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

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-OTHER-RI-BEN-LIN--202608042200
Generated at: 5 August 2026 at 07:00
Record URL: https://regbase.jp/en/enforcement/other-ri-ben-lin-chuang-jian-cha-yao-xie-hui-20190729

1. Review Summary

Disclosure name	日本臨床検査薬協会	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	29 July 2019	Authority	Ministry of Health, Labour and Welfare
Law	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices	Action type	Administrative Guidance
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	日本臨床検査薬協会

3. Enforcement Record

Target name in disclosure	日本臨床検査薬協会
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 / Administrative Guidance
Action / announcement date	Action: 29 July 2019 / Announcement: 27 April 2026
English summary	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.
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。
Official source	https://www.mhlw.go.jp/stf/newpage_06675.html
Source archive	https://kiroku.today/a/3020a68544gfl12q
Extraction / evidence timestamps	Extracted: 27 April 2026 at 09:00 / Evidence checked: 27 April 2026 at 09:00 / Archive captured: 27 April 2026 at 09:00

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

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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 日本臨床検査薬協会

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

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/api/v1/enforcements?company=%E6%97%A5%E6%9C%AC%E8%87%A8%E5%BA%8A%E6%A4%9C%E6%9F%BB%E8%96%AC%E5%8D%94%E4%BC%9A&limit=10

Open JSON Specs

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.

Evidence pack

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": "2026-08-04T22:00:35.870Z"
  },
  "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.