Drug Evaluation Committee eCTD v4.0 Educational Material
Electronic Information Subcommittee
March 2023
In addition to the current eCTD specification (v3.2.2), the new specification (v4.0) will be accepted from April 1, 2022. eCTD v4.0 is designed to assist companies to gain experience before the end of the transitional measures period in March 2026, and to provide the necessary in-house education and process review for companies to submit reference and approval applications under the new specification. This educational material has been prepared to assist companies in education (dissemination) and process review necessary for reference submissions and approval applications to the new specifications.
The materials are available as a PowerPoint file so that you can use the "Slide Show by Purpose" function of PowerPoint, select the necessary content, or edit the file according to your company's situation. We hope that this material will help in the transition to the new eCTD specification (v4.0). Please note that the PowerPoint font may appear incorrectly (symbol: □→▲) depending on the viewing environment.
The following changes were made on April 11, 2023. Please use the file after making the changes.
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As of December 2023Corrected an error in the description on p. 38.
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As of December 2023Published additional material in PDF format to ensure correct display regardless of environment.
Issued March 2023
Revised April 2023
Deliverables of the Drug Evaluation Committee Return to list of all deliverables