IRIS is EMA's secure platform for an expanding range of product-related scientific and regulatory procedures.
Core official resource
- IRIS — procedure access, registration guidance, public registers and release information.
Practical use
IRIS is not a pharmacovigilance database. It is a regulatory workflow platform. For PV professionals its relevance includes EMA processes such as GVP inspection handling, while other IRIS procedures cover scientific advice, orphan designations and related regulatory activities. Always check the procedure-specific EMA guidance before assuming that a particular submission belongs in IRIS.