Announcement of the State Food and Drug Administration on the Implementation of the Application of Electronic General Technical Documents for Drugs (No. 119 of 2021)

To implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council (Ting Zi [2017] No.
42) and the "Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Building of Drug Regulatory Capability" 》(Guobanfa [2021] No.
16) document, realize the electronic application of drug registration application, improve the "Internet + drug supervision" application service level, the State Drug Administration has fully developed and promoted the electronic general technical documentation of drugs (eCTD) ) Declare related work
.
The relevant matters concerning the implementation of eCTD application are now announced as follows: 1.
Implementation time and scope of implementation From December 29, 2021, chemical drug registration classifications are Class 1, Class 5.
1, and Class 1 therapeutic biological products and Class 1 preventive biological products.
Application for marketing authorization can be filed in accordance with eCTD
.
2.
The eCTD application document format and implementation requirements.
Applicants should prepare and submit the eCTD application document CD in accordance with the eCTD technical documents (Annex 1-4), and submit the paper within 5 working days after the eCTD registration application is accepted.
Information
.
If the applicant fails to submit the paper materials within the prescribed time, it shall be handled in accordance with the procedures for terminating the drug registration
.
At the same time, the applicant should promise that the submitted electronic materials are completely consistent with the content of the paper materials.
Any problems arising from the consistency of the materials shall be borne by the applicant
.
3.
Other matters and requirements In order to ensure the steady progress of eCTD and reduce the impact on the declaration work, for the above-mentioned registration applications, applicants can still choose the existing registration methods for registration declaration
.
With the registration application of eCTD declaration, the applicant does not need to submit the CD-ROM of declaration materials for verification and inspection and the CD-ROM of clinical trial database separately
.
Relevant technical guidelines can be found on the website of the Drug Evaluation Center of the National Bureau of Drug Administration
.
The Drug Evaluation Center of the National Medical Products Administration will do a good job in the relevant technical guidance during the implementation of this announcement
.
Special announcement
.
Attachment: 1.
eCTD Technical Specification V1.
0 2.
eCTD Verification Standard V1.
0 3.
eCTD Implementation Guide V1.
0 4.
eCTD Technical Specification V1.
0 Annex Package National Food and Drug Administration September 29, 2021 National Drug Administration Announcement No.
119 in 2021 Annex 1-eCTD Technical Specification V1.
0.
pdf State Drug Administration Announcement No.
119 in 2021 Annex 2-eCTD Verification Standard V1.
0.
pdf State Drug Administration No.
119 in 2021 Announcement Attachment 3-eCTD Implementation Guide V1.
0.
pdf National Medical Products Administration Announcement No.
119 in 2021 Annex 4-eCTD Technical Specification V1.
0 Attachment Package.
zip