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Image header Agence Europe
Europe Daily Bulletin No. 9205
Contents Publication in full By article 36 / 46
GENERAL NEWS / (eu) eu/medicine

06/06/2006 (Agence Europe) - The European Commission, the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have agreed a procedure for joint FDA/EMEA briefing meetings with sponsors following voluntary submission of genomic data by third parties (laboratories and research institutes). Current data confidentiality arrangements will continue to obtain in these meetings. A press release says that much pharmacogenomic data are of an exploratory nature and, in most cases, not required to be submitted to health authorities. Voluntary submissions of such data is encouraged as a way of ensuring that regulatory authorities are familiar with the relevant scientific information on the development of new medicines and can develop common approaches to genomics.

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GENERAL NEWS
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