{"data":[{"id":"569fae09-4212-424e-9fe7-0f7196e98bc0","company_name":"住友重機械工業 株式会社","company_name_en":"Sumitomo Heavy Industries, Ltd.","corporate_number":"9010701005032","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":"ホウ素中性子捕捉療法（BNCT）システム・再発悪性神経膠腫・切除不能な局所再発頭頸部癌並びに局所進行頭頸部癌（非扁平上皮癌）","violation_summary_en":"Boron Neutron Capture Therapy (BNCT) system for recurrent malignant glioma, inoperable local recurrent head and neck cancer, and locally advanced head and neck cancer (non-squamous cell carcinoma)","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000179802.html","url":"https://regbase.jp/enforcement/other-zhu-you-chong-ji-jie-gong-ye-20171005"},{"id":"c055baab-10b9-4ca4-80d4-7384709cfd41","company_name":"住友重機械工業株式会社","company_name_en":"Sumitomo Heavy Industries, Ltd.","corporate_number":"9010701005032","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-zhu-you-chong-ji-jie-gong-ye-20171005"},{"id":"c76d4fcf-c042-4ae9-ac8e-1e1f77168f09","company_name":"住友重機械工業株式会社","company_name_en":"Sumitomo Heavy Industries, Ltd.","corporate_number":"9010701005032","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":"ホウ素中性子捕捉療法（BNCT）に用いる中性子線を照射するための装置である。適応疾患は、悪性神経膠腫と頭頸部癌である。国内で実施中の第I相治験（12例）で確認した1年生存率は66.7％、同大学で実施した頭頸部癌を対象とした臨床研究（62例）で確認した奏効率は58％であるとの報告があり、高い有効性が示唆されている。","violation_summary_en":"This is a device used for neutron beam irradiation in boron neutron capture therapy (BNCT). The applicable diseases are malignant glioma and head and neck cancer. A Phase I clinical trial conducted domestically with 12 cases reported a one-year survival rate of 66.7%. A clinical study targeting head and neck cancer conducted at the same university with 62 cases reported an response rate of 58%, suggesting high efficacy.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/other-zhu-you-chong-ji-jie-gong-ye-20170228"}],"meta":{"query":null,"corporate_number":"9010701005032","law":null,"authority":null,"action_type":null,"count":3,"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":7,"reset_at":"2026-05-21T23:35:28.598Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":259,"reset_at":"2026-05-22T23:34:28.598Z"}}}