Plenty Of Action On EU Accelerated Assessment Front
Executive Summary
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
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EU Accelerated Assessment Tracker
One out of seven requests for the accelerated assessment of planned EU marketing authorization applications is known to have been granted this year to date.
Five New EU Filings Leave Starting Blocks at EMA
There is one orphan drug among the five new marketing authorization applications that the European Medicines Agency has under review. All five drugs will be reviewed under standard review timelines.
Rejection Rate Soars In Q4 For EU Fast-Track Requests
October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.