African health ministers have adopted a new regional strategy aimed at strengthening the systems responsible for regulating medicines, vaccines, diagnostic tests, blood products and medical devices across the continent.
The strategy, known as the Regional Strategy on Regulation of Medical Products in the African Region (2026–2035), was endorsed on August 26, 2026, during a meeting of health ministers from across the World Health Organization (WHO) African Region.
The move comes as African countries work to expand access to essential medicines, strengthen local pharmaceutical manufacturing and improve their preparedness for future public health emergencies.
Strong medical regulatory systems are considered essential because they help ensure that products reaching patients meet internationally accepted standards of quality, safety and effectiveness.
The WHO said the continent has made progress in strengthening these systems over the past decade. The African Medicines Regulatory Harmonisation initiative has increased cooperation between countries, while the African Medicines Agency has created new opportunities for regulatory collaboration.
One major sign of progress is the growing number of national regulatory authorities meeting WHO’s Maturity Level 3 benchmark, which indicates a stable and well-functioning regulatory system. The number increased from just one country in 2018 to eight countries by 2025. However, WHO said many African countries still need to strengthen their regulatory capacity.
The new 10-year strategy aims to build on this progress. It will encourage more countries to develop strong and internationally recognised regulatory authorities while also supporting the continued development of the African Medicines Agency.
The strategy also promotes the use of digital regulatory systems and better preparation for future health emergencies.
Another major focus will be cooperation among African countries. Instead of countries working completely independently, the strategy encourages joint assessments of medical products, shared inspections and greater reliance on decisions made by trusted regulatory authorities.
According to WHO, this approach could reduce unnecessary duplication, improve efficiency and help speed up access to safe and quality-assured medical products.
Dr Mohamed Yakub Janabi, WHO Regional Director for Africa, said strong regulatory systems are important for protecting lives, building trust in health systems and supporting innovation and local manufacturing.
The strategy is also expected to support Africa’s growing ambition to produce more of the medicines and health products needed by its population.
As countries begin implementing the strategy over the next decade, WHO expects stronger regulatory systems to improve access to reliable medical products, strengthen public confidence and contribute to universal health coverage across the continent.
