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
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
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
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