Drug Evaluation Committee Asian eCTD / Gateway System Information
Electronic Standard for Medical Information Expert Committee
December 2025
Drug Evaluation Committee Electronic Standard for Medical Information Expert CommitteeTask Force 1 eSubmission (Promotion and Efficiency of Electronic Submission of Applications for Approval) 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 is Japan since 2003, The eCTD has been used mainly in Japan, the U.S., and Europe since 2003. However, the eCTD has not spread quickly in Asian countries and regions other than Japan, but the introduction of eCTD in the Kingdom of Thailand in 2015, Taiwan, Korea, China, and Singapore is underway, and preparations are underway to make eCTD mandatory in those countries and regions.
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 Guide
- List of eCTD implementation status in Asian countries except Japan and Appendix
- 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 note 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 Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee Task Force 1