EMA: Revised IRIS Documents

Drug Master File Procedures in the EU, the US and Japan - Live Online Training

Recommendation

14/15 October 2025

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
With updates on the CEP 2.0!

In March 2025, the two guidance documents "IRIS guide for applicants" and "IRIS guide to registration and RPIs" were once again updated and published. You can now find version 3.7 of the "IRIS guide for applicants" and version 2.17 of the "IRIS guide to registration and RPIs" on EMA's website.

IRIS guide for applicants

Apart from formal changes, some passages have been updated and added in the new version 3.7. As mentioned in the document history, the contents of chapters 1, 2, 6, 12 and 14 have been adapted or updated, with some chapters being subject to more extensive updates than others.

IRIS guide to registration and RPIs

According to the document history, the revised version 2.17 contains updates and changes in the content of chapters "5. Access to IRIS updated" and "6. How to access IRIS after your role has been approved".

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