The Great Green North: A Discussion on Canada’s Environmental Regulations
On December 19, 2025, the Minister of Health announced the launch of consultations on two key regulatory initiatives referenced in Health Canada’s Red Tape Review report: (i) the Ministerial Reliance Order and (ii) clinical...more
On November 27, 2025, Celltrion announced that Health Canada approved EYDENZELT® (aflibercept-boav), a biosimilar referencing Regeneron’s EYLEA® (aflibercept), in both vial and pre-filled syringe form, to treat all...more
As previously reported, in December 2024, Health Canada published its agile licensing amendments to the Food and Drug Regulations (FDRs). The amendments included authorities that will come into force on April 1, 2027,...more
On December 20, 2025, Health Canada launched a consultation on modernizing the framework for clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, and cannabis. This...more
Today, roughly 60% of the average Canadian family’s diet consists of prepackaged and processed foods. These are often high in saturated fat, sugars, and sodium and Health Canada has flagged those ingredients as major...more
On December 2, 2025, Health Canada published a Notice of Intent regarding proposed regulations for lithium-ion batteries and consumer products containing lithium-ion batteries (collectively, Lithium-Ion Battery Products)...more
On November 17, 2025, Health Canada proposed Phase II amendments to the Medical Devices Regulations (MDR). The first phase of amendments came into force on December 14, 2024 and relate to recalls, modernizing medical device...more
On November 8, 2025, the Department of Health published proposed amendments to the Medical Devices Regulations, SOR/98-282 (MDR) with a specific focus on the medical device establishment licence (MDEL) regime. The proposed...more
Le 8 novembre 2025, Santé Canada a publié le Règlement modifiant le Règlement sur les instruments médicaux (licences d’établissement) (le « projet de règlement ») dans La Gazette du Canada, lequel propose des changements aux...more
In the last few weeks, Health Canada issued several decisions concerning biologics. On October 17, Health Canada approved, via a Notice of Compliance, Biocon Biologics Ltd.’s YESINTEK (ustekinumab injection) and YESINTEK...more
The Ontario government and the pan-Canadian Pharmaceutical Alliance (pCPA) announced separate initiatives in October 2025, both aimed to accelerate patient access to breakthrough cancer treatments approved through the Project...more
En réponse aux préoccupations des parties prenantes au sujet des processus administratifs obsolètes et trop prescriptifs, le gouvernement du Canada a lancé un examen du fardeau administratif dans tous les ministères et...more
In response to stakeholder concerns about outdated and overly prescriptive administrative processes, the Government of Canada launched a review of administrative burdens (referred to as “red tape”) across all federal...more
As we previously reported, Health Canada completed consultation on its draft guidance for determining medical device application type. The Medical Devices Regulations (MDR) outline five scenarios in which a medical device,...more
In July 2025, the Government of Canada launched a “Red Tape Review” across all federal departments to modernize regulatory frameworks and support economic growth. In this context, Health Canada and the Public Health Agency of...more
On August 8, 2025, the Federal Court of Appeal (FCA) determined that the Minister of Health’s decision to list Canadian Patent No. 2,970,315 on the Patent Register eight days after it was submitted to Health Canada was...more
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 (C.08.004.1 of the Food...more
Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more
Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more
On April 22, at the direction of US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., both the US Food and Drug Administration (FDA) and HHS published identical statements announcing the...more
In March 2025, Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act. The Guide sets out the principles, policies, considerations and standards that Health Canada should follow...more
As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new...more
Health Canada recently announced that it is exploring a regulatory pathway that would allow products containing cannabidiol (“CBD”) to be purchased without a prescription. Under the current regulatory scheme, all health...more
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Jim Jones, Deputy Commissioner for Human Foods at the US Food and Drug...more
Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of...more