China’s Good Pharmacovigilance Practices (GVP)

An essential Guide to China’s Good Pharmacovigilance Practices (GVP)

China’s National Medical Products Administration (NMPA), formerly known
asCFDA, released the China Good Pharmacovigilance Practice (GVP)
guidelines in May 2021. These China GVP guidelines are designed to improve
and align China’s pharmacovigilance regulations and practices with
international standards set by the International Council for Harmonization
(ICH).
The China GVP guidelines consist of nine chapters and 134 articles,
providing a comprehensive framework for marketing authorization holders
(MAHs) and drug registration applicants in China to establish and
implement a robust pharmacovigilance (PV) system. These guidelines cover
important aspects such as reporting adverse drug reactions (ADRs), signal
detection, PV master files, and strengthening of passive monitoring.
By adhering to the China GVP guidelines, MAHs and clinical drug trial
sponsors can ensure compliance with China’s PV regulations, enhance drug
safety for patients, and minimize risks associated with adverse drug
reactions. Implementing a comprehensive PV system in accordance with
global standards not only promotes patient safety but also contributes to
the overall quality and credibility of the pharmaceutical industry in
China.
The China Good Pharmacovigilance Practices (GVP) guidelines contain
the following table of content:
Chapter 1 – Overview

Chapter 2 – Quality Management

  • Section 1 Basic Requirement
  • Section 2 Internal audit
  • Section 3 Entrusting Management

Chapter 3 – Institutional Personnel and Resources

  • Section 1 Organisation/Institutions
  • Section 2 Personnel training
  • Section 3 Facility and Resources

Chapter 4 – Monitoring and Reporting

  • Section 1 Information Collection
  • Section 2 Report Assessment and Processing
  • Section 3 Report Submission

Chapter 5 – Risk Identification and Assessment

  • Section 1 Signal Detection
  • Section 2 Risk Evaluation
  • Section 3 A Post-Authorisation Safety Study (PASS)
  • Section 4 Periodic Safety Update Report

Chapter 6 – Risk Control

  • Section 1 Risk Control Measures
  • Section 2 Risk Communication
  • Section 3 Pharmacovigilance Plan

Chapter 7 – Management of Documents, Records and Data

  • Section 1 Policy and Procedural Documents
  • Section 2 Pharmacovigilance System Master File (PSMF)
  • Section 3 Record and Data

Chapter 8 – Pharmacovigilance during Clinical Trial

  • Section 1 Basic Requirement
  • Section 2 Risk Monitoring, Identification, Evaluation and Control
Chapter 9 – Supplementary Provisions
To download the full copy of China GVP guidelines, you may click here.