Consultation: Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions

Health Canada is seeking feedback on the Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions. This document will replace the current Notice of Compliance with conditions (NOC/c) policy and the Policy on terms and conditions for veterinary drugs. It explains the process for drug submissions based on promising evidence of efficacy. It also describes the new authority under the Agile Licensing Regulations, which will allow Health Canada to consider terms and conditions when reviewing these submissions. This authority will come into effect on April 1, 2027. It should be read alongside the Draft guidance on terms and conditions (T&Cs) for human and veterinary drugs.

Read the notice and draft guidance for consultation.

Join in: How to participate

Send an email to policy_bureau_enquiries@hc-sc.gc.ca with your ideas or comments. In the subject line, use "Comments on Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions".

Who is the focus of this consultation

We will engage with:

• industry
• healthcare professionals

Key questions for discussion

Your input is being sought to answer the following questions:

• Do you believe that specific sections or statements would benefit from greater clarity (if so, please identify)?
• Do you wish to share any other general suggestions or questions for consideration?

Related information

• NOC/c guidance for human drugs
• Policy on terms and conditions for veterinary drugs
• Draft guidance on terms and conditions (T&Cs) for human and veterinary drugs
• Canada Gazette, Part 2, Volume 158, Number 26: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing)

Contact us

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Email: policy_bureau_enquiries@hc-sc.gc.ca

From: Health Canada