Health Canada’s Review and Communication of Safety Findings and Clinical Trial Transparency

Module 4 describes Health Canada's review and communication of safety findings. Completion of Module 4 will enable you to provide an overview of health product vigilance in Canada and identify the stages of adverse reaction (AR) and medical device problem (MDP) report management. Health Canada builds post-market safety knowledge, which is integral to effective clinical use, from several data sources, including serious adverse drug reaction (serious ADR) and medical device incident (MDI) reports.

Health Product Vigilance and Monitoring

In addition to serious ADR and MDI reports, a variety of other data sources contribute to therapeutic product safety monitoring, including:

• mandatory reports from regulated parties,
• voluntary reports from health care professionals and consumers,
• foreign data such as manufacturer assessment of worldwide safety data,
• information sharing with foreign regulatory agencies,
• medical literature, and
• information generated from the Drug Safety and Effectiveness Network (DSEN).

Health Canada reviews and assesses reports and other data sources. This module reflects the broad scope of Health Canada's product vigilance activities beyond mandatory reporting by hospitals. Post-market surveillance monitors safety and effectiveness of health products by identifying and assessing potential safety signals through multiple sources including spontaneous reporting of adverse reactions to health products and medical device problems reports, literature review, annual safety summaries, DSEN, and liaising with other regulators.

The Health Product Vigilance Life Cycle

Health Canada's Health Product Vigilance Life Cycle encompasses everything from initial submission to post-market monitoring. The following table outlines the key stages of this process:

Communication of Safety Findings

Health Canada communicates safety findings to all Canadians, including hospitals, who are shown to share the learning. To facilitate this, Health Canada provides various resources to share AR and MDP data and findings, such as:

• Health Canada Safety Reviews
• Health Canada Recalls and Safety Alerts
• Health Product InfoWatch
• Drug and Health Product Register (DHPR)

Risk mitigation includes continuing observation, labelling changes, risk communications, product recall, and educational activities. Reporting a serious ADR or MDI to Health Canada is supported by hospital systems and processes to ensure that the care team and patients document the serious ADR or MDI effectively.

Clinical Trials Registration and Public Search Portal

Health Canada is committed to improving the transparency of Canadian clinical trial information. Health Canada has developed a draft guidance document and is proposing a clinical trials search portal. This portal would help make more Canadian authorized trial information available to the public and improve accessibility of this information. To complement this work, Health Canada is building a search portal to replace the existing Clinical Trials Database.

All Canadian authorized clinical trials would be included, with phased implementation. During the first phase of the portal, the department will publish information about authorized drug trials. Future phases will include information about trials investigating medical devices and NHPs. Users may search for clinical trials by:

• specific words
• status and location
• a certain date range

The main search interface for the Clinical Trial Portal allows you to match the medical condition to the terms in the database and refine your search further by Trial status and/or by Province or territory.