How Should Drug and Natural Health Product Companies Report Safety Information?

Official title: Consultation: Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products

Open Regulations & Permits Health & Safety
Health Canada is updating the rules for how pharmaceutical and natural health product companies must report safety information about their products. The new guidance aims to simplify and clarify reporting requirements. Companies would also get a new form to notify Health Canada when they learn something significant about a product's risks or benefits.

Why This Matters

This is mainly for pharmaceutical companies and natural health product manufacturers, not everyday Canadians. But better safety reporting means Health Canada gets faster, clearer information about drug risks. That could lead to quicker warnings or recalls when problems emerge with medications you take.

What Could Change

Drug and natural health product companies would follow updated reporting rules under the Food and Drug Regulations. A new notification form would standardize how companies alert Health Canada to significant safety findings. The guidance separates requirements for drugs and natural health products to reduce confusion.

Key Issues

  • Are the proposed changes to summary reporting requirements clear and practical for industry?
  • Does the new notification form effectively capture significant changes in product risk-benefit information?
  • Is separating guidance for drugs and natural health products helpful for compliance?

How to Participate

  1. Review the draft guidance on preparing and submitting summary reports and the draft notification form.
  2. Send your comments by email to mhpdpolicy-politiquesdpsc@hc-sc.gc.ca with the subject line "Summary Reporting Guidance – Consultation Comments".

Submit Your Input

Draft Email

Key Documents