Health Ministers from across the World Health Organisation (WHO) African Region have formally adopted a new 10-year strategy designed to strengthen the regulation of medical products across the continent.
The Regional Strategy on Regulation of Medical Products in the African Region (2026–2035) establishes a comprehensive roadmap to enhance oversight, boost local pharmaceutical manufacturing, and prepare for future public health emergencies. The initiative seeks to ensure that medicines, vaccines, diagnostics, and medical devices meet internationally accepted standards of safety, quality, and efficacy.
Progress across the continent has advanced over the past decade, with national regulatory authorities meeting WHO Maturity Level 3, the benchmark for stable, well-functioning regulatory frameworks, rising from one in 2018 to eight in 2025. The new strategy aims to expand that number significantly while accelerating joint product assessments, shared facility inspections, and reliance on regulatory decisions made by trusted bodies across member states.
WHO Regional Director for Africa, Dr Mohamed Yakub Janabi, highlighted the strategic importance of uniform regulatory frameworks for continental health security and local production.
“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,” Janabi stated. “This strategy reflects our collective commitment to ensuring that everyone in Africa can benefit from medical products they can trust.”
The adoption of the strategy also reinforces operational support for the African Medicines Agency and the African Medicines Regulatory Harmonisation initiative, promoting digital regulatory infrastructure and joint oversight mechanisms.
–ChannelAfrica/WHO–
