FDA and EMEA Launch Good Clinical Practices Initiative

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) has launched a bilateral Good Clinical Practices (GCP) Initiative, designed to ensure that clinical trials submitted in drug marketing applications in the United States and Europe are conducted uniformly, appropriately and ethically. The initiative began with an 18-month pilot phase on Sept. 1, 2009, and is focusing 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 the EMEA for the European Union will be the focus of the initiative.

Key objectives of the FDA-EMEA GCP initiative will be to conduct periodic exchanges of GCP-related information in an effort to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes; to conduct collaborative GCP inspections by sharing information, experience and inspection procedures, cooperating in the conduct of inspections and sharing best-practice knowledge; and to share information on interpretation of GCP by keeping each regulatory agency informed of GCPrelated legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.