Before revision: Health 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.
After revision: for NDSHealth 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.