{"data":[{"id":"40f655cd-daf7-412e-8fa3-cf6c79d5935d","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"薬機法","action_type":"報告命令","action_date":"2016-10-04","announcement_date":"2026-04-07","violation_summary":"厚生労働省では、10月４日に一般財団法人化学及血清療法研究所に対し、エンセバック皮下注用について製造販売承認書の記載と一部異なる製造を行っていた事実に係る報告命令の行政処分を行ったほか、業務改善命令に係る弁明の機会の付与を行いました。","violation_summary_en":"The Ministry of Health, Labour and Welfare issued an administrative disposition to the General Incorporated Foundation, Chemical and Serum Therapy Research Institute, on October 4, regarding manufacturing different from the description in the manufacturing and marketing approval for Enceback subcutaneous injection, and also provided an opportunity for explanation concerning an operational improvement order.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000139246.html","url":"https://regbase.jp/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20161004"},{"id":"b578a90e-839d-4345-bfb3-a39ae42a3ada","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"医薬品医療機器法","action_type":"報告命令等","action_date":"2016-10-04","announcement_date":"2026-03-28","violation_summary":"エンセバック皮下注用（一般的名称：乾燥細胞培養日本脳炎ワクチン）について、製造販売承認書の記載と一部異なる製造を行っていたことが確認されたため、本日付けで、一般財団法人化学及血清療法研究所に対し、下記の報告命令等を行いました。","violation_summary_en":"Regarding Enceback for subcutaneous injection (generic name: dried cell culture Japanese encephalitis vaccine), it was confirmed that manufacturing differed in some aspects from the description in the manufacturing and marketing approval certificate. As of today, a report order and related measures were issued to the Japan Serum and Vaccine Institute (General Incorporated Foundation).","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000138755.html","url":"https://regbase.jp/enforcement/other-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20161004"},{"id":"ad3646e6-dfeb-4446-8be3-adbc3958c75c","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"厚生労働省の行政指導","action_type":"出荷自粛の要請解除","action_date":"2016-02-26","announcement_date":"2026-05-01","violation_summary":"厚生労働省への報告が適切になされていないことが判明したことから、平成27年9月18日付けで出荷の自粛を要請するとともに適切な報告を求め、その後厚生労働省において報告内容の精査を行ってきました。","violation_summary_en":"It was found that reports to the Ministry of Health, Labour and Welfare were not properly made. On September 18, 2015, a request was issued to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare conducted a review of the reports.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000113746.html","url":"https://regbase.jp/enforcement/other-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20160226"},{"id":"9df0e0b2-ba2b-41d0-a200-e0bd3797cb6d","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"薬機法","action_type":"出荷自粛の要請解除","action_date":"2016-02-26","announcement_date":"2026-04-06","violation_summary":"厚生労働省において報告内容の精査を行ってきました。今般、化血研が製造販売する「エンセバック皮下注用」（乾燥細胞培養日本脳炎ワクチン）について、本日の厚生科学審議会感染症部会において、別添資料に基づき、厚生労働省による精査の結果（品質及び安全性等に重大な影響を及ぼす齟齬はないと判断していること）、及び同種の他社製品の今後の在庫見込みを報告し、化血研の製品の出荷を認めるべきかどうかについて意見を伺いました。その結果、当該製品については、日本脳炎の発生の予防及びまん延の防止を推進する観点から、出荷を認め、供給不足を避けるべきと考えられる、との意見をいただきました。厚生労働省においては、当該意見等を踏まえ、本日付で、化血研の「エンセバック皮下注用」（乾燥細胞培養日本脳炎ワクチン）の出荷自粛の要請を解除することとしましたので、お知らせいたします。","violation_summary_en":"The Ministry of Health, Labour and Welfare conducted a review of the reported information. Today, at the Infectious Disease Subcommittee of the Health Science Council, based on the attached materials, the results of the review by the Ministry (which concluded there are no discrepancies that would significantly affect quality and safety), and the inventory outlook for similar products from other companies were reported. Opinions were sought on whether to approve the shipment of Kaken Pharmaceutical's 'Enceback Injection' (dry cell culture Japanese encephalitis vaccine). As a result, it was received that, from the perspective of promoting the prevention and control of Japanese encephalitis, shipment should be permitted to avoid supply shortages. Based on these opinions, the Ministry of Health, Labour and Welfare has decided to lift the request for Kaken Pharmaceutical's 'Enceback Injection' (dry cell culture Japanese encephalitis vaccine) to refrain from shipment as of today.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000113746.html","url":"https://regbase.jp/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20160226"},{"id":"74b16d91-3e5d-4c16-8ac5-8858cc9446d9","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"不明","action_type":"出荷自粛の要請解除","action_date":"2016-01-29","announcement_date":"2026-04-06","violation_summary":"厚生労働省への報告が適切になされていないことが判明したことから、平成27年9月18日付けで出荷の自粛を要請するとともに適切な報告を求める。","violation_summary_en":"It was found that reports to the Ministry of Health, Labour and Welfare were not properly made. Accordingly, on September 18, 2015, a request was issued to suspend shipments and to submit proper reports.