{"data":[{"id":"3e22c6f2-e456-4ce3-8090-bf5332b2e9d5","company_name":"株式会社UT-Heart研究所","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬事法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-04-07","violation_summary":"心臓再同期療法※を行った重症心不全患者の中で約30％が無効例と報告されており、無効例の診断は困難である。本品は心臓再同期療法の効果予測の判断を補助できる点に新規性があり、画期性が高い。臨床研究（11例）の結果から、本品を使用した心臓のポンプ機能の改善の効果予測は実際の効果と高い相関（相関係数0.94）を示したとの報告があり、高い有効性が期待できる。","violation_summary_en":"Approximately 30% of patients with severe heart failure who underwent cardiac resynchronization therapy (CRT) were reported to have ineffective outcomes, and diagnosing ineffective cases is difficult. The product has novelty and high significance in that it can assist in predicting the effectiveness of CRT. Clinical research (11 cases) reported that the prediction of improvement in cardiac pump function using the product showed a high correlation (correlation coefficient 0.94) with actual effects, indicating high potential efficacy.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/other-ut-heartyan-jiu-suo-20170228"},{"id":"c2e33dfb-6e30-46f1-bf14-45a97b3744de","company_name":"株式会社セルシード","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬事法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-04-07","violation_summary":"患者自身の口腔粘膜から採取した上皮細胞を培養した細胞シートであり、食道がんにおける広範囲内視鏡的粘膜下層剥離術（ESD）後の狭窄の抑制及び再上皮化までの日数の短縮目的とするものである。国内で2つの臨床研究（19例）が実施されており、高い有効性を示唆する結果（本品の使用による高い非狭窄率64％）が得られた。","violation_summary_en":"The product is a cell sheet cultured from the patient's own oral mucosal epithelial cells, intended to prevent stenosis and shorten the time to re-epithelialization after endoscopic submucosal dissection (ESD) for esophageal cancer. Two clinical studies in Japan (19 cases) have been conducted, showing promising results with a high non-stenosis rate of 64%.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/other-serusido-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":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"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,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/other-sisumetukusu-20170228"},{"id":"c76d4fcf-c042-4ae9-ac8e-1e1f77168f09","company_name":"住友重機械工業株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"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,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","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"},{"id":"abfff2b1-c28d-4def-ae2d-4e3ab4fecd4f","company_name":"ステラファーマ株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-05-02","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。","violation_summary_en":"Stella Pharma Co., Ltd. was designated by the Ministry of Health, Labour and Welfare on February 28, 2017, under the Pharmaceutical and Medical Device Act for an apparatus used to irradiate neutron beams for Boron Neutron Capture Therapy (BNCT).","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/yakkiho-suterahuama-20170228"},{"id":"28af3b43-48e0-44e9-94fc-a13ca7ad7299","company_name":"株式会社セルシード","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-05-02","violation_summary":"患者自身の口腔粘膜から採取した上皮細胞を培養した細胞シートであり、食道がんにおける広範囲内視鏡的粘膜下層剥離術（ESD）後の狭窄の抑制及び再上皮化までの日数の短縮目的とするものである。","violation_summary_en":"The company was designated under the Pharmaceutical and Medical Device Act on February 28, 2017, for its cell sheet product cultured from the patient's own oral mucosal epithelial cells, intended to prevent esophageal stricture and shorten re-epithelialization time after endoscopic submucosal dissection (ESD) for esophageal cancer.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/yakkiho-serusido-20170228"},{"id":"1c49989e-fbcd-4b0f-a668-1441767e7a18","company_name":"富士フイルム株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-05-02","violation_summary":"心臓再同期療法の効果予測の判断を補助する医療機器プログラムである。","violation_summary_en":"On February 28, 2017, the Ministry of Health, Labour and Welfare designated a medical device program by Fuji Film Corporation that assists in predicting the effectiveness of cardiac resynchronization therapy under the Pharmaceutical and Medical Device Act.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/yakkiho-fu-shi-huirumu-20170228"},{"id":"2429ef6c-9971-4989-99c4-c87b054ec133","company_name":"京都大学","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-05-02","violation_summary":"非自己iPS細胞由来ドパミン神経前駆細胞を用いたパーキンソン病治療であり、従来の治療法とは異なる作用機序を有する。","violation_summary_en":"The Ministry of Health, Labour and Welfare designated Kyoto University under the Pharmaceutical and Medical Device Act on February 28, 2017, for using non-autologous iPS cell-derived dopamine neuron precursor cells in Parkinson's disease treatment, which has a different mechanism of action from conventional therapies.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/yakkiho-jing-du-da-xue-20170228"},{"id":"154f8150-abfd-411e-a432-8759f1c2e974","company_name":"第一医科株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-05-02","violation_summary":"気管欠損部位に留置し、気管の構造を保ち粘膜再建の足場となる点に新規性があり、画期性が高い。","violation_summary_en":"The company was designated by the Ministry of Health, Labour and Welfare under the Pharmaceutical and Medical Device Act on February 28, 2017, for a medical device with high novelty and innovation, which is implanted at tracheal defect sites to maintain tracheal structure and serve as a scaffold for mucosal reconstruction.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/yakkiho-di-yi-yi-ke-20170228"},{"id":"3a33e33b-7d77-4993-a812-cb180f702ae2","company_name":"大日本住友製薬株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["指定"],"regional_record_count":1,"source_document_count":1,"law_name":"薬事法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-04-07","violation_summary":"非自己iPS細胞由来ドパミン神経前駆細胞を用いたパーキンソン病治療であり、従来の治療法とは異なる作用機序を有する。臨床使用経験はないが、非臨床有効性評価により、移植6か月後から症状の有意な改善（運動症状スコア40％以上）と脳内移植部位でドパミン合成及びドパミン再取込み活性（PET画像）が認められたとの報告がある。","violation_summary_en":"This concerns Parkinson's disease treatment using non-autologous iPS cell-derived dopamine neural precursor cells, which have a different mechanism of action from conventional treatments. Although there is no clinical experience, non-clinical efficacy evaluations have reported significant symptom improvement (more than 40% in motor symptom scores) from six months after transplantation, as well as dopamine synthesis and reuptake activity (PET imaging) at the transplantation site in the brain.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/houdou/0000153128.html","url":"https://regbase.jp/enforcement/other-da-ri-ben-zhu-you-zhi-yao-20170228"}],"meta":{"query":null,"corporate_number":null,"law":null,"authority":null,"action_type":"指定","count":10,"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":9,"reset_at":"2026-08-06T15:56:08.585Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":271,"reset_at":"2026-08-07T15:55:08.585Z"}}}