There is not a particular number defined but multiple factors that will influence the number to provide assurance that there is no differences from the global population.
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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: 10-Aug-2022 16:30
From: Arundhati Sengupta
Subject: Phase 3 Clinical Trial requirements by CDSCO
The new drug approval process states that companies do not need to conduct phase 3 trials in India if their global studies include Indian patients – is there a particular number of Indian patients required in the global studies?
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Arundhati Sengupta
Senior Manager, Regulatory Affairs - CMC
Danville CA
United States
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