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U.S. Food and Drug Administration	European Commission	European Agency for the Evaluation of Medicinal Products

EXTENSION OF CONFIDENTIALITY ARRANGEMENT
BETWEEN THE UNITED STATES FOOD AND DRUG ADMINISTRATION
AND THE EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY
DIRECTORATE-GENNRAL AND THE EUROPEAN MEDICINES AGENCY
TO EXCHANGE REGULATORY INFORMATION

Whereas the United States Food and Drug Administration (USFDA) and the European Commission’s Enterprise and Industry Directorate-General (DG Enterprise) and the European Medicines Agency (EMEA) (collectively, the Participants) exchanged letters on September 12, 2003 establishing a Confidentiality Arrangement to exchange regulatory information; and

Whereas it was agreed between the participants that the Confidentiality Arrangement was intended to be in effect for a period of two years, at the completion of which the Participants would assess the arrangement’s effectiveness; and

Whereas the Participants have assessed the effectiveness of the Confidentiality Arrangement and found that it is a useful tool in transatlantic regulatory cooperation;

The Confidentiality Arrangement, in annex to this extension, is hereby extended for a period of five years from the last date of signature of this document.

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