Drug Evaluation Committee Asian eCTD / Gateway System Information
Electronic Information Subcommittee
December, 2025
Task Force 1 eSubmission (Promotion and Efficiency of Electronic Submission of Applications for Approval) of the Drug Evaluation Committee's Electronic Information Subcommittee is engaged in various activities to contribute to the smooth transition from v3.2.2 to v4.0 of the eCTD format in Japan, and to the widespread use of eCTD applications.
eCTD has been in use since 2003 Since 2003, eCTD has been used mainly in Japan, the U.S., and Europe. However, the eCTD has not spread quickly in Asian countries and regions other than Japan, but the introduction of eCTD in Thailand in 2015, Taiwan, South Korea, China, and Singapore is underway, and preparations are underway to make it mandatory.
In addition, we have also compiled information on the Gateway System in Asian countries and regions, as online applications have expanded in each country due to the Corona disaster from 2019 onward.
The following materials are to be made publicly available.
- User's Guide
- List and Appendix of eCTD implementation status in Asian countries except Japan
- M1 items, Administrative Information and General Information in 5 Asian countries
- List of gateway systems in Asian countries except Japan
- Comparison of Japanese and Chinese notifications for study data submission
The information in this material is based on the information as of the end of September 2025. Please keep in mind that the situation in each country is constantly changing and will continue to change from the information in this document.
Asian eCTD / Gateway System Information
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
eCTD Subcommittee Task Force 1
Deliverables of the Drug Evaluation Committee Return to list of all deliverables