Pharmaceutical Products Regulation and Policy in Africa: Developments and Perspectives

Abstract

This thesis provides a comprehensive analysis of pharmaceutical regulation in Africa, positioning it as both a public health safeguard and a critical determinant of industrial development, trade, and health system resilience. It demonstrates that fragmented, under-resourced, and legally misaligned regulatory systems challenge timely access to medicines and constrain local manufacturing, despite increasing global and continental momentum toward regulatory harmonisation and pharmaceutical sector development. Drawing on multi-method research, including stakeholder engagement, policy analysis, and empirical data, the study highlights regulatory fragmentation—manifested in duplicative regulatory processes, divergent requirements, and opaque processes—raises compliance costs and discourages market entry, particularly in smaller markets. The thesis further identifies misalignment between regional harmonisation initiatives and national legal frameworks as a critical challenge to achieving the goals of regulatory harmonisation. The research establishes a positive association between regulatory maturity and pharmaceutical trade flows, underscoring regulation as a foundational enabler of industrial growth. While regulatory outputs broadly align with disease burden, gaps remain, indicating the need for prioritisation mechanisms. Comparative analysis with Europe reveals that Africa’s harmonisation trajectory, though progressing, requires sustained political commitment, legal reform, and institutional strengthening. This thesis concludes that regulatory reform must be embedded within broader policy ecosystems linking public health and industrial policy. Strengthened regulatory systems—characterised by transparency, governance, and reliance models—are essential to achieving health sovereignty, improving access, and fostering a competitive pharmaceutical sector in Africa .