IRIS is the EMA’s secure online platform to carry out certain regulatory procedures with EMA. It is a core part of EMA’s digital transformation process. EMA plans to extend the platform to cover other regulatory and scientific procedures. IRIS aims to make the handling of product-related regulatory procedures more efficient and user-friendly and to ensure better data quality through integration with other EMA systems such as the substance, product, organisation and referential (SPOR) portal.
Read the pdf