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Outcome Documents of the Science Board
The Fourth Term (-March, 2020) Subcommittees
- Genome editing, an innovative technique, may cause alterations in genes other than the target gene (off-target effects) or unexpected mutations in the target gene (on-target mutations), and these mutations need to be evaluated.
The Science Board has prepared a report summarizing the issues to be considered in the development of gene therapy products using genome-editing technology.
White-paper for quality and safety for gene therapy products using gene editing technology
The article explaining the basis and comparison of the key concepts with information provided by foreign regulatory authorities has now been published in the paginated issue:
Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan (Human Gene Therapy, Volume 31, Issue 19-20, 1043-1053, 2020)
The Third Term (-March, 2018) Subcommittees
The Second Term (-March, 2016) Subcommittees
The First Term (-March, 2014) Subcommittees