Canada

Canada

Health Canada’s Clinical Trials Database

Verified on September 8, 2021

Canada does not have a clinical trial registry of its own. The health authority of Canada that is Health Canada has a Clinical Trials Database that provides a listing of information on clinical trials. Health Canada encourages the sponsor to register trials in the available public registries (ClinicalTrials.gov and EudraCT).

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
Health Canada’s Clinical Trials Database Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

(Phase 1-3)
English
French
Canadian Cancer Trials Academic/Patient Registries/Voluntary Patient organization Clinical Trial Application Not Applicable (NA) English
French
ClinicalTrials.gov Country requiring/recommending ClinicalTrials.gov use Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 2-4)
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
Health Canada’s Clinical Trials Database Registration

Yes

Prior to the initiation of the trial
Results

n/a

NA
Canadian Cancer Trials Registration

n/a

NA
Results

n/a

NA
ClinicalTrials.gov Registration

Yes

Within 21 days of the first subject enrollment
Results

Yes

Primary Results - within one year of primary completion date (PCD); Subsequent Results - within one year of the last subject last visit for each secondary outcome measure (SOM); Final Results - within one year of the study completion date

Registry Updates


  • August 2021: Canada Update - On August 23, 2021, Health Canada posted an update on the consultation paper that was released on May 20, 2021. This consultation paper focuses on the key policy proposals to modernize Canada’s clinical trials regulatory framework. One of the points discussed was clinical trial transparency. Along with the consultation paper, an online questionnaire was provided … Continue reading "August 2021: Canada Update"
  • May 2021: Canada Update - Health Canada launched a consultation paper on May 20, 2021. This paper outlines the key policy proposals for the modernization of Canada’s clinical trials regulatory framework. One of the points discussed is clinical trial transparency. Currently, Health Canada’s Clinical Trials Database provides information related to Phase I, II and III clinical trials involving drugs and … Continue reading "May 2021: Canada Update"
  • April 2021: Canada Regulatory Update - As per the Forward Regulatory Plan 2021-2023: Modernization of the Regulation of Clinical Trials, published on April 01, 2021, Health Canada is proposing to amend sections of the Food and Drug Regulations, Natural Health Products Regulations and the Medical Devices Regulations. This proposal along with aligning the regulatory framework for clinical trials in Canada will … Continue reading "April 2021: Canada Regulatory Update"

References


  1. Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications. Health Canada. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/clini/ctdcta_ctddec-eng.pdf. Published May 29, 2013. Accessed February 26, 2019.