Should Drug Companies Report Foreign Safety Actions Differently?
Official title: Consultation for guidance on notifying Health Canada of foreign actions
Health Canada is updating rules for how drug companies must report when other countries take safety actions on their products. The changes aim to make reporting clearer and more efficient for both industry and regulators.
Why This Matters
When a drug gets pulled or restricted in another country, Canadians need to know quickly. These rules determine how fast that information reaches Health Canada. Clearer reporting could mean faster safety decisions on medications you take.
What Could Change
Drug companies will have updated forms and clearer instructions for reporting foreign safety actions. The guidance document is being rewritten in plain language. Follow-up reporting requirements may become more streamlined.
Key Issues
- Are the proposed changes to the guidance document clear and practical?
- Do the updated notification forms capture the right information?
How to Participate
- Review the existing guidance document to understand current requirements.
- Contact mhpdpolicy-politiquesdpsc@hc-sc.gc.ca with questions about the consultation.
What Happened
The consultation closed on November 24, 2025. Health Canada will consider all input received before publishing the final versions of the guidance document and notification forms.