Canada Profile Updated

July 26, 2024
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The Canada profile in ClinRegs has been reviewed and updated with the following information:

  • Health Canada (HC) guidance on filing submissions electronically, including electronic Common Technical Document (eCTD) submission, non-eCTD electronic submission, and validation rules (See Submission Process) 
  • HC implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials as of 2023 (See Risk & Quality Management)
  • Additional information from HC guidance on end-of-study reporting and requirements (See Progress Reporting)
  • Additional information from HC guidance on sponsor notification to HC when a study has been suspended (See Risk & Quality Management)
  • Additional information regarding Canada's ICH membership and implementation of ICH guidelines (See Regulatory Authority)

Sources Added During this Update:

(Not Available Online) Common Electronic Submissions Gateway (CESG) Health Canada Reference Guide (Last Updated April 2022) (*Note: Only available upon request. See Submission Process section for details) (G-CESG)

(Guidance) Guidance Document: Preparation of Regulatory Activities in the Electronic Common Technical Document (eCTD) Format (G-eCTD) (Effective March 13, 2020)
Health Canada (*Note: Latest version available upon request. See Submission Process section for details)

(Guidance) Guidance Document: Preparation of Regulatory Activities in Non-eCTD Format (G-Non-eCTD) (Effective May 15, 2024)
Health Canada (*Note: Latest version available upon request. See Submission Process section for details)

(Guidance) Preparation of Clinical Trial Applications for Use of Cell Therapy Products in Humans (G-CTACell) (August 21, 2015)
Health Canada

(Guidance) Quality Requirements for Investigational Biologic Drugs Used in Clinical Trials: Notice to Clinical Trial Sponsors (G-QltyBioCTs) (Last Updated July 23, 2024)
Health Canada

(Guidance) Validation Rules for Regulatory Transactions Provided to Health Canada in the Electronic Common Technical Document (eCTD) Format (Rules-eCTD) (January 30, 2024)
Health Canada

(Notice) Implementation of ICH E19: A Selective Approach to Safety Data Collection in Specific Late-stage Pre-approval or Post-approval Clinical Trials (HCNotice-ICH-E19) (Last Updated February 27, 2024)
Health Canada

(Not Available Online) Health Canada – Clinical Trial Applications in eCTD format (September 2022) (*Note: Only available upon request. See Submission Process section for details) (CAN-36)

(Form) Dossier ID Request Form for Biologic Clinical Trial Dossiers (CAN-20) (Last Updated November 2, 2023)
Health Canada

(Form) Dossier ID Request Form for Pharmaceutical Clinical Trial Dossiers (CAN-21) (Last Updated November 2, 2023)
Health Canada

(International Guidance) A Selective Approach to Safety Data Collection in Specific Late-Stage in Specific Pre-Approval or Post-Approval Clinical Trials E19 (CAN-15) (Step 4 Version) (September 27, 2022)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Webpage) Electronic Submissions Gateway (CAN-51) (Current as of July 11, 2024)
U.S. Food and Drug Administration

(Webpage) Frequently Asked Questions - Common Electronic Submissions Gateway (CAN-28) (Last Updated January 17, 2020)
Health Canada

(Webpage) How to Use the Common Electronic Submissions Gateway to Send Regulatory Transactions to Health Canada (CAN-34) (Last Updated May 23, 2024)
Health Canada

(Webpage) International Council for Harmonisation (ICH) – Health Canada Role in ICH (CAN-10) (Last Updated February 15, 2022)
Health Canada

(Webpage) Resources (CAN-11) (Current as of July 25, 2024)
Network of Networks (N2)

(Webpage) User Guide - Electronic Submissions Gateway (CAN-47) (March 1, 2022)
U.S. Food and Drug Administration

Sources Revised During this Update:

(Guidance) Filing Submissions Electronically (ElecSubms) (Last Updated June 17, 2024)
Health Products and Food Branch, Health Canada

(Not Available Online) NIAID Communication with Health Canada (May 2024) (CAN-44)

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