Drug Evaluation Committee Structure of CTD using results of global clinical trials based on the principles of ICH E17
Data Science Subcommittee
August 2023
The ICH E17 Guideline on General Principles for the Planning and Design of Multinational Clinical Trials was agreed to by ICH Step 4 in 2017, and in 2018, the Pharmaceutical and Food Safety Agency of Japan (PSEJ) issued the Pharmaceutical Affairs Agency of Japan (PSEJ) Step 5, No. 0928010. Currently, many multinational clinical trials (MRCTs) are being conducted, and based on the results, many pharmaceutical products have obtained marketing authorization. However, few CTDs are based on the principles of ICH E17, and most of them are based on the principles of ICH E5, focusing first on the results of the country/region of application and then evaluating the similarity to other regions or to the study as a whole.
This report aims to deepen understanding of multilateral and systematic evaluation methods based on the principles of ICH E17, and proposes how to evaluate MRCT results and how to summarize them in the CTD using the 3₋Layer Approach frameworkNote proposed by Dr. Komiyama and others.
We hope that this report will help to disseminate the interpretation of MRCT results and the preparation of CTDs based on the principles of ICH E17.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee 2022 Task Force 2-2 E17 Subteam
Note: Komiyama O, Hiro S, Isogawa N, et al. (2013) Evaluation of Data for Multi-Regional Trials: A Three-Layer Approach. Applied clinical trials, vol 22, Issue 11.
-
As of December 2023
Deliverables of the Drug Evaluation Committee Return to list of all deliverables