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.

Guidance documents, notices and supporting documents

All electronic formats

• Regulatory Enrolment Process (REP)
  REP is a common intake method for transactions in eCTD and non-eCTD format across product lines (prescription drugs for human and veterinary use, biologics and radiopharmaceuticals for human use, medical devices for human use and disinfectants).
• Dossier ID request form for pharmaceutical/biologic dossiers
  A request should be sent a maximum of eight weeks prior to filing a regulatory transaction.
• Organisation and document placement for Canadian Module 1 [2024-04-02]
  This document contains a table detailing the organization and placement of documents within the Canadian module 1.
• Master File Application Form [2025-11-05] – current version 3.0.0
  Download stylesheet ZIP file
• Electronic Submissions Gateway (ESG)

eCTD format only

Depending on the regulatory activity type, this may be either the mandatory or recommended format.

• Dossier ID request form for Master File dossiers
  A request should be sent a maximum of eight weeks prior to filing a regulatory transaction.
• Dossier ID request form for clinical trial applications
  A request should be sent maximum of eight weeks prior to filing a regulatory transaction.
  • Dossier ID request form for biologic clinical trial dossiers
  • Dossier ID request form for pharmaceutical clinical trial dossiers
• Validation rules for regulatory transactions in eCTD format [2025-01-10]
• Guidance Document - Preparation of Regulatory Activities in eCTD Format, Clinical Trials in eCTD format (available upon request no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'Request for eCTD Guidance Document' is in the subject line of the email. [2020-03-31]
• Creation of the Canadian Module 1 Backbone - Guidance Document [2012-09-07]
• Canadian Module 1 Schema Version 2.2 [2012-07-06]
• Regulatory Transaction Descriptions for clinical trial transactions (available upon request no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'Request for Regulatory Transaction Descriptions' is in the subject line of the email. [2025-01-24]

Non-eCTD format only

The alternative electronic format for regulatory activities not mandatory or accepted in eCTD format.

• Guidance document - Preparation of regulatory activities in non-eCTD format (available upon request no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'non eCTD Guidance Document' is in the subject line of the email. [2025-11-27]
• Validation rules for regulatory transactions in non-eCTD format [2025-01-10]
• Dossier ID request form for biocide dossiers
  A request should be sent a maximum of eight weeks prior to filing a regulatory transaction.
• Folder structure
  The table below contains the zip files of the folder structure for each product line as outlined in the Guidance Document - Preparation of the Regulatory Activities in the non-eCTD format.

Consultations and upcoming activities

• Closed: Release of Draft Guidance Document: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format [2019-06-26]

International Council for 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)