In December 2025, Health Canada published new draft guidance documents detailing when and how terms and conditions (T&Cs) may be imposed on drugs pursuant to amendments to the Food and Drug Regulations (FDR).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
Health Canada has proposed a substantial change to the regulation of biosimilar drugs in Canada that may result in earlier applications for marketing authorization and earlier litigation under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Specifically
Canada has made wide-ranging amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR). The amendments are intended to deliver on Health Canada’s modernization commitments, codify long-standing policies and practices, and implement
Health Canada has proposed additional regulations intended to prevent, mitigate, and respond to drug shortages. The proposed amendments to the Food and Drug Regulations (Regulations) include new requirements for drug market authorization holders to develop shortage prevention and
2024 saw no shortage of headlines in the Canadian pharma space. Here we look back on the year’s most notable legal and regulatory developments and look forward to areas to watch in 2025.
In
On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will
The Federal Court (FC) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application
On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product (CRP) in the Food and Drug Regulations (Regulations). The Notice advises that if an innovative drug is
As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. We also flag what to watch out for in 2024.
The most significant legal development in 2023 was the introduction of
On January 5, 2024, the US Food and Drug Administration (FDA) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program (SIP) by the FDA. Whether