidance and evaluation expertise. The EMA can recommend authorization across the EU, while final availability decisions remain with the European Commission and national regulators. The AMA must adapt EMA experience to a vastly different African operating environment and succeed to improve access and safety.
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