Health Canada Guidance

Health Canada now fully accepts eCTD submissions without complementary paper hard copies. As of January 2014, a Common Electronic Submissions Gateway (CESG) is available for sponsors as a service of convenience. At this time Health Canada is only accepting regulatory transactions in eCTD format via CESG.

Submissions in eCTD format can also be delivered to the Agency using various forms of media (CDs, DVDs, external hard drives, etc.). 

As of April 1, 2012, Health Canada no longer accepts co-submissions or hybrid submissions. The Agency does however reserve the right to invoke ‘Print on Demand’ for certain file formats in modules 3 to 5.

To navigate to eCTD-related guidance documents issued by Health Canada, please select the appropriate links below.

2014

Electronic Health Product Submissions Gateway Comes to Canada – Regulatory Cooperation Delivers Improvements for Industry

2013

Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format

Canadian Module 1 Schema Version 2.2 (extension of deadline)

2012

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

Guidance for Industry – Creation of the Canadian Module 1 eCTD Backbone File