総括製造販売責任者の変更命令 against 沢井製薬株式会社

沢井製薬株式会社 (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfareConfirmed entity match22 December 2023
For developers: integration details

You do not need this for normal browsing. Use it when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?corporate_number=4120001000479&limit=10

Action summary

Company
沢井製薬株式会社Japanese original
Original: 沢井製薬株式会社
Corporate Number: 4120001000479
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
医薬品医療機器等法
医薬品医療機器等法
Action type
総括製造販売責任者の変更命令
総括製造販売責任者の変更命令
Action date
22 December 2023
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Based on Article 73 of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, an order was issued to change the overall manufacturing and marketing supervisor at the headquarters.

Show original Japanese text

医薬品医療機器等法第73条の規定に基づき、本社における総括製造販売責任者の変更命令を行った。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under 医薬品医療機器等法.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

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
2026-04-25T00:21:32.079+00:00
Evidence checked
2026-04-25T00:21:32.079+00:00
Archive captured
2026-04-10T06:00:41.136+00:00
Show audit JSON
{
  "record": {
    "id": "5830fb7e-fad1-48d4-933e-40d5af11d2c2",
    "url": "https://regbase.jp/en/enforcement/other-ze-jing-zhi-yao-20231222",
    "company_name_original": "沢井製薬株式会社",
    "company_name_registry": "沢井製薬株式会社",
    "corporate_number": "4120001000479",
    "law": {
      "ja": "医薬品医療機器等法",
      "en": "医薬品医療機器等法"
    },
    "action_type": {
      "ja": "総括製造販売責任者の変更命令",
      "en": "総括製造販売責任者の変更命令"
    },
    "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": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under 医薬品医療機器等法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-ze-jing-zhi-yao-20231222",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_37021.html",
    "archiveUrl": "https://kiroku.today/view/fde22bcd3civtkgt",
    "archiveCapturedAt": "2026-04-10T06:00:41.136+00:00",
    "extractedAt": "2026-04-25T00:21:32.079+00:00",
    "translatedAt": "2026-05-01T07:09:47.604+00:00",
    "evidenceCheckedAt": "2026-04-25T00:21:32.079+00:00",
    "generatedAt": "2026-06-19T09:15:24.608Z"
  },
  "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.

Company info

English name
沢井製薬株式会社 Japanese original
Japanese name
沢井製薬株式会社
Corporate Number
4120001000479
Registered address
大阪府大阪市淀川区宮原5丁目2番30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.