The European Medicines Agency’s policy on fee reductions for orphan medicinal products has been revised: from January 2014 non-SMEs sponsor gaining an ‘orphan drug’ designation will benefit of additional fee reductions. This should push the development and the availability on the market of orphan medicinal products.

These new fee reductions are detailed in the Executive Decision ‘Fee reductions for designated orphan medical products’ (EMA 622074/2013). In particular, EMA confirms the incentives for micro/small/medium-sized enterprises (SMEs), as set up by the European Regulation on Orphan Drugs (EC 141/2000) aimed to support research and innovation on medicines intended for the diagnosis, prevention or treatment of rare diseases and recommended by the Agency’s Committee for Orphan Medicinal Products (COMP).

From the other hand, new fee reductions have been established for non-SMEs sponsor: 10% fee reduction for initial Marketing Authorisation Applications and 100% fee reduction for pre-authorisation inspections. This changes the past situation when these fee reductions were provided only for SMEs.

In addition, non-SMEs sponsor that submit a Marketing Authorisation Application for an orphan drug, will benefit of 75% fee reduction (instead of 40%) for EMA protocol assistance in case of non-paediatric-related development.

For more information, please visit the web site of the EMA.