6/7 September 2023
At the end of November and in mid-December 2022, the "IRIS guide to registration and RPIs" was updated again. The "IRIS guide for applicants" has also been revised and is now valid as version 2.13. The latest versions of both documents are available on the EMA website.
The new sections and revisions in both guides are outlined below:
In version 2.10, which was published in mid-November, in addition to formal changes, the term "IRIS Industry User Admin" was replaced by the wording "IRIS - eAF Industry User Admin". This wording is used, for example, in subsection 5.1. "Access roles and permissions: principles".
In the now valid version 2.11, changes have been made to the following sub-items:
The respective changes in points 7 and 8 are marked in yellow.
In the previous version, chapter 7 "Inspections" was revised and supplemented. In the current version 2.13, the information and explanations in chapter 4 "Scientific Advice" have been updated.
The new versions of the IRIS documents can be found in:
In addition, there is a news section on the EMA website with the sub-heading "What's New in IRIS". This section always contains explanatory information on the updated guides as well as notes and information on the current status of specific topics, procedures and processes.