Drug Evaluation Committee The Future of Clinical Research undergoing a Transformation 2015.
Clinical Evaluation Subcommittee
2015.
The Drug Evaluation Committee's Clinical Evaluation Subcommittee Special Project 2 in 2014 has been studying the establishment of a new regulatory system for all clinical trials, including clinical trials and clinical research, with reference to the systems in Europe, the United States, and the OECD, so that innovative new drugs can be provided to patients as soon as possible.
Hypertension since 2013 Based on the discussions in the Study Committee on Clinical Research Cases of Therapeutic Drugs and the accompanying Study Committee on the System for Clinical Research, we have prepared two papers proposing new regulations, issues in existing regulations, and a new clinical trial system to resolve these issues.
We hope that these papers will provide an opportunity to consider the ideal regulatory system for clinical trials in Japan.