Canada

Pharmacovigilance in Canada is regulated by Health Canada. The current Good Pharmacovigilance Practices Guidelines (GUI-0102) were updated and took effect on 22 May 2026. Manufacturers/MAHs selling medicines must maintain a robust pharmacovigilance system and are subject to GVP inspections. Under the Food and Drug Regulations as presented in GUI-0102, serious adverse drug reactions occurring in Canada and serious unexpected adverse drug reactions occurring outside Canada must be reported within 15 calendar days; clinically or medically relevant follow-up information for an expedited ICSR also restarts a 15-day reporting period. Manufacturers must prepare an annual summary report, assess whether the known benefits and risks have changed significantly, notify Health Canada without delay if a significant change is identified, and provide issue-related summary reports when requested. The Canadian framework does not impose a universal EU-style local QPPV or PSMF requirement; a separate product condition may do so where applicable. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.