A comparison of new drugs approved by the EMA and the FDA in 1999-2011

OBJECTIVES: The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have different regulatory systems for the review and approval of new drugs. This study reviewed and compared the characteristics of priority review new pharmaceuticals (i.e., new molecular entities -NME- and new therapeutic biologics -BLA-) approved by EMA and the FDA in the period 1999-2011. DATA AND METHODS: Data were extracted from the FDA and EMA websites. Dates of application and approval and orphan status information were extracted from the FDA approval letters and the EMA public assessment reports. Descriptive statistics were used to compare the approval processes and characteristics of both systems; t-test was used to assess differences in average review time. Significance level was set at 0.05. RESULTS: A total of 101 drugs (82 NME and 19 BLA, all were FDA priority reviews) were approved by both regulatory agencies in the study period. BLAs were submitted to the FDA 1.25±4.18 months earlier (median= 0.33 months) and approved by the FDA 7.14±5.47 months earlier (median=5.75 months) than the EMA. NMEs were submitted to the FDA 1.44±24.52 month earlier (median= 0.44 months) and approved by the EMA 6.67±23.43 months earlier (median=7.49 months) than the FDA. The BLA average review time was statistically significantly lower (p<0.001) for the FDA 7.67±2.24 months (median=6.21 months) than for EMA 406±96 (median=13.77 months). The NME average review time was statistically significantly lower (p<0.001) for the FDA 9.25±9.10 months (median=5.98 months) than for EMA 14.48±4.09 (median=13.72 months). The number of products with orphan designation was higher in the FDA (n=57) than in the EMA (n=33). EMA granted orphan designation to two products that did not have orphan designation in the US. US granted orphan designation to 13 products that did not have orphan designation in the EU. Differences in the indications approved in both systems were observed in 24.8% (n=25) of the drugs. CONCLUSIONS: There are significant differences in the time elapsed between the filing and the approval of drugs in the US and EU. Orphan designation also varied between the two regulatory systems. Harmonization of the regulatory systems could facilitate timely approval of essential pharmaceuticals. KEY WORDS: Drug approvals, European Medicines Authority (EMA); US Food and Drug Administration (FDA)