Enforcement record

Business Improvement Order disclosure naming 第一三共エスファ株式会社

第一三共エスファ株式会社 (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 disclosure21 May 2021

Action type

Business Improvement Order

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

21 May 2021

Current page: Enforcement record

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

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1 enforcement record currently attributed
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/api/v1/enforcements?company=%E7%AC%AC%E4%B8%80%E4%B8%89%E5%85%B1%E3%82%A8%E3%82%B9%E3%83%95%E3%82%A1%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Open JSON Specs

Action summary

Company: 第一三共エスファ株式会社Japanese only
Original: 第一三共エスファ株式会社
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: Business Improvement Order
業務改善命令
Action date: 21 May 2021
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品製造

Violation

Machine-translated summary — verify against original

All pharmaceuticals found to be in violation were jointly developed products with Kobayashi Kako Co., Ltd., and approval applications were submitted by each company using materials prepared by Kobayashi Kako Co., Ltd.

Show original Japanese text

違反事実が認められた医薬品は、全て小林化工株式会社との間の共同開発品目であり、小林化工株式会社により作成された資料を用いて、各社により承認申請が行われたもの。

Compliance context

Medium-high

A formal order requiring business process or compliance control improvements.

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

Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.

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: 2026-04-24T23:38:09.542+00:00
Evidence checked: 2026-04-24T23:38:09.542+00:00
Archive captured: 2026-07-12T06:34:36.016167+00:00

Show audit JSON

{
  "record": {
    "id": "beca684c-36a3-49da-97cf-4f3bcb6fcb03",
    "url": "https://regbase.jp/en/enforcement/other-di-yi-san-gong-esuhua-20210521",
    "company_name_original": "第一三共エスファ株式会社",
    "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": "業務改善命令",
      "en": "Business Improvement Order"
    },
    "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 (第一三共エスファ株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Medium-high",
    "actionMeaning": "A formal order requiring business process or compliance control improvements.",
    "practicalNote": "Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.",
    "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-di-yi-san-gong-esuhua-20210521",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_18754.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/11c95f1ef2hf0jao",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_18754.html",
    "archiveCapturedAt": "2026-07-12T06:34:36.016167+00:00",
    "extractedAt": "2026-04-24T23:38:09.542+00:00",
    "translatedAt": "2026-05-01T06:52:01.849+00:00",
    "evidenceCheckedAt": "2026-04-24T23:38:09.542+00:00",
    "generatedAt": "2026-08-25T08:48:25.055Z"
  },
  "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.