The Government of Canada has announced the creation of the Canadian Drug Agency (CDA). According to the government, the CDA “will provide the dedicated leadership and coordination needed to make Canada’s drug system more sustainable and better prepared
On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. However, the Court refused to issue
This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations (Regulations), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.
In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics
The Patented Medicine Prices Review Board (PMPRB) has released a scoping paper on themes and questions to develop new price review Guidelines. The scoping paper also includes information on how stakeholders can participate in the consultation.
The deadline
On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary.
The Patented Medicine Prices Review Board (PMPRB) has announced a framework for the launch of its consultation on new guidelines, beginning with a scoping paper to be published in advance of Policy Roundtable sessions to be held December
Canada’s Drug and Health Technology Agency (CADTH) has published its procedures for a new time-limited reimbursement recommendation category. This recommendation category is intended to help provide earlier access to new therapies for severe, rare, or debilitating conditions where
The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its
The Patented Medicine Prices Review Board (PMPRB) has amended its Interim Guidance to address prices of “New Medicines”, implementing a review threshold based on “below the median” of the PMPRB11 countries (Median International Price, MIP). “New Medicines”