Sarcouncil Journal of Biomedical Sciences

Abstract: Multinational drug development and manufacture take place within a pharmacovigilance environment characterised by global safety standards, regional regulatory frameworks, and national legal requirements. The challenge is not merely compliance with distinct rules, but the development of an operating model which can transform diverse local rules into an integrated global safety system while maintaining local accountability. This review evaluates peer-reviewed articles published since 2015 regarding pharmacovigilance system capacity, adverse drug reaction (ADR) reporting, patient and healthcare professional reporting systems, spontaneous reporting databases, electronic monitoring, signal detection, risk mitigation, automation and product traceability. The article highlights ongoing global-local challenges in case intake, quality of individual case safety reports, regulatory reporting timelines, oversight of affiliate operations, risk communication, and local implementation of global signal decisions. The studies report varied local pharmacovigilance readiness, reporting practices, data quality and technological capability. This review concludes that multinational pharmacovigilance needs a nested governance approach incorporating global standardisation, local regulatory awareness, integrated data technology and evidence-based quality assurance. Comparative assessment of affiliate operations, global-local control and transparent evidence of digital automation across regulatory networks remain major evidence gaps.