GMP Inspections: Do you know IRIS?

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