Skip to content

News
 

EU, U.S. regulators ease process for orphan drugs

Submitted on: 11.26.2007

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 streamlined application process 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.

View Article



Back to News Items