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EMEA and FDA collaboration

The European Medicines Agency and the US Food and Drug Administration have announced a Good Clinical Practice initiative

The European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have announced a Good Clinical Practice (GCP) initiative. The two organisations will collaborate on inspections and share information on planning policy and outcomes. The aim is to ensure that clinical trials, conducted as part of the marketing authorisation process, are safe, ethical, appropriate and uniform. 

Thomas Lönngren, executive director of EMEA said in a statement that the project "marks an important step to the building of a global regulatory network for supervision of clinical trials". 

Commissioner of Food and Drugs at the FDA, Margaret Hamburg commented:

"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."

An 18-month pilot phase will begin on September 1 2009.

4th August 2009

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