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Data Packages, Inspections & Delayed Submissions: EMA Addresses Frequent Questions About Raw Data Pilot

 
• By Neena Brizmohun

Is it permissible to use data packages prepared for other international regulators? This is among the many questions the European Medicines Agency has addressed about its new pilot on analyzing raw data from clinical trials.

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The EMA is exploring if analyzing raw data is beneficial • Source: Alamy

Drug companies taking part in a new pilot that the European Medicines Agency launched to assess whether the analysis of raw data from clinical trials can help it improve its medicines evaluation process might be able to use data packages prepared for other international regulators.

In addition, once companies have confirmed their intention to participate in the voluntary initiative, under which they must submit their raw data to the EMA as part of their initial marketing authorization application (MAA) or

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