Costanza Vignoli -

Starting from October 19th, 2020, developers of human medicines should use the European Medicines Agency (EMA)’s IRIS Regulatory & Scientific Information Management Platform (which is currently used for orphan drug designation procedures), according to the last communication issued by EMA.

The IRIS platform will offer applicants and EMA to submit requests, communicate, share information and deliver documents concerning each scientific advice procedure. Therefore, developers who wish to apply for scientific advice must be first registered to use IRIS.


RPN is already registered to IRIS and can support companies through all the stages of the scientific advice procedure.

Comments are closed for this post.