Business Improvement Order against 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)

医薬品医療機器法Ministry of Health, Labour and WelfareConfirmed entity match13 November 2015

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/api/v1/enforcements?corporate_number=4010401011491&limit=10

Open API response API docs

Action summary

Company: ノバルティス　ファーマ株式会社Japanese original
Original: ノバルティスファーマ株式会社
Corporate Number: 4010401011491
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

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.

Evidence pack

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot

Extracted at: 2026-04-24T23:34:13.562+00:00
Evidence checked: 2026-04-24T23:34:13.562+00:00
Archive captured: 2026-04-04T00:30:53.323+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": "ノバルティス　ファーマ株式会社",
    "corporate_number": "4010401011491",
    "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": "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": "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",
    "archiveUrl": "https://kiroku.today/view/0b09e794f3jljpzv",
    "archiveCapturedAt": "2026-04-04T00:30:53.323+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": "2026-06-21T10:43:21.426Z"
  },
  "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: ノバルティス　ファーマ株式会社 Japanese original
Japanese name: ノバルティス　ファーマ株式会社
Corporate Number: 4010401011491
Registered address: 東京都港区虎ノ門１丁目２３番１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.

Business Improvement Order against ノバルティス ファーマ株式会社