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.