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Abstract

The European Agency for the Evaluation of Medicinal Products (EMEA) was established in July 1993 to unify regulatory practices and improve market access within the European Union (EU). In February 1995, the EMEA implemented the centralized procedure for drug approval within the EU. The current study explores the history, goals, and implementation of the centralized procedure. We examine the time to obtain product marketing authorization for products that have gone through the process relative to the goals set for the program at its inception, and we compare approval times for a group of products that have been approved by both the EMEA and the United States Food and Drug Administration (FDA). Our data indicate that the goals established by the EMEA for the timeliness of application review have generally been met. Moreover, mean approval times for products approved by both the EMEA and the FDA were similar.

Keywords

European Union EMEA Centralized procedure Harmonization

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