A Roadmap for Strengthening and Diversifying Regulatory Pathways in Africa

Access to safe, effective, and quality-assured health technologies in low- and middle-income countries (LMICs) has historically depended on the World Health Organization’s Prequalification Programme (WHO PQ), a centralized mechanism designed to support global procurement efforts. While WHO PQ has played a critical role in expanding access, it is increasingly misaligned with current priorities, including regional manufacturing, supply chain resilience, and the growing regulatory capacity of LMICs. The March 2025 draft revision of WHO PQ marks the most significant update in two decades, signaling a shift toward reliance, yet leaving key operational gaps unresolved. This paper examines the limitations of the existing regulatory framework—including its narrow scope, delayed timelines, and lack of automatic in-country approval—and assesses the extent to which newer global and regional efforts, such as the WHO Global Benchmarking Tool, WHO Listed Authorities (WLAs), and African regulatory harmonization initiatives, address these gaps. Drawing on recent developments in Africa and beyond, the paper proposes a three-part reform agenda: modernizing WHO PQ into a rapid, reliance-based validator; diversifying regional and national pathways through twinning, WLA designation, and mutual recognition; and aligning downstream enablers such as procurement rules, transparency standards, and legal frameworks. These reforms are essential for creating a more inclusive, efficient, and regionally grounded regulatory system that supports timely access to essential health products and aligns with the realities of LMICs today.