Trac Services | Orphan Drug Designation | TRAC Services
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Orphan Drug Designation

The consultancy for global, pharmaceutical regulatory affairs

TRAC works in the field of orphan drug designation, offering support and advice across all the regulatory requirements for obtaining orphan drug status.

Orphan medicinal products are used to diagnose, treat and prevent rare disease. A rare disease is defined as one which occurs in fewer than 5 per 10,000 individuals in the European Union (EU).

Numbers this small mean a correspondingly small potential market for new drugs to treat them and, consequently, those with such diseases have historically received little research attention. In 2000 however, the EU implemented the Orphan Drug Regulation (EC) No 141/2000 to promote research and development of orphan medicines in the EU to reduce this disparity.

Companies have to submit an application for orphan drug status to the European Medicines Agency (EMA). The process is free but has to happen before the company submits its product’s marketing authorisation application.

The EU provides the following incentives for developing an orphan medicinal product:

  • 10 years’ market exclusivity
  • reduced or waivered fees for a scientific advice and dossier preparation guidance from the EMA, determined by company status.
  • fee reductions or exemptions
  • access to EU funded research
  • access to the EMA Centralised Procedure (CP)
Read our industry paper to find out more about Orphan Drug Designations

Get in touch with our orphan drug designation experts