Charting a new course: Recommendations for strategic priorities for the African Medicines Agency

This article examines the strategic landscape facing the inaugural leadership of the African Medicines Agency. It outlines the core challenges constraining Africa's pharmaceutical sector: fragmented regulatory frameworks, inadequate clinical trial regulation, limited capacity for drug development (notably for neglected and emerging diseases) and slow access to novel medicines. Drawing upon the history of regulatory harmonisation in Africa, international best practices, and current continental initiatives, the article proposes a comprehensive agenda for leadership and operational priorities designed to strengthen regulatory performance, support domestic manufacturing, ensure ethical and efficient trial oversight, and broaden access to innovation. The conclusion calls for multisectoral collaboration, innovative financing and sustained political commitment to realise the vision of Agenda 2063 and universal access to quality medical products in Africa.