Canada Profile Updated
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 Consent for Specimen)
- Details on amendments to clinical trial applications and Health Canada's (HC) authority to suspend/cancel a clinical trial (See Scope of Assessment)
- Clarification on research procedures involving human reproduction, embryos, and fetuses (See Pregnant Women, Fetuses & Neonates)
- Clarification on the non-eCTD submission format and requirements to HC (See Submission Process)
- Clarification on when to submit a development safety update report (See Safety Reporting)
- Reorganization of the investigational product packaging information included in Product Management
Sources Revised During this Update:
(Guidance) Filing Submissions Electronically (ElecSubms) (Last Updated June 5, 2023)
Health Products and Food Branch, 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 2) (Updated March 14, 2023)
(Guidance) Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (G-TCPS2) (December 2022)
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada
(Legislation) Food and Drugs Act (R.S.C., 1985, c. F-27) (CanadaFDA – English and French) (Last Amended January 14, 2023)
Parliament of Canada
(Legislation) Human Pathogens and Toxins Act (S.C. 2009, c. 24) (HPTA) (Last Amended January 14, 2023)
Parliament of Canada
(Legislation) Privacy Act (R.S.C., 1985, P-21) (PrivAct) (Last Amended October 1, 2022)
Parliament of Canada