Press Release: European Medicines Agency and US Food and Drug Administration extend confidentiality arrangements indefinitely

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced, in September 2010, that they had extended their confidentiality arrangements relating to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003. The confidentiality arrangements allow both Agencies to exchange confidential information as part of their regulatory and scientific processes.

• Primary Source

EMA: Press Release: EMA/579151/2010 (15.9.10) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/09/WC500096633.pdf

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