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Canadian Government, Drug Regulation, Public Release of Clinical Information, Health Canada, Data Mining, Clinical Medicine, Canada, Health Policy, Medical Devices, Medicine and the Law, Forensic Medicine


Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, including summary-level data and metadata are made publicly available by Health Canada as a matter of policy.