After consulting on the draft in 2022, China National Medical Products Administration (NMPA) issued the Administrative Measures for Drug Good Laboratory Practice (GLP) Certification earlier this year. The regulation, effective from July 1, 2023, stipulates that GLP certification is mandatory for institutes that conduct non-clinical safety evaluation studies for drug registration applications in China. BaiPharm decodes the regulation as follows.
1. Competent Authorities
Authority | Responsibility |
In charge of GLP certification across China Establishing GLP certification work procedures Granting administrative approval | |
Reviewing GLP-related dossier Conducting on-site inspection Undertaking comprehensive evaluation Supervising and inspecting relevant institutes | |
Administrative Application Acceptance Service and Complaint Center of NMPA (hereafter referred to as Acceptance & Complaint Center) | Acceptance of GLP certification application, etc. |
Provincial medical products administrations | Routine supervision and inspection of relevant research institutes in local administrative area Investigating and punishing illegality against GLP |
2. GLP Certification Applicant
Research institutes that are going to conduct non-clinical safety evaluations to support drug registration applications shall apply for GLP certification. Applicants shall be legal organizations.
3. GLP Application Dossier
The applicant shall send the GLP Certification Application Form and required documents to the Acceptance & Complaint Center. Copies of the applicant’s qualification certificates should be stamped by the applicant’s official seal.
Documents:
1. The applicant institute’s certificate documents to prove eligibility for application
2. Institute profile
3. Organizational structure and personnel
4. Facility management
5. Apparatus & device (including computerized system) and experiment material management
6. Experiment system management
7. Standard operation procedure (SOP) management
8. State of the drug non-clinical safety evaluation research
9. Quality assurance
10. Information on the previous GLP certification and GLP-related inspections
11. Self-inspection report on GLP compliance
12. Other relevant documents:
GLP Application | Required Documents | |
First-time GLP certification | Documents 1~9 | |
Renewing GLP certification | Documents 1~11 | |
Making changes | Adding new trial project/site | Documents 1~11 with particular elaborations on the changes |
Others (Not including the changes that should be reported to the provincial medical products administration) | Specify the changes and corresponding reasons Submit the relevant documents with their names specified | |
GLP Certification Procedures
Notes:
GLP certificate is valid for 5 years. GLP certified institutes shall apply for certificate renewal 6 months before the expiration.
Every December, GLP certified institutes shall submit the 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 state, issues in the process of implementing GLP, and the measures for the issues.
Ask BaiPharm if you'd like to know more about China drug regulatory affairs.
