China to Implement Good Pharmacovigilance Practices

by Grace Wang May 28, 2021

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

Highlights of GVP

1. Responsible Subject

  • MAHs are the responsible subjects for pharmacovigilance and should assume the legal obligation even if pharmacovigilance affairs are entrusted to a third party.

  • An entrusted party should be a legal person in China that is capable of ensuring the effective operation of pharmacovigilance affairs.

2. Adverse Drug Reaction Report

Grace Wang
ChemLinked Regulatory Analyst
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