Enforcement record

Administrative Guidance disclosure naming 武田薬品工業株式会社

武田薬品工業株式会社 (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 August 2021

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

29 August 2021

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, 04:11 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: 武田薬品工業株式会社Japanese only
Original: 武田薬品工業株式会社
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: Administrative Guidance
行政指導
Action date: 29 August 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

During the manufacturing process, although the probability is very low, there is a rare possibility that fragments resembling rubber stoppers could be mixed into the vials. Even if rubber stopper fragments are mixed in, it has been reported that there are no issues with the efficacy or safety of other vials from the same lot.

Show original Japanese text

製造工程において、確率は非常に低いものの、ごくまれに製品のゴム栓様の破片がバイアル内に混入する可能性があり、万が一、ゴム栓破片が混入した場合でも、同一ロットの他のバイアルの有効性及び安全性に問題はないと報告されている。

Compliance context

Low-medium

Administrative guidance or supervision was publicly disclosed by the authority.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

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: 2026-04-25T00:17:22.694+00:00
Evidence checked: 2026-04-25T00:17:22.694+00:00
Archive captured: 2026-07-12T07:11:28.409572+00:00

Show audit JSON

{
  "record": {
    "id": "3ea64bdf-2c7d-4fb8-9188-fd0ea331c868",
    "url": "https://regbase.jp/en/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20210829",
    "company_name_original": "武田薬品工業株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬機法",
      "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 (武田薬品工業株式会社). 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": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-wu-tian-yao-pin-gong-ye-20210829",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_20760.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/c1d6ccce3bhgenl9",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_20760.html",
    "archiveCapturedAt": "2026-07-12T07:11:28.409572+00:00",
    "extractedAt": "2026-04-25T00:17:22.694+00:00",
    "translatedAt": "2026-05-01T07:06:30.244+00:00",
    "evidenceCheckedAt": "2026-04-25T00:17:22.694+00:00",
    "generatedAt": "2026-09-18T20:16:26.208Z"
  },
  "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.