In order to implement the Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices issued by General Office of the Central Committee of the CPC and the General Office of State Council, and Implementing Opinions of the General Office of the State Council on Comprehensively Strengthening the Capacity Building of Drug Supervision, realize the electronic submission of drug registration application and improve the "Internet+Drug Regulation" application service level, the National Medical Products Administration comprehensively carried out and promoted the application with electronic common technical document (eCTD). The relevant issues related to eCTD application are hereby announced as follows: 

I. Implementation date and scope 

As of December 29, 2021, the marketing authorization of chemicals with Registration Categories 1 and 5.1, therapeutic biological products with Registration Category 1 and preventive biological products with Registration Category 1 may be applied according to eCTD. 

II. Format of eCTD application dossiers and implementation requirements 

Applicants should prepare and submit the eCTD application dossiers on CD-ROM as required by the eCTD technical documents (Attachments 1-4), and submit the paper dossiers within 5 working days upon the acceptance of the eCTD registration application dossiers. If an applicant fails to submit the paper dossiers within the specified time, the drug registration process will be terminated. At the same time, the applicant should make commitment that the electronic dossiers submitted is completely consistent with the paper dossiers. The applicant should bear the responsibilities for any problem arising from the inconsistency. 

III. Other matters and requirements 

In order to ensure a steady promotion of the eCTD and minimize its impact on the application, applicants can still choose the existing registration method for the above registration applications. 

For registrations application with eCTD submission, there is no need for applicants to submit the CD-ROM of the application dossiers for verification and inspection and the CD-ROM of clinical trial database separately. 

The relevant technical guidance may be accessed on the website of the Center for Drug Evaluation of NMPA. The Center for Drug Evaluation of NMPA shall be responsible for relevant technical guidance during the implementation of this Announcement. 

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