Enforcement record
報告命令 disclosure naming バイエル薬品株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
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
31 July 2017
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-BAIERUYAO-P-202607280934
- Generated at
- 28 July 2026 at 18:34
- Record URL
- https://regbase.jp/en/enforcement/other-baieruyao-pin-20170731
1. Review Summary
| Disclosure name | バイエル薬品株式会社 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 31 July 2017 | 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 | バイエル薬品株式会社 |
|---|
3. Enforcement Record
| Target name in disclosure | バイエル薬品株式会社 |
|---|---|
| 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 / 報告命令 |
| Action / announcement date | Action: 31 July 2017 / Announcement: 8 April 2026 |
| English summary | Following the public announcement on May 26 (Friday) that there was a delay in reporting adverse reaction cases for Xarelto tablets (generic name: rivaroxaban), the Ministry of Health, Labour and Welfare conducted an investigation to determine whether there were any unreported or delayed cases for all pharmaceuticals manufactured and sold by the company, based on Article 68-10, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. The company was also asked to report by July 31 (Monday) on the causes of the delays and related matters. |
| Original Japanese text | イグザレルト錠（一般名リバーロキサバン）において副作用症例の報告遅延があったことを５月26日（金）に公表したことを受け、同社の製造販売する全ての医薬品を対象に、医薬品医療機器等法第68条の10第１項に基づく厚生労働大臣への報告が行われていない又は遅延した症例の有無を調査するとともに、遅延した原因等について、７月31日（月）までに報告を求めたもの |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000172994.html |
| Source archive | https://kiroku.today/a/4b72453360hg2yj7 |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 09:14 / Evidence checked: 25 April 2026 at 09:14 / Archive captured: 12 July 2026 at 16:05 |
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 バイエル薬品株式会社
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 バイエル薬品株式会社
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
- バイエル薬品株式会社Japanese onlyOriginal: バイエル薬品株式会社
- 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
- 報告命令報告命令
- Action date
- 31 July 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医薬品製造販売
Violation
Following the public announcement on May 26 (Friday) that there was a delay in reporting adverse reaction cases for Xarelto tablets (generic name: rivaroxaban), the Ministry of Health, Labour and Welfare conducted an investigation to determine whether there were any unreported or delayed cases for all pharmaceuticals manufactured and sold by the company, based on Article 68-10, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. The company was also asked to report by July 31 (Monday) on the causes of the delays and related matters.
Show original Japanese text
イグザレルト錠（一般名リバーロキサバン）において副作用症例の報告遅延があったことを５月26日（金）に公表したことを受け、同社の製造販売する全ての医薬品を対象に、医薬品医療機器等法第68条の10第１項に基づく厚生労働大臣への報告が行われていない又は遅延した症例の有無を調査するとともに、遅延した原因等について、７月31日（月）までに報告を求めたもの
Compliance context
Context neededThis is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.
Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.
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
- 2026-04-25T00:14:40.211+00:00
- Evidence checked
- 2026-04-25T00:14:40.211+00:00
- Archive captured
- 2026-07-12T07:05:04.404037+00:00
Show audit JSON
{
"record": {
"id": "0d663020-df6f-4eca-98d0-a17752a1de1b",
"url": "https://regbase.jp/en/enforcement/other-baieruyao-pin-20170731",
"company_name_original": "バイエル薬品株式会社",
"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": "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 (バイエル薬品株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
},
"review": {
"status": "unreviewed",
"label": "Machine extracted"
},
"compliance_context": {
"severity": "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": "Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-baieruyao-pin-20170731",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000172994.html",
"officialDocumentUrl": null,
"archiveUrl": "https://kiroku.today/a/4b72453360hg2yj7",
"archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000172994.html",
"archiveCapturedAt": "2026-07-12T07:05:04.404037+00:00",
"extractedAt": "2026-04-25T00:14:40.211+00:00",
"translatedAt": "2026-05-01T07:04:22.985+00:00",
"evidenceCheckedAt": "2026-04-25T00:14:40.211+00:00",
"generatedAt": "2026-07-28T09:34:01.204Z"
},
"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.