The New Drug Lag: EU Lags in Review Times of Monoclonal Antibodies

摘要

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.