FDA and EMA Allow Single Annual Report for Orphan Drugs

The US Food and Drug Administration and the European Medicines Agency (EMA) are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products. A primary part of the new process includes US and EU regulatory acceptance of a single annual report from sponsors that manufacture these drug products, according to a FDA press release.

Orphan and biologic drugs typically are developed to treat rare medical conditions. FDA and EMA unveiled the collaboration in recognition of World Rare Disease Day (February 28). As of Feb. 28, 2010, manufacturers no longer have to submit one annual report to FDA and one to EMA-they can produce a single report for their orphan-designated products.

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

The agencies noted that the single annual report submission is voluntary and applies only to sponsors who have obtained orphan status for their product from both FDA and EMA. The agencies plan to exchange the reports electronically through a secure portal.