Enforcement record

指定 disclosure naming 株式会社UT-Heart研究所

株式会社UT-Heart研究所 (Pharmaceutical Affairs Act)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Pharmaceutical Affairs ActMinistry of Health, Labour and WelfareGovernment disclosure28 February 2017

Action type

指定

Law

Pharmaceutical Affairs Act

Authority

Ministry of Health, Labour and Welfare

Action date

28 February 2017

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, 04:04 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: 株式会社UT-Heart研究所Japanese only
Original: 株式会社UT-Heart研究所
Governing law: Pharmaceutical Affairs Act
薬事法
Action type: 指定
指定
Action date: 28 February 2017
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Approximately 30% of patients with severe heart failure who underwent cardiac resynchronization therapy (CRT) were reported to have ineffective outcomes, and diagnosing ineffective cases is difficult. The product has novelty and high significance in that it can assist in predicting the effectiveness of CRT. Clinical research (11 cases) reported that the prediction of improvement in cardiac pump function using the product showed a high correlation (correlation coefficient 0.94) with actual effects, indicating high potential efficacy.

Show original Japanese text

心臓再同期療法※を行った重症心不全患者の中で約30％が無効例と報告されており、無効例の診断は困難である。本品は心臓再同期療法の効果予測の判断を補助できる点に新規性があり、画期性が高い。臨床研究（11例）の結果から、本品を使用した心臓のポンプ機能の改善の効果予測は実際の効果と高い相関（相関係数0.94）を示したとの報告があり、高い有効性が期待できる。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under Pharmaceutical Affairs Act.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

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: 2026-04-25T00:13:58.846+00:00
Evidence checked: 2026-04-25T00:13:58.846+00:00
Archive captured: 2026-07-12T07:04:12.296656+00:00

Show audit JSON

{
  "record": {
    "id": "3e22c6f2-e456-4ce3-8090-bf5332b2e9d5",
    "url": "https://regbase.jp/en/enforcement/other-ut-heartyan-jiu-suo-20170228",
    "company_name_original": "株式会社UT-Heart研究所",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬事法",
      "en": "Pharmaceutical Affairs Act"
    },
    "action_type": {
      "ja": "指定",
      "en": "指定"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (株式会社ＵＴ－Ｈｅａｒｔ研究所). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under Pharmaceutical Affairs Act."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-ut-heartyan-jiu-suo-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/60d0baf7afhg2xre",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveCapturedAt": "2026-07-12T07:04:12.296656+00:00",
    "extractedAt": "2026-04-25T00:13:58.846+00:00",
    "translatedAt": "2026-05-01T07:03:40.964+00:00",
    "evidenceCheckedAt": "2026-04-25T00:13:58.846+00:00",
    "generatedAt": "2026-09-18T20:59:39.973Z"
  },
  "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.