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India To Streamline Tiered Trial Approval Process – Will It Lift Sponsor Outlook?

 
• By Anju Ghangurde

India plans pivotal tweaks to its three-layered review process for clinical trial-related clearances – a move that is expected to pare approval timelines significantly and improve predictability for sponsors who have been generally cautious, over the recent past, about placing studies in the country.

Climber

A key panel of government functionaries has stipulated plans to revamp the three-tier approach for clinical trial approvals in India, bringing significant relief to the beleaguered clinical research sector in the country.

India currently follows a layered review process for clinical trial-related approvals, under which applications are initially evaluated by specialized Subject...

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