Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions: Post-market safety
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Post-market safety monitoring
For human drugs only, risks and uncertainties may need to be addressed through Risk Management Plans (RMPs).
For more information on requirements for RMPs, refer to:
All drugs that have been authorized based on promising evidence of efficacy, or subsequent-entry drugs (generic drugs and biosimilars) that compare to such a drug, may be subject to enhanced post-market safety monitoring, reporting and active surveillance.
For more information on post-market safety monitoring, reporting and surveillance, refer to:
- Reporting adverse reactions to marketed health products
- Preparing and submitting summary reports for marketed drugs and natural health products - Guidance document for industry
- Notifying Health Canada of foreign actions - Guidance document for industry
- Adverse veterinary drug reactions
Adverse reaction reporting
For human drugs
Adverse events (AE) and adverse reaction (AR) reports from confirmatory trials must follow clinical trial application requirements if conducted in Canada.
These reports, outlined in the terms and conditions letter for drugs with marketing authorization based on promising evidence of clinical effectiveness, must be reported to Health Canada. These reports should be submitted electronically whenever possible.
Sponsors are strongly encouraged to use the electronic reporting gateway to improve efficiency. We support the submission of clinical trial AR reports following international standards outlined in ICH E2B (R2). Manufacturers interested in setting up electronic reporting should contact the trading partner management office at tpmo-bgpc@hc-sc.gc.ca for assistance.
For manufacturers not yet connected to the electronic reporting gateway, reports can still be submitted by fax to the following Canada vigilance program fax lines:
- Pharmaceutical drugs directorate for pharmaceutical drugs: 613-941-2121
- Biologic and radiopharmaceutical drugs directorate for biologic and radiopharmaceutical drugs: 613-957-0364
As a reminder, market authorization holders (MAHs) of marketed human drugs must report post-market ARs to Health Canada as required by the Food and Drugs Act (FDA) and its regulations, and as explained in the Canada vigilance program's Overview of the reporting adverse reactions to marketed health products - Guidance document for industry.
On a case-by-case basis, we may ask manufacturers to update the drug labels, the human drug PM and RMP if:
- new safety concerns have been identified that were not a concern at the time of authorization
- new information has been obtained as a result of additional data obtained on the clinical benefit from the confirmatory studies
For veterinary drugs
For all veterinary drugs marketed in Canada, every MAH is required to report ARs known to them involving their marketed health products in accordance with the requirements of the FDA and its regulations. Serious adverse events occurring as part of confirmatory trials should be reported to the Veterinary Drugs Directorate (VDD) pharmacovigilance (PV) program by:
- telephone: 1-877-838-7322
- the electronic PV works gateway or
- completing the Adverse Event Reporting Form Veterinary Drugs Directorate (VDD) and submitting it by email to pv-vet@hc-sc.gc.ca
Manufacturers wanting to set up electronic reporting should contact the PV program at pv-vet@hc-sc.gc.ca for assistance.