Notice: Implementation of eCTD for clinical trial regulatory activities

February 19, 2020
Our file number: 20-102724-615

The pilot for Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format concluded on August 31, 2019. Health Canada is pleased to announce that the pilot was successful. Therefore, implementation of Clinical Trials regulatory activities in eCTD format will begin immediately for the following:

The following regulatory activities and/or transactions are out-of-scope for filing in eCTD format:

Implementation

The use of the eCTD format for Clinical Trial regulatory activities is optional. However, once a sponsor files a regulatory activity in eCTD format, all additional information and subsequent regulatory transactions for the same dossier (protocol) must also be filed in eCTD format. Sponsors cannot revert an eCTD dossier back to “non-eCTD electronic-only” format.

Use of common electronic submission gateway

All regulatory transactions in eCTD format (<10 GB) must be sent via the Common Electronic Submissions Gateway (CESG). Please refer to the CESG information page for details.

Related instructions and guidance documents

  1. Prior to filing a Clinical Trial regulatory transaction in eCTD format, each company must file a sample transaction to Health Canada in accordance with the eCTD guidance document.
  2. Health Canada recommends a Pre-technical meeting for companies using eCTD for the first time.
  3. Once Health Canada finds the eCTD sample acceptable, companies can request a Dossier Identifier (e123456) via the Dossier Request Form for Clinical Trials dossiers, available on the Filing Submissions Electronically page.
  4. Health Canada developed new documents to support companies in filing clinical trial regulatory transactions in eCTD format. Refer to the Health Canada Filing Submissions Electronically page where the following documents will be available:
    1. Life Cycle Management at the Document Layer for eCTD Clinical Trial Regulatory Activities
    2. Clinical Trial Applications in eCTD format
    3. Table of Clinical Trial Regulatory Transaction (sequence) Descriptions

Please direct all questions related to this notice via email to hc.ereview.sc@canada.ca.

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