Book by 30 June 2026 and get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
EMA: Revised IRIS Documents
Recommendation
9 June 2026
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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:
Related GMP News
27.05.2026What should you know about EU and US Drug Approval? Part 2
20.05.2026What should you know about EU and US drug approval? Part 1
18.03.2026ICH M4Q(R2): List of comments published
11.03.2026ASMF: CMDh updates Information on "Worksharing Procedure"
04.03.2026CMDh: Update of Q&As for Generic Drug Submissions
18.02.2026HMA/CMDh: Update to the Best Practice Guides on Variations