A study conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) found that the agencies are identifying the same types of deficiencies in joint good clinical practice (GCP) inspections with respect to protocol compliance, documentation deviations, and human subject protections.
**Abstract Background **
The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under diferent regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection fndings have been reported.
**Methods **
We identifed common inspections of clinical investigators, sponsors, and contract research organizations conducted by both agencies in support of marketing applications that had the same trial data submitted between 2009 and 2015. We grouped inspection fndings into defciency areas. We reviewed and compared these fndings and calculated concordance rate for each defciency area.
**Results **
Twenty-six clinical investigator sites and 23 sponsors/contract research organizations were inspected by both agencies in support of 31 marketing applications during this period. For FDA, the most common GCP fndings were defciencies related to Protocol Compliance for clinical investigator inspections and Trial Management issues for sponsor/contract research organization inspections. For EMA, defciencies related to Documentation (including Trial Master File) were the most common fndings for both clinical investigator and sponsor/contract research organization inspections. There was high concordance, of approximately 90%, for defciencies related to Protocol Compliance for clinical investigator inspections and Trial Management for sponsor/contract research organization inspections between the two agencies. There was a concordance rate of about 70% for Documentation defciencies for both clinical investigator and sponsor/contract research organization GCP inspections.
**Conclusion **
GCP inspection fndings from 49 common clinical investigator and sponsor/contract research organization inspections were comparable, providing support for continued FDA-EMA GCP collaboration.
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