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.
AMA’s role is to connect and strengthen those systems, building on the important harmonisation work already undertaken through the Regional Economic Communities (RECs) 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 AfCFTA, 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.
Ultimately, success will not be measured by how many processes AMA creates.
It will be measured by whether we help build stronger national institutions, enable African innovation and manufacturing, and get quality-assured medical products to African patients faster.
Made in Africa must increasingly also mean trusted across Africa and beyond.
Africa’s pharmaceutical manufacturing potential
Africa’s pharmaceutical industry holds great potential. The continent’s pharmaceutical market is currently projected to exceed US$50 billion by 2030.
The opportunity is clear: boosting manufacturing on the continent will expand access to safe and efficacious medical products, reduce import dependency, create jobs, and improve health outcomes.
But capturing that opportunity requires strong, predictable regulatory systems.
Currently, African small and medium-sized enterprises (SMEs) bringing a product to market must navigate multiple regulatory environments, each with its own requirements, timelines, and standards.
Continental pilot programmes point to how demanding the journey still is, with manufacturers often needing several rounds of rework before a submission is complete.
Even as national systems continue to strengthen, regulatory fragmentation remains a significant hurdle to our region’s health sovereignty, particularly for vaccines, adding real compliance costs for manufacturers seeking to build sustainable businesses.
The question of supporting manufacturing is therefore a question of Africa’s quest to achieve health security.
Africa’s health depends on its regulatory sovereignty. Without a strong, harmonised regulatory system for medical products, the continent remains dependent on external frameworks that were not designed with African needs and realities in mind.
*****Delese Mimi Darko is director general of the African Medicines Agency, an African Union (AU) specialised agency mandated to harmonise regulation of medical products, with its headquarters in Kigali.
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