Health Canada has proposed a framework under which manufacturers can ask it to rely on foreign regulatory decisions to speed up the review of new drug submissions. The framework, which would apply to new drugs in certain classes, is intended
Accelerating drug access in Canada: New pathways from the pCPA and Province of Ontario
In October 2025, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Government of Ontario announced new pathways to accelerate the funding of new drugs for Canadians. Canada currently ranks last among G7 countries in providing patients with timely access
Pharmacare update: Canada’s Drug Agency launches Appropriate Use Strategy
Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC) recently launched a strategy to advance the appropriate use of prescription drugs and related products in Canada. According to the CDA-AMC, 1.9 million Canadian seniors regularly use at least 1
National Pharmacare: Canada’s Drug Agency Consulting on National Bulk Purchasing Strategy
Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC) has launched a consultation on advice for a national bulk purchasing strategy for prescription drugs and related products. Notably, the advice proposes making the pan-Canadian Pharmaceutical Alliance (pCPA)
National Pharmacare: Canada’s Drug Agency Consulting on List of Essential Prescription Drugs
On June 19, 2025, Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC) announced a consultation on a proposed list of essential prescription drugs and related products intended to inform the development of a national formulary. The consultation is
Canada expanding national pharmacare and rare disease drug coverage
March 2025 saw a flurry of developments in Canada’s emerging national funding systems of drugs for rare diseases and pharmacare. All of Canada’s 13 provinces and territories have now reached bilateral agreements with the federal government to cover certain drugs
British Columbia becomes second province to sign pharmacare agreement
Agile licensing, risk, biologics, and more: Wide-ranging amendments to Canada’s drug and medical device regulations
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
National pharmacare in Canada: First-ever funding agreement announced
On February 27, 2025, the governments of Canada and of the Province of Manitoba announced the first-ever national pharmacare funding agreement. The two governments also announced a funding agreement under the National Strategy for Drugs for Rare Diseases.
Pharmacare
Drug shortages: New requirements proposed for the Food and Drug Regulations
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