Possible License Revocation against ロシュ

ロシュ (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfarePossible entity match17 August 2022
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/api/v1/enforcements?company=%E3%83%AD%E3%82%B7%E3%83%A5&limit=10

Action summary

Company
ロシュJapanese original
Original: ロシュ
Entity match
Possible entity match60/100Machine extracted
Company name extracted from the Japanese public disclosure
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

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.

Evidence pack

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot
Extracted at
2026-04-28T00:01:25.425+00:00
Evidence checked
2026-04-28T00:01:25.425+00:00
Archive captured
2026-04-28T00:01:25.897+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": "ロシュ",
    "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": "possible",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": null
  },
  "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",
    "archiveUrl": "https://kiroku.today/view/b6c75c64b9hv28sk",
    "archiveCapturedAt": "2026-04-28T00:01:25.897+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": "2026-06-19T09:10:20.249Z"
  },
  "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.

Company info

English name
ロシュ Japanese original
Japanese name
ロシュ
See company profile →

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