Revised Draft Guidance Document Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format

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.

This guidance document has been updated to facilitate the use of a common format for submission filings and management of information over the lifecycle of a product. Once finalized, this guidance document will supersede the 2003 Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format and all other references to the layout of Modules 1 and/or 3.2.R, where extensive changes have been made to provide placeholders for regional documents throughout the lifecycle of the product.

How to Get Involved

This consultation is open for comment starting August 8, 2011 until October 7, 2011. 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 October 7, 2011.

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.