Enforcement record

特例承認 disclosure naming アストラゼネカ株式会社

アストラゼネカ株式会社 (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 disclosure30 August 2022

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

30 August 2022

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, 04:20 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: アストラゼネカ株式会社Japanese only
Original: アストラゼネカ株式会社
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: 30 August 2022
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: Evashield Intramuscular Injection Set, Generic names: Tixagevimab (Genetically Modified) and Cilgavimab (Genetically Modified), Applicant: AstraZeneca K.K., Application date: June 9, 2022 (Reiwa 4).

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：エバシェルド筋注セット、一般名：チキサゲビマブ（遺伝子組換え）及びシルガビマブ（遺伝子組換え）、申請者：アストラゼネカ株式会社、申請日：令和４年６月９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.

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: 2026-04-25T00:19:45.949+00:00
Evidence checked: 2026-04-25T00:19:45.949+00:00
Archive captured: 2026-07-12T07:20:34.88253+00:00

Show audit JSON

{
  "record": {
    "id": "c9f87470-6fc2-44a5-ac1f-7e032448e18f",
    "url": "https://regbase.jp/en/enforcement/other-asutorazeneka-20220830",
    "company_name_original": "アストラゼネカ株式会社",
    "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 (アストラゼネカ株式会社). 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-asutorazeneka-20220830",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_27695.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/c07b8b0797hgrgv2",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_27695.html",
    "archiveCapturedAt": "2026-07-12T07:20:34.88253+00:00",
    "extractedAt": "2026-04-25T00:19:45.949+00:00",
    "translatedAt": "2026-05-01T07:08:16.52+00:00",
    "evidenceCheckedAt": "2026-04-25T00:19:45.949+00:00",
    "generatedAt": "2026-09-18T20:01:07.085Z"
  },
  "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.