ABSTRACT — EDITORS' SUMMARY

Health Canada collection of GCP compliance guidance, inspection information, and enforcement policies for clinical trials under Division 5.

HUB ENTRY

Good Clinical Practices

The Regulatory Operations and Enforcement Branch (ROEB) has the responsibility for the inspections and investigations of clinical trials.

These new functions were announced in January 2000, and along with the publication in June of the new Regulations on clinical trials involving humans, these provide a clear framework for the performance of clinical trials in Canada. In addition, these Regulations integrate the principles of Good Clinical Practices (GCP) as described by the International Conference on Harmonization (ICH).

The inspection of clinical trials will be initiated in close collaboration with the Therapeutic Products Directorate (TPD) and the Biologic and Radiopharmaceutical Drugs Directorate (BRDD). Approximately 2% of all clinical trials will be inspected, a percentage similar to what is being performed in other jurisdictions. Results of these inspections may be used in the evaluation of submissions.

These inspection and investigation functions have as main objective to reduce risks to subjects enrolled in clinical trials, while encouraging sponsors in their research activities for new therapies.

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. For more information, please consult the Notice on the period reduction for keeping clinical trial records for drugs and natural health products.