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 Process to assess products against quality and efficacy standards before allowing them onto the market in Canada, and also to determine if products are suitable to use in clinical trials or medical device investigational tests;
• Compliance and Enforcement activities to ensure that products and procedures comply with the Food and Drugs Act and the corresponding regulations; and
• Monitoring and Tracking to identify and address any problems and to assess the effectiveness of products once they are on the market.

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:

• Pre-clinical studies done in vitro (test tube) and in vivo (using animals) to assess drug performance, including the extent of any toxic effects;
• Results of clinical trials (for all drugs) or medical device investigational testing involving humans;
• The way the product is manufactured or produced (including quality controls and evidence of consistent manufacture and stability);
• Packaging and labelling;
• Therapeutic or diagnostic claims for the product;
• Conditions for use; and
• Potential side effects.

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:

• Screen the content to make sure it is complete and of suitable quality to be reviewed;
• Do a thorough review of all information to assess the potential benefits and risks of the product; and
• Review the information that the manufacturer proposes to give to health care providers and consumers (for example, on the label or in the product monograph).

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.

Related Information

For details about health products that have been authorized for sale in Canada, see:

Notice of Compliance Listings

These lists go back to 1991 and include weekly updates of all drugs authorized for sale or for clinical use in Canada. Information on products being used in clinical trials is currently considered proprietary to the sponsor and is not publicly available.

Medical Devices Active Licence Listing Database

You can search this database for information about all medical devices that are licensed for sale in Canada.

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:

Education, Consultation and Information

We encourage industry, consumers and other stakeholders to take part in developing health and safety standards and policies for health products. We promote compliance through educational activities and information sharing on regulatory issues. We also provide consumer information to help Canadians make safer and healthier choices about using health products than they may have without this information.

Compliance Monitoring

We monitor industry activities to make sure they follow established policies and procedures. Our monitoring activities vary by product, and include inspections, market surveys and analyzing product samples at our laboratories. Read more about our Laboratory Programme.

Compliance Verifications and Investigations

When we have reason to suspect a product or activity may not be following regulations, we investigate to verify the information. If there is a problem, we work with the party responsible to correct it.

Enforcement

If a party is unable or unwilling to comply with regulations, we take enforcement action. The type of action depends on a number of factors, including:

• Risks to health and safety;
• The compliance history of the regulated party; and
• Whether the same problem is likely to happen again.
  
  Some of the enforcement actions we could take include:
  
• Issuing a public warning or advisory;
• Suspending or cancelling marketing authorization or product licences;
• Removing products from stores; and
• Prosecuting the party responsible.

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.

Related Information

Good Manufacturing Practices Guidelines

These apply to the practices used to manufacture drugs.

Good Manufacturing Practices ( GMP) for Schedule D Drugs - Part 1 - Biological Drugs

This is an Annex to the GMP Guidelines. It covers the manufacture and control of biological drugs, such as vaccines, human blood, allergens and hormones.

Good Manufacturing Practices ( GMP) for Schedule C Drugs

This is an annex to the GMP Guidelines. It covers the manufacture and control of all types of radiopharmaceuticals (including kits and generators), except Positron Emitting Radiopharmaceuticals ( PERs).

Medical Device Compliance and Enforcement Directive

This describes compliance and enforcement actions for medical devices.

Inspection Strategy for Clinical Trials

This outlines the types of inspections we do to ensure that clinical trials comply with regulatory requirements.

Summary Report of the Inspections of Clinical Trials Conducted in 2003 / 2004

This report analyzes the findings of our inspections of clinical trials in Canada during 2003 / 2004.

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:

• Continuing to monitor the product;
• Reassessing the risk / benefit profile of the product;
• Asking the manufacturer to make changes to the labelling (for example, changes to directions for use, warnings about side-effects or interactions with other products);
• Issuing advisories or warnings for health care professionals, hospitals and consumers; and
• Removing the product from the marketplace.

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:

• Many of these products may bear little comparison to previous products. They are carefully tested for safety before they are allowed onto the market; however adverse reactions to products may not show up until the products have been used in real life conditions for a period of months, or years.
• Biotechnology-based products are often used to treat patients with complex medical conditions. These patients may already be taking several other medicines, so there may be more potential for interactions between health products.
• Adverse events with biotechnology products may not be as predictable as adverse events with chemical health products. The molecules in chemicals act in certain ways that are consistent. In the large, complex products derived from biotechnology, the molecules may act in different ways, so it may be more difficult to predict side effects.

Adverse Reaction Information

The MedEffect components of the Health Canada Web site is our one-stop access point for information on adverse reactions, including:

Advisories, Warnings and Recalls

Dating back to 1995.

Adverse Reaction Reporting by Health Professionals and Consumers

This brochure explains how, where, when and why to report adverse reactions to marketed health products.

How Adverse Reaction Information on Health Products is Used

This explains how adverse reaction information helps to protect the health and safety of Canadians.

Adverse Reaction Database

You can search the database for information about suspected adverse reactions reported to Health Canada.

You can also join the MedEffect mailing list to receive e-mail updates on the most recent edition of the Canadian Adverse Reaction Newsletter and marketed health product advisories for health professionals and the public.