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.
The objective is straightforward: less unnecessary duplication, greater predictability and faster access to quality-assured medical products.
But there is another lesson from my conversation with manufacturers: we need to engage much earlier. Too often, manufacturers encounter regulatory questions after significant decisions and investments have already been made.
Through AMA’s Regulatory Innovation and Manufacturing Readiness Hub, we want to create an early entry point, we call it Africa’s front door, where innovators and manufacturers can engage with AMA and the expertise of our network of NRAs during product development, clinical development, technology transfer and manufacturing readiness.
The advice is non-binding. Its value lies in helping developers understand expectations earlier, generate the right evidence and make better-informed investment and development decisions.
This early-engagement role is consistent with the model discussed with manufacturers. The Hub supports and coordinates; it does not replace NRAs or their national decision-making responsibilities.
And this matters beyond regulation. Manufacturing capacity without market access is not manufacturing sustainability.
If Africa wants manufacturers to invest, transfer technology and build production capacity on the continent, they need a sufficiently large and predictable market.
Greater convergence can support that market, complement African Continental Free Trade Area, and help create the confidence needed for African countries increasingly to procure quality assured products together.
For a continent carrying a significant share of the world’s disease burden while remaining heavily dependent on imported medical products, this is both a public- health and an economic imperative.
Our ambition is therefore not to make standards easier. It is to make the pathway clearer, more predictable and more efficient, while maintaining rigorous standards of quality, safety and efficacy.
The author is Director-General of the African Medicines Agency