Draft Guidance for Industry: Creation of the Canadian Module 1 Backbone

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.

Health Canada is pleased to announce the release of the Draft Guidance for Industry: Creation of the Canadian Module 1 Backbone for a 30 day consultation period. Once final, it will replace the 2004 Guidance for Industry: Creation of the Canadian Module 1 eCTD Backbone File.

This guidance document outlines the creation of a regional backbone file according to the Canadian Module 1 schema. The Canadian Module 1 Schema files are to be used in the preparation and filing of drug regulatory activities in the electronic Common Technical Document (eCTD) format established by the International Conference on Harmonization (ICH).

How to Get Involved

This consultation is open for comment starting March 30, 2012 until April 30, 2012. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

• eReview@hc-sc.gc.ca
• Submission and Information Policy Division (SIPD)
  Therapeutic Products Directorate
  Health Canada
  Finance Building 2,
  Address Locator 0201A1
  101 Tunney's Pasture Driveway
  Ottawa, Ontario
  K1A 0K9
• Telephone: 613-941-7281
  Fax: 613-941-0825

Consultation Document

Interested parties are encouraged to provide comments and suggestions by April 30, 2012.

Reporting to Canadians

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

If you have any questions, contact us at eReview.