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Health Canada's 2025 Red Tape Review has sparked significant regulatory reforms aimed at streamlining drug and medical device approvals through international harmonization. New draft guidance and proposed legislative changes promise to reduce clinical trial requirements for biosimilars, enable faster approvals through foreign reliance pathways, and eliminate redundant licensing requirements for medical device importers.

Important amendments to the Exception Patient Measure came into effect on June 2, 2025. A summary of the key changes is provided below.