New EMA orphan designation system comes into effect

On 19 July 2018, the EMA announced that its new orphan designation portal has become live. The system, known as Iris, is, according to the EMA, “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”.

As reported in previous MAP news articles, the system has been designed to streamline orphan drug applications for the industry, and we look forward to seeing it in action.

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Published 25. June 2018 in News, News EU