How Should Health Canada Regulate Drug Approvals with Conditions?

Official title: Consultation: Draft guidance on terms and conditions for human and veterinary drugs

Open Regulations & Permits Health & Safety
Health Canada is updating how it can attach conditions to drug approvals. Starting April 2027, the agency will have new powers to require drugmakers to meet specific terms after a medication hits the market. This consultation asks whether the draft rules are clear enough for industry and healthcare professionals to follow.

Why This Matters

Ever wonder how a drug gets approved before all the long-term data is in? These rules govern that process. When Health Canada approves a medication with conditions, it can require the company to submit more safety data later. If you take prescription medications, these rules affect how quickly new treatments reach you—and what safeguards stay in place afterward.

What Could Change

Starting April 2027, Health Canada gains expanded authority to set terms and conditions on drug approvals. Drugmakers may face new requirements to submit post-market safety data, conduct additional studies, or meet specific labeling standards. The guidance clarifies when and how these conditions will be applied to both human and veterinary medications.

Key Issues

  • Are specific sections of the draft guidance unclear and need revision?
  • What other suggestions should Health Canada consider for the terms and conditions framework?

How to Participate

  1. Read the notice and draft guidance to understand the proposed changes.
  2. Send your feedback to policy_bureau_enquiries@hc-sc.gc.ca with the subject line "Comments on Draft guidance on terms and conditions for human and veterinary drugs".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