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
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
- Queued for preservation
- Captured: Jul 12, 2026, 03:24 PM JST
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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
Public documents and saved materials
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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.
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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.