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

Name: Guidance Document - Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs)
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2022-06-07

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

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

Related open data

Health Canada