China

The Center for Drug Evaluation (CDE) is promoting implementation of the ICH eCTD v4.0 standard in China and guiding a smooth transition from v3.2.2 to v4.0. On 2026-05-27, CDE drafted the eCTD v4.0 Guidance (Draft for Public Comment) together with controlled-vocabulary and validation-criteria annexes, and opened it for public consultation (one month from publication). As of Sep 2026, no go-live or mandatory date has been announced.

eCTD v4.0 is still in public consultation and not yet implemented; the current mandatory version remains v3.2.2 (since 2026-03-01, for chemical and biological products). Follow CDE's official announcements and the eCTD column; do not hold back current v3.2.2 submissions waiting for v4.0. Consultation feedback: ectdfk@cde.org.cn.

eCTD v3.2.2 is China's current mandatory electronic submission standard, based on the ICH eCTD technical specification V3.2.2, with Module 1 as China's regional requirement. Under the NMPA Announcement No. 8 (2026), eCTD is fully implemented for chemical and biological products from 2026-03-01. To support full implementation, CDE published the revised v3.2.2 technical files (CDE Notice No. 4, 2026) on 2026-01-15, effective 2026-03-01: the mapping table between current filing requirements and eCTD / CTD directory hierarchy, eCTD technical specification V1.1 and package, eCTD implementation guide V1.1, and eCTD validation criteria V1.1.

Module 1 is China's regional requirement; the technical basis is CDE's regional specification V1.1, implementation guide V1.1 and validation criteria V1.1. eCTD submissions are made electronically via the CDE eCTD submission system (ectdapp.cde.org.cn).