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Health ministers across the WHO African Region have endorsed a new Regional Strategy on Regulation of Medical Products in Africa (2026–2035) aimed at strengthening regulatory systems and improving access to safe, effective and quality-assured health products across the continent.

The 10-year strategy comes as African countries seek to expand access to essential medicines and health technologies, increase local pharmaceutical manufacturing and strengthen preparedness for public health emergencies.

Effective regulation will be increasingly important as African countries seek to develop domestic pharmaceutical industries and reduce dependence on imported health products. Strong regulatory authorities are critical for ensuring that medicines, vaccines, diagnostics, blood products and medical devices entering the market meet required standards for quality, safety and efficacy.

Africa makes progress in regulatory capacity

Africa has made progress in strengthening pharmaceutical regulation over the past decade, including through initiatives aimed at harmonising regulatory processes across countries.

The African Medicines Agency (AMA) is now operational, providing a continental platform for greater regulatory cooperation, while the number of African national regulatory authorities achieving WHO Maturity Level 3 increased from just one in 2018 to eight in 2025.

WHO Maturity Level 3 represents an internationally recognised benchmark for a stable and well-functioning regulatory system.

Despite this progress, significant regulatory capacity gaps remain across the continent, with many countries still working to strengthen their national regulatory authorities.

Digitalisation and regulatory harmonisation

The new strategy establishes a roadmap for strengthening regulatory systems over the next decade. Among its priorities is increasing the number of regulatory authorities reaching WHO Maturity Level 3 and supporting regulatory agencies to achieve internationally recognised performance standards.

The strategy also places greater emphasis on digital regulatory systems, which could help regulators improve efficiency, information management and oversight of increasingly complex pharmaceutical markets.

Another key component is greater regulatory collaboration. African countries are encouraged to expand the use of joint product assessments, shared inspections and regulatory reliance, allowing authorities to leverage assessments and decisions made by trusted regulatory agencies.

These approaches could reduce duplication, make better use of limited regulatory resources and potentially shorten the time required to bring quality-assured medical products to patients.

Implications for Africa's pharmaceutical industry

The strategy comes at an important juncture for Africa's pharmaceutical sector.

Countries across the continent are increasingly pursuing policies aimed at expanding local pharmaceutical manufacturing, regional procurement and health-product security. However, manufacturing capacity alone will not be sufficient. Manufacturers need predictable and credible regulatory systems to register products, demonstrate compliance with quality standards and access multiple African markets.

Greater regulatory harmonisation could therefore help reduce some of the barriers faced by pharmaceutical companies operating across fragmented national markets.

For African manufacturers, stronger regulatory systems could improve confidence in locally produced medicines while creating a more predictable environment for investment. For multinational companies, increased reliance and harmonisation could potentially make market access across several African countries more efficient.

The strategy also reinforces the growing role of the African Medicines Agency in building a more coordinated regulatory environment for the continent.

A critical decade for pharmaceutical regulation

WHO Regional Director for Africa Dr Mohamed Yakub Janabi said strong regulatory systems are essential for protecting lives, building confidence in health systems and creating a foundation for local innovation and manufacturing.

The strategy will now need to move from policy commitment to implementation at national and regional levels.

Its success will depend on sustained investment in regulatory authorities, development of skilled regulatory professionals, digital infrastructure, effective cooperation between national agencies and continued support for the African Medicines Agency.

For Africa's pharmaceutical industry, the direction is significant: regulatory capacity is becoming an increasingly important component of the continent's pharmaceutical manufacturing and market-development agenda.

Over the next decade, the ability of African countries to build stronger, more harmonised regulatory systems could determine how quickly the continent can expand local production, facilitate regional pharmaceutical trade and improve access to quality-assured medicines and health technologies.

Source: WHO Regional Office for Africa

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