일본 신약 재심사 제도의 개정 현황 및 시사점 : 리얼월드데이터(Real-World Data)의 활용을 중심으로

The drug re-examination system that is being used in Korea and Japan is aimed to reconfirm the effectiveness and safety of drugs at the end of the predetermined period after approval. As clinical trials before marketing are difficult to find all potential risks, the post-marketing study is necessary. The Drug Use-Results Survey (DURS) is aimed at patients who prescribed the drugs to collect the effectiveness and safety information of the drugs. However, the survey continued to raise the limitation that there was no comparison group. Recently, Real-World Data (RWD) is being used for post-marketing surveillance worldwide. Japan revised the drug re-examination system to include database study using RWD and postmarketing observational study with primary data collection in the comparative cohort study in 2017. This paper addresses the background and contents of revised Japan's re-examination system and the implications of this change for the post-marketing study in Korea.