Health Products and Food Branch

The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system.
HPFB has seven operational Directorates with direct regulatory responsibilities:
Extraordinary Use New Drugs.
Extraordinary Use New Drugs (EUNDs) is a regulatory programme under which, in times of emergency, drugs can be granted regulatory approval under the "Food and Drug Act" and its regulations. An EUND approved through this pathway can only be sold to federal, provincial, territorial and municipal governments. The text of the EUNDs regulations is available.
On 25 March 2011 and after the pH1N1 pandemic, amendments were made to the Food and Drug Regulations (FDR) to include a specific regulatory pathway for EUNDs. 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. A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if, under paragraph C.08.002.01(1):