Upcoming publication of Good Pharmacovigilance Practices (GVP) Guidance and Policy

 

Health Canada has updated its Good Pharmacovigilance Practices (GVP) framework by revising three key documents:

 

1. Risk classification guide for good pharmacovigilance practices observations (GUI-0063),
2. Good pharmacovigilance practices guidelines (GUI-0102), and
3. Good pharmacovigilance practices inspection approach policy for human drugs (POL-0041).

 

The revised guidelines incorporate stakeholder feedback gathered during the consultation period. This updated release introduces a flexible, risk-based approach designed to reduce industry burden while clarifying current regulatory expectations.