EMEA FDA DEAL
September 1st, 2003
BY KEITH NUTHALLTHE EUROPEAN Agency for the Evaluation of Medicinal Products (EMEA) and the USA's Food and Drug Administration have struck a deal on regulatory cooperation, entailing the swapping of advance copies of draft rules, guidance, marketing authorisations and supervision notes. Because this deal would involve the transfer of commercially sensitive material, both organisations have agreed to treat such material as confidential. That said, there is a caveat that this is "to the extent permitted by their respective laws," including - of course - the US ...
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