National Medical Products Administration: Chemical drugs and biological products will be fully implemented through electronic filing.

Today, reporters learned from the National Medical Products Administration that starting from March 1 of this year, applications for clinical trials of chemical drugs, chemical raw materials, and biologics, as well as applications for drug marketing approval, supplementary applications, overseas production re-registration, and generic drug consistency evaluations, can be submitted in accordance with the electronic Common Technical Document (eCTD) format. The revised eCTD technical documents will be separately released by the Drug Evaluation Center of the National Medical Products Administration. The administration stated that starting from March 1, 2026, within one year, drug marketing approval applications submitted in electronic common technical document format will be included in the expedited service range; during the review process, drug registration applications submitted in electronic common technical document format will be prioritized, and the review process will be completed within 3 days.