Administrative Guidance against 日本臨床検査薬協会

日本臨床検査薬協会 (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfareConfirmed entity match29 July 2019
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/api/v1/enforcements?corporate_number=4010005018578&limit=10

Action summary

Company
Original: 日本臨床検査薬協会
Corporate Number: 4010005018578
Entity match
Confirmed entity match95/100Machine extracted
Normalized Japanese name matched to a company profile with Corporate Number
Matched by normalized Japanese company name to an enriched company profile with a Corporate Number.
Governing law
医薬品医療機器等法
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

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 医薬品医療機器等法.

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 announcement (Japanese)Archived source snapshot
Extracted at
2026-04-27T00:00:22.434+00:00
Evidence checked
2026-04-27T00:00:22.434+00:00
Archive captured
2026-04-27T00:00:22.895+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": "日本臨床検査薬協会",
    "corporate_number": "4010005018578",
    "law": {
      "ja": "医薬品医療機器等法",
      "en": "医薬品医療機器等法"
    },
    "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": "confirmed",
    "confidence": 95,
    "method": "normalized_name_with_corporate_number",
    "method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
    "notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
  },
  "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 医薬品医療機器等法."
  },
  "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",
    "archiveUrl": "https://kiroku.today/view/3020a68544gfl12q",
    "archiveCapturedAt": "2026-04-27T00:00:22.895+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": "2026-06-19T11:08:31.756Z"
  },
  "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
日本臨床検査薬協会 Japanese original
Japanese name
日本臨床検査薬協会
Corporate Number
4010005018578
Registered address
東京都中央区東日本橋2丁目24番14号
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.