Africa is seeking to reduce delays in medicine approvals and strengthen safeguards against unsafe and substandard medical products through a continent-wide regulatory system designed to help countries share scientific expertise and coordinate their decisions.
The African Medicines Agency (AMA) inaugurated seven specialized technical committees in Kigali on October 28, bringing together experts to support the assessment of medicines, vaccines, clinical trials, medical devices, and other health products.
The committees form part of efforts to address fragmented regulatory systems across African countries, where differences in technical capacity and approval processes can complicate the introduction of medical products and slow access to treatments.
The development was announced during the agency’s inaugural AMA Week, held in Kigali from October 25 to 30, as the institution moves from establishing its structures to implementing its continental mandate.
For patients, the intended benefits include stronger protection against unsafe or falsified medicines and faster access to quality-assured treatments. For pharmaceutical manufacturers, closer regulatory cooperation could help reduce duplicated assessments and make it easier to navigate requirements across multiple African markets.
AMA Director General Dr Delese Mimi Darko said the agency was entering a phase in which it must turn the expertise and institutional groundwork already established into practical results.
“Our task now is to bring these vast expertise and strengths we have built together into a more effective continental system, one that enables countries to share scientific work, make timely regulatory decisions, support local industry and respond collectively to public health needs,” she said.
The seven committees will provide specialized scientific and technical advice across different areas of medical product regulation.
Their responsibilities include evaluating medicines, vaccines and biological products; overseeing clinical trials and good clinical practice; monitoring medicine safety; supporting quality-control laboratories; conducting regulatory inspections; monitoring medical products in the market; and assessing medical devices, diagnostics and emerging technologies.
The committees are expected to draw on expertise from different African countries, allowing regulators to benefit from scientific assessments and technical knowledge beyond their national institutions.
This could be particularly important for countries whose regulatory authorities have limited specialist personnel or laboratory capacity to assess increasingly complex medical products.
However, the committees’ establishment does not mean that all medicines will automatically receive continent-wide approval. National regulatory authorities will retain responsibility for decisions within their jurisdictions, while AMA seeks to strengthen cooperation and encourage greater reliance on shared scientific assessments.
Darko said the committees’ effectiveness would depend on the quality and independence of their work.
“Their credibility will rest on scientific rigor, integrity and the quality of their conclusions,” she said.
She added that the agency’s success should ultimately be judged by whether its work improves patient protection and access to treatment.
“For a patient, it should mean stronger protection against unsafe, ineffective and substandard or falsified medical products, and more timely access to quality-assured treatments,” she said.
Existing regional initiatives offer an indication of how coordinated medicine assessments could help reduce regulatory delays.
A 2026 review of pharmaceutical regulatory harmonization in Africa found that the median time taken to complete joint medicine assessments under the East African Community initiative fell from 553 calendar days in 2015 to 259 days in 2023.
The reduction of 294 days illustrates the potential gains from countries sharing assessment processes rather than duplicating work independently.
For pharmaceutical companies seeking to supply several African markets, shorter and more predictable regulatory timelines could reduce administrative burdens and help products reach patients sooner.
The benefits, however, will depend on countries having the capacity to implement shared assessments, maintain strong national oversight and ensure that regulatory decisions remain grounded in scientific evidence.
World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus said fragmented regulatory systems could delay access to medical products, raise costs and weaken health security.
“The AMA is vital for stronger national authorities, greater regulatory convergence, and more reliance and work sharing across countries,” he said.
Tedros said 10 African national regulatory authorities had attained Level 3 maturity under WHO’s Global Benchmarking Tool, which assesses the performance of national regulatory systems.
The WHO and AMA are also developing a new five-year operational plan to build on efforts to strengthen regulatory capacity across the continent.
Beyond medicine approvals, AMA is seeking to address shortages of regulatory expertise and help African manufacturers navigate requirements for bringing products to market.
The agency has introduced a Capacity Strengthening Hub to identify skills gaps and coordinate training, mentoring, peer learning and professional attachments for regulatory personnel.
It has also launched a Regulatory Innovation and Manufacturing Readiness Hub to engage innovators and manufacturers earlier in product development, helping them understand regulatory expectations on quality, safety and efficacy.
The initiatives come as African countries seek to expand pharmaceutical manufacturing and reduce dependence on imported medical products.
Stronger local production alone, however, will not guarantee access to affordable medicines. Manufacturers must also meet quality standards, while regulatory systems need the expertise and resources to assess products effectively.
A more coordinated continental framework could help address some of these challenges by making regulatory requirements more consistent and enabling countries to share specialized knowledge.
Yvan Butera, Rwanda’s Minister of State in the Ministry of Health, said cooperation between countries would be essential to extending protection against unsafe medical products.
“Each country must strengthen its own health and regulatory systems, but also by working together, we can extend that protection across the continent,” he said.
The immediate challenge for AMA will be translating its new structures into measurable improvements in regulatory timelines, product quality and access to medicines across African markets.
