What Works in Canada? Everything eCTD!

Health Canada Guidance

At this time, Health Canada does not fully accept eCTD (without paper), nor has the agency announced a target date for doing so. They do accept the following:

  • eCTD-formatted submissions on CDs and DVDs accompanied by full paper submissions in CTD format, also known as "co-submissions" (being phased out)
  • Complete eCTD submission accompanied by a paper copy of Modules 1 and 2, known as a hybrid submission (Modules 3 thru 5 will be subject to 'Print on Demand' requests)

The following table summarizes the eCTD-related guidance documents issued by Health Canada:

Health Canada eCTD Guidance Documents

 Document Issue Date URL
Electronic Health Product Submissions Gateway Comes to Canada - Regulatory Cooperation Delivers Improvements for Industry  Jan 2014 http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2014/2014-012-eng.php
Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format  April 2013  http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ectd/ectd_valid_rev_v0.2a_notice_avis-eng.php
GUIDANCE FOR INDUSTRY - Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format Nov 2009 http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/prep_ectd_format-eng.pdf
Guidance to Industry: Preparation of Submissions in the Electronic Common Technical Document or eCTD Format - Questions and Answers May 2008 http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/qa_qr_guide_ectd-eng.php
Guidance for Industry - Creation of the Canadian Module 1 eCTD Backbone File Sept 2012 http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/ctd/ectd/ectd_mod1_guide-ld_fin-eng.pdf
Canadian DTD Version 1.0 for ICH Module 1 eCTD May 2004 http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/zip/prodpharma/ca-regional-1-0.zip
Health Canada eCTD Validation Rules Nov 2007 http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/ectd_validation-eng.pdf