Earticle

초록

영어

The Development Safety Update Report(DSUR) is the periodic safety report on drugs under clinical trials( including marketed drugs that are under further study). The main objective of a DSUR is to present a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period. The guidelines of International Council of Harmonization(ICH) play a standard role in pharmaceutical industries among the ICH regions(including U.S., EU and Japan) and in the case of DSUR, ICH guidelines E2F(ICH E2F) works as a standard. Those countries above(U.S., EU and Japan) already establish DSUR systems based on ICH E2F and in South Korea, Ministry of Food and Drug Safety(MFDS) is planned to implement the DSUR and make the submission mandatory gradually from 2021 to 2024. So in this report, with the implementation of the DSUR ahead off, we first reviewed ICH E2F guideline and compared with the DSUR systems of U.S., EU and Japan, then we discuss current situation and implication in South Korea including specific plan, legislation and advantages it would offer.

목차

Abstract
서론
본론
1. ICH E2F(DSUR)
2. 미국의 DSUR 제도
3. 유럽의 DSUR 제도
4. 일본의 DSUR 제도
5. 국외 DSUR 실시 사례 비교
고찰 및 결론
References

키워드

저자

• 박순제 [ Sun-Je Park | 성균관대학교 약학대학 ]
• 심다영 [ Da-Young Shim | 성균관대학교 약학대학 ]
• 박상준 [ Sang-Jun Park | 성균관대학교 약학대학 ]
• 이하은 [ Ha-Eun Rhee | 성균관대학교 약학대학 ]
• 신주영 [ Ju-Young Shin | 성균관대학교 약학대학 ] Corresponding Author

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국보건사회약료경영학회지 [Journal of Korean Academy of Managed Care Pharmacy]

• 간기

  반년간

• pISSN

  2092-8394

• 수록기간

  2009~2022

• 십진분류

  KDC 518 DDC 615