Value Seen in Joint GCP Inspections

Staff from FDA and the European Medicines Agency say good clinical practice (GCP) inspection findings from 49 common clinical investigator and sponsor/contract research organization inspections were comparable, providing support for continued collaboration between the two regulatory agencies. The two organizations have collaborated in GCP inspections since 9/2009. They operate under different regulatory frameworks for GCP oversight.

An FDA report in the open-access Therapeutic Innovation & Regulatory Science says the analysis supports the existing practice of sharing information between the two agencies for CGP inspection planning and for the exchange of inspection reports. “This in turn permits more efficient utilization of the finite resources available for GCP inspections,” the report concludes. Recently, it says, the collaboration has been expanded to include Japan’s Pharmaceuticals and Medical Devices Agency in a trilateral GCP collaboration.