An Analytical Study on Global Pharmacovigilance Regulations and their Role in Risk Management

Abstract

This analytical study examines how global pharmacovigilance (PV) regulations operationalize risk management across the product lifecycle and proposes practical tools and a convergence roadmap for regulators and Marketing Authorization Holders (MAHs). Context & Rationale. Post-marketing risks evolve as exposure broadens, indications expand, and real-world heterogeneity reveals safety issues not seen in trials. Since the thalidomide crisis, PV has been shaped by ICH E2 guidelines, EU GVP, and large safety databases (VigiBase, EudraVigilance, FAERS). Harmonization has delivered interoperability (E2B[R3]), common terminology (MedDRA), and lifecycle integration, yet meaningful divergence persists in governance (QPPV/PSMF), expedited reporting clocks, signal methods, and risk-minimization frameworks (US REMS vs EU RMP). Problem. Despite common references (ICH, MedDRA), MAHs face variable expectations across expedited reporting, periodic reports (DSUR/PBRER), PASS, RMMs, device vigilance, and emerging areas (RWE, AI, patient-generated data), creating duplication, cost, and uncertainty. Objectives & Methods. The study (i) compares PV/device frameworks across EU, US, UK, Japan, Canada, India; (ii) maps how regulations operationalize risk management (RMP/REMS, PASS, governance); (iii) develops a 12-domain capability maturity model and heatmap; (iv) builds transferable tools (DSUR↔PBRER crosswalk, model RMP checklist, compliance scorecards, SDEA outline); (v) analyzes five case studies; and (vi) derives a 12–24 month convergence roadmap. Methods blend doctrinal analysis, structured maturity scoring, and case-based synthesis with defined scoring criteria and inter-rater checks.