Canada: Notice details when off-label use is not considered investigational in a clinical trial

11-06-2019

Canada: Notice details when off-label use is not considered investigational in a clinical trial

(Source: RAPS 2019-06-12)

Health Canada last week issued a notice clarifying the circumstances in which the off-label use of an authorized drug in a clinical trial would not be considered investigational.

The agency says the notice, which went into effect on 5 June, will “serve as interim interpretive guidance until amendments can be made to the Food and Drug Regulations.”

Health Canada says its previous interpretation of the regulations governing clinical trials led it to require drugs used off-label in a clinical trial to be identified as investigational in a clinical trial application (CTA).

However, Health Canada says there are circumstances in which an authorized drug used off-label in a clinical trial may not need to be described as investigational if it is not the subject of the clinical trial.

“As the off-label uses of an authorized drug can often be supported by well-established clinical practice overseen by provincial bodies that govern medical practice, this interpretation may be creating an unnecessary barrier to clinical research,” Health Canada writes.

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