Enforcement record
Business Improvement Order disclosure naming ノバルティスファーマ株式会社
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
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
RegBase evidence report
Japanese public-record enforcement check
Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.
- Report ID
- RB-EN-ENFORCEMENT-OTHER-NOBARUTEISU-202608131057
- Generated at
- 13 August 2026 at 19:57
- Record URL
- https://regbase.jp/en/enforcement/other-nobaruteisuhuama-20151113
1. Review Summary
| Disclosure name | ノバルティスファーマ株式会社 | Corporate Number | Not stated in the disclosure |
|---|---|---|---|
| Enforcement record | 1 record | Other confirmed records for this company | Outside this report's scope |
| Action date | 13 November 2015 | Authority | Ministry of Health, Labour and Welfare |
| Law | 医薬品医療機器法 | Action type | Business Improvement Order |
| Source status | Preserved public-source archive recorded | ||
This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.
2. Published Information
| Published name | ノバルティスファーマ株式会社 |
|---|
3. Enforcement Record
| Target name in disclosure | ノバルティスファーマ株式会社 |
|---|---|
| Authority | Ministry of Health, Labour and Welfare (厚生労働省) |
| Law / action type | 医薬品医療機器法 / Business Improvement Order |
| Action / announcement date | Action: 13 November 2015 / Announcement: 27 March 2026 |
| English summary | 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. |
| 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 |
| Official source | https://www.mhlw.go.jp/stf/houdou/0000102311.html |
| Source archive | https://kiroku.today/a/0b09e794f3hemfxq |
| Extraction / evidence timestamps | Extracted: 25 April 2026 at 08:34 / Evidence checked: 25 April 2026 at 08:34 / Archive captured: 12 July 2026 at 15:24 |
4. Business Location and Permit Details
No additional structured business-location or permit fields are recorded for this disclosure.
5. Other Confirmed Records for This Company
This report covers the single government disclosure shown on this page.
Reviewer Notes
| Reviewer | Team / company | ||
|---|---|---|---|
| Review purpose | |||
| Additional notes | |||
- □ Official source URL or archived source was checked.
- □ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
- □ This document is understood as a public-record evidence file, not a credit decision or legal opinion.
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Free report
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Preserved evidence by Kiroku
Review the preserved source for ノバルティスファーマ株式会社
Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.
For developers: JSON integration details
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Action summary
- Company
- ノバルティスファーマ株式会社Japanese onlyOriginal: 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
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-highA 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
- 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": "2026-08-13T10:57:10.402Z"
},
"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.