EMA’s IRIS system to be opened to all scientific advice applications

The European Medicines Agency (EMA) Regulatory & Scientific Information Management Platform IRIS will be the compulsory submission method for scientific advice from October.

IRIS was initially used as the application system for orphan designation for a medicine, as well as post-designation administration. MAP understands that all routine scientific advice tasks will now be conducted through IRIS. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says this covers: Initial and Follow-up Scientific Advice, Initial and Follow-up Protocol Assistance, Initial and Follow-up Qualification Procedure.

The requirement to use IRIS will begin on 19th October 2020. A webinar has been scheduled to assist users in users navigating IRIS:

Online training: How to submit Initial and Follow-up Scientific Advice applications (human) using IRIS – 13/10/2020

Read more about IRIS on the EMA website.

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Published 29. September 2020 in News, News EU