Canada Profile Updated

June 16, 2023

The Canada profile in ClinRegs has been reviewed and updated with the following information:

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