Drug Evaluation Committee Announcement of "eCTD v4 Implementation Promotion Symposium Presentation Materials
March 10, 2025
The Drug Evaluation Committee's Electronic Information Subcommittee Task Force 1 eSubmission (Promotion of Electronic Filing of Applications for Approval and Efficiency) has released materials to explain the features of eCTD v4. eCTD v4.0 Educational Materials, Second Edition. The material has been prepared as "eCTD v4.0 Educational Material, Second Edition". In addition, in order to introduce the process of creating the said materials, their purpose, and how to utilize them, a "Symposium to Promote eCTD v4 Implementation" was held on November 28, 2024, with the cooperation of PMDA. The presentation materials of this symposium are available below. Please note that the answers to the preliminary questions addressed to the JPMA were published, but since the questions were not within the scope of this symposium, the answers will not be made public.
The presentation materials from PMDA are available on PMDA's website Reference Materials for eCTD v4 Domestic Operation page of PMDA's website.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Electronic Information Subcommittee 2024 Task Force 1