Health Canada
The Canadian federal department responsible for national health policy and drug regulation. Health Canada evaluates new drug submissions for safety, efficacy, and quality. Health Canada approval is one of the three regulatory jurisdictions tracked by PeptideTrace for compound regulatory status.
Technical Context
Health Canada's drug review is conducted by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD, for biologics) and Pharmaceutical Drugs Directorate (PDD, for other drugs). The New Drug Submission (NDS) follows CTD format. Standard review target: 300 days. Priority review target: 180 days. Health Canada participates in international regulatory cooperation: the Australia-Canada-Singapore-Switzerland (ACSS) consortium enables work-sharing on product evaluations, and Project Orbis enables concurrent review of oncology products with FDA and other agencies. Canada's Drug Products Database (DPD) is publicly accessible and contains information on all drugs marketed in Canada. The Notice of Compliance (NOC) is the Canadian equivalent of FDA approval, authorising the drug for sale.