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Why the African Medicines Agency’s Hour Has Arrived

With SARS-CoV-2 infections on the rise, health systems across Africa are facing increasing pressure. Though researchers are working around the clock to unlock the science to help treat the disease, regulators must play a key role in ensuring the rapid – yet safe - development of treatments and vaccines. But Africa faces a significant stumbling block in its ability to address the pandemic: varying regulatory systems across the continent make it difficult to mount appropriate responses. Efforts for regulatory harmonization have been underway for the past decade, and this work has never been more important. Parliaments are now calling for approval to establish the African Medicines Agency (AMA) (1) – a proposed regulatory authority that would oversee the harmonization and convergence of medical and pharmaceutical regulation for African Union (AU) member states. Recently, Margaret Agama-Anyetei, Head of Health, Nutrition, and Population at the African Union Commission, urged the AU to ratify the treaty for the formation of the AMA before its next assembly in February 2021. The benefit, she explained, was that “instead of talking to eight regional economic communities or 55 countries, there would be one organization speaking on behalf of the continent (2).” 

The AMA is expected to be essential in enabling patients to access safe, effective, high-quality, and affordable drugs, treatments, and vaccines. The main purpose of the agency will be to coordinate ongoing regulatory systems, provide guidance, and to foster reliance and regulatory harmonization across the continent. These are crucial to responding to public health threats, such as COVID-19. They will also help thwart the dangerously large and thriving market for falsified medicines. The unregulated sale of fake drugs is responsible for tens of thousands of premature and unnecessary deaths among African patients who unwittingly fall prey to counterfeiters. The WHO stated that the continent accounted for 42 percent of all counterfeit drug reports between 2013 and 2017 (3).

With the need to manage such significant issues, most people are in agreement that a continent-wide body will coordinate the work already being done by national regulatory authorities (NRAs) and allow the pharmaceutical industry to make good on its promise to leave no-one behind. But with the disruption caused by the pandemic, how near are African governments to realizing their goal?

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About the Authors

Sarah Adam

Head of Regulatory Science Policy, Africa at IFPMA

Cyntia Genolet

Head of Health Systems and Africa Policy at IFPMA.

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