Offer extended until 31 July 2026: 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
GMP Inspections: Do you know IRIS?
Recommendation
10-12 November 2026
Hamburg, Germany
An advanced Auditor Course with many interactive Sessions and practical Examples
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
28.10.2026Inadequate Supplier Oversight and missing Tests: Lessons from an FDA Warning Letter
21.10.2026FDA Cites Serious CGMP Deficiencies at Stream2Sea
23.09.2026FDA Inspection as GMP Evidence? Swissmedic Opens Up a New Option
23.09.2026New: Coordination of GMP Inspections for Centrally Authorised Products
16.09.2026How GMP Non-Compliance can stop a Marketing Authorisation Application
10.09.2026FDA Warning Letter: Inadequate Warehouse Controls and Lot Traceability