Should Drug Safety Monitoring Rules Be Updated?

Official title: Consultation: Guidance document updates for Good Pharmacovigilance Practices (GVP) inspections

Closed Regulations & Permits Health & Safety
Health Canada updated its guidelines for inspecting how drug companies track safety problems with their products. These rules, last updated in 2013, tell companies how to report side effects and safety issues. The consultation ran for 45 days and is now closed.

Why This Matters

Take any prescription or over-the-counter medication? These rules affect how drug companies track and report side effects. Stronger monitoring means problems get caught faster. That includes vaccines, blood products, and even medical gases used in hospitals.

What Could Change

Health Canada will finalize updated inspection guidelines for drug safety monitoring. Companies selling drugs in Canada will need to follow new standards for tracking and reporting adverse reactions. The 2013 guidelines will be replaced.

Key Issues

  • What updates are needed to the Good Pharmacovigilance Practices guidelines?
  • How should safety observations be classified by risk level?

How to Participate

  1. Review the GUI-0102: Good pharmacovigilance practices guidelines and GUI-0063: Risk classification guide.
  2. Comments could be submitted to gvp-bpv@hc-sc.gc.ca by the deadline.

What Happened

The consultation ran from September 15 to October 30, 2025. Input gathered will be considered when finalizing the guidance documents, which will replace the 2013 versions.

Key Documents