Africa Sets a New 10-Year Strategy to Make Medicines, Vaccines and Medical Products Safer

Regulatory capacity across the region has improved during the past decade, supported by initiatives that encourage countries to work together rather than develop every system independently.

Millions of people across Africa receive medicines, vaccines, diagnostic tests, blood products and medical devices, often without seeing the complex regulatory work that determines whether those products are safe, effective and good enough to reach patients. African health ministers have now endorsed a new regional strategy designed to strengthen this crucial layer of healthcare, giving countries a shared roadmap for improving medical product regulation during the next decade.

The Regional Strategy on Regulation of Medical Products in the African Region (2026–2035) comes as countries expand access to essential treatments, build local pharmaceutical manufacturing capacity and prepare health systems for future emergencies. Stronger regulation is central to each of these priorities because increasing the supply of health products has little value unless patients, healthcare workers and governments can trust their quality and performance.

Africa Has Made Progress, but Regulatory Gaps Remain

Regulatory capacity across the region has improved during the past decade, supported by initiatives that encourage countries to work together rather than develop every system independently. The African Medicines Regulatory Harmonization initiative has expanded cooperation, while the African Medicines Agency is now operational and offers another route for closer coordination across national borders.

The clearest sign of progress can be seen in the number of national regulatory authorities reaching WHO Maturity Level 3, a benchmark associated with stable and well-functioning regulatory systems. Only one authority had reached this level in 2018, compared with eight by 2025. Most countries in the region still need further capacity development, showing why the next decade will be important for building stronger and more consistent oversight.

A Decade of Stronger Regulation and Digital Systems

The new strategy sets out several priorities for 2026–2035, including increasing the number of regulatory authorities reaching Maturity Level 3 and supporting regulators as they develop internationally recognized levels of performance. It also calls for strengthening the African Medicines Agency and expanding digital regulatory systems that can make oversight faster, better connected and more responsive.

Public health emergencies are another major part of the plan. The COVID-19 pandemic and other disease outbreaks showed how quickly demand for vaccines, diagnostics, medicines and medical equipment can rise, making regulatory systems capable of evaluating products rapidly without compromising safety an important part of health security.

Dr Mohamed Yakub Janabi, WHO Regional Director for Africa, described strong regulatory systems as essential for protecting lives and building confidence in healthcare, while also creating conditions that support local innovation, manufacturing and faster access to quality-assured products.

Countries Will Share More Assessments, Inspections and Decisions

The strategy recognizes that increasingly complex medical technologies can place heavy demands on regulators, particularly where financial resources, specialist expertise and technical infrastructure are limited. Greater regional cooperation could reduce that pressure through joint product assessments, shared inspections and increased reliance on decisions made by trusted regulatory authorities.

Such cooperation can prevent countries from repeatedly carrying out the same work, allowing scarce regulatory resources to be used more effectively while helping quality-assured products reach patients sooner. It could also become increasingly valuable as Africa expands domestic manufacturing and more locally produced medicines, vaccines and other health technologies enter regional markets.

By 2035, stronger national authorities working alongside regional institutions could give African countries a more resilient system for overseeing the products people depend on throughout their lives. Better regulation can support universal health coverage, strengthen preparedness for health emergencies, encourage responsible local manufacturing and, most importantly, give patients greater confidence that the medical products reaching them meet accepted standards for quality, safety and effectiveness.