{"data":[{"id":"127c21e1-ce0d-43db-a0d9-d0d41de1d7f1","company_name":"モデルナ・ジャパン株式会社","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":"2023-09-12","announcement_date":"2026-04-10","violation_summary":"本日、以下のとおり、スパイクバックス筋注の一部変更について承認を行いました。なお、添付文書は別添のとおりです。","violation_summary_en":"Today, approval was granted for some changes to Spikevax intramuscular injection. The attached document is provided separately.","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_35190.html","url":"https://regbase.jp/enforcement/yakkiho-moderunaziyapan-20230912"},{"id":"4ff09305-3973-407c-9cf5-fcadafff2371","company_name":"富士レビオ株式会社","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":"医薬品医療機器等法","action_type":"承認","action_date":"2022-12-05","announcement_date":"2026-04-28","violation_summary":"医薬品医療機器等法に基づき、一般用新型コロナウイルス抗原・インフルエンザウイルス抗原定性同時検査キットの承認について","violation_summary_en":"Approval regarding the general-use new coronavirus antigen and influenza virus antigen qualitative simultaneous test kit under the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices.","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_29560.html","url":"https://regbase.jp/enforcement/other-fu-shi-rebio-20221205"},{"id":"9d2758e1-618b-432c-8f4a-0375a0592d61","company_name":"ファイザー株式会社","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":"2022-09-12","announcement_date":"2026-04-02","violation_summary":"本日、以下のとおり、コミナティRTU筋注及びスパイクバックス筋注に対する効能・効果、用法・用量の一部変更について承認を行いました。","violation_summary_en":"Today, approval was granted for partial changes to the indications, usage, and dosage of Cominaty RTU intramuscular injection and Spikevax intramuscular injection.","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_27929.html","url":"https://regbase.jp/enforcement/yakkiho-huaiza-20220912"},{"id":"55950ee8-c1b3-4e71-8adb-73d09641a9cf","company_name":"ファイザー株式会社","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":"医薬品医療機器等法","action_type":"承認","action_date":"2022-09-12","announcement_date":"2026-04-09","violation_summary":"本日、以下のとおり、コミナティRTU筋注及びスパイクバックス筋注に対する効能・効果、用法・用量の一部変更について承認を行いました。","violation_summary_en":"Today, approval was granted for partial changes to the indications, usage, and dosage of Comirnaty RTU intramuscular injection and Spikevax intramuscular injection.","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_27929.html","url":"https://regbase.jp/enforcement/other-huaiza-20220912"},{"id":"5c8b913b-50e6-479a-b8ae-27d05b0dfbe2","company_name":"モデルナ・ジャパン株式会社","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":"2022-09-12","announcement_date":"2026-04-28","violation_summary":"本日、以下のとおり、コミナティRTU筋注及びスパイクバックス筋注に対する効能・効果、用法・用量の一部変更について承認を行いました。","violation_summary_en":"Today, approval was granted for partial changes to the indications, usage, and dosage of Cominaty RTU intramuscular injection and Spikevax intramuscular injection.","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_27929.html","url":"https://regbase.jp/enforcement/yakkiho-moderunaziyapan-20220912"},{"id":"f23c0591-9465-44c7-bdff-e5b7462bdf59","company_name":"モデルナ・ジャパン株式会社","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":"医薬品医療機器等法","action_type":"承認","action_date":"2022-09-12","announcement_date":"2026-04-09","violation_summary":"本日、以下のとおり、コミナティRTU筋注及びスパイクバックス筋注に対する効能・効果、用法・用量の一部変更について承認を行いました。","violation_summary_en":"Today, approval was granted for partial changes to the indications, usage, and dosage of Comirnaty RTU intramuscular injection and Spikevax intramuscular injection.","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_27929.html","url":"https://regbase.jp/enforcement/other-moderunaziyapan-20220912"},{"id":"9bc593c5-dd56-4b41-9d9e-5c31e4a05cdc","company_name":"ロシュ・ダイアグノスティックス株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["承認"],"regional_record_count":1,"source_document_count":1,"law_name":"医薬品医療機器等法","action_type":"承認","action_date":"2022-08-24","announcement_date":"2026-05-05","violation_summary":"医薬品医療機器等法に基づく一般用新型コロナウイルス抗原定性検査キットの承認について","violation_summary_en":"The Ministry of Health, Labour and Welfare approved an over-the-counter COVID-19 antigen qualitative test kit developed by Roche Diagnostics Corporation on August 24, 2022, under the Pharmaceuticals and Medical Devices Act, Article 23-2-5, Paragraph 1.","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_27545.html","url":"https://regbase.jp/enforcement/other-rosiyudaiagunosuteitukusu-20220824"},{"id":"adce976a-17a8-49aa-b272-4397eaa7361f","company_name":"ロシュ・ダイアグノスティクス株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["承認"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"承認","action_date":"2022-08-17","announcement_date":"2026-04-21","violation_summary":"新型コロナウイルス抗原検査キットのOTC化を迅速に承認していただきました。誠にありがとうございました。","violation_summary_en":"The OTC approval for the COVID-19 antigen test kit was granted promptly. Thank you very much.","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_28612.html","url":"https://regbase.jp/enforcement/yakkiho-rosiyudaiagunosuteikusu-20220817"},{"id":"bdb870a2-dc6a-43ea-b217-de332a32d03a","company_name":"ロシュ・ダイアグノスティックス株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["承認"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"承認","action_date":"2022-08-17","announcement_date":"2026-05-05","violation_summary":"新型コロナウイルス抗原検査キットのOTC化を迅速に承認していただきました。","violation_summary_en":"The Ministry of Health, Labour and Welfare approved the OTC status of a COVID-19 antigen test kit from Roche Diagnostics Corporation on August 17, 2022, facilitating rapid online sales.","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_28612.html","url":"https://regbase.jp/enforcement/yakkiho-rosiyudaiagunosuteitukusu-20220817"},{"id":"d2fc2dde-dfcf-4d34-b3a6-343b1c062bae","company_name":"KMバイオロジクス株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["承認"],"regional_record_count":1,"source_document_count":1,"law_name":"薬機法","action_type":"承認","action_date":"2022-08-02","announcement_date":"2026-04-09","violation_summary":"乾燥細胞培養痘そうワクチンに対するサル痘の予防の効能追加について承認を行いました。","violation_summary_en":"Approval was granted for the addition of efficacy for monkeypox prevention to the dry cell culture smallpox vaccine.","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_27201.html","url":"https://regbase.jp/enforcement/yakkiho-kmbaiorozikusu-20220802"}],"meta":{"query":null,"corporate_number":null,"law":null,"authority":null,"action_type":"承認","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":"2026-08-06T15:56:08.637Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":271,"reset_at":"2026-08-07T15:55:08.637Z"}}}