EMA: Regulatory information - Replacement of GCP non-compliant pivotal studies in centralised marketing-authorisation applications not accepted

The European Medicines Agency (EMA) will not accept the replacement of a pivotal clinical study that has been found to be non-compliant with good clinical practice (GCP) by another study during the assessment of a centralised marketing-authorisation application. This position, outlined in a paper published today, aims to reinforce the application of GCP during the conduct of clinical trials by applicants.