Enforcement record

改善指導 disclosure naming バイエル薬品株式会社

バイエル薬品株式会社 (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)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

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Ministry of Health, Labour and WelfareGovernment disclosure29 September 2017

Action type

改善指導

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

Authority

Ministry of Health, Labour and Welfare

Action date

29 September 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-202607260341
Generated at: 26 July 2026 at 12:41
Record URL: https://regbase.jp/en/enforcement/other-baieruyao-pin-20170929

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	29 September 2017	Authority	Ministry of Health, Labour and Welfare
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	Action type	改善指導
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	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 / 改善指導
Action / announcement date	Action: 29 September 2017 / Announcement: 29 March 2026
English summary	Delayed adverse effect reporting occurred for the pharmaceuticals: Xarelto, Biaaspirin (anticoagulant), Stivarga, Nexavar (anticancer drugs)
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）
Official source	https://www.mhlw.go.jp/stf/houdou/0000179072.html
Source archive	https://kiroku.today/a/b2da0ba2eahf0gqz
Extraction / evidence timestamps	Extracted: 25 April 2026 at 08:35 / Evidence checked: 25 April 2026 at 08:35 / Archive captured: 12 July 2026 at 15:32

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.

Open preserved source and evidence pack

For developers: JSON integration details

You do not need this for normal browsing. Use it only when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?company=%E3%83%90%E3%82%A4%E3%82%A8%E3%83%AB%E8%96%AC%E5%93%81%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Open JSON Specs

Action summary

Company: バイエル薬品株式会社Japanese only
Original: バイエル薬品株式会社
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
Industry context: 医薬品

Violation

Machine-translated summary — verify against original

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 needed

This 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

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-24T23:35:55.696+00:00
Evidence checked: 2026-04-24T23:35:55.696+00:00
Archive captured: 2026-07-12T06:32:36.482158+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": null,
    "corporate_number": null,
    "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": "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 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",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/b2da0ba2eahf0gqz",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000179072.html",
    "archiveCapturedAt": "2026-07-12T06:32:36.482158+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": "2026-07-26T03:41:12.421Z"
  },
  "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.