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Genome editing technologies, including clustered regularly interspaced short palindromic repeat (CRISPR)/CRISPR-associated protein 9 (Cas9) system, are expected to become a state-of-the-art strategy for human gene therapy. However, there are several new safety issues to be addressed before clinical use. This review article summarizes the current regulatory status of the safety assessment of genome editing for human gene therapy. In addition, with a focus on unintended genome editing bydoi:10.33611/trs.2020_011 fatcat:qx2e6rxnrzd6llw5izgqmrqbfu