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Watching The Clock Stop: US/EU Regulatory Review Time Parity In Sight, Study Suggests

 
• By Bridget Silverman

European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.

US EU clocks
Will European policy changes help their reviews spring forward? • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

“Clock stop” time in European Medicines Agency drug reviews accounts for the biggest difference between US and European review duration, according to a recent study published in the Annals of Internal Medicine.

The findings provide support for European Union reform proposals that could reduce the “clock stop” periods when drug evaluation is stopped while the applicant prepares answers to questions from

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