16 April 2019 - 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.