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.
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