FDA and EMEA launch Good Clinical Practices Initiative

The US Food and Drug Administration and the European Medicines Agency (EMEA) reached an agreement, announced August 3, to launch a bilateral Good Clinical Practices (GCP) Initiative, designed to ensure that clinical trials submitted in drug marketing applications in the USA 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 USA 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,' said Commissioner of Food and Drugs Margaret Hamburg, 'This important effort will help to strengthen safeguards for participants and others involved in clinical studies,' she added

Key objectives of the FDA-EMEA GCP initiative will be: