GMP Inspections: Do you know IRIS?
Recommendation
Tuesday, 24 February 2026 13.00 - 16.30 h
Compliant and Successful Self-Inspections and Internal Audits
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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
03.12.2025What are GMP Audits and what Qualifications do GMP Auditors need to have?
19.11.2025Root Cause Analysis and CAPA - Why FDA Keeps Calling Them Out
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