In accordance with the requirements of the Announcement of National Medical Products Administration (NMPA) on the Implementation of Electronic Application for Drug Registration (No. 110, 2022), the application for drug registration for evaluation and approval by NMPA and the supplementary materials in the evaluation process submitted by the applicant will be adjusted to submit application materials in electronic form from January 1, 2023. The specific requirements for electronic application are notified as follows:

The applicant should prepare the electronic application materials (including the letter of commitment) in accordance with the relevant requirements of current laws and regulations, the technical requirements of the application materials electronic CD and the structure of the electronic document of drug registration application, and submit the CD to the Center for Drug Evaluation (CDE)to apply for drug registration.

2. Receiving and accepting electronic declaration materials

(1) After receiving the CD submitted by the applicant, CDE accept the CD that can be read normally, pass the electronic signature verification and no computer virus is found. If the CD is damaged, the CD data cannot be read, the electronic signature verification fails or the computer virus is found, CDE will communicate with the applicant in time and remind him to submit it again. At the same time, the original CD will be disposed of according to the destruction procedure.

(2) CDE will examine the application materials received in the form of acceptance within 5 working days. The electronic documents for accepting administrative license will be pushed by the "Drug Business Application System" and "Drug eCTD Registration System" and reminded by SMS. The applicants can query and print immediately. CDE will no longer mail the paper documents for accepting administrative license.

If the application materials are not complete or do not conform to the statutory form and need to be corrected, or do not conform to the requirements and need not be accepted, or the supplementary materials in the evaluation process do not conform to the relevant receiving requirements of the Drug Evaluation Center Supplementary Data Procedures (Trial), the application data CD will be destroyed by CDE according to the procedures and will not be returned to the applicant. Please keep a copy.