改善指導 against Bayer Yakuhin, Ltd.
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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、医療機器等の品質、有効性及び安全性の確保等に関する法律医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律
- Action type
- 改善指導改善指導
- Action date
- 29 September 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Delayed adverse effect reporting occurred for the pharmaceuticals: Xarelto, Biaaspirin (anticoagulant), Stivarga, Nexavar (anticancer drugs)
Show original Japanese text
副作用報告の遅延が生じた医薬品:イグザレルト、バイアスピリン(抗血液凝固剤)、スチバーガ、ネクサバール(抗がん剤)
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、医療機器等の品質、有効性及び安全性の確保等に関する法律.
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
- 2026-04-24T23:35:55.696+00:00
- Evidence checked
- 2026-04-24T23:35:55.696+00:00
- Archive captured
- 2026-04-03T18:30:53.75+00:00
Show audit JSON
{
"record": {
"id": "2fe1ad59-6feb-4434-96bd-6156ba5d429a",
"url": "https://regbase.jp/en/enforcement/other-baieruyao-pin-20170929",
"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、医療機器等の品質、有効性及び安全性の確保等に関する法律",
"en": "医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律"
},
"action_type": {
"ja": "改善指導",
"en": "改善指導"
},
"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、医療機器等の品質、有効性及び安全性の確保等に関する法律."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-baieruyao-pin-20170929",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000179072.html",
"archiveUrl": "https://kiroku.today/view/b2da0ba2eaj8orn6",
"archiveCapturedAt": "2026-04-03T18:30:53.75+00:00",
"extractedAt": "2026-04-24T23:35:55.696+00:00",
"translatedAt": "2026-05-01T06:50:53.074+00:00",
"evidenceCheckedAt": "2026-04-24T23:35:55.696+00:00",
"generatedAt": "2026-05-21T21:50:55.383Z"
},
"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.