Enforcement record

Criminal Accusation disclosure naming ノバルティス　ファーマ株式会社

ノバルティス　ファーマ株式会社 (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 disclosure9 January 2014

Action type

Criminal Accusation

Law

Pharmaceutical Affairs Act

Authority

Ministry of Health, Labour and Welfare

Action date

9 January 2014

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, 03:14 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: ノバルティス　ファーマ株式会社Japanese only
Original: ノバルティス　ファーマ株式会社
Governing law: Pharmaceutical Affairs Act
薬事法
Action type: Criminal Accusation
告発
Action date: 9 January 2014
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品広告

Violation

Machine-translated summary — verify against original

Novartis Pharma K.K. used materials that described the results of clinical studies, the 'JIKEI HEART Study' conducted at Tokyo Jikei Medical University and the 'KYOTO HEART Study' conducted at Kyoto Prefectural University of Medicine, to advertise the efficacy or effects of the drug Diovan tablets. These advertisements were made using the results of these clinical studies.

Show original Japanese text

ノバルティス　ファーマ株式会社は、平成23年から平成24年にかけて、ディオバン錠に係る東京慈恵会医科大学において実施された臨床研究である「JIKEI HEART Study」及び京都府立医科大学において実施された臨床研究である「KYOTO HEART Study」の結果を記載した資材を用いて、同医薬品の効能又は効果に関して広告を行った。

Compliance context

High

The authority announced a criminal accusation or referral based on the disclosed facts.

Japanese regulatory disclosure under Pharmaceutical Affairs Act.

Escalate for legal review and check whether later public records changed the status of the matter.

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: 2026-04-24T23:31:43.527+00:00
Evidence checked: 2026-04-24T23:31:43.527+00:00
Archive captured: 2026-07-12T06:14:01.017315+00:00

Show audit JSON

{
  "record": {
    "id": "c6dd049c-afab-4bc2-9b85-802c589b86f2",
    "url": "https://regbase.jp/en/enforcement/other-nobaruteisuhuama-20140109",
    "company_name_original": "ノバルティス　ファーマ株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬事法",
      "en": "Pharmaceutical Affairs Act"
    },
    "action_type": {
      "ja": "告発",
      "en": "Criminal Accusation"
    },
    "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 (ノバルティスファーマ株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "High",
    "actionMeaning": "The authority announced a criminal accusation or referral based on the disclosed facts.",
    "practicalNote": "Escalate for legal review and check whether later public records changed the status of the matter.",
    "lawContext": "Japanese regulatory disclosure under Pharmaceutical Affairs Act."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-nobaruteisuhuama-20140109",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000034241.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/db56d347f1he9l4c",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000034241.html",
    "archiveCapturedAt": "2026-07-12T06:14:01.017315+00:00",
    "extractedAt": "2026-04-24T23:31:43.527+00:00",
    "translatedAt": "2026-05-01T06:48:30.886+00:00",
    "evidenceCheckedAt": "2026-04-24T23:31:43.527+00:00",
    "generatedAt": "2026-09-27T20:54:28.827Z"
  },
  "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.