Consultation on draft guidance on Ministerial Reliance Order for certain human and veterinary drugs

Health Canada is seeking feedback on draft guidance on the Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities. This draft guidance sets out the regulatory requirements and process for manufacturers seeking deeming under the Order when filing human or veterinary drug submissions.

The guidance is to be read along with the Order.

Learn more:

• Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs
• Draft guidance on Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities

Also read the notice for the new draft guidance.

Join in: How to participate

Send us an email

Send an email to policy_bureau_enquiries@hc-sc.gc.ca with your ideas or comments. In the subject line of the email, use "Comments on Draft guidance on Ministerial reliance order for human and veterinary drugs".

Who is the focus of this consultation

We will engage with:

• industry (human and veterinary)
• health care professionals

Key questions for discussion

We are seeking your input on the following:

• Do you believe that specific sections or statements would benefit from more clarity (if so, please identify)?
• Do you have any other general suggestions or questions for us to consider?

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