미국, 일본, 유럽의 의약품 생애주기 데이터 구축 및 활용 현황 = Development and Utilization of Drug Lifecycle Data in the United States, Japan, and Europe

다국어 초록 (Multilingual Abstract)

Objectives: With the growing interest in big data, regulatory agencies in United States, Japan, and Europe are showing active movements to use RWD and RWE to manage drug safety and development activation. Along with the global movements, it is necessary to establish a basic system for utilizing RWD based drug lifecycle data for drug safety management in Korea. The purpose of this study is to review and find implication of the collection and utilization of drug lifecycle data in the U.S., Japan, and Europe. Methods: In order to investigate the current status and contents of each country’s system, we searched the websites of each country’s regulatory agency and related agencies, and collected and investigated related laws, papers, and reports. We compared and analyzed focusing on solving regulatory problems that may occur in the drug lifecycle or exploring the safety and potential effects of drugs in drug lifecycle phases. Results: Based on FDA Sentinel 5-year plan and MID-NET, the U.S. and Japan are accelerating the generation of real data and real evidence for regulatory decision-making in post-marketing safety management. In Europe, various clinical field-specific projects have been undertaken to assess the effectiveness and safety of drugs due to disease. Various research cases using drug lifecycle data collected from drug safety management systems in each country have been represented. Conclusions: By identifying drug safety management systems and cases of drug lifecycle data utilization in various countries, we expect to serve as a stepping stone for discussions on the direction and utilization plan to efficiently develop drug safety management systems in Korea.