国家药监局：化学药品和生物制品将全面实施电子申报

Core Viewpoint - The National Medical Products Administration (NMPA) of China has announced that starting from March 1, 2024, drug clinical trial applications, drug marketing authorization applications, supplementary applications, overseas production drug re-registration applications, and generic drug consistency evaluation applications can be submitted using the electronic Common Technical Document (eCTD) format [1] Group 1 - The revised eCTD technical documents will be published separately by the NMPA's Drug Evaluation Center [1] - From March 1, 2026, within one year, drug marketing authorization applications submitted using the eCTD format will be prioritized for acceptance services [1] - During the acceptance review phase, drug registration applications submitted using the eCTD format will be queued separately, with acceptance reviews completed within three days [1]