To accelerate the implementation process of the Electronic Common Technical Document (eCTD) in China and enhance the service capabilities of "Internet + Drug Regulation" applications, the following matters concerning the expansion of the eCTD implementation scope are hereby announced:

I. Based on the eCTD implementation scope outlined in the NPMA Announcement on Implementing the Application with Electronic Common Technical Documents (No.119, 2021), the implementation scope will be further expanded, allowing the following applications to be submitted in eCTD format starting from January 27, 2025: drug clinical trial applications for Class 1 to 5 chemical drugs; marketing authorization applications for Class 2, 3, 4, and 5.2 chemical drugs; drug clinical trial applications for Class 1 to 3 preventive biological products and therapeutic biological products; and marketing authorization applications for Class 2 and 3.

II. For submissions made in eCTD format, applicants shall prepare and submit eCTD electronic submission dossiers in accordance with the current eCTD technical document requirements. Applicants are encouraged to submit eCTD electronic dossiers via online transmission. For detailed operational guidelines, please refer to the Notice on Pilot Implementation of Online Transmission for Drug Registration Electronic Application Dossier Submission published on the official website of the Center for Drug Evaluation of the National Medical Products Administration.

It is hereby announced.

National Medical Products Administration

January 22, 2025