<b>Comparative Analysis of Safety Concerns and Pharmacovigilance Activities in Japan and Europe </b>-Reference-Cited by-同舟云学术

Comparative Analysis of Safety Concerns and Pharmacovigilance Activities in Japan and Europe

Published:2018 Issue:1 Volume:49 Page:23-34
ISSN:0388-1601
Container-title:Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
language:en
Short-container-title:Jpn. J. Clin. Pharmacol. Ther.

Author:

IWASAKI Mami¹²,KANEKO Masayuki¹,NARUKAWA Mamoru¹

Affiliation:

1. Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato University Graduate School of Pharmaceutical Sciences

2. Pharmaceuticals and Medical Devices Agency

Publisher

Japanese Society of Clinical Pharmacology and Therapeutics

Subject

Pharmacology (medical),Pharmacology

Link

https://www.jstage.jst.go.jp/article/jscpt/49/1/49_23/_pdf

Reference12 articles.

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2. 2) Tsuji K, Tsutani K. Approval of new biopharmaceuticals 1999-2006 : comparison of the US, EU and Japan situations. Eur J Pharm Biopharm. 2008; 68 (3) : 496-502. doi: 10.1016/j.ejpb.2007.07.013.

3. 4) 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 (12) : 1976-85. doi: 10.1345/aph.1P153.

4. 5) European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) . Module V - risk management systems. London : EMA; 2014.［http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf (accessed 2016-5-12) ]

5. 6) Bahri P, Tsintis P. Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH) . Pharmacoepidemiol Drug Saf. 2005; 14 (6) : 377-87. doi: 10.1002/pds.1043.

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