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
The Patented Medicine Prices Review Board (PMPRB or Board) has released a draft of its new price review Guidelines (the Draft Guidelines) for consultation. The Draft Guidelines outline a proposed new price-review process for Board Staff, with
The Federal Court of Appeal (FCA) has confirmed that the Patented Medicine Prices Review Board (PMPRB or Board) does not have jurisdiction over the prices of unpatented medicines. In doing so, the FCA overturned decisions of
The Patented Medicine Prices Review Board (PMPRB) has released a new Discussion Guide for consultation on new price review Guidelines. The Discussion Guide outlines a proposed new price review process and requests stakeholder feedback on several specific topics
Canada’s Drug and Health Technology Agency (CADTH) has announced that, as of May 1, 2024, its new operating name will be Canada’s Drug Agency / l’Agence des médicaments du Canada (CDA-AMC). The official launch will occur
The Patented Medicine Prices Review Board (PMPRB) has announced new details regarding the progress of its consultation on new price review Guidelines.
The next phase of the PMPRB’s consultation will begin in summer 2024
The pan-Canadian Pharmaceutical Alliance (pCPA) has launched its Temporary Access Process (pTAP) to facilitate early market access to new drugs that were assessed under the time-limited reimbursement recommendation (TLR) pathway at the Canada Drug
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