Enforcement record

報告命令 disclosure naming バイエル薬品株式会社

バイエル薬品株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

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

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure29 May 2017

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

29 May 2017

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Source verification

Public-source and preservation status

Publishing authority: Ministry of Health, Labour and Welfare
Official source URL: Recorded by RegBase
Entity match: Not confirmed; shown under the published name
Kiroku preservation: Completed archive verified; Captured: Jul 12, 2026, 03:24 PM JST

“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.

Open the official source links in the section below to review the original disclosure.

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: 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: 29 May 2017
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品製造販売

Violation

Machine-translated summary — verify against original

Following the public disclosure on May 26 (Friday) that Bayer Yakuhin Ltd. experienced a delay in reporting 12 cases of adverse reactions related to Xarelto tablets (generic name: rivaroxaban), the Ministry of Health, Labour and Welfare is investigating whether there have been any unreported or delayed cases for all pharmaceuticals manufactured and sold by the company, based on Article 68-10, Paragraph 1 of the Pharmaceuticals and Medical Devices Act. The company is also required to report by July 31 (Monday) on the causes of delays and other relevant details.

Show original Japanese text

バイエル薬品株式会社が、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12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）までに報告を求めるものです。

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 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.

Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive

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

Extracted at: 2026-04-24T23:34:51.029+00:00
Evidence checked: 2026-04-24T23:34:51.029+00:00
Archive captured: 2026-07-12T06:24:41.878129+00:00

Show audit JSON

{
  "record": {
    "id": "7ea6adbc-b240-4df6-8dd5-f9a974d8d04b",
    "url": "https://regbase.jp/en/enforcement/other-baieruyao-pin-20170529",
    "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-20170529",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000165950.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/adfa5fabcehemg82",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000165950.html",
    "archiveCapturedAt": "2026-07-12T06:24:41.878129+00:00",
    "extractedAt": "2026-04-24T23:34:51.029+00:00",
    "translatedAt": "2026-05-01T06:50:24.695+00:00",
    "evidenceCheckedAt": "2026-04-24T23:34:51.029+00:00",
    "generatedAt": "2026-09-20T13:08:47.895Z"
  },
  "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.