Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan-Reference-Cited by-同舟云学术

Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan

Published:2017-03-15 Issue:6 Volume:40 Page:475-482
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Inokuma Yasuko

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Link

http://link.springer.com/content/pdf/10.1007/s40264-017-0517-2.pdf

Reference34 articles.

1. Pharmaceutical Affairs Law. Law No. 145 of 10 August; 1960 (in Japanese).

2. The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Law No. 145 of 10 August, 1960), Final Revision: Law No. 50 of 26 June; 2015 (in Japanese).

3. US Food and Drug Administration. Human cells, tissues, and cellular and tissue-based products, 21CFR1271; 2012. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271&showFR=1 . Accessed 14 Dec 2016.

4. Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004.

5. Noriko M. Yakujieisei no rekishiteki hensen to yakugaku kyoiku (in Japanese). Nihon Ishigaku Zasshi. 2008;54(3):305–6.

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