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 (Affiliation)(*) |
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 I) |
April 2017 - March 2020 | |
| 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 (Specialist) |
April 2018 - March 2020 |
|
| 4 | The comparison of adverse event reports between pre-market and post-market phase in medical device approval | Nobuhiro Handa (Office of Medical Devices I) |
April 2018 - March 2020 | |
| 5 | 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 (Specialist) |
April 2018 - March 2021 | |
| 6 | Research on the current status of drug development utilizing quantitative Modeling & Simulation approaches in Japan | Shinichi Kijima (Office of Advanced Evaluation with Electronic Data) |
April 2019 - March 2021 | |
| 7 | Evaluation of the medical review of new drugs approved in Japan prior to foreign approval | Mototsugu Tanaka (Office of New Drug I) |
April 2019 - March 2021 |
(*)As of Apr 1st, 2019