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Orphan Drugs

Orphan drugs used for the diagnosis, prevention and treatment of diseases that are considered as rare, i.e. affecting a very low share of patients, do not represent an interesting market for the pharmaceutical industry.

In order to promote the development of these medicines, the European Union has adopted a series of regulations (EC 141/2000 and EC 847/2000), that define the criteria and procedures for the designation of an orphan drug by a dedicated committee: the Committee for Orphan Medicinal Products, COMP of the European Medicine Agency, with the attribution of incentives and the release of MAs with an assisted path via the “Protocol Assistance” procedure.

Thanks to its dedicated team, Di Renzo Regulatory Affairs can assist the companies operating in this sector during the developmental steps of orphan drugs, from obtaining the initial orphan designation until the marketing authorisation, offering the necessary regulatory advice.

Foto di AVAKAphoto da Pixabay