(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) today announced an agreement to launch 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 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.

“Collaboration with international allies like the EMEA will lead to exciting opportunities for progress in public health,” says commissioner of food and drugs, Margaret A. Hamburg, M.D. “This important effort will help to strengthen safeguards for participants and others involved in clinical studies.” 

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