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

RegBase evidence report

Japanese public-record enforcement check

Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.

Report ID: RB-EN-ENFORCEMENT-YAKKIHO-ROSIYU-20-202608041527
Generated at: 5 August 2026 at 00:27
Record URL: https://regbase.jp/en/enforcement/yakkiho-rosiyu-20220817

1. Review Summary

Disclosure name	ロシュ	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	17 August 2022	Authority	Ministry of Health, Labour and Welfare
Law	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices	Action type	License Revocation
Source status	Preserved public-source archive recorded

This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.

2. Published Information

Published name	ロシュ

3. Enforcement Record

Target name in disclosure	ロシュ
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / License Revocation
Action / announcement date	Action: 17 August 2022 / Announcement: 28 April 2026
English summary	Rapidly approved OTC status for COVID-19 antigen test kits and began internet sales.
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。
Official source	https://www.mhlw.go.jp/stf/newpage_28612.html
Source archive	https://kiroku.today/a/b6c75c64b9hv28sk
Extraction / evidence timestamps	Extracted: 28 April 2026 at 09:01 / Evidence checked: 28 April 2026 at 09:01 / Archive captured: 28 April 2026 at 09:01

4. Business Location and Permit Details

No additional structured business-location or permit fields are recorded for this disclosure.

5. Other Confirmed Records for This Company

This report covers the single government disclosure shown on this page.

Reviewer Notes

Reviewer		Team / company
Review purpose
Additional notes

□ Official source URL or archived source was checked.
□ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
□ This document is understood as a public-record evidence file, not a credit decision or legal opinion.

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

Save the disclosure record naming ロシュ

Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.

Preserved evidence by Kiroku

Review the preserved source for ロシュ

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack

For developers: JSON integration details

You do not need this for normal browsing. Use it only when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?company=%E3%83%AD%E3%82%B7%E3%83%A5&limit=10

Open JSON Specs

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.

Evidence pack

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": "2026-08-04T15:27:17.285Z"
  },
  "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.