NMPA issued the Announcement on “Implementing Electronic Application of Drug Registration”

In order to improve the efficiency of drug review and approval, the National Medical Products Administration has decided to implement electronic submission of drug registration application materials. The specific requirements are announced as follows:

1. From January 1, 2023, the drug registration application submitted by the applicant for review and approval by the National Medical Products Administration and the supplementary materials during the review process will be adjusted to submit application materials in electronic form, and the applicant does not need to submit paper application materials. The existing work procedures remain unchanged.

2. Applicants shall prepare electronic application materials in accordance with current laws and regulations and electronic application materials requirements, and submit the CD to the Drug Review Center of the National Medical Products Administration (hereinafter referred to as the Drug Review Center) to apply. The Drug Review Center will carry out acceptance, review and approval work based on electronic application materials. The relevant technical requirements for electronic application materials will be issued separately by the Drug Review Center.

3. From the date of implementation of this announcement, the electronic documents for the acceptance of drug registration applications for administrative approval will be pushed instantly by the "Drug Business Application System" and "Drug eCTD Registration System", and the electronic documents for the acceptance of administrative approval will have the same legal effect as paper documents.

4. From the date of implementation of this announcement, applicants who use electronic common technical documents (eCTD) for drug applications no longer need to submit paper application materials. Other requirements must still be implemented in accordance with the "Announcement on the Implementation of Electronic Common Technical Document Application for Drugs" (No. 119 of 2021).

National Medical Products Administration

November 30, 2022

Specific news link: Announcement on the implementation of electronic submission of drug registration applications (No. 110, 2022)