Access to EMA’s IRIS portal, a must-have for Orphan Designation Applications

by Annegret Vaggelas

Since 19 September 2018, Sponsors need to use EMA's new secure online portal called IRIS for the submission of applications for orphan designation and the management of post-designation activities. The portal supports companies throughout the orphan drug designation (ODD) application life cycle and aims at reducing the time needed to prepare and submit applications. With the new portal it is e.g. not required anymore to send a notification for the intention to file ODD ahead of the submission. Instead the application should be directly submitted through the portal or a pre-submission meeting should be requested at least two months ahead of the planned submission dates. 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. Before IRIS went live it was tested in a pilot in March 2018 by 35 volunteers from 26 different organizations whose feedback helped to optimize the portal. The portal is part of a longer-term EMA program that aims to make the handling of product-related applications easier and is treated as pilot for a future Agency-wide platform. To access IRIS, Sponsors need an active EMA user account and must register their organization in the SPOR program as well as the new active substance in the EUTCT database. Moreover, a research product identifier (RPI) needs to be requested if not already obtained (for more details on each step, check out IRIS Quick guide to the portal for Orphan Industry users. Therefore, Applicant’s will need to invest some time upfront and it is recommended to start the registration process well in advance of the envisaged submission date.

What can we do for you?

As Biopharma Excellence is already registered for IRIS portal, we can offer to either do the submission on your behalf or to support you during the IRIS registration process. Moreover, we are also experienced in the preparation of ODD application packages. For further information on our services regarding orphan drugs and orphan drug designations, please contact us.