Health Canada regulatory references
Find source-linked guidance for Canadian regulatory work. Start with a topic below, then consult the official document for its scope and applicable requirements.
Post-market safety reporting
Health Canada’s summary-report guidance covers annual reports for marketed drugs and natural health products, alongside interim and issue-related reports. Our reference page connects this guidance with the agency’s PSUR and PBRER questions and answers.
Safety summary reports: PSUR and PBRERRead the official summary-report guidanceCanadian legislation
Use the legislation collection to navigate the legal text alongside the relevant guidance.
Explore the Food and Drugs Act