EMA Modernizes Orphan Drug Process

On June 19, 2018, the European Medicines Agency (EMA) announced the launch of “Iris”, a secure online portal for the submission of orphan drug designation applications. The new portal will allow applicants to submit and manage information and documents related to their application. The agency hopes the portal will reduce the time needed to prepare and submit applications.

Part of a long-term program to handle product-related applications and utilize master data in pharmaceutical regulatory processes, Iris allows applicants to check the status of their applications and receive automatic notifications of changes.

While the existing submission process will be available until Sept. 19, 2018, EMA is encouraging companies to start using the new portal. The agency has developed two new guidance documents with step-by-step instructions on how to use the new system.

Source: EMA