Accelerated EMA Centralized Review Timelines Under EU Pharma Reform

The European Union’s revised Pharma Package introduces accelerated centralized assessment timelines for medicinal products reviewed through the European Medicines Agency (EMA). Under the updated framework, standard review timelines are reduced from 210 days to 180 days, while products addressing public-health priorities may qualify for accelerated review within 150 days. The reform is intended to improve patient access to innovative therapies while increasing expectations for submission quality, lifecycle management readiness, and timely regulatory responses from Marketing Authorization Holders (MAHs).