Drug Evaluation Committee
A Study on the Handling of Safety Information during Clinical Trials in the Era of Internationalization of Drug Development
Study on Handling of Safety Information during Clinical Trials in the Era of Internationalization of Drug Development
Clinical Evaluation Subcommittee
June 2020
As the internationalization of drug development progresses further, the handling of safety information during clinical trials is an essential issue to consider for fostering an internationally competitive clinical trial environment, as well as issues such as improving the efficiency of the clinical trial process and enhancing case accumulation.
Task Force 5 in FY2018 and Task Force 4 in FY2019 of the Clinical Evaluation Subcommittee will discuss how clinical trial safety information should be handled in order to eliminate the gap between Japan and Europe and the United States regarding the handling of safety information and to further activate Japan's participation in international joint clinical trials without compromising the safety of the subjects participating in the trials. We have examined the ideal form of the handling of clinical trial safety information and summarized it in this report, focusing on the discussions and views of the companies participating in this task force. Our ideal situation cannot be achieved by the sponsor alone, but requires the cooperation of all stakeholders. This report is intended to serve as a catalyst for promoting collaboration among each stakeholder to solve the problem.
TF4_2019 Subcommittee Materials_20200601_Public Version (1.0MB)
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