Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?

摘要

IntroductionThe US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA.