Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD)

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Health Canada is pleased to announce the release of the Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) for a 60-day consultation period. Once final, it will replace the 2009 Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document Format.

The guidance document defines the electronic format requirements and process, as well as provides additional guidance on the structure and content of information to be included in regulatory activities in eCTD format. It provides a few examples of documents and their locations in the new structure define in the revised Canadian Module 1 Backbone. It also includes a complete discussion of the eCTD electronic-only filling format and the regulatory activity types now accepted in this filling format.

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.