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Drugs and Health Products

Draft Guidance Document - The Use of Foreign Reviews by Health Canada

The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.

The purpose of this document is to provide guidance to market authorization holders on how Health Canada uses foreign reviews, and how they can help facilitate this use. Recognizing that market authorization holders currently provide foreign reviews to Health Canada, the principles and practices described in this draft document may currently be used, and will serve to formalize the existing practices until such time as the guidance is finalized. This guidance document is applicable to human and veterinary biologics, disinfectants, radiopharmaceuticals and pharmaceuticals (hereafter collectively referred to as drugs), and medical devices.

How to Get Involved

This consultation is open for comment starting September 9, 2011 until March 31, 2013. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

UFRI_URRE@hc-sc.gc.ca

Use of Foreign Regulatory Information Steering Committee
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Graham Spry Building 2004A
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-2758
Fax: 613-954-9981

Consultation Document - Updated

Interested parties are encouraged to provide comments and suggestions by March 31, 2013.

Reporting to Canadians

Health Canada will make the results of this consultation available on this website.

If you have any questions, contact us at the Use of Foreign Regulatory Information Steering Committee.