At the 2025 China (Suzhou) Innovation Drug Medical Congress and CMAC Annual Meeting held today, Sophia Huang, General Manager of Beijing BrilliantMed Pharmaceutical Technology Co., Ltd., provided a detailed interpretation of the new policies for the expanded implementation of eCTD (Electronic Common Technical Document). According to Announcement No. 10 of 2025, starting from January 27, 2025, eCTD submissions will cover clinical trial applications for chemical drugs in Classes 1-5, marketing authorization applications for chemical drugs in Classes 2/3/4/5.2, as well as clinical trial applications for preventive and therapeutic biologics in Classes 1-3 and marketing authorization applications for biologics in Classes 2-3, marking the official entry of China's drug registration into a fully electronic era.
