By notice dated February 25, 2008, Health Canada has provided a revision to the Draft Guidance for Industry on Electronic Review Documents submitted as part of the preparation of a new drug submission. The document defines the electronic file requirements and provides guidance on the structure, content and format of electronic information to be included with submissions in the CTD format. This is the latest phase in this project that Health Canada is developing as a phased migration from the current paper-based and proprietary standards to the ICHe CTD specification. Submissions currently in preparation may continue to follow the Health Canada Guidance Documents in effect prior to the date of the release of this notice. However, effective April 1, 2008, all subsequent submissions should be compiled using the most recent revisions to the guidance documents.
For more information, please see: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/notice_avis_ctd_e.html