On November 30, 2018, Global Affairs Canada issued a news release announcing the signing of the Canada-United States-Mexico Agreement (CUSMA or USMCA), a new agreement to modernize the North American Free Trade Agreement between Canada, the United States, and Mexico. The changes relating to intellectual property are particularly notable as they modify the landscape for pharmaceuticals, and for patent, copyright and trademark owners. The potential impact on Canada's intellectual property laws was previously reported here, including the requirement to provide a data protection term (market exclusivity) for biologics of at least ten years from the date of first marketing approval. Canada must implement this change within five years of the date the CUSMA enters into force.
Related Publications & Articles
-
Health Canada releases its Statistical Report 2024/2025 for PMNOC Regulations, data protection and CSPs
On July 25, 2025, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2024/2025 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection...Read More -
Health Canada aims to reduce red tape by increasing international collaboration, alignment and reliance
In July 2025, the Government of Canada launched a “Red Tape Review” across all federal departments to modernize regulatory frameworks and support economic growth.Read More -
Medical devices updates: new Health Canada guidance for determining medical device application type and Medical Devices Directorate performance reports released
In August 2025, Health Canada released the Guidance for determining medical device application type.Read More