Orphan Medicinal Products in the EU
Orphan Medicinal Products in the EU:
Integrated Available Tools for Their Development
Laura Pintado Batlle, Regulatory Officer, Veristat
This paper captures the key aspects that Orphan Medicinal Products (OMP)s sponsors should
consider when applying for the Orphan Drug Designation (ODD) in Europe, analyses their proclivity
to make use of available interactions and regulatory tools provided by the European Medicines
Agency (EMA), and identifies the most common causes of OMP development failure.
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