 Typically, clinical trials in human subjects are conducted and the results are provided as part of the clinical information package of a New Drug Submission (NDS) to Health Canada, the federal authority that reviews the safety and efficacy of human drugs.Health Canada recognizes that there are circumstances in which sponsors cannot reasonably provide substantial evidence demonstrating the safety and efficacy of a therapeutic product for NDS as there are logistical or ethical challenges in conducting the appropriate human clinical trials.The EUND pathway was developed to allow a mechanism for authorization of these drugs based on non-clinical and limited clinical information.