Health Canada Pre-Submission Meeting

Pre-Submission meetings are not limited to new drug submissions. They can be requested by sponsors before filing a submission/application for any product, including Natural Health Products, Cosmetics, Foods, and Medical Devices. Meetings can be conducted face-to-face or by teleconference with the appropriate Directorate within Health Canada if they have any questions.  Also, meetings are held before filing a clinical trial application, a drug submission/application, a request for a combination product classification, a priority review, or a submission for Extraordinary Use New Drugs (EUNDS).

Health Canada Pre-Submission Meetings are held to provide a valuable opportunity for input, both from the client and from Health Canada. These meetings are used to address complex areas of submission or novel ingredients that cannot be dealt with effectively via email or telephone.  In addition, the purpose of meetings could also be to:

• Become familiar with Health Canada review staff 
• Discuss the data in the submission/application to facilitate its review
• Detect potential problems or issues 
• Manage disputes early in the submission/application process
• Provide an opportunity for discussing details of the submission/application
• Get feedback about areas of concern based on regulatory requirements