Canada Profile Updated

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 for clinical trial submissions/applications in the eCTD and non-eCTD electronic-only formats (See Submission Process)

Change to the retention period for clinical trial-related documentation from 25 years to 15 years (See Scope of Review, Quality, Data, & Records Management and Product Management)
Requirements related to data protection (See Quality, Data, & Records Management)

Sources Added During this Update:

(Guidance) Filing Submissions Electronically (ElecSubms) (Last Updated August 8, 2022)
Health Products and Food Branch, Health Canada

(Guidance) Guidance Document: Preparation of Regulatory Activities in Non-eCTD Format (Non-eCTDformat) (Effective February 28, 2022)
Health Canada

(Guidance) Policy Statement: Use of Pharmacometrics in Drug Submissions and Clinical Trial Applications (G-Pharmacometrics) (Last Updated March 31, 2021)
Health Canada

(Guidance) Validation Rules for Regulatory Transactions Provided to Health Canada in the “non-eCTD electronic-only” Format (Rules-Non-eCTD) (Version 5.1) (Effective August 1, 2022)
Health Canada

(Legislation) Personal Information Protection and Electronic Documents Act (S.C. 2000, c.5) (PIPEDA) (Last Amended June 21, 2019)
Parliament of Canada

(Legislation) Privacy Act (R.S.C., 1985, P-21) (PrivAct) (Last Amended June 23, 2022)
Parliament of Canada

(International Guidance) General Considerations for Clinical Studies E8(R1) (CAN-49) (October 6, 2021)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) ICH E8(R1): General Considerations for Clinical Studies (CAN-48) (October 6, 2021)
Health Canada

(Not Available Online) NIAID Communication with Health Canada (June 2022) (CAN-44)

(Webpage) ClinicalTrials.gov (CAN-45) (Current as of August 11, 2022)
US National Library of Medicine

(Webpage) ISRCTN Registry (CAN-46) (Current as of August 11, 2022)
ISRCTN Registry

(Webpage) Office of the Privacy Commissioner of Canada (CAN-42) (Last Updated July 5, 2022)
Office of Privacy Commissioner of Canada

(Webpage) Provincial and Territorial Privacy Laws and Oversight (CAN-43) (Last Updated June 11, 2020)
Office of Privacy Commissioner of Canada

(Webpage) REB Review Fees (CAN-1) (Effective January 1, 2022)
University of Alberta

(Webpage) Regulatory Innovation for Health Products: Overview (CAN-41) (Last Updated February 23, 2022)
Health Canada

Sources Revised During this Update:

(Webpage) Pharmaceutical Drugs Directorate (CAN-18) (Last Updated May 2, 2022)
Health Products and Food Branch, Health Canada

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