{"data":[{"id":"784daf35-8b72-434a-922b-7ba47dcf9ba3","company_name":"中外製薬株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["承認"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"承認","action_date":"2022-01-21","announcement_date":"2026-04-27","violation_summary":"新型コロナウイルス感染症治療薬の承認について\n\n本日、以下のとおり、医薬品アクテムラ点滴静注用について、新型コロナウイルス感染症に関する効能・効果の追加に係る承認を行いました。","violation_summary_en":"Approval regarding treatment for COVID-19 with the drug Actemra intravenous infusion.\n\nToday, approval was granted for the addition of indications and effects related to COVID-19 for the pharmaceutical product Actemra intravenous infusion.","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_23497.html","url":"https://regbase.jp/enforcement/yakkiho-zhong-wai-zhi-yao-20220121"},{"id":"093131aa-10b4-4b98-a53c-e9c997030caa","company_name":"中外製薬株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["特例承認"],"regional_record_count":1,"source_document_count":1,"law_name":"医薬品医療機器等法","action_type":"特例承認","action_date":"2021-11-05","announcement_date":"2026-04-27","violation_summary":"新型コロナウイルス感染症に係る治療薬の製造販売承認事項の一部変更等について、医薬品医療機器等法第14条の３に基づく特例承認を行いました。","violation_summary_en":"A special approval was granted under Article 14-3 of the Pharmaceuticals and Medical Devices Act regarding some changes to the manufacturing and marketing approval for a COVID-19 treatment drug.","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_22075.html","url":"https://regbase.jp/enforcement/other-zhong-wai-zhi-yao-20211105"},{"id":"8e0beb66-f95c-4962-8b1d-3a8830f761a3","company_name":"中外製薬株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["特例承認"],"regional_record_count":1,"source_document_count":1,"law_name":"医薬品医療機器等法","action_type":"特例承認","action_date":"2021-07-19","announcement_date":"2026-03-30","violation_summary":"新型コロナウイルス感染症に係る治療薬について、医薬品医療機器等法第14条の３に基づく特例承認を行いました。","violation_summary_en":"Special approval was granted under Article 14-3 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices for a treatment drug related to COVID-19.","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_19940.html","url":"https://regbase.jp/enforcement/other-zhong-wai-zhi-yao-20210719"}],"meta":{"query":"中外製薬株式会社","corporate_number":null,"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":"2026-08-04T16:27:51.632Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":227,"reset_at":"2026-08-05T16:26:51.632Z"}}}