EMEA and FDA agree details for voluntary data meetings

The European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have "agreed to a procedure for joint briefing meetings with sponsors following voluntary submission of genomic data [voluntary genomic data submission - VGDS]" by pharmaceutical companies, according to an EMEA statement.

The Agencies say that while in most cases genomic data are of an exploratory nature, are not required in submissions for marketing authorisation and will not be used in the regulatory procedure, "voluntary submissions of such data are 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".

The procedure will see data being sent by the applicant to the Agencies" pharmacogenomic working groups over a ten-week period prior to their meeting (in principle by video-conference) and a four-week post-meeting timetable for the Agencies" report to the applicant.