{"data":[{"id":"eb6d119b-1a60-4e54-9a74-d1748fddd746","company_name":"シスメックス 株式会社","company_name_en":null,"corporate_number":"9140001009530","authority":"厚生労働省","law_name":"薬事法","action_type":"先駆け審査指定制度対象品目の募集","action_date":"2017-10-05","announcement_date":"2026-04-03","violation_summary":"がん関連遺伝子パネル検査システム 固形がん患者の腫瘍組織中のDNAにおける遺伝子の異常（変異、増幅又は融合）を一括検出することで、がん患者の遺伝子異常プロファイリングを行い、診療方針決定の補助に用いる","violation_summary_en":"A cancer-related gene panel testing system that detects gene abnormalities (mutations, amplifications, or fusions) in tumor tissue DNA from solid cancer patients to perform genetic abnormality profiling and assist in treatment decision-making.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000179802.html","url":"https://regbase.jp/enforcement/other-sisumetukusu-20171005"},{"id":"100029dc-6472-4916-8543-f9f00985c1bc","company_name":"シスメックス株式会社","company_name_en":null,"corporate_number":"9140001009530","authority":"厚生労働省","law_name":"薬機法","action_type":"先駆け審査指定制度対象品目の募集","action_date":"2017-10-05","announcement_date":"2026-04-27","violation_summary":"厚生労働省は、革新的医薬品・医療機器・再生医療等製品を日本で早期に実用化することを目的として、その開発を促進するために、平成27年４月１日に「先駆け審査指定制度」を創設しました。","violation_summary_en":"The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, with the aim of facilitating their early practical use in Japan.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000179802.html","url":"https://regbase.jp/enforcement/yakkiho-sisumetukusu-20171005"},{"id":"7d168af1-23d4-4495-af19-c02d180aa9b8","company_name":"シスメックス株式会社","company_name_en":null,"corporate_number":"9140001009530","authority":"厚生労働省","law_name":"薬機法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-05-02","violation_summary":"がん関連遺伝子の変異・増幅・融合を網羅的に検査するDNAシークエンサー診断システム。","violation_summary_en":null,"penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/yakkiho-sisumetukusu-20170228"},{"id":"93131601-30a9-453c-8b20-8b885d6c46d1","company_name":"シスメックス株式会社","company_name_en":null,"corporate_number":"9140001009530","authority":"厚生労働省","law_name":"薬事法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-04-07","violation_summary":"がん関連遺伝子の変異・増幅・融合を網羅的に検査するDNAシークエンサー診断システムであり、がん患者の遺伝子異常プロファイリングを行い、診療方針決定の補助に用いる。国内で承認されたものがなく、今後、がん関連遺伝子異常プロファイリングの有用性を裏付けるために必要な試験を行い、世界に先駆けて日本で承認申請予定。","violation_summary_en":"A DNA sequencer diagnostic system that comprehensively tests for mutations, amplifications, and fusions of cancer-related genes, used for genetic abnormality profiling of cancer patients and assisting in clinical decision-making. There are no domestically approved products, and future plans include conducting necessary tests to substantiate the usefulness of cancer-related gene abnormality profiling and submitting an approval application in Japan ahead of the world.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/other-sisumetukusu-20170228"}],"meta":{"query":null,"corporate_number":"9140001009530","law":null,"authority":null,"action_type":null,"count":4,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":6,"reset_at":"2026-05-21T22:55:09.677Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":273,"reset_at":"2026-05-22T22:54:09.677Z"}}}