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 (AMA) matters.
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.
AMA’s role is to connect and strengthen those systems, building on the important harmonisation work already undertaken through the regional economic communities and other continental initiatives, strengthening capacity where needed, and creating greater confidence and trust for countries to rely on one another’s work.
