Drug Evaluation Committee Basic Policy on Safety Forms for Clinical Trials
February 2023
With E19 having reached Step 4, it is anticipated that awareness of the importance of safety profile evaluation will continue to grow. Therefore, this report proposes a basic framework—from the planning of analyses to the reporting of results—by examining the standard safety information to be included in safety reports for the systematic evaluation of safety profiles.
Published February 2023
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee, DS Subcommittee
FY2017 Continuing Task Force 4 / FY2022 Continuing Task Force 9