FDA, European Medicines Agency Launch Good Clinical Practices Initiative

FDA NEWS RELEASE
For Immediate Release: August 3, 2009

Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA, European Medicines Agency Launch Good Clinical Practices Initiative
Collaborative effort aims to ensure appropriate conduct of clinical trials

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.

“Collaboration with international allies like the EMEA will lead to exciting opportunities for progress in public health,” said 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.”

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

--To conduct periodic information exchanges on GCP-related information in order 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.

--To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.

“The clinical development of medicines is a global undertaking,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”

At the conclusion of the pilot phase, a joint assessment will be made by the FDA and the EMEA, with the scope and process modified and amended as needed.

"This is another initiative that will further strengthen the very robust relationship between the FDA and the EMEA," said Murray M. Lumpkin, M.D, Deputy Commissioner for International Programs. "This will allow both the FDA and the EMEA to leverage each other's GCP inspectional resources so both of us can use our resources to assure more of the clinical trials submitted to both agencies are of the highest quality."

Companies planning on submitting their marketing applications simultaneously to the FDA and the EMEA, and interested in participating in the joint inspections component of the initiative should contact Leslie Ball, M.D., director, Division of Scientific Investigations, Center for Drug Evaluation and Research, at Leslie.Ball@fda.hhs.gov.

For more information: EMEA-FDA GCP Initiative.

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