African Medicines Agency launches two regulatory hubs in Kigali to boost local drug manufacturing
The agency inaugurated the Capacity Strengthening Hub and the Regulatory Innovation and Manufacturing Readiness Hub during its inaugural AMA Week on October 27, 2026.
RWANDA — The African Medicines Agency (AMA) has launched two regulatory hubs in Kigali to strengthen medicines regulation, accelerate product approvals and support pharmaceutical manufacturing across Africa.
The agency inaugurated the Capacity Strengthening Hub and the Regulatory Innovation and Manufacturing Readiness Hub during its inaugural AMA Week on October 27, 2026.
Both are based at AMA headquarters in Kigali and will support efforts to improve regulatory coordination and build local manufacturing capacity.
“Such a system should enable countries to share scientific work, make timely regulatory decisions, support local industry and respond collectively and rapidly to public health needs,” said Delese Mimi Darko, AMA Director-General.
Building regulatory expertise across Africa
The Capacity Strengthening Hub will identify skills gaps among regulatory professionals and coordinate training, mentorship, peer learning and professional exchange programmes across the continent.
Darko said the initiative would complement existing capacity-building programmes supported by the World Health Organization (WHO), regional economic communities, national regulatory authorities, universities and technical partners.
Rather than duplicate existing efforts, the hub will draw on expertise from African regulatory agencies that have attained Maturity Level 3 under the WHO Global Benchmarking Tool, alongside Regional Centres of Regulatory Excellence and other established networks.
The approach is intended to strengthen the technical capabilities of national regulators while encouraging countries to share expertise and regulatory resources.
Supporting pharmaceutical innovation and manufacturing
The second initiative, the Regulatory Innovation and Manufacturing Readiness Hub, will engage pharmaceutical manufacturers and innovators earlier in product development.
It will provide scientific guidance and help companies prepare to meet regulatory requirements for product quality, safety and efficacy.
“Africa cannot continue to be primarily a destination for medical products developed and manufactured elsewhere,” Darko said.
She stressed the need for timely scientific advice, clear regulatory expectations and an enabling environment that allows local manufacturers to meet regulatory standards.
As an example, she cited AMA’s engagement in the development of an Ebola vaccine candidate being developed and manufactured in Egypt, highlighting the value of early regulatory guidance in advancing medical products.
Regional cooperation to accelerate market access
Michel Sidibé, African Union Special Envoy for AMA, said the hubs would enable the agency to mobilise expertise across African countries instead of concentrating its activities at its Kigali headquarters.
He noted that stronger cooperation could help regulators assess medicines, monitor adverse reactions, evaluate the equivalence of generic medicines and exchange scientific assessments and regulatory documentation.
Sharing completed assessments could reduce duplicated work among national authorities and shorten the time required to approve medicines.
This is particularly relevant in Africa, where manufacturers often face multiple regulatory processes when seeking market access across different countries.
“Some molecules are waiting for five, six years, when you have to navigate between 55 countries,” Sidibé said.
He added that coordinated regulatory systems could also strengthen African countries’ negotiating position with pharmaceutical manufacturers and suppliers.
Prof. Paul Lalvani, founder and executive director of the Empower School of Health, said AMA could work with existing training institutions and regulatory networks to expand technical expertise across the continent.
He identified local production of pharmaceuticals, vaccines, medical devices and diagnostics as an important measure of the hubs’ impact.
Lalvani also pointed to the potential role of AMA and the African Continental Free Trade Area (AfCFTA) in supporting pharmaceutical production through stronger regulatory systems, improved market access and fewer barriers to cross-border business operations
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