Canada Updates
Canada Profile Updated with Single Ethics Committee Review Guidance
Dec 23, 2024 - The Canada profile in ClinRegs has been updated to include the Panel on Research Ethics (PRE) guidance on single ethics committee review for minimal risk research across multiple jurisdictions. The guidance supports the implementation of the Tri-Council Policy Statement: Ethical Conduct for ...
Canada Profile Updated with Additional Details on Therapeutic Products Oversight and ICH Guidelines Implementation
Oct 1, 2024 - The Canada profile in ClinRegs has been updated with the following information:Information related to the Minister of Health’s regulatory authority regarding therapeutic products that may present a risk of injury to health (See Regulatory Authority)Webpage providing details on Health Canada’s ...
Canada Profile Updated
Jul 26, 2024 - 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 ...
Canada Profile Updated
Jun 16, 2023 - The Canada profile in ClinRegs has been reviewed and updated with the following information:
Updated version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) (2022) (See Scope of Review, Personal Data Protection, Documentation Requirements, and ...
Canada Profile Updated
Aug 11, 2022 - The Canada profile in ClinRegs has been reviewed and updated with the following information:
New name of the Pharmaceutical Drugs Directorate (formerly Therapeutic Products Directorate) in Health Canada and updated contact information (See Regulatory Authority)
Updates to the process ...
Canada Profile Updated in ClinRegs
Aug 6, 2021 - The Canada profile in ClinRegs has been reviewed and updated with the following information:
Updated Drug Submission Application Form and Qualified Investigator Undertaking Form (See Submission Process, Trial Initiation, and Site/Investigator Selection)
New guideline ...
Canada Profile Updated in ClinRegs
Aug 20, 2020 - The Canada profile in ClinRegs now includes the following updates:
Updates to Health Canada contact information (See Regulatory Authority)
New information on the Research Ethics Board Attestation (See Scope of Review)
Revised versions of the Clinical Trial ...
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