UPDATE: China GLP Certification Regulation Takes Effect on July 1, 2023
On Oct. 21, 2022, China National Medical Products Administration (NMPA) issued the draft of Administrative Measures for Good Laboratory Practice (GLP) Certification for public comments. GLP certification means that NMPA inspects and evaluates whether research institutes comply with GLP during non-clinical safety evaluation for pharmaceuticals.1 The following are specific regulatory requirements from the draft.
Competent Authorities
Authority | Responsibility |
In charge of GLP certification across China Establishing GLP certification work procedures Granting administrative approval | |
GLP-related dossier review and on-site inspection comprehensive evaluation and supervision | |
Administrative Application Acceptance Service and Complaint Center of NMPA (hereafter referred to as Acceptance and Complaint Center) | Acceptance of GLP certification application Delivery of GLP certificate |
Provincial medical products administrations | Routine supervision for and inspection on relevant research institutes in local administrative area Investigating and punishing illegality against GLP |
GLP Certification Applicant
Research institutes that plan to conduct non-clinical safety evaluation to support drug registration application shall apply for GLP certification. Applicants shall be legal organizations.
GLP Application Dossier
The applicant shall send the GLP Certification Application Form and required documents to the Acceptance and Complaint Center. The required copies of certificates should be stamped by the applicant's official seal.
Documents:
1. The applicant's qualification certificate document (a copy of any of the four documents: Unified Social Credit Code Certificate / Business License / Public-sector Organization Certificate / effective certificate signed and issued by the authority regulating the institute)
2. Introduction to the institute
3. Organizational structure and each department's responsibility
4. Personnel's structure, basic information, and trainings they have attended.
5. Information of the major responsible persons
6. Information of the animal feeding area and animal trial area
7. Metrological verification of the apparatus, meters, measuring instrument, weighing scales, and verification of analytical instruments
8. A list of the main apparatus used by the institute
9. Table of contents: standard operation procedures (SOPs)’ formulation and revision, as well as the invalidated SOPs and their titles
10. Operation and management of the computerized system
11. The progress of drug's non-clinical safety evaluation research
12. Information on the previous GLP certification and GLP-related inspections
13. Self-inspection report on GLP compliance
14. Other documents
GLP Application | Required Documents | |
First-time GLP certification | Documents 1~11 and 14 | |
Renewing GLP certification | Documents 1~14 | |
Making changes | Adding new trial project/site | Documents 1~14 with elaborations on the changes |
Changing the applicant's name, registered address, and/or the name of the institute which carries out the specific non-clinical safety evaluation research | A copy (with the applicant's seal) of the administrative authority's document for approving the change A copy (with the applicant's seal) of the changed Business License A statement promising that the change does not affect GLP compliance | |
Changing the organizational structure, major responsible persons, trial equipment, or other elements related to the quality management system (QMS) | A paper report that should be submitted to the provincial medical products administration within 20 workdays from the day when the change takes place | |
GLP Certification Application Procedures (Draft)
China GLP Certification Application Review & Approval Procedures
Notes:
GLP certificate is valid for 5 years. GLP certified institutes shall apply for certificate renewal 2-6 months before the expiration.
Every December, GLP certified institutes shall submit a GLP Annual Report to the provincial medical products administration of the province where the institutes are. The report shall include the institute's basic information, QMS operation, research progress, issues in the process of carrying out GLP, and the measures for the issues.
Submit Your Comments
If there are any advice or comments on the GLP certification regulation draft, you're welcomed to send them to NMPA via yjjyjc@126.com before Nov. 21, 2022.
