Drug Evaluation Committee eCTD v4.0 Educational Material Version 2 is now available.
Electronic Standard for Medical Information Expert Committee
November 2024
Drug Evaluation Committee Electronic Standard for Medical Information Expert CommitteeTask Force 1 eSubmission (Promotion and Efficiency of Electronic Submission for Approval) prepared and published the " eCTD v4.0 Educational Material " in March 2023 to assist companies with internal education (awareness) and process review necessary for reference submission and submission for approval with eCTD v4. In March 2023, we prepared and published the "eCTD v4.0 Educational Materials" to assist in the internal education (awareness) and process review necessary for reference submissions and approval applications.
In FY2024, less than two years before the complete transition to eCTD v4 in April 2026, companies that produce eCTD in-house are expected to introduce the system, while companies that outsource the system are expected to consider specific methods. Based on these decisions, we have created the "eCTD v4.0 Educational Materials, Second Edition" to explain the features of v4. The purpose of this document has been changed from the previous version, and it is intended for use by those who lead the creation of eCTD at their companies and those who lead the implementation of v4 for their own staff in charge of the practical implementation.
The materials are available in both PowerPoint and PDF formats. The PowerPoint file may be adapted and used at your convenience, and the PDF file has been prepared to facilitate review of the content prepared as TF1.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee 2024 Task Force 1