The European Medicines Agency has released for public consultation a draft guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products.

This guideline defines scientific principles and provides guidance for the development and evaluation of gene therapy medicinal products (GTMP) intended for use in humans and presented for marketing authorisation. Its focus is on the quality, safety and efficacy requirements of GTMPs. The guideline is applicable to gene therapy medicinal products containing recombinant nucleic acid sequences (e.g. DNA vectors) or genetically modified micro-organisms or viruses.


The document open for consultation is available by clicking: http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500187020&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc

Comments should be provided using this template:  WC500004016 (http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/10/WC500004016.doc). The completed comments form should be sent to advancedtherapies@ema.europa.eu


Please note that the deadline for comments for this guideline is 31 August 2015.
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