The FDA and the European Medicines Agency (EMEA) have launched a bilateral Good Clinical Practices (GCP) initiative, designed to ensure that clinical trials submitted for drug marketing applications in the United States and Europe are conducted uniformly, appropriately and ethically.
The initiative will begin with an 18-month pilot phase on Sept. 1, and will focus on collaborative efforts to inspect clinical trial sites and studies. Products regulated by the FDA's Center for Drug Evaluation and Research in the United States, and by the EMEA for the European Union, will be the focus of the initiative.
According to the agencies, the objectives of the FDA-EMEA GCP initiative will be:
- To conduct periodic information exchanges on GCP-related information to streamline sharing of GCP inspection planning information, and timely communication on inspection outcomes.
- To conduct collaborative GCP inspections by sharing information, experience and inspection procedures, by cooperating in the conduct of inspections and sharing best-practice knowledge.
- To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to jointly act to benefit the clinical research process.
"The clinical development of medicines is a global undertaking," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. "With limited resources available to address the global nature of clinical research, this is an outstanding opportunity for the FDA and the EMEA to work together to carry out inspections and share information."
At the conclusion of the pilot phase, the FDA and the EMEA will jointly assess the initiative, with the scope and process modified and amended as needed.