China to Implement Good Pharmacovigilance Practices
China National Medical Products Administration (NMPA) officially issued the Good Pharmacovigilance Practices (GVP) on May 13, 2021, after releasing the consultation draft in December last year. GVP, made for regulating and guiding pharmacovigilance activities, is set to come into enforcement on Dec. 1, 2021.
Who does GVP address?
The Chinese GVP applies to Marketing Authorization Holders (MAHs)\’s pharmacovigilance activities about medicinal products and drug registration applicants with authorization to carry out clinical trials.
Pharmacovigilance activities are defined as activities to monitor, identify, evaluate and control adverse drug reactions (ADRs) or other negative reactions related to medication.
As NMPA announced GVP, the authority asked MAHs and drug registration applicants to gear up for fulfilling the GVP requirements, saying they should establish pharmacovigilance systems to organize relevant activities in line with laws and regulations.
NMPA also noted that MAHs should register at China National ADR Monitoring System within 60 days from GVP\’s release date.
Covering Every Stage of Drug Life Cycle
The GVP has comprehensive contents, whose effects cover every phase of the drug life cycle.
| Content of Chinese Good Pharmacovigilance Practices | |
| 1. General Principles | |
| 2. Quality Management | Fundamental Requirements |
| Internal Review | |
| Entrusted Management by Third-party | |
| 3. Personnel and Resources in the Organization | Organization (of Drug Safety Committee and Pharmacovigilance Departments) |
| Personnel and Training | |
| Equipment and Resources | |
| 4. Monitoring and Report | Information Collection |
| Evaluation and Feedback of the Report | |
| Report Submission | |
| 5. Risk Identification and Assessment | Risk Signal Detection |
| Risk Assessment | |
| Post-market Study on Drug Safety | |
| Periodic Safety Update Report (PSUR) | |
| 6. Risk Control | Measures for Risk Control |
| Risk Communication | |
| Pharmacovigilance Plan | |
| 7. Documentation, Records and Data Management | Documents on Pharmacovigilance System, Standards and Procedure |
| Master Files on Pharmacovigilance System | |
| Records and Data | |
| 8. Pharmacovigilance During Clinical Trial | Fundamental Requirements |
| Risk Monitoring, Identification, Assessment and Control | |
| 9. Supplemental Principles | |
