Health Canada

Diclectin is a drug authorized in Canada to treat nausea and vomiting in pregnancy (i.e. morning sickness). The safety of Diclectin was recently reviewed by Health Canada as part of its routine health product monitoring. Public interest was also raised by recent media reports on Diclectin.

A safety review was carried out by Health Canada to evaluate the increased risk of heart failure with the use of DPP-4 inhibitors as a follow-up to a risk communication released by the U.S. FDA stating that saxagliptin and alogliptin might increase the risk of heart failure, in particular in...

Health Canada reviewed the risk of IR thermometers being inaccurate when checking the temperature of children under 2 years old because of new information that became available. At the time of the review, IR thermometers were not recommended to be used in children under 2 years old.

Health Canada carried out a safety review due to concerns regarding complications associated with the Essure device after it is inserted into the fallopian tubes. In certain cases, the symptoms have led patients to have the Essure device removed, which requires surgical intervention and may...

Health Canada's top priority is protecting the health and safety of Canadians. The department has a strong record of enhancing drug safety in Canada and is continually looking for ways to strengthen it.

Thousands of Canadians are turning to laser eye surgery to correct their vision and eliminate their dependency on glasses or contact lenses. Like all medical procedures, laser eye surgery provides benefits, but poses risks.

Acetaminophen is safe and effective when used as directed, but there is a limit to how much you can take in one day. Taking more than the recommended dose can cause severe or even fatal liver damage.

Educational module includes an outline of Vanessa’s Law, who/what/when of regulations for mandatory reporting of adverse drug reactions and medical device incidents, required data elements in reports.

Educational module includes considerations for mandatory reporting of adverse drug reactions and medical device incidents, reporting options to Health Canada, differentiating types of reactions, incidents and problems.

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.