Health Canada

Health Canada has adopted and integrated the use of risk management plans (RMPs) and the International Conference on Harmonization (ICH) E2E Guideline into the regulatory review of drugs in Canada. A risk management plan (RMP) is a document that identifies and characterizes risks and...

Information on risk management plan submissions for drugs including when to file, considerations, requirements, and compliance.

Opioid products need to include specific content within their RMP to address: the risk and uncertainties of opioid-related harms in Canada and other risks and uncertainties posed by the product, where warranted.

The RMP summary should include specific sections, which mirror the EU RMP Summary format sections.

A Canadian-specific addendum should address: risks or uncertainties that are unique to the Canadian context, and measures that the manufacturer intends to take that are unique to the Canadian context.

Each year, Health Canada receives thousands of reports of suspected adverse reactions (side effects) about drugs and natural health products and of suspected medical device incidents. These reports, captured through the Canada Vigilance Program, contribute to Health Canada’s post-market...

To ensure that advertising material meets Canadian regulatory standards for advertisements for drugs and medical devices, advertising preclearance agencies (APAs) provide review and preclearance services.

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in August 2023 by Health Canada.

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in September 2023 by Health Canada.

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in October 2023 by Health Canada.

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in November 2023 by Health Canada.

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in December 2023 by Health Canada.

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in January 2024 by Health Canada.

In Canada, many different organizations and individuals play a role in communicating risks associated with health products.

Despite the strong foundation of Canada’s existing Regulations, more can be done to improve the safety and effectiveness of medical devices and to optimize health outcomes for patients.

This guidance document is to help holders of Canadian authorizations for medical devices understand and comply with the regulatory requirements on foreign risk notification (FRN).

Requirements for manufacturers and importers for collecting medical device safety information and provide notification to Health Canada. A monitoring process should be in place to ensure compliance.

Medical device licence holders and importers of Class II to IV devices must notify Health Canada when there’s a serious risk of injury to human health concerning a device authorized for sale in Canada

Information needed for a submission to comply with the Regulations, licence holders and/or importers of Class II to IV medical devices

Health Canada and the Canadian Advertising Preclearance Agencies (APAs) share the common goal of maintaining integrity in health product advertising. The purpose of this guidance document is to inform staff and stakeholders of the different roles these organizations play in achieving this goal.