Drug Evaluation Committee Guidance for Efficient Preparation of Regulatory Documentation (CSR and CTD (Clinical Part)) in Response to Changes in the Environment
Data Science Subcommittee
July 2025
More than 20 years have passed since the ICH E3 (CSR) and ICH M4E (CTD) guidelines were issued. New ICH guidelines have been issued, digital technology has advanced, and the clinical trial environment has changed. We identified a total of 100 issues in CSRs and CTDs (clinical parts), and examined measures to improve them. While most of the issues can be addressed through creative work, there are some issues that should be addressed across organizations due to the revision of the ICH guidelines and changes in domestic regulations. This report aims to improve the efficiency of CSR and CTD preparation, as well as to be used as a reference material for proposals for revision of ICH guidelines and discussions on domestic regulations. We hope it will be of help to CSR and CTD authors involved in clinical trials and regulatory applications for pharmaceutical products.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee Task Force 2-2 for 2024
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