BRIEF—New online platform for scientific advice from EMA

From October 19, 2020, developers of human or veterinary medicines should use the European Medicines Agency’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice.

At any stage of a medicine's development, the developer can ask for guidance and direction from the EMA, known as scientific advice, on the best methods and study designs to generate robust data on how well a medicine works and how safe it is.

The IRIS platform will provide a single space for applicants and EMA to submit requests, communicate, share information and deliver documents concerning each scientific advice procedure.

Medicine developers wishing to apply for scientific advice must first be registered to use IRIS. Guidance is available on how to register for and use IRIS for scientific advice and other regulatory procedures.