EMA Publishes Updated IRIS Guidance Documents in July 2025

In July 2025, the European Medicines Agency (EMA) released updated versions of two key IRIS (Integrated Regulatory Information System) guidance documents: IRIS guide for applicants (Version 3.9) and IRIS guide to registration and RPIs (Version 2.18). Both documents are now available on the EMA website.

The revised IRIS guide for applicants introduces several formal updates. According to the revision history, chapters 13 and 14 have been modified. Notable changes include section 13.1 on creating an initial Paediatric Investigation Plan (PIP), subsection 13.1.1 on submitting responses to Paediatric Committee requests for supplementary information or PIP modifications, and section 14.1, which adds the paediatric procedure format to the annexes table.

Meanwhile, Version 2.18 of the IRIS guide to registration and RPIs updates chapter 5, specifically paragraph 5.1 on access roles and permissions. The revision clarifies provisions related to the “Industry Coordinator Role.”

03-09-2025