{"data":[{"id":"160f0e9c-cadf-4f1b-9da2-beff810e9504","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":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"行政指導","action_date":"2020-04-27","announcement_date":"2026-04-09","violation_summary":"大阪府より、大日本住友製薬株式会社が下記の医薬品の自主回収に着手した旨の情報提供がなされました。","violation_summary_en":"Osaka Prefecture provided information that Daiichi Sankyo Company, Limited has begun voluntary recall of the following pharmaceuticals.","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/newpage_11052.html","url":"https://regbase.jp/enforcement/yakkiho-da-ri-ben-zhu-you-zhi-yao-20200427"},{"id":"53e7034a-660d-49e2-a38d-5ffda40a731e","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":["自主回収"],"regional_record_count":1,"source_document_count":1,"law_name":"医薬品医療機器等法","action_type":"自主回収","action_date":"2020-04-27","announcement_date":"2026-05-05","violation_summary":"医薬品自主回収のお知らせ（クラスⅠ）","violation_summary_en":"Daiichi Sankyo Co., Ltd. announced a Class I voluntary recall of certain pharmaceutical products on April 27, 2020, under the Pharmaceutical and Medical Device Act, due to issues identified with the products Metgluco Tablets 250 mg and 500 mg.","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/newpage_11052.html","url":"https://regbase.jp/enforcement/other-da-ri-ben-zhu-you-zhi-yao-20200427"},{"id":"0ad675eb-1ab8-4608-821c-ec979b190fa8","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":["先駆け審査指定制度対象品目の募集"],"regional_record_count":1,"source_document_count":1,"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":"非自己iPS細胞由来ドパミン神経前駆細胞 パーキンソン病","violation_summary_en":"Unapproved Parkinson's disease treatment using non-self iPS cell-derived dopamine neural precursor cells","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/0000179802.html","url":"https://regbase.jp/enforcement/other-da-ri-ben-zhu-you-zhi-yao-20171005"},{"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"},{"id":"5dd9a1cd-b619-4b74-9645-897bd4ec845e","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":"薬機法","action_type":"指定","action_date":"2017-02-28","announcement_date":"2026-05-02","violation_summary":"パーキンソン病に対するiPS細胞由来のドパミン神経前駆細胞を用いた治療。","violation_summary_en":"The company was designated under the Pharmaceutical and Medical Device Act (PMDA) by the Ministry of Health, Labour and Welfare on February 28, 2017, for using iPS cell-derived dopamine precursor cells in treatment for Parkinson's disease.","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-da-ri-ben-zhu-you-zhi-yao-20170228"}],"meta":{"query":"大日本住友製薬株式会社","corporate_number":null,"law":null,"authority":null,"action_type":null,"count":5,"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":"2026-08-04T18:51:27.766Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":53,"reset_at":"2026-08-05T18:50:27.766Z"}}}