Product Life Cycle
As part of our mission to help Canadians maintain and improve their health, we evaluate and monitor the quality, efficacy and safety of biotechnology-based health products throughout their life cycle.
Product life cycle refers to all stages in the pre- and post-market "life" of a health product, including:
- Pre-clinical studies;
- Clinical trials;
- Submission of product information to Health Canada for review and evaluation;
- Decision whether to authorize sale of the product in Canada;
- Public access to the product; and
- Post-market surveillance, inspection and investigation.
Our work to minimize the risk of health products falls into three main areas:
Review and Evaluation
We assess all health products risks and verify their quality and efficacy before we allow them to be used by Canadians. Regulations defining the conditions for activities and materials associated with the testing, manufacture, preparation, preservation, packaging, administration, storage and sale of any health product are set out in the Food and Drugs Act, the Food and Drug Regulations and the Medical Devices Regulations.
As with all health products, manufacturers who want to sell biotechnology-based health products in Canada must submit detailed information to Health Canada about:
In the case of biologics, manufacturers must also provide samples of at least three lots of the product for testing as part of our product evaluation activities.
When we receive a new biotechnology-based health product submission, we:
If we conclude that the benefits outweigh the risks and that risks can be mitigated and/or managed, we provide the manufacturer with a market authorization to sell the product in Canada, referred to as a Notice of Compliance (NOC) or medical device license.
For details about health products that have been authorized for sale in Canada, see:
Compliance and Enforcement
We carry out compliance and enforcement activities during the product life cycle to ensure that the quality of biotechnology-based health products is assured and that associated risks are minimized.
The purpose of compliance and enforcement is to ensure that industry meets all of the requirements set out in the Food and Drugs Act, the Food and Drug Regulations and the Medical Devices Regulations.
Our national compliance and enforcement program involves:
The guiding principles for our compliance and enforcement program are transparency, fairness, management of risk, commitment to quality, and hiring of qualified staff.
Our Compliance and Enforcement Policy has more details about how we deliver our program.
Monitoring and Tracking
Health Canada continues to monitor the safety, effectiveness and quality of medicines and health products after they reach the marketplace. This provides new and up-to-date information that only becomes available after people start using health products under "real life" conditions.
Once a product goes onto the market, we watch for signals that there may be a problem. Signals may come from many sources, including:
- Reports in medical journals;
- Reports from other governments;
- Presentations at conferences;
- Adverse reaction reports we receive from health professionals and consumers; and
- Periodic safety reports we receive from manufacturers.
When we identify a signal, our evaluators do further research and look for patterns. This helps determine whether there is a safety issue that requires action.
Some of the actions we may take to address safety issues for biotechnology-based health products on the market include:
Although biotechnology-based health products are often copies or close analogs of naturally occurring proteins, they still require close post-market surveillance. There are three main reasons for this:
Adverse Reaction Information
The MedEffect components of the Health Canada Web site is our one-stop access point for information on adverse reactions, including:
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