US FDA and Sweden's MPA arrange to share drug safety surveillance data

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  • Reactions 1102 - 20 May 2006

    Drug safety surveillance information can now beshared between the US FDA and Swedens MedicalProducts Agency (MPA), as the two agencies havesigned a mutual Confidentiality Arrangement,according to an FDA announcement. TheArrangement, which became effective as of April 2006,will allow the agencies to share drug safetysurveillance data and other critical nonpublic healthinformation, including internal pre-decisional and lawenforcement information, says the FDA. According tothe announcement, the deal will be useful for sharingdrug safety data that may result in regulatory measuresthat the agencies wish to "implement globally in aconcerted manner", and will alleviate time-differencedifficulties experienced in simultaneous riskcommunications.FDA. FDA Signs Arrangement With Swedens Medical Products Agency.Media Release : 28 Apr 2006. Available from: URL: 809063533


    Reactions 20 May 2006 No. 11020114-9954/10/1102-0001/$14.95 Adis 2010 Springer International Publishing AG. All rights reserved


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