EMA Tells Companies How To Boost Their Approval Chances Under PRIME
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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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.
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.
The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.