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FDA, EMEA Release Joint Pharmacogenomics Data-Submission Guidance

NEW YORK, June 1 (GenomeWeb News) - US and European drug regulators today said they have agreed to a joint procedure that drug makers can follow to voluntarily submit pharmacogenomic data to both agencies.


The document, which can be found here, could benefit pharmaceutical companies interested in simultaneously selling products in Europe and the US that have pharmacogenomic components.


Specifically, the European Medicines Agency and the US Food and Drug Administration today released a set of "guiding principles" describing how they will process drug makers' requests to jointly meet with both agencies about voluntary genomic data submission.


The guiding principles have a list of definitions agreed to by the agencies, and a flowchart describing how voluntary submissions would be procssed. The FDA's Interdisciplinary Pharmacogenomic Review Group and the EMEA's Pharmacogenetics Working Party will review the data submission packages.


The FDA and the EMEA have issued industry guidance on pharmacogenomic data submissions and briefing meetings in the past. While researchers are not required to submit pharmacogenomic data to health authorities in most cases, voluntary submissions are encouraged to help regulators become familiar with issues arising in drug development.


The FDA published guidelines on voluntary submissions in 2004. The FDA and EMEA informally met at the time to help the agencies synchronize their pharmacogenomic goals and strategies. The most recent guidance for voluntary submissions on the FDA web site is dated March 2005.

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