The African Medicines Agency (AMA) has launched two hubs in Kigali to help African countries make faster regulatory decisions on medicines and support local manufacturers in bringing medical products to market.
The Capacity Strengthening Hub and the Regulatory Innovation and Manufacturing Readiness Hub were launched on Tuesday, October 27, during the inaugural AMA Week in Kigali. Both are based at AMA headquarters in Kigali.
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"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,” Delese Mimi Darko, Director-General of AMA, said, speaking at the launch.
The Capacity Strengthening Hub will identify priority skills gaps and coordinate training, mentoring, peer learning and professional attachments for regulatory professionals across the continent.
Darko said the hub would build on existing capacity-building initiatives supported by the World Health Organization (WHO), regional economic communities, national regulatory authorities, universities and technical partners rather than duplicate their work.
It will draw on expertise from African regulatory authorities, particularly those that have achieved Maturity Level 3 under the WHO Global Benchmarking Tool, as well as Regional Centres of Regulatory Excellence and other established networks.
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The second hub, the Regulatory Innovation and Manufacturing Readiness Hub, will engage manufacturers and innovators earlier in product development, providing scientific guidance and helping them prepare to meet regulatory requirements for quality, safety and efficacy.
"Africa cannot continue to be primarily a destination for medical products developed and manufactured elsewhere,” she said.
"Our innovators and manufacturers need an enabling environment that includes timely scientific guidance, clear regulatory expectations and support to prepare them to meet the rigorous standards of our regulatory agencies.”
She cited AMA’s work on an Ebola vaccine candidate being developed and manufactured in Egypt as an example of the value of providing scientific advice early in product development.
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Michel Sidibé, the African Union Special Envoy for AMA, said the hubs would allow the agency to draw on expertise across the continent rather than centralise all its activities at its Kigali headquarters.
He said the hubs could help regulators assess medicines, monitor side effects, check whether generic medicines work similarly to their original versions, and share scientific assessments and regulatory documents.
This could allow countries to draw on work already done by other regulators, reducing duplication and potentially speeding up the approval of medicines.
"Some molecules are waiting for five, six years, when you have to navigate between 55 countries,” he said, referring to the challenges of navigating separate regulatory systems across the continent.
Sidibé added that a more coordinated regulatory system could also strengthen Africa’s negotiating position when dealing 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 spread expertise across countries.
"The real metric of the hubs is how self-reliant is Africa when it comes to local manufacturing of pharmaceuticals, vaccines, medical devices, medical diagnostics,” he added.
He said AMA and the African Continental Free Trade Area (AfCFTA) could help accelerate local production by strengthening regulatory capacity, easing access to markets and making it easier for businesses to operate across borders.