ICH Considerations: general principles to address the risk of inadvertent germline integration of gene therapy vectors - Scientific guideline

This document identifies general principles for investigating and addressing risks for inadvertent germline integration. It provides considerations to minimise this potential risk in humans enrolled in clinical trials. This document applies to gene therapy vectors and could also apply to oncolytic viruses.

Keywords: Gene therapy vectors, non-clinical, clinical, biosafety, oncolytic viruses

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations: General principles to address the risk of inadvertent germline integration of gene th...

AdoptedReference Number: CHMP/ICH/469991/2006