Drug Evaluation Committee February 5, 2025 Single IRB Workshop
May 16, 2025
With limited human resources available for clinical trials in Japan, it is an urgent issue to improve the clinical trial environment in Japan, taking into consideration the reduction of the burden on those involved in clinical trials.
The Japan Pharmaceutical Manufacturers Association, the U.S. Association of Research Pharmaceutical Manufacturers, and the European Federation of Pharmaceutical Manufacturers and Associations have co-organized a workshop on the implementation of Single IRB in Japan.
At the workshop, healthcare organizations, government authorities, and industry associations will exchange their views on the implementation of Single IRB, and discuss the direction in which it should be taken.
Date: Wednesday, February 5, 2025, 17:30-19:00 *Event has ended.
Presentation Materials
- 1: Program and participation
- 2: Purpose of this meeting
- 3: Why the transition to Single IRB?
- 4: Research Ethics Review: Recovering from the Delay in Streamlining
- 5: R&D Head Club's Concept of Single IRB Model
- 6: Concerns and responses to the implementation of Single IRB
- 7: Information sharing from PMDA
Results of the Survey on the Status of IRB Examinations in Each Country
We conducted a survey with the cooperation of companies that are members of the Clinical Section of the Technical Committee of the European Federation of Pharmaceutical Manufacturers and Associations, the Clinical Section of the American Association of Research Pharmaceutical Manufacturers and Associations, and the Drug Evaluation Committee of the Japan Manufacturers Association to understand the current situation in Japan and overseas in order to set numerical targets for the diffusion of batch review, or Single IRB, in Japan. The results of the survey are presented below.