Posted by Michael Wonder on 01 May 2018
A comparative review of marketing authorisation decisions in Switzerland, the EU, and the USA
19 April 2018 - In this study we compared Swissmedic’s regulatory marketing authorisation decisions to those of the US FDA and European drug regulatory authorities.
We investigated the overall similarity of the regulatory decisions, approval, and postmarketing withdrawal rates in the 3 jurisdictions. In case regulatory decisions diverged, we analysed the reasons for rejection of marketing authorisation applications
The study comprises 255 new molecular entity applications assessed by SwissMedic by the EU and FDA between 2005 through 2014. Study parameters included the regulatory decision, post-marketing withdrawal rates, and the official reasons for rejection.
