FDA, European Medicines Agency Launch Good Clinical Practices Initiative
The U.S. Food and Drug Administration 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 September 1, 2009 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.