Drug Evaluation Committee Notice of Release of eCTD v4 Preparation Guide Version 1.0
Electronic Information Subcommittee
November 2025
Task Force 1 eSubmission (Promotion and Efficiency of Electronic Submission of Applications for Approval) of the Drug Evaluation Committee's Electronic Information Subcommittee is conducting various activities to contribute to the smooth transition from v3.2.2 to v4.0 of the eCTD format in Japan and the widespread use of eCTD applications.
In 2023, we published " eCTD v4.0Educational Materials " to contribute to the preparation of companies that will introduce eCTD v4.0, and in 2024, we published " eCTD v4.0 Educational Materials Version 2 " to be used for eCTD v4.0 education for those in charge of eCTD preparation. The year 2025 will see the release of v4.0.
In 2025, we carefully selected the important information related to the preparation of eCTD v4.0 and published the "eCTD v4 Preparation Guide Version 1.0" in a reduced volume so that those in charge of eCTD preparation can refer to it as needed. Following the previous educational material, we are releasing this document as an eCTD Information Subcommittee document so that it can be widely used by those who are involved in the application for drug approval. We hope that this document will be useful to you.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
eCTD Subcommittee Task Force 1
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