Health Canada Issues Guidance on Off-Label Uses of Drugs in Trials

June 18, 2019

Health Canada released new guidance that the agency hopes will make it easier to study the off-label benefits of drugs in clinical trials.

Canadian regulations currently require any treatments sold to clinical trials for their off-label properties to be designated “investigational drugs.” But Canadian officials are worried that the requirements are getting in the way of life-saving or life-changing research, so they’re proposing a new approach.

Under the new guidelines, Canadian officials will ask a series of questions about a given treatment before deciding that it must be designated an investigational drug for an off-label trial. Sponsors will have to explain how the proposed use is “consistent with current or recognized medical practice,” why the off-label use shouldn’t be considered as a separate clinical trial, and the risks of off-label use, the agency said.

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