FDA and Its Counterparts Release Drug Inspection Collaboration Reports

The pilot programs are part of the FDA's global strategy to ensure the safety and quality of imported products.

The U.S. FDA and its European and Australian counterparts released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.

The report on the Good Clinical Practice (GCP) initiative details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the GCP pilot program, the FDA and the European Medicines Agency (EMA) exchanged more than 250 documents relating to 54 different drug products and, in conjunction with the GCP inspectors of the EU member states, organized 13 collaborative inspections of clinical trials. This lays the foundation for a more efficient use of limited resources, improved inspectional coverage, and better understanding of each agency's inspection proced