A Good Clinical Practices (GCP) Initiative designed to regulate clinical trials submitted in drug marketing applications in both Europe and the United States has been announced.
Products supervised by the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) will be the focus of the new initiative, which will begin an 18-month pilot phase on September 1, 2009.
The main objectives of the new initiative are: to streamline inspection planning and to communicate the outcomes effectively, conduct collaborative inspections by sharing information and experiences, and to share information on the interpretation of GCP.
Commissioner of Food and Drugs Margaret A Hamburg said: “Collaboration with international allies like the EMEA will lead to exciting opportunities for progress in public health.
“This important effort will help to strengthen safeguards for participants and others involved in clinical studies.”
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said: “The clinical development of medicines is a global undertaking. 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.”
Copyright Press Association 2009