Administrative Guidance against 日本臨床検査薬協会
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/api/v1/enforcements?corporate_number=4010005018578&limit=10Action summary
- Company
- 日本臨床検査薬協会Japanese originalOriginal: 日本臨床検査薬協会Corporate Number: 4010005018578
- Entity match
- Confirmed entity match95/100Machine extractedNormalized Japanese name matched to a company profile with Corporate NumberMatched 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
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-mediumAdministrative 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
- 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": "2026-06-19T12:15:27.159Z"
},
"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)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
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.