Non-clinical testing for inadvertent germline transmission of gene transfer vectors

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Current version

Adopted guideline

Reference numberEMEA/273974/05
Published16/11/2006
Effective from01/05/2007
KeywordsNon-clinical, inadvertent germline transmission, gene transfer vector, genetically modified viruses, adeno-associated viral (AAV)
DescriptionThis 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.


Document history

First version 

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/05/2007–present


Published: 17/11/2005


Published: 17/11/2005


Published: 18/11/2006


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