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October 29, 2003

Information Sharing Agreement between the United States Food & Drug Administration and the European Union

Arnold & Porter Advisory

On 12 September 2003, the United States Food and Drug Administration (FDA) and the European Commission, European Agency for the Evaluation of Medicinal Products (EMEA) signed an agreement which will pave the way for greater co-operation between the two most influential regulatory authorities in the sphere of global pharmaceutical development. The exchange of letters took place as part of the regular cycle of EU-FDA bilateral meetings that have been on-going since 1989. The agreement is not intended to create any legal obligations under international or other law on the part of the USA, the FDA, the European Commission, the EMEA or the EU.

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