EMA updates IRIS Documents

In July 2025, updated versions of the two guidance documents 'IRIS guide for applicants' and 'IRIS guide to registration and RPIs' were published once again. Version 3.9 of the 'IRIS guide for applicants' and version 2.18 of the 'IRIS guide to registration and RPIs' are now available on the EMA website.

IRIS guide for applicants

In addition to formal changes, several passages have been updated in the new version 3.9. In line with the document history, the contents of chapters 13 and 14 have been revised. This includes paragraphs 13.1. Create an application for initial paediatric investigation plan (PIP), 13.1.1 Submitting the response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) and 14.1 Addition of paediatric procedure format in annexes table.

IRIS guide to registration and RPIs

In the revised version 2.18, the contents of chapter '5. Access to IRIS' in paragraph '5.1 Access roles and permissions: principles' have been updated in accordance with the document history with regard to the 'Industry Coordinator Role'.

The new versions of the IRIS documents can be found at:

• IRIS guide to registration and RPIs (Version 2.18)
• IRIS guide for applicants (Version 3.9)