Non-clinical testing for inadvertent germline transmission of gene transfer vectors
Table of contents
This document provides guidance on non-clinical inadvertent germline transmission testing needed to support clinical development of gene transfer medicinal products consisting of or containing replication-incompetent vectors, genetically modified viruses or so-called naked nucleic acids directly administered to humans.
Keywords: Non-clinical, inadvertent germline transmission, gene transfer vector, genetically modified viruses, adeno-associated viral (AAV)
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Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors (PDF/112.84 KB)
Adopted
First published: 16/11/2006
Last updated: 16/11/2006
Legal effective date: 01/05/2007
EMEA/273974/2005 -
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Overview of comments received on a draft guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors(EMEA/273974/2005) (PDF/57.76 KB)
First published: 16/11/2006
Last updated: 16/11/2006
EMEA/360592/2006 -
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Draft note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products annex on non-clinical testing for inadvertent germline transmission of gene transfer vectors (PDF/120.06 KB)
Draft: consultation closed
First published: 17/11/2005
Last updated: 17/11/2005
Consultation dates: 01/11/2005 to 01/05/2006
EMEA/273974/2005 -
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Concept paper on the development of a committee for medicinal Products for human use (CHMP) guideline on nonclinical testing for Inadvertent germline transmission of gene transfer vectors (PDF/127.08 KB)
First published: 18/11/2004
Last updated: 18/11/2004
EMEA/CHMP/SWP/110180/2004