Enforcement record
報告命令 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
報告命令
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
4 October 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-202608041531
- Generated at
- 5 August 2026 at 00:31
- Record URL
- https://regbase.jp/en/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20161004
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 | 4 October 2016 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | 報告命令 |
| 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 / 報告命令 |
| Action / announcement date | Action: 4 October 2016 / Announcement: 7 April 2026 |
| English summary | The fact that Enceback subcutaneous injection was manufactured differently from the description in the manufacturing and marketing approval. |
| Original Japanese text | 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 |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000139246.html |
| Source archive | https://kiroku.today/a/40e151476chg2wt9 |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 09:12 / Evidence checked: 25 April 2026 at 09:12 / Archive captured: 12 July 2026 at 16:03 |
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
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Free report
Save the disclosure record naming 一般財団法人化学及血清療法研究所
Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.
Preserved evidence by Kiroku
Review the preserved source for 一般財団法人化学及血清療法研究所
Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.
For developers: JSON integration details
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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
- 報告命令報告命令
- Action date
- 4 October 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 fact that Enceback subcutaneous injection was manufactured differently from the description in the manufacturing and marketing approval.
Show original Japanese text
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
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
- 2026-04-25T00:12:59.442+00:00
- Evidence checked
- 2026-04-25T00:12:59.442+00:00
- Archive captured
- 2026-07-12T07:03:35.945366+00:00
Show audit JSON
{
"record": {
"id": "40f655cd-daf7-412e-8fa3-cf6c79d5935d",
"url": "https://regbase.jp/en/enforcement/yakkiho-hua-xue-ji-xie-qing-liao-fa-yan-jiu-suo-20161004",
"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": "報告命令",
"en": "報告命令"
},
"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-20161004",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000139246.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/40e151476chg2wt9",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000139246.html",
"archiveCapturedAt": "2026-07-12T07:03:35.945366+00:00",
"extractedAt": "2026-04-25T00:12:59.442+00:00",
"translatedAt": "2026-05-01T07:02:49.616+00:00",
"evidenceCheckedAt": "2026-04-25T00:12:59.442+00:00",
"generatedAt": "2026-08-04T15:31:00.379Z"
},
"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.