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Regulatory Science Research in PMDA

In order to conduct regulatory science research with accuracy, fairness, and transparency, the basic research policy of the PMDA was published in August 2011.
Under this policy, the Regulatory Science Research Steering Committee discusses the agency's designated resarch projects.

  Designated resarch proposed by PMDA staff.

NO. Title Main Researcher
Duration Publication
1 Factor analyses of efficacy data from neuropsychiatric disorder trials in support of new drug applications submitted to the Pharmaceuticals and Medical Devices Agency Tetsuo Nakabayashi
June 2012 - March 2018  
2 Evaluation of the effects of ethnic factors on the efficacy and safety of the drug based on global clinical trial data. Yuki Ando
August 2012 - March 2018  
3 Standerdization of medical device registry Nobuhiro Handa
(Office of Medical Devices III)
April 2014 - March 2018  
4 Proposal for Repositoning of Japanese Pharmacopoeia based on the comparative research of USP and Ph. Eur. Tsuyoshi Ando
(Office of Standards and Guidelines Development)
April 2016 - March 2018  
5 Comparative analysis of overlaps in clinical phenotypic profiles in ADR grobal database for pharmacovigilance Rika Wakao
(Office of Regulatory Science)
April 2017 - March 2020  
6 A study for analysis of adverse events and safety measure of implantable
 medical device
Tomoko Kobayashi
(Office of Medical Devices I)
April 2017 - March 2019  
7 The study about the problems of phase I trials for antineoplastic dugs in Japan: consideration of the transition and present condition Tomoyasu Mimori
(Office of New Drug V)
April 2017 - March 2018  
8 Comparison of Phase III clinical trials with a predictive biomarker for personalized medicine in Oncology Takahiro Nonaka
(Office of New Drug V)
April 2017 - March 2018  

(*)As of April 1st, 2017

JCN 3010005007409

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Regulatory Science Research in PMDA