Orphan Drugs

Regulating drugs for rare diseases is a carefully monitored process by the unit. A main feature of this is providing guidelines for sponsers on how to apply for orphan medicinal product designation to transfer drugs to the European Medicines Agency (EMEA). This is a step that has not only been taken by the European Commission and the EMEA acting within it; the United States and Food and Drug Administration (FDA) also have adopted a common applcation that sponsers must fill out in the request to transfer orphan products intended for rare diseases in the EU and US.