China to Implement Good Pharmacovigilance Practices

Nov. 19th, 2021
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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 yearGVP, 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

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