Drug Evaluation Committee Notice of Publication of Presentation Material for eCTD v4 Implementation Promotion Symposium (November 28, 2025, Web-based)
Electronic Information Subcommittee
December, 2025
Task Force 1 eSubmission (Promotion of Electronic Filing of Applications for Approval and Streamlining) of the Drug Evaluation Committee's Electronic Information Subcommittee has produced 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, Chairman, Drug Evaluation Committee
- Information for the promotion of eCTD v4 implementation: Ryo Saito, Pharmaceuticals and Medical Devices Agency
- Introduction of "eCTD v4 Creation Guide": Takahiko Yoshii, Makiko Saito and Makiko Kato, Electronic Information Subcommittee
- Information on eCTD v4: Akiko Kusunoki, Electronic Information Subcommittee
- Closing remarks: Naoki Sakuma, Chair, Databases and Information Technology Subcommittee
Of the above presentations, the presentation materials from the JPMA are available below.
eCTD v4 Implementation Promotion Symposium Presentation 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, Committee on Drug Evaluation
Electronic Information Subcommittee 2024 Task Force 1
Deliverables of the Drug Evaluation Committee Return to list of all deliverables