Health Canada safety summary reports: PSUR and PBRER
Use these official references to distinguish report preparation, format and submission when reviewing Canadian post-market safety reporting.
Start with the current summary-report guidance
Health Canada’s guidance addresses annual summary reports for marketed drugs and natural health products, interim reports for natural health products, and issue-related reports for drugs. Check the product scope and the dedicated preparation and submission sections before applying it to a reporting activity.
Guidance on preparing and submitting summary reports
Official source page date: .
Check the PSUR and PBRER references
The agency’s PBRER questions and answers discuss PSUR and PBRER formats for annual summary reports. Read this background alongside the current guidance; preparing a report and submitting it are separate questions.
Health Canada PBRER adoption questions and answers
Official source page date: .