Abstract
Recently, it is becoming increasingly difficult to develop innovative drugs. Thus, the role of regulatory science research in drug development and postmarketing settings has become more important. In this article, the authors discuss the roles of regulatory science research at the Pharmaceuticals and Medical Devices Agency (PMDA), which aims to improve public health in Japan.
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References
1.
Tominaga
T
Asahina
Y
Uyama
Y
Kondo
T
. Regulatory science as a bridge between science and society . Clin Pharmacol Ther . 2011 ;90 (1 ):29 –31 .
2.Pharmaceuticals and Medical Devices Agency . Profile of services 2011-2012 . Available at : http://www.pmda.go.jp/english/about/pdf/profile_of_services.pdf. Accessed August 20, 2012 .
3.
Mori
K
Toyoshima
S
. Recent approaches by the PMDA to promoting new drug development: change in the status of the PMDA in relation to new drug development over the last five years . Drug Inf J . 2009 ;43 (1 ):47 –55 .
4.Pharmaceuticals and Medical Devices Agency . Pharmacovigilance activities in Japan (presented by Hori A) . Available at : http://www.pmda.go.jp/regulatory/file/english_presentation/safety/S-E2hori.pdf. Accessed September 6, 2012 .
5.Pharmaceuticals and Medical Devices Agency . Relief service for adverse health effects in Japan (presented by Miyazaki S) . Available at : http://www.pmda.go.jp/regulatory/file/english_presentation/relief_funds/RF-E1miyazaki.pdf. Accessed September 6, 2012 .
6.Pharmaceuticals and Medical Devices Agency . The basic concept on regulatory science in PMDA . Available at : http://www.pmda.go.jp/english/publications/pdf/Basic_Concept_Reg_Sci.pdf. Accessed August 20, 2012 .
7.Pharmaceuticals and Medical Devices Agency . Regulatory science research in PMDA (in Japanese) . Available at : http://www.pmda.go.jp/regulatory/research.html. Accessed
August 20, 2012 .
8.Pharmaceuticals and Medical Devices Agency . Annual report FY 2010 . Available at : http://www.pmda.go.jp/english/about/pdf/2010/annual_report_FY2010.pdf. Accessed August 20, 2012 .
9.Ministry of Health, Labour and Welfare . Project for MHLW/PMDA/NIHS/academia collaborative study (in Japanese) . Available at : http://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/kakushin/. Accessed August 20, 2012 .