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In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report).

On March 25, 2025, Canada's Drug Agency published its annual Watch List, which identifies technologies with the most potential to transform health systems and shape the future of health care in Canada.

On June 9, 2021, the Federal Court of Appeal (FCA), following grant of leave to hear Sunovion's appeal, dismissed Sunovion's appeal from a Federal Court (FC) decision of Furlanetto J. (2021 FC 37)...

On November 28, 2024, the Federal Court updated its Case and Trial Management Guidelines for Complex Proceedings and Proceedings under the PM(NOC) Regulations (Guidelines for Complex Proceedings).

In July 2025, the Government of Canada launched a "Red Tape Review" across all federal departments to modernize regulatory frameworks and support economic growth.

On March 27, 2023, Health Canada opened for consultation a proposed application of the definition of Canadian reference product under C.08.001.1(b) of the Food and Drug Regulations.

On March 18, 2025, Health Canada released a Notice that it is seeking feedback on a draft guidance on co-packaged drug products.

Health Canada has announced significant regulatory changes for medical device establishment licensing, set to take effect in December 2026. These Phase II amendments aim to streamline requirements...

Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical device transactions as of April 1, 2026. As we previously reported, manufacturers of medical devices could voluntarily use the REP and CESG for medical device regulatory transactions as of July 2024.

Last year, the European Medicines Agency (EMA) granted marketing authorizations to two biosimilar versions of Johnson & Johnson’s rheumatoid arthritis blockbuster drug Remicade

This is the second decision to dismiss a claim by Apotex seeking remedies beyond s. 8 of the Patented Medicines Regulations

The Patented Medicine Prices Review Board (PMPRB) has launched a second 30-day consultation on revised proposed Practice Directions for hearings related to excessive medicine pricing and compliance with filing requirements. The revised directions incorporate feedback from the initial consultation, with a summary chart detailing all edits available for stakeholder review.

As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines.

On March 17, 2021 the Patented Medicine Prices Review Board (PMPRB) announced the result of the Consultation opened in January (reported here)

On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations.

In July 2022, the Pharmaceutical Advertising Advisory Board (PAAB) will launch four Accelerated Review Options (ARO) to its standard pre-clearance pathway...

In IP litigation, expert testimony is common and important. Experts may provide the court with a scientific primer in highly complex cases. In patent litigation,...