Keeping health products in Canada safe

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Life cycle of a product

A health product is a drug or other product used for health purposes. Health products include:

The life cycle of a health product refers to all stages in the product's "life", before and after it comes onto the market. There may be many stages in the life cycle of a health product.

Depending on the product, the stages may include several or all of the following:

Regulatory frameworks have been developed to provide oversight of products.

Before a product comes to market

Once a product is identified as having the potential to be used for a health purpose, it goes through various phases of testing and evaluation.

Submissions for market authorization are required for the following:

The submission includes data from pre-clinical studies and clinical trials for drugs and biologics and/or other scientific information. Following a rigorous evaluation by Health Canada, the health product is authorized for use in Canada if it meets established standards for safety, efficacy and quality.

After a product comes to market

Health Canada's role doesn't end once a product is approved for use in Canada. In fact, we conduct a wide range of activities to make sure health products continue to be safe, effective and of high quality. These activities include the following:

Monitoring and reviewing safety information

Health Canada closely monitors reports of adverse reactions we receive through the Canada Vigilance Program from:

Companies and hospitals are mandated to report suspected serious adverse reactions and medical device incidents. This mandate is stated in the Food and Drug Regulations or the Medical Devices Regulations. Health professionals and consumers are also strongly encouraged to report adverse reactions and medical device incidents.

Anyone can report a side effect or medical device problem or incident from a health product. You can also report a side effect to other specific products. Your report can help make these products safer for people in Canada. Every report counts. Together, they tell a story.

In addition to reviewing adverse reaction and incident reports from domestic and international sources, Health Canada also conducts its own monitoring. We identify potential safety signals using multiple sources of information, including from:

A committee of scientific and medical evaluators reviews potential signals. This initial review is done to determine if a more detailed assessment is required.

Further assessment activities may include working with the Drug Safety and Effectiveness Network (DSEN) to fill information gaps in the evidence and literature. The Canadian Institutes of Health Research created DSEN in collaboration with Health Canada and other stakeholders to conduct real-world drug safety and effectiveness research.

If necessary, Health Canada may ask a company to carry out additional activities or post-market studies. We may need these studies done to help us gain more knowledge about the safety, effectiveness and quality of their health product.

How we respond to safety concerns

If any new safety issues are identified, we take prompt action, using the most appropriate level of intervention. To manage the risks to people in Canada, we may:

We may also require a company to establish, or revise, their risk management plans (RMPs). RMPs provide information on:

A plan may be requested for products that pose a new or more serious risk than was initially known at the pre-market stage.

Monitoring advertising and marketing

In addition to monitoring the safety and effectiveness of products and medical devices, Health Canada pays close attention to the marketing of authorized health products. Illegal marketing may potentially harm patients and adversely influence prescribing practices. Advertising and marketing is illegal if the claims:

When we are made aware of potential illegal advertising or marketing activities, we investigate the claims. We will take action as required. To keep people in Canada informed of illegal marketing, we publish summary tables:

For more information on illegal marketing activities, check out our stop illegal marketing program video. You can file a marketing complaint whenever you see marketing activities involving health products that may be illegal.

How we inform people in Canada

Health Canada is committed to providing information and data to consumers in an open and transparent manner. We communicate findings from our assessments and the decisions we make about various health products in a number of ways:

We also publish information for health care professionals. The Health Product InfoWatch is a monthly safety bulletin providing clinically relevant safety information.

Health care professionals and consumers can also find information through MedEffect. This centralized source of health product safety information provides access to:

Responding to COVID-19

Many potential health products for use against COVID-19 are being evaluated in Canada and around the world. Health Canada continues to work with international regulatory counterparts on an ongoing basis. This collaboration supports the review process and post-market activities of COVID-19 health products.

Following a rigorous scientific review, Health Canada approved a number of COVID-19 treatments and vaccines. As is the case with all health products, we continue to monitor the safety and effectiveness of COVID-19-related products.

For more information, we publish post-market information in the databases and publications listed above and on Canada's COVID-19 vaccine safety in Canada website. Information and resources for physicians, nurses, pharmacists and other health care providers can also be found on the COVID-19 page for health professionals.

Health Canada is closely monitoring post-marketing data for COVID-19 health products. Our enhanced approach in response to COVID-19 helps keep people in Canada both safe and informed.

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