Quality, non-clinical and clinical issues relating specifically to recombinant adeno-associated viral vectors - Scientific guideline
This document aims to discuss quality, non-clinical and clinical issues that should be considered during the development of medicinal products derived from adeno-associated viral vectors. It indicates requirements that might be expected at the time of a marketing authorisation application.
Keywords: Adeno-associated virus, self complementary adeno-associated virus, recombinant adeno-associated virus, production systems, quality, non-clinical, clinical, follow-up, tissue tropism, germ-line transmission, environmental risk, immunogenicity, biodistribution, shedding, animal models, persistence, reactivation, advanced therapy medicinal products (ATMPs), gene therapy medicinal products
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Reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors (PDF/199.76 KB)
Adopted
First published: 08/07/2010
Last updated: 08/07/2010
EMEA/CHMP/GTWP/587488/2007 -
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Overview of comments received on 'Reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors' (PDF/290.24 KB)
First published: 08/07/2010
Last updated: 08/07/2010
EMA/CHMP/GTWP/629733/2009 -
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Draft reflection paper on quality, non-clinical and clinical issues relating specifically to recombinant adeno-associated viral vectors (PDF/127.05 KB)
First published: 19/03/2009
Last updated: 19/03/2009
EMEA/CHMP/GTWP/587488/2007