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In order to strengthen the management of non-clinical drug safety evaluation research institutions (hereinafter referred to as GLP institutions), in accordance with the Drug Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration and other relevant provisions, the State Medical Products Administration organized and established the "Information Platform for Research Institutions for Non-clinical Safety Evaluation of Drugs" (hereinafter referred to as GLP Institutional Information Platform).
From the date of issuance of the circular, the GLP institutional information platform has been put into operation
.
The relevant matters are notified as follows:
1.
From the date of issuance of the circular, GLP institutions, relevant provincial drug administrations, and the Food and Drug Inspection and Inspection Center of the State Medical Products Administration (hereinafter referred to as the verification center) shall log in to the GLP institution information platform and promptly fill in GLP institution information, GLP certification status, supervision and inspection results of GLP institutions, investigation and handling of illegal acts, and other information
.
2.
GLP institutional users log in to the GLP institutional information platform through the "NMPA Online Office Hall" (zwfw.
nmpa.
gov.
cn) public service matter entrance, and fill in information
.
GLP institutions are requested to complete user registration and initial information filling by January 31
, 2023.
When the GLP organization information and GLP certification status change, the GLP institution shall update the platform information
within 5 working days after the change.
Where it is necessary to obtain permission from the regulatory departments as required, the platform information
shall be updated within 5 working days after the regulatory authorities' permission.
3.
Regulatory users such as the provincial drug administration and the verification center log in to the GLP institutional information platform through the "National Drug Smart Supervision Platform" to fill in and confirm
the corresponding information.
All relevant provincial drug administration bureaus and verification centers are requested to complete user registration and review and confirmation of the information filled in by GLP institutions for the first time before February 28, 2023, and confirm the relevant update information of GLP institutions in a timely manner in the future, and enter information such as the results of supervision and inspection of GLP institutions and the investigation and punishment of illegal acts
.
4.
The public can enter "Drug Inquiry" through the "Inquiry" column on the homepage of the NMPA website to view the public information
of GLP institutions in the "Information Platform of Drug Non-clinical Safety Evaluation Research Institutions".
GLP institutions and regulatory users can also download registration/login instructions on this public information page; After logging in to the GLP Institutional Information Platform, you can download the system operation manual
.
5.
All provincial-level drug administration bureaus should earnestly implement their territorial regulatory responsibilities, and urge GLP institutions within their jurisdictions to complete information filling in in a timely manner
.
Organize the daily supervision of GLP institutions, increase the frequency of supervision and inspection of bad records, organize the investigation and handling of violations of laws and regulations discovered in accordance with law, and disclose
them in accordance with regulations.
6.
The verification center is responsible for the daily maintenance
of the GLP institutional information platform.
If you have any questions about the use of GLP institutional information platform, please contact: 010-68441520 (Inspection Center Inspection Division II), 010-68441191 (Verification Center Information Management Office).
Notice is hereby given
.
State Food and Drug Administration
, December 13, 2022
From the date of issuance of the circular, the GLP institutional information platform has been put into operation
.
The relevant matters are notified as follows:
1.
From the date of issuance of the circular, GLP institutions, relevant provincial drug administrations, and the Food and Drug Inspection and Inspection Center of the State Medical Products Administration (hereinafter referred to as the verification center) shall log in to the GLP institution information platform and promptly fill in GLP institution information, GLP certification status, supervision and inspection results of GLP institutions, investigation and handling of illegal acts, and other information
.
2.
GLP institutional users log in to the GLP institutional information platform through the "NMPA Online Office Hall" (zwfw.
nmpa.
gov.
cn) public service matter entrance, and fill in information
.
GLP institutions are requested to complete user registration and initial information filling by January 31
, 2023.
When the GLP organization information and GLP certification status change, the GLP institution shall update the platform information
within 5 working days after the change.
Where it is necessary to obtain permission from the regulatory departments as required, the platform information
shall be updated within 5 working days after the regulatory authorities' permission.
3.
Regulatory users such as the provincial drug administration and the verification center log in to the GLP institutional information platform through the "National Drug Smart Supervision Platform" to fill in and confirm
the corresponding information.
All relevant provincial drug administration bureaus and verification centers are requested to complete user registration and review and confirmation of the information filled in by GLP institutions for the first time before February 28, 2023, and confirm the relevant update information of GLP institutions in a timely manner in the future, and enter information such as the results of supervision and inspection of GLP institutions and the investigation and punishment of illegal acts
.
4.
The public can enter "Drug Inquiry" through the "Inquiry" column on the homepage of the NMPA website to view the public information
of GLP institutions in the "Information Platform of Drug Non-clinical Safety Evaluation Research Institutions".
GLP institutions and regulatory users can also download registration/login instructions on this public information page; After logging in to the GLP Institutional Information Platform, you can download the system operation manual
.
5.
All provincial-level drug administration bureaus should earnestly implement their territorial regulatory responsibilities, and urge GLP institutions within their jurisdictions to complete information filling in in a timely manner
.
Organize the daily supervision of GLP institutions, increase the frequency of supervision and inspection of bad records, organize the investigation and handling of violations of laws and regulations discovered in accordance with law, and disclose
them in accordance with regulations.
6.
The verification center is responsible for the daily maintenance
of the GLP institutional information platform.
If you have any questions about the use of GLP institutional information platform, please contact: 010-68441520 (Inspection Center Inspection Division II), 010-68441191 (Verification Center Information Management Office).
Notice is hereby given
.
State Food and Drug Administration
, December 13, 2022
