Guidance Document - Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs) (French, HTML)

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Publisher-reported update

2022-06-07

Health Canada, the federal regulatory authority that evaluates the quality, safety, and efficacy of human drugs available in Canada, recognizes that there are circumstances in which sponsors cannot reasonably provide substantial evidence demonstrating the safety and efficacy of a therapeutic product as there are logistical or ethical challenges in conducting the appropriate human clinical trials. The Extraordinary Use New Drugs (EUND) pathway was developed to allow a mechanism for authorization of these drugs based on non-clinical and limited clinical information.

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