Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Is there a pre-IND equivalent program or a path to get initial feedback (before full submission) from regulators in Hong Kong and Canada?

For Health Canada, you can request a pre-CTA meeting:  https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/pre-clinical-trial-application.html

Don't know about Hong Kong.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 14-Jul-2022 11:23
From: Anonymous Member
Subject: pre-IND equivalent program in countries other than US

This message was posted by a user wishing to remain anonymous

Is there a pre-IND equivalent program or a path to get initial feedback (before full submission) from regulators in Hong Kong and Canada?