EU (European Commission and EMEA) and FDA agree on guiding principles for joint FDA EMEA meetings

May 31, 2006

Applied Clinical Trials

EU (European Commission and EMEA) and FDA agree on guiding principles for joint FDA EMEA voluntary genomic data submission briefing meetings

The European Commission (EC), the European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA) have agreed to a procedure for joint FDA EMEA briefing meetings with sponsors following voluntary submission of genomic data. The procedure has been agreed to within the scope of the confidentiality arrangements between the EC/EMEA and the FDA and is based on prior experience with joint briefings.

Much of pharmacogenomic data are of an exploratory nature and not required to be submitted to health authorities in most cases. However, voluntary submissions of such data is encouraged as a means to ensure that regulatory authorities are familiar with the issues arising from the integration of pharmacogenomics in drug development and to ensure that industry has an opportunity to hear scientific perspectives from the regulatory authorities. These joint voluntary submissions are important for regulatory agencies to ensure that evolving policies are based on the best science, to help in the development of common approaches to genomics in drug development, and to facilitate the use of pharmacogenomic tests during global drug development.

Voluntary genomic data submission packages will be reviewed by the FDA's Interdisciplinary Pharmacogenomic Review Group (IPRG) and the EMEA Pharmacogenetics Working Party (PGWP). Contact information for submitting a request for a joint voluntary genomic data submission meeting can be found in the guiding principles document.

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