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Canada consults on use of foreign review reports in evaluation of drugs, devices

This article was originally published in Clinica

Executive Summary

Health Canada is seeking feedback on a draft guideline on how it uses review reports from foreign regulatory authorities when evaluating pharmaceutical and medical device applications. The draft document is designed to inform sponsors of the procedures to follow when including foreign review reports in their filings with the government department. It also explains how companies can facilitate Health Canada's use of foreign review reports.