Abstract
Background Many African countries have established national pharmacovigilance (PV) centers under their medicines regulatory authorities, but multiple barriers still limit system performance. Comprehensive, well-enforced PV regulations are often lacking, and the reporting culture among healthcare professionals and patients remains weak due to limited awareness, heavy workloads, and fear of legal consequences. The limited uptake of digital tools also leads to continued reliance on paper-based reporting, undermining data management and analysis. This manuscript summarizes an Africa–Europe roundtable where regulators discussed experiences, challenges, and priorities for strengthening PV systems. Methods The Center for Medical Ethics at the University of Oslo, in collaboration with Gispen4Regulatory Science, organized an in-person, two-day Europe-Africa roundtable discussion on June 5-6, 2025, focusing on global reflections on PV. This manuscript synthesizes discussions from a high-level Africa-Europe drug regulators, researchers and policy experts on the development and integration of PV. The roundtable brought together 30 experts for a cross-regional dialogue on drug regulation. This exchange illuminated common goals and significant asymmetries in infrastructure, capacity, and policy implementation across regions. Results The event fostered critical discussions on real-world safety monitoring, regulatory practices, and differences in health systems through short, problem-focused presentations based on active research and field practice. The roundtable discussion revealed disparities in technological and infrastructural capacity, human-resource challenges and sustainability, funding stability, community and patient engagement, and the utilization of data. It also highlighted gaps in regional harmonization, and institutional models. The study also emphasized shared values, the development of mechanisms for mutual learning and coordinated approaches. Conclusion Drawing on shared experiences, participants formulated a series of actionable recommendations aimed at fostering sustainable, collaborative, and technology- supported PV systems in Africa. The insights inform future strategies for harmonization and mutual learning within global drug safety governance.