• Add this page to "Favorite pages"
  • Print Text
Here begins the text.

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 Comparative analysis of overlaps in clinical phenotypic profiles in ADR grobal database for pharmacovigilance Rika Wakao
 (Office of Reserch Promotion)
April 2017 - March 2020  
2 A study for analysis of adverse events and safety measure of implantable medical device April 2017~
Tomoko Kobayashi
 (Office of Medical Devices I)
Aug 2018~
Nobuhiro Handa
 (Office of Medical Devices III)
April 2017 - March 2019  
3 Importance of collaboration with academic societies for review of medical devices including proper use guidelines and academic standards for medical institutions and physicians Mami Ho

April 2018 - March 2019
4 The comparison of adverse event reports between pre-market and post-market phase in medical device approval Nobuhiro Handa
 (Office of Medical Devices III)
April 2018 - March 2020  
5 Analysis of the latest trend of drug-induced lung disease based on information in JADER April 2018~
Masashi Bando
Sep 2018~
Satoshi Sakaguchi
(Office of New Drug IV)
April 2018 - March 2019  
6 Evaluation of design, end points and results of clinical trials and medical reviews of cardiovascular drugs in Japan - potential differences in approvals of new drug applications in Japan and EU/US Kaori Shinagawa
April 2018 - March 2021  

(*)As of Oct 1st, 2018

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan


Copyright (C) Pharmaceuticals and Medical Devices Agency, All Rights Reserved.

Regulatory Science Research in PMDA