How can I apply and benefit from an Orphan Drug Designation?
How to apply and benefit from an Orphan Drug Designation – EJPRD IMT. In this tutorial, the benefits of an ODD are outlined, along with steps to apply, access IRIS, and submit applications to EMA. Guidance is provided on completing forms, the evaluation process, protocol assistance, post-designation activities, and resources for drug development strategies.
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Thanks Rosan. Just to add to your useful link; Orphan Drug Designations can be obtained by different stakeholders including academia, patient organisations and companies. Once obtained, it provides some waivers and discounts in the regulatory route to registration.