Background: FDA had been criticized for its slow review of new drugs. Critics complained of a "drug lag" from which US patients suffered when compared to Europeans. Since the advent of PDUFA, however, the FDA has demonstrated a possible slight advantage in review time when compared to the EMA.
Methods: Submission and approval dates for monoclonal antibodies were collected from the FDA and EMA websites.
Results: When using monoclonal antibodies as examples of complex, yet important new therapeutic agents, it was determined that the FDA reviews these agents on average 5 months faster than the EMA.
Conclusion: The review processes within each agency may have reached their highest efficiencies without making further changes in a review system.
Keywords: EMA; FDA; Monoclonal antibodies; Regulatory review.