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EMA Tells Companies How To Boost Their Approval Chances Under PRIME

Executive Summary

Companies find it challenging when it comes to preparing robust quality data packages for their marketing applications for investigational products that have made it onto the European Medicines Agency’s popular priority medicines scheme.

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PRIME Scheme: EMA To Tackle Problem Of Premature Marketing Applications

After finding that products developed under the PRIME scheme frequently lost their accelerated status while they were being reviewed for potential EU marketing approval, the European Medicines Agency is looking into whether it should start holding “submission readiness” meetings.

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Nineteen new products that were developed under PRIME, the European Medicines Agency’s priority medicines scheme, are now approved for use in the EU. Pink Sheet analysis finds that many were reviewed much faster than they would have been under standard review timelines.

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