Enforcement record

Recommendation disclosure naming 日本臨床検査薬協会

日本臨床検査薬協会 (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 August 2021

Action type

Recommendation

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

27 August 2021

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, 03:35 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: 日本臨床検査薬協会Japanese only
Original: 日本臨床検査薬協会
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: Recommendation
勧告
Action date: 27 August 2021
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Opinions and recommendations on accelerating digitalization, international harmonization, promotion of clinical research, electronic labeling, UDI promotion, and international expansion strategies.

Show original Japanese text

デジタル化の加速、国際整合、臨床研究の促進、添付文書の電子化、UDIの推進、国際展開戦略についての意見と提言。

Compliance context

Medium

A regulator issued a recommendation or formal request for corrective action.

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

Review the facts and follow-up status. This is usually less severe than a suspension or revocation, but still a public enforcement signal.

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: 2026-04-25T00:20:38.532+00:00
Evidence checked: 2026-04-25T00:20:38.532+00:00
Archive captured: 2026-07-12T06:35:14.648772+00:00

Show audit JSON

{
  "record": {
    "id": "9c91c54a-9d3a-4274-b16e-83330b4b61b6",
    "url": "https://regbase.jp/en/enforcement/yakkiho-ri-ben-lin-chuang-jian-cha-yao-xie-hui-20210827",
    "company_name_original": "日本臨床検査薬協会",
    "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": "勧告",
      "en": "Recommendation"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 60,
    "method": "linked_profile_without_source_identifier",
    "method_label": "linked_profile_without_source_identifier",
    "notes": "The linked profile has a Corporate Number, but the public disclosure does not contain that number and no unique independent NTA name/address match was found."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Medium",
    "actionMeaning": "A regulator issued a recommendation or formal request for corrective action.",
    "practicalNote": "Review the facts and follow-up status. This is usually less severe than a suspension or revocation, but still a public enforcement signal.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-ri-ben-lin-chuang-jian-cha-yao-xie-hui-20210827",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/2077ea6711hf0jbv",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
    "archiveCapturedAt": "2026-07-12T06:35:14.648772+00:00",
    "extractedAt": "2026-04-25T00:20:38.532+00:00",
    "translatedAt": "2026-05-01T07:08:58.028+00:00",
    "evidenceCheckedAt": "2026-04-25T00:20:38.532+00:00",
    "generatedAt": "2026-09-18T20:16:35.031Z"
  },
  "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.