Non-clinical testing for inadvertent germline transmission of gene transfer vectors
| Current version |
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| Reference number | EMEA/273974/05 |
| Published | 16/11/2006 |
| Effective from | 01/05/2007 |
| Keywords | Non-clinical, inadvertent germline transmission, gene transfer vector, genetically modified viruses, adeno-associated viral (AAV) |
| Description | 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. |
Document history
First version Current version | In operation: 01/05/2007–present Published: 17/11/2005 Published: 17/11/2005 Published: 18/11/2006 |