Health Products and Food Branch Inspectorate (HPFBI)

The primary role of the HPFB Inspectorate is to deliver a national compliance and enforcement program for products under the mandate of the Health Products and Food Branch. Additionally, the Inspectorate works in close association with Healthy Environments and Consumer Safety Branch in the delivery of inspection and investigation activities for products regulated under the Controlled Drugs and Substances Act, and with the Canadian Food Inspection Agency which is responsible for inspection, compliance and enforcement activities related to food products.

The Inspectorate's program is accomplished through industry inspection, product investigation, establishment licensing and related laboratory functions. In fulfilling these responsibilities, a risk management approach to decision-making is applied and senior management's vision of a comprehensive regulatory strategy across all product classes is supported.

Please refer to the policy document on Inspection Strategy for Clinical Trials. Two phases were planned for the implementation of inspections of clinical trials. First, a "voluntary" phase in 2002 when sites selected for inspections were selected on a voluntary basis.

The final phase of implementation was initiated in January 2003, and from that date the selection of sites for inspection is jointly made by the Therapeutic Products Directorate (TPD), the Biologics and Genetic Therapies Directorate (BGTD) and the Inspectorate. A formal rating is issued to the inspected party and, in cases of serious deficiencies, could have an impact on maintaining the authorization to conduct a clinical trial.

A Summary Report of the Inspections conducted in 2003/2004 is available.

All clinical trials should adhere to the Health Canada / ICH Guidance Document E6: Good Clinical Practice: Consolidated Guideline.