Increasing access to new treatments for special patient populations 

April 16, 2019 - Health Canada - Ottawa, ON

Health Canada is helping Canadians get timely access to new drugs

Canadians want timely access to the drugs they need. The Government of Canada is committed to ensuring accelerated access to treatments as a key priority of its Regulatory Review of Drugs and Devices initiative.

Today, to encourage drug companies to bring forward drug submissions that include evidence gathered from real-life settings, Health Canada has posted a Quality of Evidence guide that will assist drug companies in collecting and submitting high-quality real-world evidence that meets the evidence requirements for approval.

Evidence about how drugs are being used in real-life settings, outside traditional clinical research settings, can help us understand how to safely and effectively use them. This can be particularly useful for approving new drugs for some of our most vulnerable patients (such as children, pregnant women, seniors and those with rare diseases), where there can be unique challenges in gathering evidence to demonstrate a drug’s safety and efficacy.

Health Canada is already facilitating the review of drug submissions that include evidence gathered from real-life settings, including for cancer. The Department anticipates receiving new submissions in areas such as pediatric drugs and expects that this new guide will facilitate even more drug submissions to Health Canada that include real-world evidence.

Expanding how we use evidence gathered from real-life settings will help increase treatment options available to Canada’s most vulnerable populations, and will make Canada’s regulatory system even more responsive to the needs of Canadian patients.