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EMA PRIME Rejects Told: ‘Add Something New’ If You Resubmit

 
• By Neena Brizmohun

The European Medicines Agency says it has been disappointing to see previously rejected applications for its PRIME scheme sent back to the agency with no additional data. On the other hand, the scheme, which is designed to get drugs for unmet medical needs to patients faster, is going from strength to strength. Kick-off meetings are identifying issues that sometime surprise companies but can be dealt with early on, well before a product is filed for authorization.

Drug developers that fail to get accepted on the European Medicines Agency’s priority medicines (PRIME) program for speeding patient access to medicines for unmet medical needs are being asked not to resubmit their application to the scheme unless they have something new to add.

“We’ve had some resubmissions” from applicants whose initial application for PRIME was rejected and “we are happy to see products...

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