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EU Accelerated Assessment Tracker

 
• By Maureen Kenny

The European Medicines Agency this year is known to have granted ten requests for accelerated assessment of planned EU marketing authorization applications. Nine such requests are known to have been rejected. As 2019 draws to a close, the outcomes of five requests are still unknown.

The tracker below provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that are known to have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision since January 2018.

This latest edition has been updated among other things to reflect the fact that the planned MAA for OTL-200, Orchard Therapeutics' investigational gene therapy for metachromatic leukodystrophy, was granted...

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