Simon Dalla Torre Di Sanguinetto1, Esa Heinonen2, Janine Antonov3, Claus Bolte1. 1. 1 Marketing Authorization Sector, Swiss Agency for Therapeutic Products (Swissmedic), Bern, Switzerland. 2. 2 Division for Assessment of Medicinal Products, Finnish Medicines Agency, Helsinki, Finland. 3. 3 Unitectra, Technology Transfer Office for the Universities of Basel, Bern and Zürich, Bern, Switzerland.
Abstract
BACKGROUND: In this study we compared Swissmedic's (SMC's) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug regulatory authorities (EU). We investigated the overall similarity of the regulatory decisions, approval, and postmarketing withdrawal rates in the 3 jurisdictions. In case regulatory decisions diverged, we analyzed the reasons for rejection of marketing authorization applications (MAAs). METHODS: The study comprises 255 new molecular entity (NME) MAAs assessed by SMC by the EU and FDA between 2005 through 2014. Study parameters included the regulatory decision, postmarketing withdrawal rates, and the official reasons for rejection. RESULTS: Regulatory decisions converged to a high degree among all 3 agencies (between 84% and 90%). SMC's average approval rate (84%) was slightly lower than those of the FDA (87%) and the EU (91%). Postmarketing withdrawal rates were generally low (4%-5%) but were 3 to 5 times higher when decisions among the drug regulatory authorities (DRAs) diverged. SMC's primary grounds for rejection were lack of efficacy (45%) and safety (40%). CONCLUSIONS: The 3 investigated DRAs adhere largely to the same scientific principles and regulatory guidelines; therefore, remaining disparities ought to be considered in a cultural, legal and public health priority context.
BACKGROUND: In this study we compared Swissmedic's (SMC's) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug regulatory authorities (EU). We investigated the overall similarity of the regulatory decisions, approval, and postmarketing withdrawal rates in the 3 jurisdictions. In case regulatory decisions diverged, we analyzed the reasons for rejection of marketing authorization applications (MAAs). METHODS: The study comprises 255 new molecular entity (NME) MAAs assessed by SMC by the EU and FDA between 2005 through 2014. Study parameters included the regulatory decision, postmarketing withdrawal rates, and the official reasons for rejection. RESULTS: Regulatory decisions converged to a high degree among all 3 agencies (between 84% and 90%). SMC's average approval rate (84%) was slightly lower than those of the FDA (87%) and the EU (91%). Postmarketing withdrawal rates were generally low (4%-5%) but were 3 to 5 times higher when decisions among the drug regulatory authorities (DRAs) diverged. SMC's primary grounds for rejection were lack of efficacy (45%) and safety (40%). CONCLUSIONS: The 3 investigated DRAs adhere largely to the same scientific principles and regulatory guidelines; therefore, remaining disparities ought to be considered in a cultural, legal and public health priority context.
Keywords:
EMA; MAA; SMC; Swissmedic; US FDA; regulatory decisions