EMA is pleased to announce the launch of the GCP Inspections feature in the IRIS platform. With the implementation of this new feature, Marketing Authorisation Applicants/Holders as well as EU/EEA inspectorates will be able to interact with EMA via a single portal for the exchange of documents and information on GCP Inspections procedures.
This is expected to streamline the Inspection co-ordination process, ensure more secure information exchanges, and increase data quality through integration with other EMA master data systems (e.g. SPOR).

For more information please check the updated IRIS guide for applicants or the Guidance for applicants/MAHs involved in GMP and GCP inspections co-ordinated by EMA.
Kindly note a recording from the training session on GMP and GCP for Industry users is available from the IRIS portal section “Additional guidance & training videos”.

If you have general questions with regard to the IRIS feature on GCP Inspections, please post a new thread in the IRIS Forum “General Discussion and Self-Help”. If you have technical questions or issues please raise a ticket via the EMA ServiceDesk.