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On November 30, the NMPA website published an announcement
on the implementation of electronic declaration of drug registration applications.
The full text is as follows:
on the implementation of electronic declaration of drug registration applications.
The full text is as follows:
In order to improve the efficiency of drug review and approval, the State Food and Drug Administration has decided to implement electronic submission of application materials for drug registration, and the specific requirements are announced as follows:
1.
Starting from January 1, 2023, the application submitted by the applicant for review and approval of drug registration and supplementary information during the review process will be adjusted to submit the application materials in electronic form, and the applicant does not need to submit paper declaration materials
.
The existing working procedures remain unchanged
.
Starting from January 1, 2023, the application submitted by the applicant for review and approval of drug registration and supplementary information during the review process will be adjusted to submit the application materials in electronic form, and the applicant does not need to submit paper declaration materials
.
The existing working procedures remain unchanged
.
2.
The applicant shall prepare the electronic declaration materials in accordance with the current regulations and the requirements of electronic declaration materials, and submit the CD-ROM to the Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Drug Review Center) for application
.
The Drug Review Center will carry out acceptance, review and approval based on electronic declaration materials
.
The technical requirements related to electronic declaration materials shall be separately
issued by the Drug Review Center.
The applicant shall prepare the electronic declaration materials in accordance with the current regulations and the requirements of electronic declaration materials, and submit the CD-ROM to the Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Drug Review Center) for application
.
The Drug Review Center will carry out acceptance, review and approval based on electronic declaration materials
.
The technical requirements related to electronic declaration materials shall be separately
issued by the Drug Review Center.
3.
From the date of implementation of this announcement, the electronic documents for accepting administrative licenses for drug registration applications will be immediately pushed by the "Drug Business Application System" and "Drug eCTD Registration System", and the electronic documents for accepting administrative licenses have the same legal effect
as paper documents.
From the date of implementation of this announcement, the electronic documents for accepting administrative licenses for drug registration applications will be immediately pushed by the "Drug Business Application System" and "Drug eCTD Registration System", and the electronic documents for accepting administrative licenses have the same legal effect
as paper documents.
4.
From the date of implementation of this announcement, if the applicant uses the electronic general technical file (eCTD) for the declaration, there is no need to submit paper declaration materials, and other requirements still need to be implemented
in accordance with the "Announcement on the Implementation of the Application of Electronic General Technical Document for Drugs" (No.
119 of 2021).
From the date of implementation of this announcement, if the applicant uses the electronic general technical file (eCTD) for the declaration, there is no need to submit paper declaration materials, and other requirements still need to be implemented
in accordance with the "Announcement on the Implementation of the Application of Electronic General Technical Document for Drugs" (No.
119 of 2021).
