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Abstract

In 1995, the European Medicines Agency (EMEA) implemented the centralized procedure for the approval of human medicines to facilitate marketing authorizations that are valid throughout the European Union (EU). Over the last decade, the European Commission (EC) has promulgated additional regulations, such as exceptional circumstances approvals and orphan designations, to enhance the quality and speed of drug development for products that go through the EMEA's centralized procedure. These regulations have parallel programs in the US Food and Drug Administration (FDA). The current study examines the EMEA's centralized procedure and analyzes regulatory review times for products approved from 2000 through 2005. EMEA performance metrics are then compared with those of the FDA for the 71 products approved by both agencies during the study period. Time from application submission to approval, as well as the effect of regulatory initiatives implemented by each regulatory body on drug approval times, are analyzed and compared. The results indicate that the EMEA met its mandated performance goals for review milestones. Whereas mean approval times for products approved by both the EMEA and the FDA were similar (15.8 versus 15.7 months, respectively), there was considerably more variability in FDA approval times. Regulatory designations designed to facilitate access to new medicines were shown to be effective in both the EMEA and FDA. For products approved by both agencies, nearly three times as many were approved first in the United States (52 versus 19 were first approved in the United States and the EU, respectively).

Keywords

European Union European Medicines Agency EMEA FDA Drug approval Orphan designation

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Assessing the Performance of the EMEA's Centralized Procedure: A Comparative Analysis with the US FDA

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