EMA: New Update of the "IRIS" Documents

In June 2022, we reported in our News about the supplemented and updated points of the guideline "IRIS guide for applicants (version 2.10)". Now, the guideline "IRIS guide for applicants" has already been updated to version 2.12 and contains some new features and revisions. Additionally, the "IRIS guide to registration and RPIs" has also been revised and is now available in version 2.9.

IRIS guide to registration and RPIs (version 2.9)

In addition to formal changes, the information on Affiliated Roles has been updated in the "Scientific procedures" section of subsection 5.1. "Access roles and permissions: principles". Changes and additions have been made to the "Parallel distribution procedures" section, too. There are also updates in subsection 5.4. "What can I see in IRIS, with my new role?".

IRIS guide for applicants (version 2.12)

In version 10 of the "IRIS guide for applicants" the subitem 7.2. "GCP inspections" was added. Chapter 7 "Inspections" now contains the subitem 7.3. "GVP inspections". Similar to the other two subsections (7.1. "GMP inspections" and 7.2. "GCP inspections"), this chapter explains the procedure how to use the IRIS portal with regard to GVP inspections.

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

In addition, a News section with the subheading "What's New in IRIS" is available on the EMA website. In this section, 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.

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