Enforcement record

License Revocation disclosure naming ロシュ

ロシュ (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 August 2022

Action type

License Revocation

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

17 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: Apr 28, 2026, 09:01 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: ロシュJapanese only
Original: ロシュ
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: License Revocation
許可取消し
Action date: 17 August 2022
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品・医療機器

Violation

Machine-translated summary — verify against original

Rapidly approved OTC status for COVID-19 antigen test kits and began internet sales.

Show original Japanese text

新型コロナウイルス抗原検査キットのOTC化を迅速に承認し、インターネット販売を開始。

Compliance context

High

A regulator revoked an authorization or license required for the covered activity.

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

Verify the affected business line and whether the company can legally perform the contemplated service.

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: 2026-04-28T00:01:25.425+00:00
Evidence checked: 2026-04-28T00:01:25.425+00:00
Archive captured: 2026-04-28T00:01:32.613498+00:00

Show audit JSON

{
  "record": {
    "id": "21e852a8-a139-4eb0-b09e-a1bb7d85715f",
    "url": "https://regbase.jp/en/enforcement/yakkiho-rosiyu-20220817",
    "company_name_original": "ロシュ",
    "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": "許可取消し",
      "en": "License Revocation"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": "The linked company profile has not been verified under the current identity policy."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "High",
    "actionMeaning": "A regulator revoked an authorization or license required for the covered activity.",
    "practicalNote": "Verify the affected business line and whether the company can legally perform the contemplated service.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-rosiyu-20220817",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_28612.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/b6c75c64b9hv28sk",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_28612.html",
    "archiveCapturedAt": "2026-04-28T00:01:32.613498+00:00",
    "extractedAt": "2026-04-28T00:01:25.425+00:00",
    "translatedAt": "2026-05-01T09:44:03.999+00:00",
    "evidenceCheckedAt": "2026-04-28T00:01:25.425+00:00",
    "generatedAt": "2026-09-18T20:01:15.106Z"
  },
  "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.