Filing Submissions Electronically
Companies are required to file submissions electronically to Health Canada in either Electronic Common Technical Document (eCTD) format or non-eCTD format, depending on the regulatory activity type. The sections below include links to documents that provide detailed information on these formats and other information related to filing submissions electronically.
Due to their format, some documents are only available and labeled as "available upon request". If you have an email client installed on your computer, when you click the link to these documents, an email message should appear with some information pre-filled; Simply 'Send' this message. If an email message does not appear, send an email to email@example.com, and request the titled document.
Guidance Documents, Notices and Supporting Documents
All Electronic Formats
- Dossier ID Request Form for Pharmaceutical/Biologic Dossiers [2019-08-12]
- New Dossier ID Process – Effective immediately, the Dossier ID Request Form must be the only method used to request for a Dossier ID from Health Canada for REP and eCTD dossiers (Master Files and Clinical Trial eCTD Pilot excluded). Upon completion of the form, an email will automatically be sent to the firstname.lastname@example.org inbox.
- Organisation and Document Placement for Canadian Module 1 of the Common Technical Document (CTD) Structure (available upon request via email at: email@example.com) [2019-07-17]
- This table details the organization and placement of documents within the Canadian Regional Module 1 section of the Common Technical Document (CTD) structure. It lists the Module 1 sections/subfolders, along with a list of the possible documents that must be placed in these sections/subfolders when provided as part of a regulatory transaction to Health Canada.
- Regulatory Transaction Descriptions (available upon request via email at: firstname.lastname@example.org) [2019-07-15]
- A list of descriptions, by regulatory activity type, that details the reason for filing a transaction. Note: This document is updated frequently.
- New regulatory activity types for filing to the Marketed Health Products Directorate (MHPD) [2019-06-14]
eCTD Format only
Depending on the regulatory activity type of the drug, this may be either the mandatory or recommended format.
- Validation Rules for regulatory transactions filed in eCTD format [2018-11-30]
- Mandatory use of eCTD Format - Notice [2019-09-13]
- Mandatory use of Common Electronic Submission Gateway (CESG) [2016-12-28]
- Preparation of Regulatory Activities in eCTD Format - Guidance Document [2015-06-11]
- Creation of the Canadian Module 1 Backbone - Guidance Document [2012-09-07]
- Canadian Module 1 Schema Version 2.2 [2012-07-06]
Non-eCTD Format only
The alternative electronic format for regulatory activities not mandatory or accepted in eCTD format.
- Validation Rules for regulatory transactions filed in non-eCTD format [2019-02-05]
- Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format - Guidance Document [2016-12-14]
- eCTD Pilot for Clinical Trial Regulatory Activities - Notice [2017-12-19]
- Regulatory Enrolment Process (REP) Pilots
Open Consultations and Upcoming Activities
- Release of Draft Guidance Document: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format [2019-06-26]
- Mandatory Requirements of using eCTD Format for Master Files (MF) - Notice [2018-05-07]
Supporting documents and pages from the International Conference on Harmonisation (ICH)
- ICH Working Group on Electronic Standards for the Transfer of Regulatory Information (ESTRI)
- ICH eCTD Specification and Related Files
- ICH M4: The Common Technical Document (CTD)
- Preparation of Regulatory Activities in the Common Technical Document (CTD) Format [2012-06-22]
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