의약품 해외제조소 실사 대상 선정 현황:국제기준 및 미국, 유럽, 한국 중심으로

초록

The expanding globalization of pharmaceutical manufacturing necessitates rigorous quality oversight for imported drugs. As comprehensive inspections of all overseas sites are resource-prohibitive, implementing a strategic risk-based approach is imperative. This study aims to analyze and compare inspection target selection models and derive policy implications for the Ministry of Food and Drug Safety (MFDS) in Korea by analyzing international standards, including the International Council for Harmonisation (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). We compared the risk assessment algorithms and data management systems of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) with the status of the MFDS. The findings indicate that unlike the FDA and EMA, which utilize dynamic models and integrated platforms such as the Site-Selection Model (SSM) and EudraGMDP (European Union Drug Regulating Authorities – Good Manufacturing and Distribution Practices) to reflect intrinsic product risks and real-time compliance history, the MFDS does not publicly disclose a quantitative scoring algorithm or weighting scheme, and its inspection-related data remain in fragmented systems. Consequently, this study suggests policy considerations for improving the current system. Furthermore, we suggest establishing an integrated data platform and a dedicated department to enhance inspection efficiency. These measures are expected to strengthen the scientific validity and regulatory rigor of drug safety management in Korea.

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