Hot Topics in International Trade - Wood Chucks Chuck Canadian Lumber tariffs
Regulatory Ramblings: Episode 72 - Cultural Roots, Belonging, and the Fear of Change: What’s Next for Inclusion?
Daily Compliance News: June 24, 2025, The Questions, Questions, and More Questions Edition
Hot Topics in International Trade - Tariff Mitigation Strategies
Everything Compliance, Shout Outs and Rants: Episode 151, The What is Illegal DEI Edition
Daily Compliance News: March 7, 2025, The No Jail Time Edition
Adapting to Tariffs and Other Trade Policy Shifts Under the Trump Administration
A Brief Primer on Tariffs Under the Trump Administration
Protect, Prepare, Prevail: Navigating a Complex Cybersecurity World
Private M&A 2024: Key Trends and Forecasts
Patent Considerations in View of the Nearshoring Trends to the Americas
Examining E-Discovery in Competition Law
No Password Required: Education Lead at Semgrep and Former Czar for Canada’s Election Security
Shifting Dynamics in Private Equity
4 Key Takeaways | Major U.S. Supreme Court Trademark & Copyright Decisions
Hidden Traffic : New Human Trafficking and Child Labor Regulation in Canada with Sean Stephenson
[Podcast] Catching Up on Canadian Environmental Regulation
[Podcast] USMCA in Review, with C.J. Mahoney, Former Deputy U.S. Trade Representative
Episode 4 - USMCA and the trade relationship between the U.S.A, Mexico, & China
Five Questions, Five Answers: Electric Mobility Canada on Its Promises for a Cleaner Economy
Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more
Health Canada is making changes (via legislative amendments) to the manner in which medical devices and pharmaceutical products are recalled under the Medical Device Regulations, SOR/98-282 (MDR) and the Food and Drug...more
On October 10, 2024, Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received Royal Assent. This legislation establishes a framework for a national universal pharmacare system, aiming to enhance the...more
On April 5, 2024, the pan-Canadian Pharmaceutical Alliance (pCPA) announced that it was ready to accept drugs through the pCPA Temporary Access Process (pTAP) (see our previous article regarding the consultation)....more
On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more
On June 5, 2023, the Minister of Health released a statement on drug and other health product shortages, providing an update on actions being taken aimed at minimizing shortages and their impacts. ...more
On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection. The changes are described as being made to reflect current administrative practices, and to...more
On April 15, 2023, Health Canada proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations (together, the “Proposed Amendments”). The Proposed Amendments are intended to modernize the frameworks...more
Update: Health Canada has prepared an overview of its special access programs, and has finalized the Guidance Document: Sale of Drugs - Public or Canadian Armed Forces Health Emergencies. On February 15, 2023, Regulations...more
On March 1, 2023, Biogen Canada Inc. announced that BYOOVIZTM (ranibizumab injection), a biosimilar to Genentech’s LUCENTIS, is now available in Canada. BYOOVIZ is an anti-VEGF (vascular endothelial growth factor)...more
UPDATE: The consultation period has been extended until April 26, 2023. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under...more
This week, Celltrion obtained full label approval from Health Canada to sell Vegzelma (CT-P16), a bevacizumab biosimilar indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, epithelial...more
On January 3, 2023, Samsung Bioepis announced that Health Canada has approved their citrate-free, high concentration (40 mg/0.4 mL) HUMIRA biosimilar, HADLIMA (also known as SB5). HADLIMA is indicated for the treatment of...more
Organon, a global woman’s health company, recently announced its launch of two biosimilar products in Canada. On November 7, Organon announced the launch and availability of AYBINTIO in Canada....more
Health Canada released a number of reports over the summer: - Annual Health Product Highlights for 2021, which provides an overview of new health products, including drugs and medical devices, that Health Canada approved...more
In the recent decision of Palmer v Teva Canada Ltd., Justice Perell of the Ontario Superior Court dismissed the plaintiff's motion to certify a class action against manufacturers of the anti-hypertensive drug valsartan. The...more
We provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in October 2021....more
Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more
On May 19, 2022, Viatris Inc. and Biocon Biologics Ltd. announced that ABEVMY, a bevacizumab biosimilar, is now available in Canada. According to the press release, Viatris and Biocon Biologics co-developed ABEVMY, which...more
The Canadian Agency for Drugs and Technologies in Health (CADTH) held consultations which ended April 14, 2022 on two new proposals: (1) a proposed process for non-sponsored reimbursement reviews and (2) a streamlined process...more
As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more
Samsung Bioepis Co. Ltd. announced that Health Canada approved ONTRUZANT (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer, Metastatic Breast Cancer...more
On February 4, 2022, Nova Scotia announced that as part of the Nova Scotia biosimilar initiative, Nova Scotians enrolled in Pharmacare programs will have 12 months (until February 3, 2023) to work with their healthcare...more
On January 5, 2022, amendments came into force amending the Food and Drug Regulations to allow practitioners to request access to restricted drugs through the Special Access Program (SAP), which was previously prohibited....more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more