Turning the Tables
FDA outpaces the EMA on regulatory review and approvals
For some years, there has been a general (mis)perception that product approval is faster through the European Medicines Agency (EMA) than through the US Food and Drug Administration (FDA). But now, conclusive proof comes from a recently published study that compares the two agencies between 2011 and 2015: the FDA has outpaced the EMA in terms of review times and approvals of new therapeutic agents (1).
Here, we present some key results:
- The FDA approved 170 new therapeutic agents compared with 144 approved by the EMA.
- Median total review time for the FDA was significantly shorter than the EMA for all regulatory reviews (306 versus 383 days, p<0.001), as well as for the 142 therapeutic agents approved by both agencies (303 days versus 369 days, p<0.001).
- On average, FDA review times were 60 days shorter than the EMA’s.
- The FDA approved a higher percentage of orphan drugs than the EMA (43.5 percent of all approvals versus 25 percent of all approvals, p<0.001).
The authors were driven to perform the analysis by the imminent expiry (October 2017) of the Prescription Drug User Fee Act (PDUFA) – a regulation that oversees the speed of the regulatory review process; Congress need to consider its reauthorization. Given that the findings are similar to those from analyses of the period 2001–2010 (2), the authors assert that their analysis “provides reassurance that the FDA continues to complete regulatory reviews more quickly than the EMA, and has the potential to inform discussions regarding the reauthorization of the PDUFA.”
- NS Downing et al., “Regulatory review of new therapeutic agents – FDA versus EMA, 2011–2015”, N Engl J Med, 376, 1386–1387 (2017). PMID: 28379798.
- NS Downing et al., “Regulatory review of novel therapeutics – comparison of three regulatory agencies”, N Engl J Med, 366, 2284–2293 (2012). PMID: 22591257.
