EMA: Another Update of the "IRIS" Documents

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

In March 2022, you could aready read about the supplemented and updated points of the two guidelines "IRIS guide for applicants (version 2.6)" and "IRIS guide to registration and RPIs (version 2.8)" in the news "EMA: Update of "IRIS" - documents".

Now the "IRIS guide for applicants" is already valid in version 2.10 and contains some innovations and revisions. In addition to formal changes, the subsection 7.2 GCP inspections has been restructured and some existing chapters have been updated. These include, for example, the adjustments in Chapter 6 regarding the "marketing status" of the individual products and the additions in Chapter 2 in subsection 2.3 Create a new submission (general procedure for all submission types).

Basically, the "IRIS guide for applicants" consists of eight chapters. It should be seen as an aid for the submission of applications using the IRIS platform and provides supporting information for the presentation of various procedures in IRIS, such as scientific advice and GMP/GCP inspections. Chapters 1, 2, 3, 4, 6, 7 and 8 each contain subsections with detailed explanations and screenshots on the respective topics and issues.

In addition, there is a news section on the EMA website with the sub-item "What's New in IRIS". Here you will always find explanatory information on the updated guides as well as notes and information on the current status of specific topics, procedures and processes.

To find out more, please see version 2.10 of the IRIS Guide.