의약품 약물감시 실태조사 체계 다국가 비교를 통한 한국의 발전 방향 분석 = A Cross-National Comparison of Pharmacovigilance Inspection Systems for Korea’s Advancement

다국어 초록 (Multilingual Abstract)

The continuous expansion of the global pharmaceutical industry, driven by aging populations and the increasing prevalence of diseases, has underscored the need for robust pharmacovigilance (PV) systems.
While regulatory authorities such as the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Therapeutic Goods Administration (TGA), Pharmaceuticals and Medical Devices Agency (PMDA) have established structured post-marketing surveillance (PMS) and inspection programs, South Korea's PV framework remains less developed in terms of data integration and regulatory enforcement. This study conducts a comparative review of international PV inspection systems to identify gaps and propose improvements for South Korea. Official pharmacovigilance guidelines and regulatory reports from the United States, European Union, United Kingdom, Australia, and Japan were analyzed, focusing on differences in inspection methodologies, risk assessment strategies, and enforcement mechanisms. The findings reveal that the FDA adopts a risk-based approach to inspection target selection, leveraging the Food and Drug Administration Adverse Event Reporting System (FAERS) database for adverse event monitoring and enforcing compliance through Risk Evaluation and Mitigation Strategies (REMS) and Postmarketing Adverse Drug Experience (PADE) evaluations. The EMA mandates the submission of Pharmacovigilance System Master Files (PSMF) and Periodic Safety Update Reports (PSUR), while the MHRA, TGA, and PMDA conduct detailed pharmacovigilance inspections with stringent corrective and preventive action (CAPA) requirements. In contrast, South Korea's pharmacovigilance framework exhibits limited realtime data integration, relies primarily on individual case reports, and lacks strong regulatory enforcement mechanisms compared to international standards. To enhance drug safety and align with global pharmacovigilance standards, South Korea should implement a structured risk-based PMS approach, strengthen data integration, and establish clear regulatory enforcement protocols. Improving post-inspection corrective actions and enhancing transparency will be crucial in advancing Korea’s pharmacovigilance framework