Enforcement record

Administrative Guidance 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 disclosure29 July 2019

Action type

Administrative Guidance

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

29 July 2019

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 27, 2026, 09:00 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: 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
医薬品医療機器等法
Action type: Administrative Guidance
行政指導
Action date: 29 July 2019
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 体外診断薬

Violation

Machine-translated summary — verify against original

Proposed recommendations on the digitization and operation of package inserts, the provision of paper package inserts, international harmonization, regulatory streamlining, and the rationalization of pre-approval testing.

Show original Japanese text

添付文書の電子化運用、紙の添付文書提供の運用、国際整合、規制の合理化、承認前試験の合理化などについて提言。

Compliance context

Low-medium

Administrative guidance or supervision was publicly disclosed by the authority.

Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.

Use as a monitoring signal. Confirm details before treating it as a formal sanction.

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: 2026-04-27T00:00:22.434+00:00
Evidence checked: 2026-04-27T00:00:22.434+00:00
Archive captured: 2026-04-27T00:00:30.51523+00:00

Show audit JSON

{
  "record": {
    "id": "c0429d3e-75a5-44dc-a7f7-bcf3c7a2fa0f",
    "url": "https://regbase.jp/en/enforcement/other-ri-ben-lin-chuang-jian-cha-yao-xie-hui-20190729",
    "company_name_original": "日本臨床検査薬協会",
    "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": "行政指導",
      "en": "Administrative Guidance"
    },
    "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": "Low-medium",
    "actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
    "practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
    "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-ri-ben-lin-chuang-jian-cha-yao-xie-hui-20190729",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_06675.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/3020a68544gfl12q",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_06675.html",
    "archiveCapturedAt": "2026-04-27T00:00:30.51523+00:00",
    "extractedAt": "2026-04-27T00:00:22.434+00:00",
    "translatedAt": "2026-05-01T09:42:11.601+00:00",
    "evidenceCheckedAt": "2026-04-27T00:00:22.434+00:00",
    "generatedAt": "2026-09-20T20:33:11.666Z"
  },
  "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.