China’s NMPA announces that it will expedite review applications for the marketing of Novel Drugs.
China’s CDE has released “Working Procedure for Accelerating the Review of Marketing Application of Innovative Drugs (Trial Implementation)”(hereinafter referred to as “Working Procedure”) for industry comments due March 4th, 2022.
China’s NMPA announces draft Guidelines on the Dossier Acceptance for Chemical Drug and Biologics.
China’s NMPA to improve the transparency and efficiency of the registration dossier acceptance and review, NMPA CDE issued a revision of the guidelines of the registration dossier acceptance for chemical drug and biologics, which is now ready for public comment due by March 4th, 2022.