EMA: Modernising the orphan designation process

19/06/2018

Modernising the orphan designation process

EMA launches new submission portal today

The European Medicines Agency (EMA) has launched a new secure online portal for orphan designation 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 (SPOR).

Applicants will still be able to use the existing submission process until 19 September 2018. However, the Agency strongly encourages companies to start using the new portal from today.

In order to help applicants with the transition, EMA has developed two guidance documents. These step-by-step guides provide detailed instructions on how to use the new system and explain what has changed with its introduction.

EMA tested a pilot of the new system in March 2018 with 35 volunteers from 26 different organisations. Feedback from this test helped EMA to optimise the portal and showed high levels of satisfaction.

In future, the new system may be extended to include other procedures, taking user feedback and experience into account.

This document was originally posted by the EMA here.