Addis Ababa—Millions of people in Africa rely on medicines, vaccines, diagnostic tests and medical devices without worrying about the systems that ensure they are safe, effective and of good quality. Behind every product that reaches a patient is a regulatory system working to protect public health
Today, Ministers of Health from across the WHO African Region took an important step to strengthen those systems by endorsing a new regional strategy that will help countries improve the regulation of medical products over the next decade
The Regional Strategy on Regulation of Medical Products in the African Region (2026–2035) comes at a time when countries are expanding access to essential health products, strengthening local manufacturing and preparing for future public health emergencies. Effective regulatory systems are fundamental to these efforts, ensuring that medicines, vaccines, blood products, diagnostics and medical devices consistently meet internationally accepted standards of quality, safety and effectiveness.
Over the past decade, the African Region has made progress in strengthening regulatory systems. The African Medicines Regulatory Harmonization initiative has expanded collaboration among countries, while the African Medicines Agency has become operational, creating new opportunities for regulatory cooperation across the continent. The number of national regulatory authorities achieving WHO Maturity Level 3, an internationally recognized benchmark indicating a stable and well-functioning regulatory systems, has increased from one in 2018 to eight in 2025. Yet significant gaps remain, with most countries continuing to strengthen their regulatory capacity.
“Strong regulatory systems protect lives, strengthen confidence in health systems and create the foundation for local innovation, manufacturing and faster access to quality-assured health products. This strategy reflects our collective commitment to ensuring that everyone in Africa can benefit from medical products they can trust,” said Dr Mohamed Yakub Janabi, WHO Regional Director for Africa.
The new strategy outlines a roadmap for the next decade to strengthen regulatory systems across the Region. It aims to increase the number of regulatory authorities reaching WHO Maturity Level 3, support the development of regulatory authorities operating at internationally recognized levels of performance, strengthen the African Medicines Agency, expand the use of digital regulatory systems and improve preparedness for future public health emergencies.
Recognizing that no country can address increasingly complex regulatory challenges alone, the strategy also promotes greater collaboration through joint product assessments, shared inspections and increased reliance on regulatory decisions made by trusted authorities. These approaches will help improve efficiency, reduce duplication and accelerate access to quality-assured medical products while making the best use of limited resources.
As countries implement the strategy over the next decade, stronger regulatory systems are expected to improve access to quality-assured medical products, reinforce public confidence in health systems and support Africa’s growing ambition to manufacture and regulate more of the health products its people need. Together, these efforts will help build resilient regulatory systems that protect public health, support universal health coverage, strengthen health security and foster sustainable development across the African Region.
