African Medicines Agency .[Courtesy]
Last week, during a discussion with African vaccine manufacturers, one manufacturer asked me a deceptively simple question:
Can the African Medicines Agency help make it easier for a manufacturer to reach multiple African markets without navigating a completely separate process in every country?
It is a question I have encountered throughout my career as a regulator, and one that goes to the heart of why the African Medicines Agency matters.
For a vaccine manufacturer, an API producer, a medical-device developer or a biotech investor, fragmentation has a cost. Different requirements, repeated processes and multiple sequential pathways consume time, expertise and resources.
But the greater cost is ultimately borne by patients when quality-assured innovations take longer than necessary to reach them.
Africa cannot build a sustainable pharmaceutical manufacturing industry while retaining permanently fragmented pathways to its markets.
This does not mean replacing National Regulatory Authorities (NRAs) or removing national sovereignty. Indeed, strong NRAs are the scientific backbone of Africa’s continental regulatory agency.