EMA is pleased to announce that the management of GMP inspections in IRISwent live on 20 September (see Good manufacturing practice | European Medicines Agency (europa.eu) and Pharmaceutical industry | European Medicines Agency (europa.eu)).

This is a key milestone and is part of the Agency’s digital transformation programme.

The new system is expected to streamline the EMA inspection co-ordination process, improving efficiency, transparency and security.

Key benefits of IRIS for inspections:

Efficiency gains for EMA, MAHs/applicants and the EU/EEA regulatory network
Harmonisation across different inspections types;
Easier collaboration among EU/EEA regulators;
Automation of notifications to stakeholders;
Increased data quality through integration with other EMA systems, making use of SPOR (Substances, Products, Organisations and Referentials) master data.

Increased security, reducing the risk of unintentional disclosure of confidential information
Streamlined and secured processes for information exchange;

Better knowledge management
Easier reporting on inspection data;
Better overview of scientific/regulatory data and quicker searches.

Change management:

To ensure a smooth rollout, a training session for industry users was held on 10 September. The slides and recording of this session will be made available to the training participants by e-mail in due course.

This training session is an integral part of our change management plan, which also included a number of webinars with change champions from various industry trade associations. We are particularly grateful to the industry colleagues who participated in the various webinars held over the last few months for their helpful contributions.  

Further information:

As you may already know, EMA is currently working on the onboarding of Good Clinical Practice (GCP) and Pharmacovigilance (PhV) inspections in IRIS, which are expected to go live later in 2021.

More information on the use of the system can be found on the IRIS guide for applicants.

If you have any general questions on IRIS, please post a new thread in the IRIS Forum “General Discussion and Self-Help". For any technical questions or issues, please raise a ticket via the IT Service Desk.