On December 20, 2025, Health Canada announced draft Clinical Trial Regulations (CT Regulations) and related guidance that would revamp how clinical trials are regulated in Canada. The draft regulations are intended to clarify and simplify existing rules and
January 2026
Pharma in Brief’s 2025 Year in Review and What to Watch for in 2026
By Fiona Sarazin, Paul Jorgensen & Kristin Wall on
The Pharma in Brief team is looking back at 2025’s most notable legal and regulatory developments in the Canadian pharmaceutical space and highlighting hot topics for 2026. To those who don’t make it to the end of the article, we’ll…
Agile drug licensing: Health Canada consulting on new “terms and conditions” guidance to replace its Notice of Compliance with Conditions policy
By Fiona Sarazin, Paul Jorgensen & Kristin Wall on
In December 2025, Health Canada published new draft guidance documents detailing when and how terms and conditions (T&Cs) may be imposed on drugs pursuant to amendments to the Food and Drug Regulations (FDR). The related FDR…