{"data":[{"id":"beca684c-36a3-49da-97cf-4f3bcb6fcb03","company_name":"第一三共エスファ株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["業務改善命令"],"regional_record_count":1,"source_document_count":1,"law_name":"医薬品医療機器等法","action_type":"業務改善命令","action_date":"2021-05-21","announcement_date":"2026-04-03","violation_summary":"医薬品医療機器等法第72条の４第１項に基づく業務改善命令（行政処分）を行いました。","violation_summary_en":"Issued an administrative disposition of business improvement order based on Article 72-4, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc.","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/newpage_18754.html","url":"https://regbase.jp/enforcement/other-di-yi-san-gong-esuhua-20210521"},{"id":"fb6f219a-b06b-4ea6-a79a-b44f4de01bce","company_name":"第一三共株式会社","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, etc., with the aim of facilitating their early practical use in Japan.","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/0000179802.html","url":"https://regbase.jp/enforcement/yakkiho-di-yi-san-gong-20171005"},{"id":"e2a6b310-7534-4772-8940-2355e5870bc9","company_name":"第一三共 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":"DS-5141b デュシェンヌ型筋ジストロフィー（ジストロフィン遺伝子のエクソン45スキッピングにより効果が期待できる患者）","violation_summary_en":"DS-5141b Duchenne muscular dystrophy (patients expected to benefit from exon 45 skipping of the dystrophin gene)","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/0000179802.html","url":"https://regbase.jp/enforcement/other-di-yi-san-gong-20171005"},{"id":"b595af54-f75e-4968-85d0-595a8b0f23b8","company_name":"第一三共株式会社","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":"2017-04-21","announcement_date":"2026-04-27","violation_summary":"「先駆け審査指定制度」の対象品目として指定された医薬品の名称、予定される効能または効果、申請者の氏名または名称を記載。","violation_summary_en":"Listed the names of pharmaceuticals designated as target items under the Priority Review Designation System, along with their intended effects or efficacy and the applicant's name or organization.","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/0000162665.html","url":"https://regbase.jp/enforcement/yakkiho-di-yi-san-gong-20170421"}],"meta":{"query":"第一三共株式会社","corporate_number":null,"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. 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