WHO backs African Medicines Agency drive to strengthen regulatory systems in Kigali
The meetings brought together regulators, policymakers, pharmaceutical industry representatives and international partners to accelerate regulatory cooperation and improve access to safe, effective and quality-assured medical products across the continent.
RWANDA—The World Health Organization (WHO) has reaffirmed its support for stronger pharmaceutical regulation in Africa during the inaugural African Medicines Agency (AMA) Week and the 11th African Medicines Regulators Conference (AMRC), held from 25 to 30 October 2026 in Kigali, Rwanda.
The meetings brought together regulators, policymakers, pharmaceutical industry representatives and international partners to accelerate regulatory cooperation and improve access to safe, effective and quality-assured medical products across the continent.
WHO calls for greater investment in regulatory capacity
In a video message, WHO Director-General Dr Tedros Adhanom Ghebreyesus highlighted progress in strengthening national regulatory authorities.
He noted that 10 African countries had attained Maturity Level 3 under WHO’s Global Benchmarking Tool, indicating that their regulatory authorities had developed stable, integrated and well-functioning systems.
He reaffirmed WHO’s commitment to supporting AMA and national regulators, while calling for sustained political and financial investment in regulatory infrastructure.
He also urged more African countries to ratify the AMA Treaty to accelerate the agency’s operationalization.
AMA establishes technical committees and innovation hubs
A key development during the week was the inauguration of AMA’s seven technical committees.
The committees will provide independent scientific advice across major regulatory functions, including the evaluation of medicines and vaccines, clinical trial oversight, inspections, safety monitoring and medical devices regulation.
Their establishment is expected to strengthen evidence-based decision-making and encourage regulatory reliance and work-sharing among African countries.
These approaches could reduce duplication in product assessments, improve regulatory efficiency and shorten approval timelines for pharmaceutical products entering African markets.
AMA also launched its Regulatory Innovation and Manufacturing Readiness Hub and Capacity Strengthening Hub.
The initiatives will provide early scientific advice, support pharmaceutical manufacturers and strengthen technical expertise among regulators.
For the pharmaceutical industry, these developments offer opportunities to improve engagement with regulators, support local manufacturing and facilitate more coordinated product registration across African markets.
WHO and AMA strengthen regulatory cooperation
WHO co-convened the 11th AMRC with AMA to advance regulatory harmonization, convergence and reliance.
Discussions focused on strengthening national regulatory authorities, which remain central to the development of a coordinated continental regulatory system.
Representing WHO, Hiiti Sillo, Head of the Regulation and Safety Unit and Acting Director of the Regulation and Prequalification Department, emphasized the need to invest in African regulatory expertise.
He also highlighted the importance of building trust between regulatory authorities and ensuring that cooperation translates into measurable public health benefits.
The discussions followed the Framework Agreement for Collaboration signed by WHO and AMA in May 2026 and the subsequent five-year joint operational plan.
The agreement provides a framework for coordinated efforts to strengthen regulatory capacity, improve safety surveillance, combat substandard and falsified medical products, and support pharmaceutical innovation and local manufacturing.
WHO will continue providing technical expertise, internationally recognized standards and capacity development support as AMA advances its operations.
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