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 hc.ereview.sc@canada.ca, 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 hc.ereview.sc@canada.ca inbox.
  • Organisation and Document Placement for Canadian Module 1 of the Common Technical Document (CTD) Structure (available upon request via email at: hc.publications-publications.sc@canada.ca) [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.

eCTD Format only

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

Non-eCTD Format only

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

Current Pilots

Open Consultations and Upcoming Activities

Supporting documents and pages from the International Conference on Harmonisation (ICH)

Additional information

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