On June 27th 2022 European Medicines Agency (EMA) published revised IRIS guide for applicants (EMA/444925/2018). IRIS is a secure online platform for handling product-related scientific and regulatory procedures with EMA.
Currently valid version 2.11 contains some innovations and revisions compared to previous version published in March 2022. 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).
Document consists of eight chapters and can 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.
More information with explanatory information on the updated guides as well as notes and information on the status of specific topics, procedures and processes can be found on EMA website – IRIS Stakeholder Forums / What’s New in IRIS.