Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency

Author:

Ishiguro Chieko1ORCID,Misu Takashi1,Iwasa Eiko1,Izawa Tadashi1

Affiliation:

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

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference14 articles.

1. Analysis of pharmaceutical safety-related regulatory actions in Japan: do tradeoffs exist between safer drugs and launch delay?;Yamada;Ann Pharmacother,2010

2. Evaluation of FDA safety-related drug label changes in 2010;Lester;Pharmacoepidemiol Drug Saf,2013

3. A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009;Mol;Drug Saf,2010

4. PMDA Annual Report 2014. PMDA, Tokyo 2015 http://www.pmda.go.jp/files/000206931.pdf

5. PMDA Annual Report 2012. PMDA, Tokyo 2013 https://www.pmda.go.jp/files/000156512.pdf

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