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ARTICLE · 20 JANUARY 2026

Canada Accelerates Regulatory Modernization

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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 New draft guidance and proposed legislative changes promise to reduce clinical trial requirements for biosimilars, enable faster approvals through foreign reliance pathways, and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.

CanadaFood, Drugs, Healthcare, Life Sciences
Melissa Dimilta
Melissa Dimilta
Benjamin Reingold
Benjamin Reingold
Emma Danaher
Emma Danaher
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In 2025, the Government of Canada launched a Red Tape Review across all federal departments and agencies. The Red Tape Review initiative was aimed at reducing regulatory burdens, streamlining processes and improving efficiency across federal departments and agencies. Following the Red Tape Review, Health Canada and the Public Agency of Health released a report identifying initiatives and actions to remove red tape. One key initiative focused on aligning Health Canada with international regulators and reducing trade barriers for Health Canada regulated products. Draft guidance documents and proposed legislative changes have been introduced to implement this initiative. In this update, we review these guidance documents and proposed legislative changes, looking ahead to 2026.

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