Drug Evaluation Committee Announcement of the release of eCTD v4 Guidance for Preparing eCTD v4 Version 1.0
Electronic Standard for Medical Information Expert Committee
November 2025
Drug Evaluation Committee Electronic Standard for Medical Information Expert CommitteeTask Force 1 eSubmission (Promotion and Efficiency of Electronic Submission for Approval) 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 spread 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 to the public at Electronic Standard for Medical Information Expert Committeeso that it can be widely used by those who are involved in drug approval applications. We hope this document will be useful to you.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee Task Force 1