FDA, EMEA adopt orphan drug report system

ROCKVILLE, Md. Companies developing drugs to treat especially rare conditions may find winning regulatory approval in the United States and European Union a bit easier under a plan adopted by regulators on both sides of the Atlantic.

The Food and Drug Administration and its EU counterpart, the European Medicines Agency, announced Friday that they had adopted a single annual report system for orphan drugs, accepting the submission of a single annual report from sponsors of orphan drugs designated by the FDA and EMEA. The two agencies said it would allow regulators to better identify and share information throughout the development process.

Under current regulations, if a product receives orphan drug designation on the same day in the United States and European Union, sponsors must submit separate reports to each agency.

“This process provides benefits for both agencies,” FDA Office of Orphan Products Development director Timothy Cote said in a statement. “Additionally, it reduces the duplication involved for sponsors in reporting to two separate regulatory agencies.”