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.).

Health Canada eCTD Guidance

 

 

 

 

 

 

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.

Drug Master Files (DMFs)

As of January 1, 2016, Health Canada is no longer accepted paper DMFs. Paper DMF submissions received after this date will be shredded and returned at the owner’s expense.

By March 31, 2016, all existing DMFs in paper format must be replaced by a complete DMF conversion in “non-eCTD electronic-only” format. The following should be provided in “non-eCTD electronic-only” format effective immediately:

  • New DMFs
  • Transactions related to existing DMFs
  • DMF updates

DMFs can also be filed in eCTD format despite the lack of a formal guidance document as long as the following requirements are met:

  • Prior to filing a DMF in eCTD format a sample according to the eCTD guidelines must be provided to Health Canada, regardless of a company’s experience using eCTD format
  • A pre-technical meeting is recommended for companies using eCTD for the first time and is mandatory for DMF Type II and III.
  • A Dossier Identifier (e123456) should be requested via email to ereview@hc-sc.gc.ca, for all DMFs filed in eCTD format. The request should include a fully completed DMF application form.
  • DMFs provided in eCTD format must be sent via the Common Electronic Submission Gateway (CESG)

Clinical Trial Applications

A notice posted to the Health Canada website March 2 announced the acceptance of Clinical Trial Applications (CTA) in “non-eCTD electronic-only” format effective immediately. The following regulatory activities, and transactions related to those regulatory activities, will be accepted:

  • Clinical Trial Application (CTA)
  • Clinical Trial Application – Amendment (CTA-A)
  • Clinical Trial Application – Notification (CTA-N)
  • Clinical Trial Site Information (CTSI) Forms
  • Pre-CTA Meeting information
  • Response to Clarification Request
  • Response to Notice of Screening Deficiency Notice (SDN)
  • Authorization for Sharing Information (Consent Letter)

As of June 1, 2016, Health Canada will no longer accept paper copies of these regulatory activities or their related transactions.

2016

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

2015

Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format

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