Support for Orphan Drug Designation (ODD) in Europe

Case studies -

Support for Orphan Drug Designation (ODD) in Europe


BlueReg (BR) was engaged to assist a start-up company with the preparation of their orphan drug designation application dossier in Europe and to provide regulatory support during the procedure. 



  • Timelines: the client contacted BR a short time ahead of the planned submission date requesting a review and update of their draft ODD dossier. At this time, the client had been in contact with the EMA but had not followed up them for some time.
  • Regulatory context: at the time the project started, a new EU guideline laying down new requirements for ODD, in particular to justify significant benefit over existing therapies that would directly impact this application, was issued.

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