RE: 66 Days!31 May 2024 14:03
Thought this was interesting especially the latter part where the new method has to be superior to the existing.
One of the key differences between the orphan designation process in the EU and US is that, in the latter the emphasis is on demonstrating the scientific rationale and disease prevalence, whilst in the EU there are two additional requirements: i) that the condition is life-threatening or seriously debilitating, and ii) that there is currently either no satisfactory method (of diagnosis, prevention or treatment) or that the new product will be of significant benefit over the existing method. Any product with a MA in any EU country would be considered to be a “satisfactory” method and, even where a product is not authorised, if it is widely used it may be considered to be satisfactory. In such a case, the applicant needs to provide a solid argument as to why the new method is expected to be superior.