OBJECTIVES: This study aims at comparing new human pharmaceutical drug approvals between the Food and Drug Administration (FDA), the European Medicine Agency (EMA) and Swissmedic (SMC) for the period January 2007 - 2017 using a comprehensive comparative analysis.

METHODS: This study include regulatory information, approval date, indication of new drug in the assessment period. Descriptive statistic analyses were performed for all variables. Significant level (p-value) was set at 0.05. T-test and x-test were used to assess differences. All analyses were performed using Microsoft Excel 2016. Data are presented using proportions (%) and time lag between approval dates in months.

RESULTS: From January 2007 to 2017, FDA, EMA and SMC approved 134 new drugs in common. Overall, 66.4% of the products were first approved by the FDA while 30,6% by the EMA and 3.0% by SMC. T-test indicates that the difference in approval dates between SMC and EMA was non-significant (p=0.636) while it was significant between SMC and FDA (p<0.0001) as well as between EMA and FDA (p<0.0001). The indications approved by the FDA, EMA and SMC for the same product were similar in content for 31 (23.1%) drugs while it was different for 103 (76.9%). Significant differences (p<0.0001) exist between FDA and SMC as well as FDA and EMA. But differences were not significant between EMA and SMC (p=0.146).

CONCLUSIONS: Drugs tend to be first approved by the FDA. Significant differences exist in characteristics of new drug in the assessment period between FDA on one side and EMA and SMC on the other side. Despite international trend to harmonization, based on scientific data included in a marketing application, regulatory decisions are complex and depend in part on an environment of public health policy and law as well as demands through researchers and health professional in the patient interest.