Health Canada Pre-Submission Meeting

Get guidance from professionals to submit a meeting request with Health Canada officials, stay prepared for discussion and identify potential problems that require discussion. Our experts will attend meetings to support you while discussing with officials.

Pre-Submission Meetings with Health Canada

Pre-submission meetings with Health Canada 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).

Why Pre-Submission Meetings May Be Required

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
Pre-Submission Meeting
How We Help With Health Canada Pre-Submission Meetings

We will guide you through the entire process, such as submitting meeting requests, preparing for the discussion, attending with you to facilitate, lead, or provide support during your meeting with Health Canada officials.

Frequently Asked Questions

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
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