Orphan drug application process to ease in U.S., Europe

WASHINGTON & LONDON The Food and Drug Administration, European Commission and European Medicines Agency have decided to ease the application process for orphan drugs, drugs that are necessary but would be expensive and unprofitable to develop, in a move aimed at increasing the development of treatments for rare diseases, according to Reuters.

The agencies have adopted a common application, which would allow drug companies to apply to both regions at the same time with one application.

Rare diseases are defined as those affecting fewer than five in 10,000 people in the European Union and fewer than 200,000 people in the United States. About 30 million people in the European Union and about 25 million Americans suffer from more than 6,000 rare diseases.