Gene Therapy

Report Summarizes Gene Therapy Study Findings from Paul Ehrlich Institute

Published in Gene Therapy Weekly, March 1st, 2012

2012 MAR 1 -- "Gene-therapy medicinal products are currently applied to patients enrolled in authorized clinical trials to demonstrate safety and efficacy. Given a positive outcome, marketing authorization can subsequently be achieved via the centralized procedure coordinated by the European Medicines Agency," scientists in Langen, Germany report.

"With Regulation (EC) No. 1394/2007 in force, advanced therapy medicinal products, including gene- and cell-therapy products, can be excepted from the obligation of obtaining a marketing authorization via the centralized procedure under specific conditions (so-called 'hospital exemption'). This hospital exemption...

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Source: Gene Therapy Weekly (2012-03-01)

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