ABSTRACT:
Strong health systems rely on regulatory functions that ensure the efficacy, safety, quality, and appropriate use of medicines and vaccines. Pharmacovigilance is a core but often under-integrated component of health systems strengthening, which can result in a regulatory framework without the safety data it requires to ensure public trust. The Gates Foundation has supported regulatory systems strengthening across Africa for many years, with a focus on embedding pharmacovigilance within national and regional health architecture. This work has demonstrated, for the first time, the feasibility of pooling African safety data and conducting joint signal detection and assessment. Through customized digital infrastructure, including the ongoing development of a continental safety database, countries have been able to move beyond isolated reporting toward integrated, continental-level safety surveillance. In addition, joint signal management activities, led by African regulators and experts utilizing African data, have strengthened regulatory capacity, promoted harmonized decision-making, and reduced duplication across countries. These achievements provide practical evidence that pharmacovigilance can function as a shared continental public health asset rather than a collection of national silos. As the African Medicines Agency (AMA) assumes its role as the continental authority for pharmacovigilance, these capabilities are now being transitioned into a sustainable institutional framework. Aligning pooled data systems, harmonized procedures, and regulatory collaboration under AMA positions pharmacovigilance as a durable, critical component of health systems strengthening. The Gates Foundation’s experience underscores the importance of catalytic and partnership-driven investment to move from an innovative pilot to continent-wide public health infrastructure that supports better and more equitable patient safety.