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EU Accelerated Assessment Tracker

Takeda's Dengue Vaccine Candidate Reverts To Standard Review Timelines

 
• By Maureen Kenny

The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, four requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.

This tracker provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision. It also tracks whether companies retain fast-track status for MAAs as they make their way through the EU centralized procedure.

Fast-track review can cut a few months off the approximately 12 months it generally takes to review an application under standard EU centralized drug evaluation procedure timelines. 

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