일본 신약 재심사 제도의 개정 현황 및 시사점

• 영문명: Recent Reforms in Japan’s Drug Re-examination System and its Implications: Focusing on Using Real-World Data
• 발행기관: 한국보건사회약료경영학회
• 저자명: 김선하(Seon-Ha Kim) 김희진(Hee-Jin Kim) 최남경(Nam-Kyong Choi)
• 간행물 정보: 『한국보건사회약료경영학회지』제8권 제1호, 7~14쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2020.05.30

영문 초록

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.

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고찰 및 결론

키워드

drug re-examination system post-marketing study real world data Japan