Should Drugs Be Approved Faster 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Official title: Consultation: Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions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 to change how it approves drugs that show promise but don't yet have full clinical trial data. Right now, some drugs get conditional approval through the "Notice of Compliance with conditions" process. The new rules would let Health Canada attach specific terms and conditions to these approvals, requiring drugmakers to complete studies after the drug hits the market.

Why This Matters

Waiting for a new treatment that could help you or a loved one? This affects how quickly promising drugs reach Canadian patients. Faster approvals could mean earlier access to life-saving treatments. But there's a trade-off: less data upfront means more uncertainty about long-term safety.

What Could Change

Starting April 1, 2027, Health Canada will have new powers under the Agile Licensing Regulations. Drugmakers could get approval based on "promising evidence" instead of full clinical trials. In exchange, they'd have to meet specific conditions—like completing additional studies or reporting safety data. This replaces the current NOC/c policy for human drugs and the terms and conditions policy for veterinary drugs.

Key Issues

  • Are there sections of the draft guidance that need clearer explanation?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

How to Participate

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 Read the draft guidance document and the related announcement notice.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 Send your feedback to policy_bureau_enquiries@hc-sc.gc.ca with the subject line "Comments on Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions".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