How Should Health Canada Approve Drugs Based on Promising Evidence?

Official title: Consultation: Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions

Open Regulations & Permits Health & Safety
Health Canada wants feedback on new rules for approving drugs faster when early evidence looks promising. Right now, some drugs get approved with conditions attached. The new "Agile Licensing" system would formalize this process for both human and veterinary medicines, taking effect April 2027.

Why This Matters

Ever wonder how new treatments get to patients faster? This is about that. When a drug shows promise but needs more study, Health Canada can approve it with conditions. These rules affect how quickly you might access new medications—and what safeguards stay in place.

What Could Change

The current "Notice of Compliance with conditions" policy gets replaced by new Agile Licensing rules. Drug companies could get faster approvals for promising treatments, but with strings attached. Health Canada gains formal authority to set terms and conditions on these approvals starting April 2027.

Key Issues

  • Are there sections of the draft guidance that need clearer wording?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

How to Participate

  1. Read the draft guidance document and the related announcement notice.
  2. Email your feedback to policy_bureau_enquiries@hc-sc.gc.ca with the subject line "Comments on Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions".

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