Clinical information on drugs and health products

From: Health Canada

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 to reach a decision on whether or not to approve a drug or medical device.

What information you will find

You will find data about the tests and trials that were performed on drugs and medical devices to evaluate their safety and efficacy.

When information is available

Clinical information will be proactively released following completion of Health Canada’s regulatory review. This will be phased in for different submission and product types over four years. Clinical information is available on request for previously reviewed products. Follow the link below to view information currently available on the Health Canada clinical information portal.

 

If you can’t find what you're looking for

Relevant information may already be available from other Health Canada databases listed below. Please review this information and the list of clinical information releases in progress before deciding to submit a new request for clinical information. Further information on submitting requests is available on Health Canada’s clinical information portal.

 

Related databases

Other current information for drugs and health products

Drugs and health product clinical trials

  • The Clinical Trials Database provides a list of specific information relating to phase I, II and III clinical trials in patients involving human pharmaceutical and biological drugs.
  • The Clinical Trials Inspection Database allows you to see the current clinical trials that are being inspected by Health Canada and the results of the inspection.

Changes to regulations

Amendments to the Food and Drug Regulations and Medical Device Regulations were introduced on February 28, 2019 to identify the clinical information that will no longer be treated as confidential and to permit its release. We have published guidance on the public release of clinical information that includes:

  • the scope and application of these authorities
  • procedures to prepare information for release
  • information that continues to be subject to the definition of Confidential Business Information (CBI)
  • protection of personal information

Visit our consultation page for further information on the development of these regulations and related guidance.

Contact us for help

Mailing address:
Information Science and Openness Division
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Graham Spry Building
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9

Telephone:
613-960-4687

Email:
hc.clinicaldata-donneescliniques.sc@canada.ca

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