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000110599.html","url":"https://regbase.jp/enforcement/other-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20160129"},{"id":"7f666122-fc0b-42d4-87ce-d98c81afcb58","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"薬機法","action_type":"行政指導","action_date":"2016-01-29","announcement_date":"2026-03-27","violation_summary":"厚生労働省への報告が適切になされていないことが判明したことから、平成27年9月18日付けで出荷の自粛を要請するとともに適切な報告を求める。","violation_summary_en":"It was found that reports to the Ministry of Health, Labour and Welfare were not properly made. Consequently, on September 18, 2015, a request was issued to refrain from shipment and to submit appropriate reports.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000110599.html","url":"https://regbase.jp/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20160129"},{"id":"26d42f29-3d7e-4ca6-b555-c4d1cfb1f896","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"医薬品医療機器法","action_type":"業務停止命令","action_date":"2016-01-18","announcement_date":"2026-03-27","violation_summary":"厚生労働省では、本日付けで、一般財団法人化学及血清療法研究所に対し医薬品医療機器法第75条第１項の規定に基づき、別紙のとおり平成28年１月18日(月)から同年５月６日(金)までの110日間の業務停止命令(行政処分)を行いましたので、お知らせします。","violation_summary_en":"The Ministry of Health, Labour and Welfare has issued an administrative suspension order to the General Incorporated Foundation, Chemical and Serum Therapy Institute, based on Article 75, Paragraph 1 of the Pharmaceuticals and Medical Devices Act, for a period of 110 days from January 18, 2016 (Monday) to May 6, 2016 (Friday).","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000108663.html","url":"https://regbase.jp/enforcement/other-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20160118"},{"id":"32aea8f3-82c5-42cb-9f2b-276f73b5895c","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"薬機法","action_type":"出荷自粛の要請解除","action_date":"2015-11-26","announcement_date":"2026-05-01","violation_summary":"厚生労働省への報告が適切になされていないことが判明したことから、9月18日付けで出荷の自粛を要請するとともに適切な報告を求め、その後厚生労働省において報告内容の精査を行ってきました。","violation_summary_en":"It was found that reports to the Ministry of Health, Labour and Welfare were not properly made. Consequently, on September 18, a request was issued to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare reviewed the reported information.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000105418.html","url":"https://regbase.jp/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20151126"},{"id":"1ac7b7dd-0870-45b9-85bb-003a5288652e","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"厚生労働省の指導・命令","action_type":"出荷自粛の要請解除","action_date":"2015-11-26","announcement_date":"2026-04-06","violation_summary":"厚生労働省への報告が適切になされていないことが判明したことから、9月18日付けで出荷の自粛を要請するとともに適切な報告を求め、その後厚生労働省において報告内容の精査を行ってきました。","violation_summary_en":"It was found that reports to the Ministry of Health, Labour and Welfare were not properly made. On September 18, a request was issued to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare reviewed the reported information.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000105418.html","url":"https://regbase.jp/enforcement/other-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20151126"},{"id":"74b03afd-be8a-40cb-bc29-5daa6fcb66bb","company_name":"一般財団法人化学及血清療法研究所","company_name_en":null,"corporate_number":"6330005006672","authority":"厚生労働省","law_name":"厚生労働省","action_type":"出荷自粛の要請解除","action_date":"2015-10-21","announcement_date":"2026-04-05","violation_summary":"化血研が製造販売するワクチン製剤等については、承認書と製造実態の齟齬等についての厚生労働省への報告が適切になされていないことが判明したことから、９月18日付けで出荷の自粛を要請するとともに適切な報告を求め、その後厚生労働省において報告内容の精査を行ってきました。","violation_summary_en":"It was found that for vaccines and related products manufactured and sold by Kasei Ken, appropriate reports had not been made to the Ministry of Health, Labour and Welfare regarding discrepancies between the approval documents and manufacturing practices. Consequently, on September 18, a request was made to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare has been reviewing the reported information.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/houdou/0000101868.html","url":"https://regbase.jp/enforcement/other-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20151021"}],"meta":{"query":null,"corporate_number":"6330005006672","law":null,"authority":null,"action_type":null,"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":3,"reset_at":"2026-05-21T09:25:27.305Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":242,"reset_at":"2026-05-22T09:24:27.305Z"}}}