EMA Updates IRIS (Integrated Regulatory Information System) Guide for Applicants to Version 3.12

In November 2025 and January 2026, the IRIS guide for applicants was revised and released as version 3.12, while the IRIS guide to registration and RPIs remains unchanged at version 2.18 from July 2025. Both documents are now available on the EMA website.

Version 3.12 of the applicants’ guide includes formal updates and revised passages, notably in Chapter 2: Common operations for all submission types. This includes updates to section 2.3, “Create a new submission,” covering general procedures for all submissions except PLM procedures. Previous adaptations, such as paragraph 13.3 on creating a modification for a Paediatric Investigation Plan (PIP), remain in effect.

These updates aim to improve clarity and guide applicants in preparing submissions through IRIS in compliance with current EMA procedures.

Current IRIS documents:

• IRIS guide for applicants: v3.12
• IRIS guide to registration and RPIs: v2.18

31-01-2026