Drug Evaluation Committee eCTD v4.0 Educational Materials
Electronic Standard for Medical Information Expert Committee
March 2023
In addition to the current eCTD specification (v3.2.2), the new specification (v4.0) will be accepted from April 1, 2022. 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 be aware 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.
- *Corrected an error in the description on p. 38.
- *Published additional material in PDF format to ensure correct display regardless of environment.
Issued March 2023
Revised April 2023