Enforcement record

Administrative Guidance disclosure naming ヤンセンファーマ株式会社

ヤンセンファーマ株式会社 (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 disclosure17 April 2014

Action type

Administrative Guidance

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

17 April 2014

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: May 6, 2026, 09:02 AM 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: ヤンセンファーマ株式会社Japanese only
Original: ヤンセンファーマ株式会社
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: Administrative Guidance
行政指導
Action date: 17 April 2014
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

On April 17, 2014, the Ministry of Health, Labour and Welfare issued administrative guidance to Janssen Pharma Co., Ltd., a pharmaceutical manufacturer and distributor, concerning the schizophrenia treatment drug Zepreon (Zepreon water suspension injection). This action was taken after reports of multiple deaths among patients using the drug, with an unclear causal relationship. The guidance required the company to revise the 'Precautions for Use' section of the product's package insert and to promptly notify healthcare professionals through a safety bulletin (Blue Letter) to ensure proper use and awareness of safety concerns.

Show original Japanese text

添付文書の「使用上の注意」の改訂と、「安全性速報（ブルーレター）」により医療関係者等に注意喚起を行うこと

Compliance context

Low-medium

Administrative guidance or supervision was publicly disclosed by the authority.

Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.

Use as a monitoring signal. Confirm details before treating it as a formal sanction.

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: 2026-05-06T00:02:11.855+00:00
Evidence checked: 2026-05-06T00:02:11.855+00:00
Archive captured: 2026-05-06T00:02:22.982994+00:00

Show audit JSON

{
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    "id": "8dae1131-9c00-4b6a-939e-0083e6b911a7",
    "url": "https://regbase.jp/en/enforcement/other-yansenhuama-20140417",
    "company_name_original": "ヤンセンファーマ株式会社",
    "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": "行政指導",
      "en": "Administrative Guidance"
    },
    "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 (ヤンセンファーマ株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Low-medium",
    "actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
    "practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
    "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-yansenhuama-20140417",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043861.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/2bab1a77aftam3jo",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000043861.html",
    "archiveCapturedAt": "2026-05-06T00:02:22.982994+00:00",
    "extractedAt": "2026-05-06T00:02:11.855+00:00",
    "translatedAt": "2026-07-06T07:42:00.04+00:00",
    "evidenceCheckedAt": "2026-05-06T00:02:11.855+00:00",
    "generatedAt": "2026-09-19T12:51:23.885Z"
  },
  "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.