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EMA Moves To Ensure ‘Smooth’ Evaluation Of Drug Approval Dossiers

Complex Cases May Still Require Tailored Meeting

Executive Summary

Drug sponsors seeking centralized EU marketing authorizations now have the opportunity to have simpler pre-submission “interactions” with the European Medicines Agency six months before the submission to help avoid complications down the line. Full meetings may still be appropriate for complex issues such as requests for accelerated assessment or conditional approval.

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