CDE: Notice on the requirements for electronic declaration of drug registration applications released!

Notice on the requirements for electronic declaration of drug registration applications

In accordance with the requirements of the Announcement of the State Food and Drug Administration on the Implementation of Electronic Declaration of Drug Registration Applications (No.
110 of 2022), from January 1, 2023, the application submitted by the State Food and Drug Administration for review and approval of drug registration applications and supplementary materials during the review process submitted by the applicant has been adjusted to submit the application materials in electronic form, and the specific requirements for electronic declaration are hereby notified as follows:

1.
Preparation of electronic declaration materials

The applicant shall prepare electronic declaration materials (including letters of commitment) in accordance with the current regulations, technical requirements for electronic CD-ROMs of application materials, and electronic file structure of drug registration applications, and submit the CD-ROMs to the Drug Review Center to submit an application
for drug registration.
The applicant or the registered agent is required to electronically sign the electronic declaration materials, and the application and use of the electronic seal can be found in the "CA Direct Train" column of the "Applicant's Window"
section on the website of the Drug Review Center.

For details of the cover requirements for the cover of the CD case and the cover of the file bag, please refer to the Technical Requirements for Electronic CD-ROM (Annex 1)
of the Declaration Materials.

2.
Receipt and acceptance of electronic declaration materials

(1) After receiving the disc submitted by the applicant, the drug review center shall receive the disc that can be read normally, passed the verification of electronic signatures, and has not found computer viruses; If the disc is damaged, the disc data cannot be read, the electronic signature verification is not passed, or a computer virus is found, the drug review center will communicate with the applicant in time and remind it to resubmit, and the original disc will be disposed of
in accordance with the destruction procedure.

(2) The Drug Review Center shall conduct a formal review
of the accepted application materials within 5 working days.
The electronic documents for accepting administrative licenses are all pushed by the "Drug Business Application System" and "Drug eCTD Registration System" and reminded by SMS, and applicants can immediately query and print, and the Drug Review Center no longer accepts paper documents
for administrative licensing by mail.

(3) Where the application materials are incomplete or do not conform to the statutory form and need to be corrected, or do not meet the requirements and need not be accepted, or the supplementary materials during the review process do not meet the relevant acceptance requirements such as the "Working Procedures for Supplementary Information of the Drug Evaluation Center (Trial)", the CD-ROM of the declaration materials shall be destroyed by the Drug Review Center in accordance with the procedures, and will not be returned to the applicant, and the applicant is requested to keep a good backup
.

3.
Other requirements

(1) On the arrangement of optical discs

Applicants are required to submit 1 complete set of electronic application materials CD-ROM (including clinical trial database, if applicable) for review as required by this notice
.

At the same time, in addition to applications that do not involve verification, such as drug clinical trial applications, applications for re-registration of drugs produced abroad, and supplementary applications for direct administrative approval, applicants are also required to submit one complete set of electronic declaration materials CD-ROM (including clinical trial databases, if applicable) for verification at
the same time.
For generic name approval materials, clinical trial database data, over-the-counter drug suitability review and label review, etc.
, the relevant materials need to prepare a separate set of CD-ROMs
.

In the future, with the gradual advancement of informatization, the drug review center will adjust the relevant requirements
in time.

(2) Requirements for submitting materials during the review process

Before the implementation of electronic declaration, if the applicant has submitted an application for drug registration and has been accepted, the supplementary materials such as supplementary materials during the review process shall still be submitted
in the form of paper declaration materials.

Drug registration applications accepted after the implementation of electronic declaration, supplementary materials, etc.
during the review process shall be submitted
in the form of electronic declaration materials.

(3) Requirements for submitting materials at the "Applicant Window"

Within 5 working days after the acceptance of the drug registration application, the applicant shall upload the WORD file of the application materials such as pharmacy, non-clinical and clinical reviews through the "Applicant's Window" column of the drug review center website to ensure that the content of the document is independent and complete, and meet the requirements
of copying and retrieval.

(4) Registration materials for APIs, pharmaceutical excipients and pharmaceutical packaging materials

API registration materials should be sorted out in PDF format, and relevant requirements such as electronic signatures should meet the technical requirements
of electronic CD-ROMs of application materials.
Encourage the registration materials of pharmaceutical excipients and pharmaceutical packaging materials to be implemented by reference
.

Annexes: 1.
Technical requirements for electronic CD-ROMs of declaration materials

2.
Electronic file structure of drug registration application

3.
Letter of Commitment

Drug Review Center, State Food and Drug Administration

December 2, 2022

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