Keeping health products in Canada safe

Life cycle of a product

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

biologics, such as:
- vaccines
- biotechnology products
- human cells, tissues and organs
- human blood and blood components (for example, plasma, red blood cells, platelets)
- fractionated blood products (products from fractionating plasma, such as albumin and immonoglobulins)
medical devices
radiopharmaceuticals
natural health products
disinfectants and sanitizers
prescription and non-prescription drugs

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:

pre-clinical studies
clinical trial
submission of product information to Health Canada for review and evaluation
decision whether to authorize the product for use in Canada
ensuring compliance with manufacturing quality standards
licensing, registration and authorization of those involved in the supply chain (they're known as establishments), such as:
- manufacturing or processing
- testing
- packaging
- importation
- distribution
public access to the product
post-market activities

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:

conducting post-market surveillance
monitoring health product advertising
reviewing literature and new research data for emerging safety information
reviewing reported adverse reactions (side effects)
conducting safety assessments and reviewing medical device problems
engaging with stakeholders on new information available about a product, such as:
- industry stakeholders (including industry associations)
- Public Health Agency of Canada
- other federal departments
- provincial and territorial health authorities
- health professionals
- hospitals
- patient safety associations
- poison control centres
collaborating and exchanging data with international regulatory agencies
communicating proactively about potential risks associated with a health product

can include updating the product monograph or the instructions for use and, in extreme cases, restricting the use or removing the product from the market

conducting inspections and compliance verifications of regulated parties and products
taking compliance and enforcement action to reduce health risks

Monitoring and reviewing safety information

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

hospitals
health professionals and consumers
companies (market authorization holders or entities that hold the health product licence authorization or registration)

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:

international regulators
the Public Health Agency of Canada
provincial and territorial health authorities
environmental scanning of the scientific literature and media reports
periodic benefit-risk evaluation reports and safety reports submitted by companies

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:

work with the company to update product labels
communicate any new risks to the public and health professionals in Canada
place a "stop sale" order on the product until further review
work with the Canadian Border Services Agency to help prevent non-compliant products from being imported
recall the product
seize the product
suspend or cancel authorizations or licences

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

known and potential risks
methods to gather additional safety information to better characterize risks
how a company will monitor and assess the effectiveness of those measures
areas with limited data (or missing information) that need to be closely monitored post-market
the measures a company will implement to monitor, prevent or minimize risks in patients

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:

are false, deceptive or misleading
do not provide a balanced representation of benefits and risks
are not consistent with the terms of market authorization of the product
- for example, a drug may be marketed as providing relief within 2 days, whereas the product monograph indicates that the drug provides relief after 10 days

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:

Canada Vigilance adverse reaction online database: updated monthly, it contains information about suspected adverse reactions (side effects) to health products reported to Health Canada
medical device incident online database: updated quarterly, it contains information about reported medical device problems and incidents
drug and health product inspection database: contains information about drug and health products inspections conducted by Health Canada, in Canada and abroad
summary safety reviews: contains summaries of safety issues assessed, the findings and actions taken by Health Canada, if any
recalls and safety alert database: includes recent notifications for health products
drug and medical device highlights reports: give information (for example, potential safety issues and overview of accomplishments) relating to new drugs and medical devices that Health Canada approved for sale in Canada

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:

recalls, advisories and safety alerts
adverse reaction information

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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2024-08-02

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