報告命令 against Bayer Yakuhin, Ltd.
For developers: integration details
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/api/v1/enforcements?corporate_number=5120001057709&limit=10Action summary
- Company
- Bayer Yakuhin, Ltd.OfficialOriginal: バイエル薬品株式会社Corporate Number: 5120001057709
- Entity match
- Confirmed entity match95/100Machine extractedNormalized Japanese name matched to a company profile with Corporate NumberMatched by normalized Japanese company name to an enriched company profile with a Corporate Number.
- Governing law
- 医薬品医療機器等法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
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 医薬品医療機器等法.
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
- 2026-04-08T00:00:41.776+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": "バイエル薬品株式会社",
"corporate_number": "5120001057709",
"law": {
"ja": "医薬品医療機器等法",
"en": "医薬品医療機器等法"
},
"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": "confirmed",
"confidence": 95,
"method": "normalized_name_with_corporate_number",
"method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
"notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
},
"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 医薬品医療機器等法."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-baieruyao-pin-20170731",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000172994.html",
"archiveUrl": "https://kiroku.today/view/4b72453360pa8av1",
"archiveCapturedAt": "2026-04-08T00:00:41.776+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": "2026-05-21T22:43:44.167Z"
},
"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)Company info
- English name
- Bayer Yakuhin, Ltd. Official
- Japanese name
- バイエル薬品株式会社
- Corporate Number
- 5120001057709
- Registered address
- 大阪府大阪市北区梅田２丁目４番９号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.