Abstract
ICH gene therapy discussion group has been expected to exchange information with the following objectives:monitoring emerging scientific issues, developing new ways of communication to ensure that the outcomes of ICH are well understood and widely disseminated, proactively setting out principles that may have a beneficial impact on harmonizing regulation of gene therapy products. The group has been discussing and published the concept papers about reference materials for gene therapy vectors, virus/vector shedding, evaluation of risk of X-SCID gene therapy, oncolytic virus products, and risk of germline integration of gene therapy products.
