ABSTRACT:
Decolonizing public health requires shifting from externally driven models toward systems that are governed, owned, and sustained by the regions they serve. In pharmacovigilance in Africa, drug and vaccine safety assessments have historically relied on analyses conducted outside Africa, despite widespread use of medicines and vaccines across the continent. This has limited the relevance of safety decisions and constrained equitable participation in global health governance. From the Gates Foundation’s perspective, supporting decolonization in pharmacovigilance has meant investing in African-led institutions, data infrastructure, and regulatory expertise. A major milestone in this work has been the successful delivery of a groundbreaking pilot – African Union Smart Safety Surveillance’ or ‘AU-3S’1, to aggregate safety data across multiple African countries, enabling joint signal detection and assessment to be conducted by African regulators and technical experts. The parallel development of ‘AfriVigilance’, a customized continental safety database designed for African contexts, represents a huge shift toward sustainable data sovereignty and regionally governed evidence generation. These efforts now converge with the establishment of the African Medicines Agency (AMA), which offers a continental framework to institutionalize African ownership of medicine and vaccine safety monitoring. By anchoring pooled data systems and joint decision-making within AMA, pharmacovigilance moves from fragmented, donor-supported activities to a core public health function embedded in African governance structures. This enables transparent, context-relevant regulatory action and reduces reliance on external analyses. The experience demonstrates decolonization in action: it is achieved through investments in data systems, expertise, and institutions that allow African actors to define safety questions and responses. Strengthening AMA-led pharmacovigilance enhances public trust, supports equitable access to innovation, and positions Africa as an active contributor to global drug and vaccine safety.