Comparative Evaluation of Pharmacovigilance Regulatory Requirements in India, USA and European Union

Abstract

Pharmacovigilance is an essential scientific and regulatory discipline concerned with the detection, assessment, understanding and prevention of adverse drug reactions and other medicine-related problems throughout the life cycle of medicinal products. As pre-marketing clinical trials involve limited and selected populations, important safety concerns may emerge only after widespread post-marketing use, making continuous safety surveillance essential for public health. This study comparatively evaluates pharmacovigilance regulatory requirements in India, the United States of America and the European Union, focusing on adverse drug reaction reporting, individual case safety reports, pharmacovigilance databases, signal detection and management, risk management, periodic safety reporting, post-marketing surveillance and system oversight. A comparative, descriptive regulatory-review methodology was adopted using publications from WHO, ICH, CDSCO, IPC, PvPI, FDA, EMA and peer-reviewed literature. The findings demonstrate substantial convergence among the three regions in fundamental pharmacovigilance objectives, including adverse-event reporting, ICSR management, signal detection and post-marketing safety actions. However, important differences exist in regulatory structure, documentation and system oversight. The USA operates a mature centralized system based on FDA and FAERS, supported by REMS. The EU follows a structured network-based framework involving Eudra Vigilance, GVP, QPPV, PSMF, RMP, PSUR and PASS. India, through PvPI, IPC and ADR Monitoring Centres, continues to strengthen its pharmacovigilance infrastructure. The study concludes that strengthening reporting culture, data integration, signal detection and regulatory documentation in India, supported by international harmonisation and emerging digital technologies, can further enhance medicine-safety monitoring.