The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safe-Reference-Cited by-同舟云学术

The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safe

Published:2018-09-25 Issue:11 Volume:27 Page:1265-1276
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Watanabe Ko¹^ORCID,Murakami Masayasu²,Masuyama Koichi³,Ishiguro Chieko⁴^ORCID,Matsuda Tsutomu³⁵

Affiliation:

1. Department of Pharmaceutical and Medical Device Regulatory Science, Graduate School of Medical Science; Yamagata University; Yamagata Japan

2. Department of Health Policy Science, Graduate School of Medical Science; Yamagata University; Yamagata Japan

3. Faculty of Pharmaceutical Sciences; Tokyo University of Pharmacy and Life Sciences; Tokyo Japan

4. Division of Epidemiology; Office of Medical informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency; Tokyo Japan

5. Kowa Co., Ltd.; Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.4662/fullpdf

Reference19 articles.

1. ICH harmonised tripartite guideline pharmacovigilance planning E2E http://www.pmda.go.jp/files/000156732.pdf

2. Ministry of Health, Labour and Welfare Guide for pharmaceutical risk management planning https://www.pmda.go.jp/files/000143712.pdf

3. Post-approval appending of CSARs to drug package inserts: an analysis of the types of reactions and time to addition;Tamura;Pharmacoepidemiol Drug Saf,2015

4. Pharmaceuticals and medical devices agency information search for ethical drugs http://www.pmda.go.jp/PmdaSearch/iyakuSearch/

5. Pharmaceuticals and medical devices agency drug safety update http://www.pmda.go.jp/safety/info-services/drugs/calling-attention/dsu/0001.html

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1. Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post‐approval in Japan;Pharmacology Research & Perspectives;2023-06-26

2. Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks;Expert Opinion on Drug Safety;2021-07-15