The Food and Drug Administration and the European Medicines Agency announced an agreement to launch a bilateral good clinical practices initiative to ensure that clinical trials submitted in drug marketing applications in the U.S. and Europe are conducted in a uniform and ethical manner.
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. A key objective will be to conduct periodic information exchanges on good clinical practices in order to streamline sharing of inspection planning information, and to communicate effectively on inspection outcomes.
Products regulated by the FDA's Center for Drug Evaluation and Research in the U.S. and by the European Medicines Agency, known as 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,” FDA Commissioner Margaret Hamburg said in a written statement. “This important effort will help to strengthen safeguards for participants and others involved in clinical studies.”
A joint assessment will be made by the FDA and the European Medicines Agency at the conclusion of the pilot phase, to see if the initiative needs to be modified.
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