In order to speed up the implementation process of electronic general technical documents for drugs (hereinafter referred to as eCTD) in China and improve the application service level of "Internet plus drug supervision", we hereby announce the matters related to expanding the implementation scope of eCTD as follows:
1、 On the basis of the "Announcement of the National Medical Products Administration on Implementing the Application of Electronic General Technical Documents for Drugs" (No. 119 of 2021), the implementation scope of eCTD has been further expanded. Starting from January 27, 2025, clinical trial applications for Class 1 to Class 5 chemical drugs, marketing authorization applications for Class 2, Class 3, Class 4, and Class 5.2 chemical drugs, as well as clinical trial applications for Class 1 to Class 3 preventive and therapeutic biological products, and marketing authorization applications for Class 2 and Class 3 drugs, can be applied for according to eCTD.
2、 For those who use eCTD for declaration, the applicant shall prepare and submit eCTD electronic declaration materials in accordance with the current eCTD technical document requirements. Encourage the use of network transmission to submit eCTD electronic application materials. For specific instructions, please refer to the "Notice on the Trial Implementation of Submitting Drug Registration Electronic Application Materials via Network Transmission" on the website of the Drug Evaluation Center of the National Medical Products Administration.