Regulating health products

On this page

• Approving health products
• Monitoring safety and quality
• Creating policies and setting standards
• Promoting and enforcing compliance
• Collaborating with partners
• Engaging and informing Canadians
• For more information

Approving health products

Health products we regulate include:

• drugs
• medical devices
• natural health products

Companies must submit information to Health Canada before their health product can be sold. The information required depends on the type of product and its level of risk.

Before a health product is authorized for sale, Health Canada must be satisfied that:

• its benefits outweigh its risks
• the evidence supports its health claims
• the risks and uncertainties can be managed

For biologics, like vaccines, companies may also be required to provide samples. We test the samples in our laboratories to make sure that the company is able to consistently produce a high-quality product.

We post information on:

• drug submissions under review
• decisions to approve or refuse the sale of drugs and medical devices

Drugs and natural health products authorized for sale by Health Canada have an 8-digit number on their labels. An authorized product will be identified with one of the following numbers:

1. natural product number (NPN)
2. drug identification number (DIN)
3. homeopathic medicines number (DIN-HM)

Higher-risk medical devices authorized for sale have a device identifier, which appears on the product or its packaging as either:

• a unique series or combination of letters or numbers, which is usually the catalogue number
• a bar code

Health Canada makes searchable databases available with information on authorized products, including the:

• Drug Product Database
• Medical Devices Active License Listing
• Licensed Natural Health Products Database

To make sure companies meet regulatory requirements and manufacturing standards, they must obtain licences from us for product:

• manufacturing
• packaging
• testing
• importing
• distributing
• wholesaling

Our Special Access Programmes allow physicians to access certain drugs and medical devices that are not currently authorized for sale in Canada.

Some health products, like drugs and certain high-risk medical devices, must first be tested in humans before they can be approved. Health Canada does not do clinical trials. However, we:

• review, approve and monitor clinical trials for drugs and medical devices carried out in Canada
• require companies to provide clinical trial evidence as part of their product applications

Find a list of authorized clinical trials and the benefits and risks of participating in one.

Monitoring safety and quality

Sometimes, new evidence about a health product arises on a previously unknown risk. That is why once a product is authorized for sale we continue to monitor its safety. For as long as a product is available to the public, we:

• conduct safety reviews
• require that companies report on the safety of their products, including new risks
• evaluate changes to product formulas or designs
• monitor actions taken by other regulators, and share information with them
• review scientific literature, including published and unpublished studies
• collect and analyze complaints and adverse reaction reports from:
  • companies
  • patients and consumers
  • health professionals

If a company manufactures vaccines or other biologic drugs, we require that company to submit:

• the results of its own testing
• samples for testing in Health Canada laboratories
• an application to Health Canada for approval if the company changes its processes for making a product

If there is a possible new safety concern with a product authorized for sale, we review available details to:

• confirm the risk
• decide how best to address the risk

Depending on the severity of the concern, we may:

• recommend:
  • changes to how the product can be used
  • new warnings be added to the safety information
• request that the company change its:
  • formula
  • packaging
  • instructions for use
• communicate the risks to health professionals and the public
• remove the product from the market

Through the Chemicals Management Plan we assess and take action on potentially harmful chemical substances, including those that may be found in health products.

Creating policies and setting standards

All health products must meet the requirements of the Food and Drugs Act and its regulations to be legally sold in Canada.

To help companies understand their requirements and responsibilities more clearly we produce:

• policies
• standards
• guidance documents

Promoting and enforcing compliance

Health Canada helps make sure companies and products meet Canada's high safety and quality standards by promoting and enforcing compliance with laws and regulations.

We conduct more than a thousand inspections each year to monitor compliance. We inspect:

• clinical trials
• drug companies
  • this includes verifying that companies continually evaluate the safety and effectiveness of their drugs
• medical devices
• blood establishments
• cells, tissues and organs
• donor semen establishments

We also:

• carry out targeted or planned reviews of specific product types
• perform laboratory analysis to detect problems, like undeclared ingredients or contamination
• oversee regulated advertising activities, to help prevent false, misleading or deceptive ads

Companies and consumers should report problems or complaints on:

• packaging errors
• quality or safety issues
• the promotion or sale of fake or unauthorized products
• other issues they may be concerned about

We have a range of options to promote, monitor and enforce compliance.

We post information on our compliance and enforcement activities, including:

• advertising complaints
• annual compliance and enforcement reports
• a drug and health product inspections database, which allows you to:
  • search for inspections results
  • browse lists of inspections in Canada and at foreign sites
• the inspection tracker, which provides early notice about potential new safety issues involving drug manufacturing companies

Collaborating with partners

Health Canada helps to protect your health and safety by working with a range of partners and stakeholders, such as:

• national regulators in other countries, like the U.S. Food and Drug Administration and the European Medicines Agency
• provincial and territorial governments
• scientific research communities, like the Drug Safety and Effectiveness Network
• health professional and industry associations
• consumer advocate and patient safety groups

Our work with these groups includes:

• sharing information
• seeking independent expert advice on specific health product issues
• addressing shared issues like drug shortages
• collaborating to advance health science and set regulatory requirements

Engaging and informing Canadians

Health Canada engages and informs Canadians on important issues. We provide information to help protect you from potential health product hazards. Our information includes:

• recalls and safety alerts
• information on buying, using and disposing of health products safely
• email alerts on the latest health product safety news
• the searchable Drug and Health Product Portal, which:
  • lists the drug and health products approved for use in Canada
  • gives consumer information on product use, safety and side effects
• the Drug Product Database, which:
  • lists the drug products approved for use in Canada
  • mainly serves health professionals, but may be useful to consumers
• Health Product InfoWatch, a monthly publication with health product safety information for health professionals

As the consumer, you play an important role in maintaining and protecting your health and safety. Read product labels and follow instructions carefully. Look for new public information about safety risks. Report serious side effects or complaints related to health products to Health Canada.