Clinical information on drugs and medical devices
From: Health Canada
On this page
- What information you will find
- Changes to regulations and our approach to disclosing clinical information on drugs and medical devices
- Contact us
What information you will find
Drug and medical device manufacturers submit clinical information to Health Canada for the approval of new products. Health Canada assesses this clinical information and other kinds of information provided by companies. We then decide whether we will approve a drug or medical device.
Once we have finished a regulatory review on a drug or medical device, we release the clinical information. This information is available on request for previously reviewed products.
You can find clinical information about the tests and trials that were performed on drugs and medical devices to evaluate their safety and efficacy.
If you can't find what you're looking for, you should review the list of clinical information releases in progress before submitting a new request.
Changes to regulations and our approach to disclosing clinical information on drugs and medical devices
Amendments were made on February 28, 2019, to the Food and Drug Regulations and Medical Device Regulations stating clinical information will no longer be treated as confidential and may be released.
We published guidance on the public release of clinical information. This guidance includes the following information:
- scope and how these authorities are applied
- procedures to follow to prepare information for release
- that continues to be subject to the definition of confidential business information
- protecting personal information
Learn more:
- Guidance document on public release of clinical information
- Consultation on the public release of clinical information
- New approach to disclosing clinical information on Class III medical devices: Notice
Contact us
Information Science and Openness Division
Business Facilitation and Modernization Directorate
Health Products and Food Branch
Health Canada
150 Tunney's Pasture Driveway
Ottawa ON K1A 0K9
Email: clinicaldata-donneescliniques@hc-sc.gc.ca.
Related links and databases
- Food and Drug Regulations
- Medical Device Regulations
- Submissions Under Review Lists
- information on drugs and other health products that are being reviewed for market approval in Canada
- Notice of Compliance Database
- notices of compliance that have been issued for new drugs and health products
- Drug Product Database
- information on drug products and product monographs for approved or marketed products
- Medical Device Active Licence Listing Database
- information on approved medical device licences and licence holders
- Drug and Health Product Portal
- product information and regulatory documentation such as summary basis of decisions
- Clinical Trials Database
- information on phase I, II and III clinical trials in patients involving human pharmaceutical and biological drugs
- Clinical Trials Inspection Database
- clinical trials that are being inspected by Health Canada and inspection results