Switzerland presents an attractive opportunity for US biotech companies considering launching orphan drugs in Europe. It’s the third-fastest country for reimbursing new medicines post-approval and recent regulatory changes look likely to speed this up even further. Its regulatory independence from the EU, alongside its commitment to improving access to rare disease treatments, offers a unique opportunity. In our exclusive guide we explore: the national regulatory bodies the steps involved in gaining market access in Switzerland the new regulatory framework pre-approval routes, including early access programs and the reasons why you may want to look at Switzerland for the launch of your orphan drugs in Europe. |