Drug Evaluation Committee The "Clinical Trial Ecosystem Industry Declaration 2025" Implementation Industry Workshop
May 07, 2026
In order to implement the "Clinical Trial Ecosystem Industry Declaration 2025" issued by the JPMA, PhRMA, EFPIA, and the Federation of Japanese CRO Associations last October, the "Clinical Trial Ecosystem Industry Declaration 2025" Implementation Industry Workshop will be held on April 1 and April 21, 2026. The workshop was held on April 1 and 21, 2026, with the aim of implementing the " Clinical Trials Ecosystem Industry Declaration 2025" as an industry-wide effort. In addition to the four organizations, the workshop was attended by a total of 180 participants from PMDA's Reliability Assurance Department, medical institutions participating in the Clinical Trial Ecosystem Promotion Project, and the Japan QA Society, who exchanged opinions on the implementation of the "Clinical Trial Ecosystem Industry Declaration 2025.
In particular, this workshop reexamined clinical trial practices that have been considered unique to Japan, using Critical to Quality (CTQ) as a common language, and held a frank dialogue among participants from different perspectives on what is reasonable and acceptable operation based on the ICH E6(R3) concept. The workshop was a great opportunity for the participants to discuss the issues and suggestions that emerged from the workshop.
The suggestions and issues raised in this workshop will be utilized in the future activities of each organization and their efforts for smooth implementation of the revised ICH-GCP (E6(R3)).
