Enforcement record
出荷自粛の要請解除 disclosure naming 一般財団法人化学及血清療法研究所
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
出荷自粛の要請解除
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
26 February 2016
RegBase evidence report
Japanese public-record enforcement check
Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.
- Report ID
- RB-EN-ENFORCEMENT-YAKKIHO-HUA-XUE-J-202608041532
- Generated at
- 5 August 2026 at 00:32
- Record URL
- https://regbase.jp/en/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20160226
1. Review Summary
| Disclosure name | 一般財団法人化学及血清療法研究所 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 26 February 2016 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | 出荷自粛の要請解除 |
| Source status | Preserved public-source archive recorded | ||
This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.
2. Published Information
| Published name | 一般財団法人化学及血清療法研究所 |
|---|
3. Enforcement Record
| Target name in disclosure | 一般財団法人化学及血清療法研究所 |
|---|---|
| Authority | Ministry of Health, Labour and Welfare (厚生労働省) |
| Law / action type | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / 出荷自粛の要請解除 |
| Action / announcement date | Action: 26 February 2016 / Announcement: 6 April 2026 |
| English summary | 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. |
| Original Japanese text | 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。 |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000113746.html |
| Source archive | https://kiroku.today/a/c6439689d6hg2vik |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 09:11 / Evidence checked: 25 April 2026 at 09:11 / Archive captured: 12 July 2026 at 16:02 |
4. Business Location and Permit Details
No additional structured business-location or permit fields are recorded for this disclosure.
5. Other Confirmed Records for This Company
This report covers the single government disclosure shown on this page.
Reviewer Notes
| Reviewer | Team / company | ||
|---|---|---|---|
| Review purpose | |||
| Additional notes | |||
- □ Official source URL or archived source was checked.
- □ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
- □ This document is understood as a public-record evidence file, not a credit decision or legal opinion.
Current page: Enforcement record
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Preserved evidence by Kiroku
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Action summary
- Company
- 一般財団法人化学及血清療法研究所Japanese onlyOriginal: 一般財団法人化学及血清療法研究所
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- 出荷自粛の要請解除出荷自粛の要請解除
- Action date
- 26 February 2016
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医薬品製造販売
Violation
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.
Show original Japanese text
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。
Compliance context
Context neededThis is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.
Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.
Review the original Japanese source and determine relevance to your counterparty-risk workflow.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Evidence pack
- Extracted at
- 2026-04-25T00:11:00.204+00:00
- Evidence checked
- 2026-04-25T00:11:00.204+00:00
- Archive captured
- 2026-07-12T07:02:37.096842+00:00
Show audit JSON
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"url": "https://regbase.jp/en/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20160226",
"company_name_original": "一般財団法人化学及血清療法研究所",
"company_name_registry": null,
"corporate_number": null,
"law": {
"ja": "薬機法",
"en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
},
"action_type": {
"ja": "出荷自粛の要請解除",
"en": "出荷自粛の要請解除"
},
"authority": {
"ja": "厚生労働省",
"en": "Ministry of Health, Labour and Welfare"
}
},
"entity_match": {
"status": "unresolved",
"confidence": 85,
"method": "nta_strict_name_nationally_unique",
"method_label": "nta_strict_name_nationally_unique",
"notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (一般財団法人化学及血清療法研究所). No Corporate Number was present in the disclosure, so this remains a likely match."
},
"review": {
"status": "unreviewed",
"label": "Machine extracted"
},
"compliance_context": {
"severity": "Context needed",
"actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
"practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
"lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20160226",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000113746.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/c6439689d6hg2vik",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000113746.html",
"archiveCapturedAt": "2026-07-12T07:02:37.096842+00:00",
"extractedAt": "2026-04-25T00:11:00.204+00:00",
"translatedAt": "2026-05-01T07:00:55.144+00:00",
"evidenceCheckedAt": "2026-04-25T00:11:00.204+00:00",
"generatedAt": "2026-08-04T15:32:31.659Z"
},
"limitations": [
"RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
"English summaries are provided for reference. The original Japanese source is authoritative.",
"Possible or unresolved entity matches should be manually verified before use in a decision."
]
}The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.
Language
日本語版を見る (Japanese)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.