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

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)

Current effective version

Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors

Adopted Reference Number: EMEA/273974/2005 Legal effective date: 01/05/2007

Document history - First version (current)

Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors

Adopted Reference Number: EMEA/273974/2005 Legal effective date: 01/05/2007

Overview of comments received on a draft guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors(EMEA/273974/2005)

Reference Number: EMEA/360592/2006

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

Draft: consultation closed Consultation dates: 01/11/2005 to 01/05/2006 Reference Number: EMEA/273974/2005

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

Reference Number: EMEA/CHMP/SWP/110180/2004