Enforcement record
Business Improvement Order disclosure naming エルメッド株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Business Improvement Order
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
21 May 2021
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-OTHER-ERUMETUDO-2-202607261334
- Generated at
- 26 July 2026 at 22:34
- Record URL
- https://regbase.jp/en/enforcement/other-erumetudo-20210521
1. Review Summary
| Disclosure name | エルメッド株式会社 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 21 May 2021 | Authority | Ministry of Health, Labour and Welfare |
| Law | Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices | Action type | Business Improvement Order |
| 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 | エルメッド株式会社 |
|---|
3. Enforcement Record
| Target name in disclosure | エルメッド株式会社 |
|---|---|
| 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 / Business Improvement Order |
| Action / announcement date | Action: 21 May 2021 / Announcement: 3 April 2026 |
| English summary | All of the pharmaceuticals found to be in violation were jointly developed with Kobayashi Kako Co., Ltd., and approval applications were submitted by each company using materials prepared by Kobayashi Kako Co., Ltd. |
| Original Japanese text | 違反事実が認められた医薬品は、全て小林化工株式会社との間の共同開発品目であり、小林化工株式会社により作成された資料を用いて、各社により承認申請が行われたもの。 |
| Official source | https://www.mhlw.go.jp/stf/newpage_18754.html |
| Source archive | https://kiroku.today/a/11c95f1ef2hf0jbj |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 08:38 / Evidence checked: 25 April 2026 at 08:38 / Archive captured: 12 July 2026 at 15:35 |
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 エルメッド株式会社
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 エルメッド株式会社
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
- エルメッド株式会社Japanese onlyOriginal: エルメッド株式会社
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices医薬品医療機器等法
- Action type
- Business Improvement Order業務改善命令
- Action date
- 21 May 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医薬品製造
Violation
All of the pharmaceuticals found to be in violation were jointly developed with Kobayashi Kako Co., Ltd., and approval applications were submitted by each company using materials prepared by Kobayashi Kako Co., Ltd.
Show original Japanese text
違反事実が認められた医薬品は、全て小林化工株式会社との間の共同開発品目であり、小林化工株式会社により作成された資料を用いて、各社により承認申請が行われたもの。
Compliance context
Medium-highA formal order requiring business process or compliance control improvements.
Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.
Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Evidence pack
- Extracted at
- 2026-04-24T23:38:09.273+00:00
- Evidence checked
- 2026-04-24T23:38:09.273+00:00
- Archive captured
- 2026-07-12T06:35:05.383945+00:00
Show audit JSON
{
"record": {
"id": "f601590f-4130-4312-8e39-16bc1c5dcdda",
"url": "https://regbase.jp/en/enforcement/other-erumetudo-20210521",
"company_name_original": "エルメッド株式会社",
"company_name_registry": null,
"corporate_number": null,
"law": {
"ja": "医薬品医療機器等法",
"en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
},
"action_type": {
"ja": "業務改善命令",
"en": "Business Improvement Order"
},
"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 (エルメッド株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
},
"review": {
"status": "unreviewed",
"label": "Machine extracted"
},
"compliance_context": {
"severity": "Medium-high",
"actionMeaning": "A formal order requiring business process or compliance control improvements.",
"practicalNote": "Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.",
"lawContext": "Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-erumetudo-20210521",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_18754.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/11c95f1ef2hf0jbj",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_18754.html",
"archiveCapturedAt": "2026-07-12T06:35:05.383945+00:00",
"extractedAt": "2026-04-24T23:38:09.273+00:00",
"translatedAt": "2026-05-01T06:51:59.996+00:00",
"evidenceCheckedAt": "2026-04-24T23:38:09.273+00:00",
"generatedAt": "2026-07-26T13:34:04.657Z"
},
"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.