The European Commission, the European Medicines Agency and the U.S. Food and Drug Administration said they have adopted a common application form for drugmakers seeking orphan designation for their medicines.
LONDON (Reuters) - U.S and European regulators said on Monday they have eased the application process for orphan drugs, a move aimed at spurring development of treatments for rare diseases.
The European Commission, the European Medicines Agency and the U.S. Food and Drug Administration said they have adopted a common application form for drugmakers seeking orphan designation for their medicines.
This will allow companies to apply to both jurisdictions at the same time with one application while also helping the regulatory agencies to better understand each other's systems.
Some 30 million people in the European Union and about 25 million Americans suffer from more than 6,000 rare diseases. This makes it unprofitable for drug companies to develop new drugs for such conditions without incentives.
!ADVERTISEMENT!European and U.S. regulators already offer financial and other incentives to pharmaceutical companies willing to take on the costs of developing drugs used by small numbers of people.
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.
(Reporting by Michael Kahn; Editing by Sue Thomas)
