On June 20, 2018, the EMA launched a new secure online portal called IRIS for the submission of applications for orphan designation and the management of post-designation activities. The aim is for the portal to be used for all activities relating to orphan designation, including applying for orphan designation, requesting pre-submission meetings, responding to requests for supplementary information and transferring orphan designation to a new sponsor. The hope is that this will provide a “comprehensive procedural and scientific support system for orphan designations”, and IRIS is being treated as a “pilot for [a] future Agency-wide platform for procedure management”.
In November 2017, the EMA publicized its intention to pilot new software, which was intended to improve the process for managing orphan designations, and improve the efficiency, and user experience, of such procedures. Shortly afterwards, in January 2018, configuration and development of IRIS began, with initial testing being run from March 2018.
Before an application can be drafted on IRIS, the IRIS Quick guide to registration explains that users must be registered with the EMA Account Management portal. Users will then be asked to select their organisation via the Organisations Management System (OMS) – all organisations must be registered in OMS, which is part of the SPOR web portal. Next, users must request access to IRIS via the EMA Account Management portal, before selecting the active substance to which their application relates. New active substances will need to be registered through the EMA Service Desk; only once this has been assigned may the application be drafted and submitted via IRIS.
Access to the database is limited to those with EMA accounts, and currently, users are only able to access information about their own products.
The EMA will continue to accept PDF and Word form-based applications until 19 September, at which point use of IRIS will become mandatory.