Coordination of GCP inspections

This page describes the procedure for co-ordinating Good Clinical Practice inspections of the clinical trial sites (e.g. investigators, sponsors, CROs, laboratories etc.) that performed clinical studies included in marketing authorisation applications submitted to the European Medicines Agency through the centralised procedure.

The European Medicines Agency has a co-ordinating role for these inspections whilst the responsibility for carrying them out rests with the National Competent Authorities.

GCP inspections

The procedure for the Coordination of pre-approval GxP Inspections (effective 16 May 2007) describes the co-ordination of pre-authorisation GCP inspections of clinical trial sites providing data used in marketing authorisation application dossiers under the centralised system.