The World Health Organization (WHO) reinforced its support for Africa’s efforts to strengthen pharmaceutical regulation during the inaugural African Medicines Agency (AMA) Week and the 11th African Medicines Regulators Conference (AMRC), which took place in Kigali, Rwanda, between October 25 and 30, 2026. The gathering assembled regulators, government officials, and industry representatives to advocate for greater collaboration and expanded access to safe, high-quality medicines across the continent.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus highlighted in a video message that 10 African countries had achieved Maturity Level 3 under the WHO’s Global Benchmarking Tool, indicating these nations now operate fully functional regulatory systems. He stressed the need for additional countries to approve the AMA Treaty to accelerate its implementation and emphasized the importance of continued political and financial commitments to regulatory development.
Key discussions centered on regulatory efficiency and interdependence. The AMA established seven technical committees to deliver independent scientific assessments for medicine evaluations, clinical trials, inspections, and medical device regulation. These committees will help eliminate duplicate reviews, shorten approval timelines, and promote collaborative regulatory work among African nations.
Alongside these committees, the AMA unveiled two new specialized hubs: the Regulatory Innovation and Manufacturing Readiness Hub and the Capacity Strengthening Hub. The first will provide early-stage scientific advice to manufacturers, while the second aims to enhance technical capabilities among regulators. Pharmaceutical companies will benefit from these initiatives, which create more transparent processes for local production and coordinated market access.
Harmonizing regulatory standards remained a core focus. WHO and the AMA co-organized the AMRC to develop unified benchmarks, with sessions addressing trust-building between authorities and ensuring cooperation yields measurable public health improvements. A five-year joint operational plan, finalized in May 2026, will govern their partnership on drug safety monitoring, combating counterfeit and substandard medications, and supporting local pharmaceutical manufacturing.
This initiative builds on broader regional efforts to transition from disjointed national systems to a cohesive regulatory framework. Obstacles such as funding shortages and political engagement gaps persist, but the established structure now provides a foundation to simplify oversight, reduce bureaucratic delays, and enhance access to essential medicines.
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