Analysis of Safety-Related Regulatory Actions for New Drugs in Japan by Nature of Identified Risks-Reference-Cited by-同舟云学术

Analysis of Safety-Related Regulatory Actions for New Drugs in Japan by Nature of Identified Risks

Published:2017-07-13 Issue:5 Volume:31 Page:317-327
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Fujikawa Makoto,Ono Shunsuke

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

http://link.springer.com/article/10.1007/s40290-017-0198-2/fulltext.html

Reference19 articles.

1. Mol PG, Arnardottir AH, Motola D, et al. Post-approval safety issues with innovative drug: a European cohort study. Drug Saf. 2013;36:1105–15.

2. Schultz WB. Bolstering the FDA’s drug-safety authority. NEJM. 2007;357(22):2217–9.

3. FDA. Breakthrough therapy designation. http://www.fda.gov/forpatients/approvals/fast/ucm405397.htm . Accessed 1 May 2017.

4. EMA. PRIME: priority medicines. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000660.jsp&mid=WC0b01ac05809f8439 . Accessed 1 May 2017.

5. MHLW. Strategy of SAKIGAKE. http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/140729-01.html . Accessed 1 May 2017.

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