Drug Evaluation Committee Guidance for Efficient Preparation of Pharmaceutical Documents (CSRs and CTDs (Clinical Parts)) in Response to Changes in the Environment
Data Science Expert Committee
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 for improvement. While most of the issues can be addressed through creative work, there are some issues that should be addressed across the organization due to the revision of 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 Drug Evaluation Committee
Data Science Subcommittee 2024 Task Force 2-2