Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) - Summary
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From Health Canada, Regulatory Operations and Enforcement Branch (ROEB)
Overview
This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in human subjects in Canada to comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations) and to understand the International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2) in the Canadian context.
Guidance documents are administrative instruments not having force of law. Alternate approaches to the principles and practices described in this guidance document and ICH E6(R2) may be acceptable provided they are supported by adequate scientific justification.
This guidance document was developed by Health Canada in consultation with stakeholders.
Who this guide is for
This guidance document is for any parties involved in the conduct of clinical trials of drugs in human subjects in Canada, such as:
- Sponsors
- Qualified Investigators (QIs)
- Contract Research Organizations (CROs)
- Site Management Organizations (SMOs)
Health Canada would like to inform stakeholders of a change to retain clinical trial records for drugs from 25 years to 15 years under the Food and Drug Regulations, effective February 11, 2022. This guidance document has been updated to reflect the change to a 15-year record retention period under the Food and Drug Regulations.
In this guide
- About this document
- Purpose
- Scope
- Introduction
- Guidance for implementation
- Regulations and Interpretations
- 5.1 Interpretation
- 5.2 Application
- 5.3 Prohibition
- 5.4 General
- 5.5 Application for Authorization
- 5.6 Authorization
- 5.7 Notification
- 5.8 Amendment
- 5.9 Additional Information and Samples
- 5.10 Good Clinical Practices
- 5.11 Labelling
- 5.12 Records
- 5.13 Submission of Information and Samples
- 5.14 Serious Unexpected Adverse Drug Reaction Reporting
- 5.15 Discontinuance of a Clinical Trial
- 5.16 Suspension and Cancellation (Intent to Suspend)
- 5.17 Suspension and Cancellation
Details and history
- Published:
- August 20, 2019
- Updated:
- March 14, 2023, version 2
- Consulted:
- December 15, 2017 to April 15, 2018 (see the consultation)
- Part of topic:
- Interpretation of Part C, Division 5 of the Food and Drug Regulations
Health Canada would like to inform stakeholders of the following minor changes for version 2 of this guidance document:
- The clinical trial records retention period for drugs has been changed from 25 years to 15 years as per section C.05.012 (4) of the Food and Drug Regulations, as of February 11, 2022.
- All links have been reviewed and updated (if required) for accuracy.
- The acronym TPD (for Therapeutic Drugs Directorate) has been changed to PDD (for Pharmaceutical Drugs Directorate).
- The acronym BGTD (for Biologics and Genetic Therapies Directorate) has been changed to BRDD (for Biologic and Radiopharmaceutical Drugs Directorate).
- The observation examples included in this guidance document have been updated for consistency with the cited observations in GUI-0043: Risk classification guide for observations related to inspections of clinical trials of human drugs.
For assistance
Clinical Trial Compliance Program
Contact us by email: GCP_BPC@hc-sc.gc.ca
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