After encouraging sponsors to begin using its new online portal for submitting and managing orphan designations last month, the European Medicines Agency (EMA) on Friday issued a guideline providing instructions on using the new portal.

In June, EMA launched the new secure portal, called Iris, giving sponsors three months to familiarize themselves with the system before it becomes mandatory on 19 September 2018. In the interim, sponsors may still use the existing process to file for orphan drug designation and EMA has updated its guideline for doing so, noting the 19 September deadline for switching to Iris…

Read more – RAPS