Posted by Michael Wonder on 19 Jun 2018
Modernising the orphan designation process
19 June 2018 - The EMA has launched a new secure online portal for orphan designationExternal link icon applications.
The portal, named 'Iris', provides a single space where applicants can submit and manage the information and documents related to their applications for orphan designation. This is expected to reduce the time needed to prepare and submit the applications. During the review process, applicants can check the status of their applications from any device and receive automatic notifications when the status of the application changes.
Iris is part of a longer-term programme that aims to make the handling of product-related applications easier and utilises the domains of master data in pharmaceutical regulatory processes.
