The National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) in China has issued a notification to initiate a pilot program for the electronic submission of drug registration materials via network transmission. This new initiative aims to complement the existing method of submission via CDs and enhance the efficiency for applicants when submitting electronic documents.
The trial period for this new electronic filing system began on July 1, 2024, allowing applicants to submit their drug application materials electronically. During the pilot phase, applicants have the option to submit their materials either electronically or on CD to prevent duplicate filings. There is a size limitation for the electronic submissions; the total size of the materials submitted through the network should not exceed 10GB. For electronic declaration materials that exceed 10GB, applicants are still required to submit them on CD, in accordance with current guidelines.- Flcube.com
