Health Canada

Educational module helps identify and overcome barriers to hospital mandatory reporting of adverse drug reactions and medical device incidents, recognize opportunities and describe strategies and systems.

Educational module provides overview of health product vigilance, report management, post-market surveillance activities and Health Canada risk communications.

This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required by Health Canada, such as controlled distribution programs, are not intended to restrict access to Canadian Reference Products (CRPs) for generic drug manufacturers for...

We are issuing this notice to help drug manufacturers and sponsors when preparing the Canadian-specific considerations and elements in the risk management plans (RMPs) for certain drug products. This notice describes what is required for certain drug products.

Health Canada’s Evolving Approach to Leveraging Real World Evidence (RWE) for Drug Regulatory Decisions.

This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products, but excluding...

Health Canada sets the standards for health product advertising material in Canada to help advertisers produce messages that are not false, misleading or deceptive.

Learn how Health Canada makes sure that the health products you use are safe, effective and of high quality.

Only health products that Health Canada authorizes for sale in Canada may be advertised. Specific requirements exist for advertisements of prescription drugs to consumers.

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.