Development process of Orphan Medicines


This brochure, produced by the EBE-EuropaBio Joint Task Force on Rare Diseases and Orphan Medicinal Products, compares the research, development and approval processes of a usual medicine with the specific features of Orphan Medicinal Products (OMPs). 

OMPs, which are intended for the diagnosis, prevention or treatment of rare, chronically debilitating and life-threatening diseases, are approved at European level. The brochure presents a good overview of their specificities and of the various hurdles that these medicines have to face along the way, from their conception to their prescription to patients.