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Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the European Medicines Agency.
Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the European Medicines Agency (EMA), but more harmonization of the U.S. and European regulatory frameworks may facilitate timely approval of pharmaceutical products, according to new research published online on May 27 by the journal Pharmacoepidemiology and Drug Safety.
The FDA priority review process applies to a drug that is considered to be a significant improvement over the available alternatives, while the EMA’s accelerated approval applies to a product that is of major public health interest, explains lead author Saad Alqahtani and colleagues.
Their study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and EMA, including regulatory information on drug applications, approvals, indications, and orphan designations of all priority review drugs approved by the FDA and the EMA in the period 1999-2011.
Overall, 100 FDA priority review new molecular entities and new therapeutic biologics were approved by both agencies, and 87% of the products were first approved by the FDA. The average FDA review time (9.2 ± 8.4 months) was significantly lower than the EMA average review time (14.6 ± 4 months) (p < 0.0001). The FDA and the EMA granted orphan designation to 43% and 33%, respectively, of the applications. There were differences in the administration route (1% of all products), dosage (8%), strength (23%), posology (51%), indications (30%), restrictions of use (52%), limitations of use (19.0%), and outcomes limitations (28.0%) approved by both regulatory agencies.