{"ok":true,"entity":{"id":"gene-therapy","name":"Gene therapy","entityType":"concept","officialName":"Gene therapy（human gene therapy）","canonicalName":"Gene therapy","displayName":"Gene therapy","category":"医療技術の概念（遺伝子治療）","shortDescription":"遺伝子治療は、遺伝子の発現を改変・操作することで疾患の治療を目指す医療技術の概念で、遺伝子の置換、不活性化、新規または改変遺伝子の導入といった手法が含まれる。米国ではFDAのCBERが規制し、FDAの承認済み細胞・遺伝子治療製品一覧（2026年9月17日時点）には54件が掲載され、EUではEMAが先端医療医薬品（ATMP）として中央審査で承認を扱う。企業や個別製品ではなく、治療技術そのものを指す項目である。","primaryCluster":"biotech-genomics","parentEntity":null,"verificationStatus":"draft","website":"https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy","updatedAt":"2026-10-29T04:31:31.488Z","secondaryClusters":[],"alias":["human gene therapy"],"searchKeywords":["gene therapy","human gene therapy","gene transfer","genome editing","viral vector","CBER","advanced therapy medicinal products","ATMP","FDA approved cellular and gene therapy products"]},"referenceIndex":["P-01-001","P-02-001","P-04-001","P-05-001","P-06-001"]}