Drug Evaluation Committee Guidance for Efficient Preparation of Regulatory Documentation (CSR and CTD (Clinical Part)) in Response to Changes in the Environment
July 2025
More than 20 years have passed since the issuance of the ICH E3 (CSR) and ICH M4E (CTD) guidelines, and during this time, new ICH guidelines have been issued, digital technology has advanced, and the clinical trial environment has changed. In light of these changes, the ideal format for CSRs and CTDs is evolving.We identified a total of 100 issues regarding the content of the CSR and CTD (clinical section) and explored potential solutions. While many of these issues can be addressed through creative approaches during the drafting process, some require a cross-organizational response due to revisions to ICH guidelines or changes in domestic regulations.This report aims to streamline the preparation of CSRs and CTDs, and is intended to serve as a reference for proposals regarding revisions to ICH guidelines and discussions on domestic regulations. We hope it will be of use to CSRs and CTD authors involved in clinical trials and marketing authorization applications for pharmaceuticals.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
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