In order to implement the relevant requirements of the Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Capacity Building of Drug Administration (GBF [2021] No. 16) and improve the application service level of "Internet plus Drug Administration", the Drug Evaluation Center of the State Drug Administration has established a network transmission channel for electronic declaration materials. On the basis of using CDs to submit electronic declaration materials, the network transmission mode has been increased to provide multiple options for applicants to submit electronic declaration materials, so as to improve the submission efficiency of electronic declaration materials. The relevant matters are hereby notified as follows:
1、 Starting from July 1, 2024, the trial work of network transmission of electronic drug registration application materials will be launched. Applicants can submit electronic drug registration application materials through network transmission.
2、 The trial scope includes the electronic application materials for drug registration prepared by applicants in accordance with the "Technical Requirements for Electronic CD of Application Materials" or "eCTD Technical Specifications".
3、 During the trial period, applicants can choose to submit their application materials in the form of network transmission or CD to avoid the situation of repeated submission of application materials. The total size of electronic declaration materials submitted through the network transmission system should be less than 10GB, and electronic declaration materials exceeding 10GB should still be submitted in the form of CDs according to current requirements.
4、 During the trial period, for drug registration applications submitted through network transmission, except for applications that do not involve verification such as drug clinical trial applications, overseas production drug re registration applications, and supplementary applications for direct administrative approval, the applicant must also submit a complete set of electronic application materials CD (including clinical trial databases, if applicable) for verification within 10 days after the acceptance of the new registration application or within 10 days after the formal receipt of materials during the review process; For clinical trial database data, an additional set of clinical trial database CDs needs to be prepared separately. Pay attention to marking the acceptance number and specific information type on the CD cover.
5、 If the applicant needs to perform network transmission of drug registration application materials, they can enter the applicant window to make network transmission appointments and certificate applications, and download the electronic application material network transmission software, operation manual, and operation video (specific steps are detailed in the attachment). After installing the electronic declaration data network transmission software, the applicant can use the software to transmit declaration data according to the operation manual and operation video. Our center will verify the received application materials according to the "Electronic Application Material Verification Standard" or "eCTD Verification Standard". The verified application materials will be received and registered by the center. Application materials that cannot be verified will not be able to enter the subsequent process.
Please pay attention to the deadline requirements for submitting relevant documents such as the "Notice of Supplementary Information" and "Professional Evaluation Inquiry Letter". At the same time, it is recommended that the applicant use the verification function in the electronic application material production software to carry out pre verification work in advance, ensuring that the electronic application materials that meet the above verification standards are submitted within the prescribed time limit.
6、 To ensure the smooth implementation of network transmission work, help applicants understand the requirements of network transmission related work, and familiarize themselves with system operation, our center will strengthen training through the drug review cloud classroom in the near future. Please stay tuned.
Attachment: Instructions for Reservation and Operation Steps for Network Transmission of Electronic Declaration Materials

National Medical Products Administration Drug Evaluation Center
July 1, 2024