Quality, non-clinical and clinical issues relating specifically to recombinant adeno-associated viral vectors

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Revision 1 - Reflection paper

Reference numberCHMP/GTWP/587488/2007 Rev. 1
Published08/07/2010
KeywordsAdeno-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
DescriptionThis 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.


Document history

Revision 1

Current version

Reflection paper


Overview of comments


Concept paper

Published: 08/07/2010


Published: 08/07/2010


Published: 19/03/2009


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