How Should Health Canada Regulate Drug Approval Conditions?

Official title: Consultation: Draft guidance on terms and conditions for human and veterinary drugs

Open Regulations & Permits Health & Safety
Health Canada is updating the rules for attaching conditions to drug approvals. These conditions can require drugmakers to do things like submit more safety data or restrict how a drug is used. The new framework takes effect April 1, 2027, and this consultation asks whether the draft guidance is clear enough.

Why This Matters

Ever wonder how drugs get approved with strings attached? This is about that. When Health Canada approves a medication but wants more safety data, they can set conditions. These rules affect how quickly new treatments reach patients—and what safeguards come with them.

What Could Change

Starting April 2027, Health Canada will have new powers to attach conditions to drug approvals. The guidance clarifies when and how these conditions apply to both human and veterinary drugs. Drugmakers will need to follow updated rules for meeting these requirements.

Key Issues

  • Are there sections of the draft guidance that need clearer wording?
  • What other suggestions should Health Canada consider for this guidance?

How to Participate

  1. Read the notice explaining the consultation context.
  2. Review the draft guidance document on terms and conditions.
  3. Email your feedback to policy_bureau_enquiries@hc-sc.gc.ca with the subject line "Comments on Draft guidance on terms and conditions for human and veterinary drugs".

Submit Your Input

Draft Email
Questions Being Asked (2)
  1. Do you believe that specific sections or statements would benefit from greater clarity (if so, please identify)?
  2. Do you wish to share any other general suggestions or questions for consideration?

Key Documents