Drug Evaluation Committee Notice of Publication of Presentation Material for eCTD v4 Implementation Promotion Symposium (Web-based on November 28, 2025)
Electronic Standard for Medical Information Expert Committee
December 2025
Drug Evaluation Committee Electronic Standard for Medical Information Expert CommitteeTask Force 1 eSubmission (Promotion of Electronic Filing of Applications for Approval and Streamlining) has prepared the "eCTD Preparation Guide Version 1.0" and released it in November 2025. In addition, in order to introduce the purpose and utilization of the said document, the "eCTD v4 Implementation Promotion Symposium" was held on November 28, 2025 with the cooperation of PMDA with the following program.
- Opening Remarks: Shigeru Nakaji, Chairperson, Drug Evaluation Committee
- Information for promotion of eCTD v4 implementation: Ryo Saito, Pharmaceuticals and Medical Devices Agency
- Introduction of "eCTD v4 Creation Guide": Electronic Standard for Medical Information Expert Committee Takahiko Yoshii, Makiko Saito, Makiko Kato
- Information on eCTD v4: Electronic Standard for Medical Information Expert CommitteeAkiko Kusunoki
- Closing remarks: Electronic Standard for Medical Information Expert CommitteeNaoki Sakuma, Director
Of the above presentations, the presentation materials from the JPMA are available below.
eCTD v4 Implementation Promotion Symposium Lecture Slides (JPMA Presentation)
The PMDA's presentation materials are available at PMDA website PMDA's presentation materials are available on the PMDA website.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee 2024 Task Force 1