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EU Accelerated Assessment Tracker

It's Not Been A Great Year For Companies Seeking Speedy Review In The EU

 
• By Maureen Kenny

In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.

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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