GMP Inspections: Do you know IRIS?
Recommendation
11-13 November 2025
Vienna, Austria
An advanced Auditor Course with many interactive Sessions and practical Examples
Register now for ECA's GMP Newsletter
IRIS is an online platform for handling product-related scientific and regulatory procedures with the EMA. In 2018, it was established in a first step for orphan drug procedures. It was then expanded step by step. The aim is to shorten the time of applications within the framework of scientific procedures.
In the meantime, there are a number of different instructions for use and an IRIS stakeholder forum where users (primarily applicants) can find out about news (e.g. new IRIS functions, version information). It allows asking questions, submitting proposals and further discussions.
As it expands, the platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.
There are a lot of links to further information on the IRIS website:
- Access & submission
- Public registers & lists
- Guidance & support
- News
Related GMP News
22.10.2025EMA Questions & Answers on Mutual Recognition Agreement (MRA) with US updated
22.10.2025FDA continues to take Root Cause Analysis and CAPA very seriously
14.10.2025Two new GDP Non-Compliance Reports from Romania
01.10.2025Alternative Inspection Methods of the FDA
24.09.2025FDA issues final Guidance on Remote Oversight Tools
24.09.2025Four Warning Letter concerning CAPA and Root Cause Analysis published