Enforcement record

Business Improvement Order 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 (医薬品医療機器法)

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

医薬品医療機器法Ministry of Health, Labour and WelfareGovernment disclosure13 November 2015

Action type

Business Improvement Order

Law

医薬品医療機器法

Authority

Ministry of Health, Labour and Welfare

Action date

13 November 2015

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, 03:24 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: 医薬品医療機器法
医薬品医療機器法
Action type: Business Improvement Order
業務改善命令
Action date: 13 November 2015
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品製造販売

Violation

Machine-translated summary — verify against original

Due to a malfunction in the adverse reaction reporting system, violations of reporting obligations for adverse reactions involving 57 prescription drugs containing 57 ingredients manufactured and sold by the company were identified, with 5,475 cases. Additionally, due to the same cause, there were violations involving 28 ingredients' clinical trial drugs, with 154 cases of adverse reactions.

Show original Japanese text

副作用システムの障害により、57成分の第一種医薬品の副作用報告義務違反と、同じ原因により発生した28成分の治験の被験薬に関する154症例の副作用報告義務違反

Compliance context

Medium-high

A formal order requiring business process or compliance control improvements.

Japanese regulatory disclosure under 医薬品医療機器法.

Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.

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: 2026-04-24T23:34:13.562+00:00
Evidence checked: 2026-04-24T23:34:13.562+00:00
Archive captured: 2026-07-12T06:24:05.20069+00:00

Show audit JSON

{
  "record": {
    "id": "368e560f-e751-4bf1-a059-04ca384238c1",
    "url": "https://regbase.jp/en/enforcement/other-nobaruteisuhuama-20151113",
    "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": "医薬品医療機器法",
      "en": "医薬品医療機器法"
    },
    "action_type": {
      "ja": "業務改善命令",
      "en": "Business Improvement Order"
    },
    "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": "Medium-high",
    "actionMeaning": "A formal order requiring business process or compliance control improvements.",
    "practicalNote": "Ask for remediation evidence if the company is material to your compliance, finance, or customer-facing operations.",
    "lawContext": "Japanese regulatory disclosure under 医薬品医療機器法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-nobaruteisuhuama-20151113",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000102311.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/0b09e794f3hemfxq",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000102311.html",
    "archiveCapturedAt": "2026-07-12T06:24:05.20069+00:00",
    "extractedAt": "2026-04-24T23:34:13.562+00:00",
    "translatedAt": "2026-05-01T06:49:59.511+00:00",
    "evidenceCheckedAt": "2026-04-24T23:34:13.562+00:00",
    "generatedAt": "2026-09-27T20:56:24.838Z"
  },
  "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.