Center for Drug Evaluation, NMPA Release Date: July 2, 2025
To enhance the efficiency of preparing electronic application dossier for drug registration and further reduce the burden on applicants, applicants will no longer be required to submit a separate CD-ROM containing clinical trial database as of August 1, 2025.
Additionally, to improve the software usability of the electronic application dossier preparation, CDE has updated the software including the addition of a feature to automatically create a clinical trial database folder for supplementary document, the improvement to the electronic document structure for drug registration applications and related software functions (including the addition of simplified content for applications seeking mainland market authorization for traditional oral Chinese patent medicines already marketed in Hong Kong and Macao). This is hereby notified.
Attachment:
- Electronic Document Structure for Drug Registration Application
- Electronic Application Dossier Preparation Software (V 1.0.2)
Center for Drug Evaluation, NMPA
2025.07.02
