EMA aims to reinforce compliance with good clinical practice

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.

GCP is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects.

According to European Union (EU) legislation, all clinical trials submitted to a regulatory authority in the EU to support a marketing-authorisation application must be conducted in compliance with GCP.

This ensures that the rights, safety and well-being of the individuals recruited for these trials are protected and that clinical trial data are credible and reliable irrespective of where in the world the trials have been carried out.

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