NMPA Announcement on Expanding the Scope of Implementation of Electronic Common Technical Documentation for Pharmaceuticals (No. 10 of 2025)

The National Medical Products Administration (NMPA) announced that it is expanding the scope of the electronic Common Technical Document (eCTD) implementation. As of January 27, the following types of applications can be submitted using the eCTD format:

• Clinical trial applications for chemical drugs in categories 1–5 as well as for preventive biological products and therapeutic biological products in categories 1–3 • Marketing authorization applications for chemical drugs in categories 2–4 and 5.2, as well as for preventive biological products and therapeutic biological products in categories 2 and 3.

NMPA encourages applicants to submit eCTD materials via network transmission according to the guidelines published by the Center for Drug Evaluation (CDE).

Original link：https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20250123164542175.html