ICH Considerations: oncolytic viruses - Scientific guideline

This document describes the general principles for the manufacturing, characterisation, non-clinical and clinical testing of medicinal products based on oncolytic viruses.

Keywords: Gene therapy, oncolytic viruses, wild type, genetically modified oncolytic viruses, manufacture, characterisation, non-clinical, clinical, biosafety

Current version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations: Oncolytic viruses

AdoptedReference Number: EMEA/CHMP/ICH/607698/2008