Canada Profile Updated

November 6, 2026
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The Canada profile in ClinRegs has been reviewed and updated with the following information:

  • Health Canada’s (HC) implementation of the International Council for Harmonisation (ICH) E6(R3) Good Clinical Practice guideline, and clarification that the Food and Drug Regulations take precedence where they exceed the guidance (reflected throughout the profile)
  • Information on HC’s interim policy for modernizing the clinical trial framework, including streamlined ethics committee (EC) contact information for multi-site trials, investigator eligibility requirements, records retention requirements for sponsors, and documented informed consent approaches (See Submission Content, Site/Investigator Selection, Data & Records Management, and Documentation Requirements)
  • HC guidance for clinical trials with decentralized elements, addressing regulatory and ethics review, site identification, delegated activities, oversight, monitoring, digital technologies, participant consent, and investigational product handling (See Scope of Assessment, Scope of Review, Initiation, Agreements & Registration, the Sponsorship topic, Documentation Requirements, and Product Management)
  • Additional information from HC on expanded access clinical trials, including eligibility and HC review (See Scope of Assessment)
  • Updated HC information on submissions in non-electronic Common Technical Document (non-eCTD) format, including file preparation, validation, and delivery of initial clinical trial applications and amendments (See Submission Process)
  • Expanded information from the Tri-Council Policy Statement (TCPS) on EC procedures, including member training, quorum, delegated and full-board review, continuing review, recordkeeping, and the safety monitoring information submitted for ethics review (See Ethics Committee and Submission Content)
  • HC guidance on trial registration and public disclosure of results, including registration timing, Canadian sites in multinational trials, summary results reporting timelines and permitted exceptions and deferrals, and the Canadian Clinical Trial Search Portal (See Initiation, Agreements & Registration and Progress Reporting)
  • HC guidance on sponsor and investigator responsibilities and requirements related to trial agreements, safety assessments, risk-based quality management and monitoring, serious noncompliance reporting, site and investigator selection, electronic systems and records, and risk classification (See Initiation, Agreements & Registration, Safety Reporting, and the Sponsorship topic)
  • Additional TCPS and HC information on informed consent, including on documentation, language accessibility, emergency enrollment safeguards, pediatric assent, and research during publicly declared emergencies (See the Informed Consent topic)
  • Expanded TCPS information on future unspecified use of data and biological materials, biobank governance and safeguards, ethics approval for data linkage, and broad consent (See Personal Data Protection, Specimen Import & Export, and Consent for Specimen)
  • Additional HC information on investigational product manufacturing and quality control, import authorization, labeling and traceability, expiration dating, drug accountability records, and PIC/S membership (See the Investigational Products topic)

Sources Added During this Update:

(Guidance) Broad Consent: Clarifications and Considerations for Researchers and Research Ethics Boards (Brd-Cnst) (Last Updated August 4, 2026)
Panel on Research Ethics, Government of Canada

(Guidance) Guidance for Clinical Trials with Decentralized Elements (G-Dcntrl) (Effective October 27, 2026)
Health Canada

(Guidance) Guidance on Expanded Access Clinical Trials (Expd-CTs) (Effective September 29, 2025)
Health Canada

(Guidance) Guidance on the Registration of Clinical Trials and Public Disclosure of Results (CT-Rgstrn) (Effective July 29, 2026)
Health Canada

(Guidance) Research Ethics During Publicly Declared Emergencies (Ethcs-Emrgcy) (Last Updated May 27, 2026)
Panel on Research Ethics, Government of Canada

(Guidance) Risk Classification Guide for Observations Related to Inspections of Clinical Trials of Human Drugs (GUI-0043) (Risk-Insp) (Version 3) (Effective April 1, 2026)
Health Canada

(Notice) Interim Policy for the Modernization of the Clinical Trial Framework (Mdrn-CTFrmwrk) (Last Updated September 14, 2026)
Health Canada

(Article) Core Elements of Consent Documentation for Clinical Research in Canada: Guidance for Policy (CAN-57) (September 15, 2025)
Longstaff, H, et al., Canadian Medical Association Journal

(International Guidance) Declaration of Helsinki (CAN-58) (October 2024)
World Medical Association

(Webpage) Canadian Clinical Trial Search Portal (CAN-59) (Current as of November 2, 2026)
Health Canada

(Webpage) International Clinical Trials Registry Platform (ICTRP) (CAN-60) (Current as of November 2, 2026)
World Health Organization

(Webpage) PIC/S - Pharmaceutical Inspection Co-operation Scheme (CAN-55) (Last Updated May 4, 2017)
Health Canada

(Webpage) Regulatory Roadmap for Biologic (Schedule D) Drugs in Canada (CAN-56) (Last Updated October 23, 2026)
Health Canada

Sources Revised During this Update:

(Guidance) Annex 13 to the Good Manufacturing Practices Guide - Drugs Used In Clinical Trials (GUI 0036) (G-GMP-Annex13) (Effective February 4, 2026)
Health Canada

(Guidance) Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (G-FDR-0100) (Version 4) (Effective August 14, 2026)
Health Canada

(Guidance) Guidance Document: Preparation of Regulatory Activities in Non-eCTD Format (G-Non-eCTD) (Effective November 27, 2025)
Health Canada (*Note: Latest version available upon request. See Submission Process section for details)

(International Guidance) ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3) (CAN-52) (Step 5 Version) (Implemented April 1, 2026)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Webpage) Instructions for Completing the Clinical Trial Site Information Form (CAN-30) (Last Updated September 14, 2026)
Health Canada

(Webpage) International Council for Harmonisation (ICH) – Guidelines (CAN-50) (Last Updated May 15, 2026)
Health Canada

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