Enforcement record

特例承認 disclosure naming グラクソ・スミスクライン株式会社

グラクソ・スミスクライン株式会社 (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 disclosure27 September 2021

Action type

特例承認

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

27 September 2021

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

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Preserved evidence by Kiroku

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Open preserved source and evidence pack
For developers: JSON integration details

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/api/v1/enforcements?company=%E3%82%B0%E3%83%A9%E3%82%AF%E3%82%BD%E3%83%BB%E3%82%B9%E3%83%9F%E3%82%B9%E3%82%AF%E3%83%A9%E3%82%A4%E3%83%B3%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Action summary

Company
グラクソ・スミスクライン株式会社Japanese only
Original: グラクソ・スミスクライン株式会社
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
特例承認
特例承認
Action date
27 September 2021
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

Name of the COVID-19 treatment drug: Zevudy intravenous infusion 500mg, Generic name: Sotrovimab (recombinant), Applicant: GlaxoSmithKline K.K., Application date: September 6, 2021.

Show original Japanese text

新型コロナウイルス感染症に係る治療薬の販売名:ゼビュディ点滴静注液500mg、一般名:ソトロビマブ(遺伝子組換え)、申請者:グラクソ・スミスクライン株式会社、申請日:令和3年9月6日

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.

Evidence pack

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack
Extracted at
2026-04-25T00:20:23.402+00:00
Evidence checked
2026-04-25T00:20:23.402+00:00
Archive captured
2026-07-12T07:20:48.616121+00:00
Show audit JSON
{
  "record": {
    "id": "4cb2e776-2377-4d60-bff4-79eb3ffa97c1",
    "url": "https://regbase.jp/en/enforcement/other-gurakusosumisukurain-20210927",
    "company_name_original": "グラクソ・スミスクライン株式会社",
    "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": "特例承認",
      "en": "特例承認"
    },
    "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 (グラクソ・スミスクライン株式会社). 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-gurakusosumisukurain-20210927",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21273.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/25fb607d95hgrhry",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21273.html",
    "archiveCapturedAt": "2026-07-12T07:20:48.616121+00:00",
    "extractedAt": "2026-04-25T00:20:23.402+00:00",
    "translatedAt": "2026-05-01T07:08:44.984+00:00",
    "evidenceCheckedAt": "2026-04-25T00:20:23.402+00:00",
    "generatedAt": "2026-07-26T03:42:16.970Z"
  },
  "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.

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.