2. Japanese Pharmaceutical Regulation's Paradigm Shift to Real-world Data Utilization in Pharmacovigilance-Reference-Cited by-同舟云学术

2. Japanese Pharmaceutical Regulation's Paradigm Shift to Real-world Data Utilization in Pharmacovigilance

Published:2019-03-31 Issue:1 Volume:24 Page:11-18
ISSN:1342-0445
Container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
language:en
Short-container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku

Author:

ISHIGURO Chieko¹,UYAMA Yoshiaki¹

Affiliation:

1. Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Japan

Publisher

Japanese Society for Pharmacoepidemiology

Subject

General Medicine

Link

https://www.jstage.jst.go.jp/article/jjpe/24/1/24_24.11/_pdf

Reference5 articles.

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2. 5) Ishiguro C, Takeuchi Y, Uyama Y, Tawaragi T. The MIHARI project：establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan. Pharmacoepidemiol Drug Saf. 2016；25：854-9.

3. 7) PMDA. MID-NET^® (Medical Information Database Network). ［https://www.pmda.go.jp/safety/mid-net/0001.html (accessed 2018-12-14)]

4. 8) Center for Innovation in Regulatory Science (CIRS). New drug approvals in six major authorities 2008-2017. R & D Briefing67. ［http://www.cirsci.org/wp-content/uploads/2018/05/CIRS-RD-Briefing-67-04052018_FINAL.pdf (accessed 2018-12-14)]

5. 11) Yamada T, Kusama M, Hirai Y, Arnold F, Sugiyama Y, Ono S. Analysis of pharmaceutical safety-related regulatory actions in Japan： do tradeoffs exist between safer drugs and launch delay? Ann Pharmacother 2010；44：1976-85.

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