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Orphan Drug Designation

EMA is responsible for reviewing applications from sponsors for orphan designation. Applications for orphan designation are examined by the EMA's Committee for Orphan Medicinal Products (COMP), using the network of experts that the Committee has built up.

At Assion, we have extensive experience in obtaining orphan drug designation (ODD) and can advise you on all regulatory aspects related to Orphan Drug approval. Some example areas of support available include:

  • ODD applications for start-up companies
  • Obtaining ODD status in the US or making parallel applications
  • ODD maintenance activities for both EU & other markets
  • Developing an ODD product through to MAA stage
  • Preparation and submission of Marketing Authorisation Applications
  • Obtaining rapid approval by use of the ‘exceptional circumstances’ route

Talk to one of our experts

On demand regulatory team an Assion case study

A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.