Health products post-market surveillance cycle
Recognize
- All health products have risks and benefits associated with their use.
- Drug and medical device safety knowledge and issues evolve over time. New risks can become evident once a product is used by broader populations, for longer durations and under different conditions than those studied before being approved for sale.
- Side effects and complications are known as adverse reactions (ARs) and medical device incidents (MDIs). Health Canada monitors ARs and MDIs to keep up-to-date on new information related to the safety and effectiveness of health products.
Report
- Anyone can report ARs and MDIs.
- Health care providers and consumers report voluntarily. Market authorization holders (manufacturers and distributors) and hospitals must report under the Food and Drugs Act.
Collect
- AR and MDI reports are entered into the Canada Vigilance Adverse Reaction Online Database and the Medical Devices Incident Database.
- These databases allow users to search for AR and MDI reports
Analyse
- We look at AR and MDI reports received and other sources of product-related safety information, such as:
- pre-market trials and tests
- medical and scientific literature
- additional reports from manufacturers
- information from foreign regulatory agencies
- We carefully assess the available safety information to look for a possible cause-effect link between the health product and the AR or MDI.
Act
- When Health Canada identifies new safety issues, we take action. We use the most appropriate level of intervention to manage the risks and help people in Canada make informed decisions.
- We may:
- continue to monitor safety information
- reassess at a future date if new information becomes available
- ask the manufacturer to supply additional post-market safety and effectiveness information
- request post-market tests and studies
- restrict access to and distribution of the drug or device
- update the product label
- issue a risk communication
- withdraw from the market the drug or device
- We also monitor and respond to advertising complaints to ensure that companies don't make false and misleading claims, or engage in illegal marketing of health products.
Communicate
- We let people in Canada know about safety information in several ways:
- Recalls and safety advisories
- Summary safety reviews
- Health Product InfoWatch (monthly safety bulletin)
- Advertising complaints database
- You can also look up information for specific drugs or medical devices through our:
If you experience an AR or MDI with a drug or a medical device, we want to hear from you.
Report to Health Canada