指定 against Sumitomo Heavy Industries, Ltd.

住友重機械工業株式会社 (薬事法)

薬事法Ministry of Health, Labour and WelfareConfirmed entity match28 February 2017

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/api/v1/enforcements?corporate_number=9010701005032&limit=10

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Action summary

Company: Sumitomo Heavy Industries, Ltd.Official
Original: 住友重機械工業株式会社
Corporate Number: 9010701005032
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: 薬事法
薬事法
Action type: 指定
指定
Action date: 28 February 2017
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

This is a device used for neutron beam irradiation in boron neutron capture therapy (BNCT). The applicable diseases are malignant glioma and head and neck cancer. A Phase I clinical trial conducted domestically with 12 cases reported a one-year survival rate of 66.7%. A clinical study targeting head and neck cancer conducted at the same university with 62 cases reported an response rate of 58%, suggesting high efficacy.

Show original Japanese text

ホウ素中性子捕捉療法（BNCT）に用いる中性子線を照射するための装置である。適応疾患は、悪性神経膠腫と頭頸部癌である。国内で実施中の第I相治験（12例）で確認した1年生存率は66.7％、同大学で実施した頭頸部癌を対象とした臨床研究（62例）で確認した奏効率は58％であるとの報告があり、高い有効性が示唆されている。

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 薬事法.

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: 2026-04-25T00:13:58.578+00:00
Evidence checked: 2026-04-25T00:13:58.578+00:00
Archive captured: 2026-04-07T12:02:05.779+00:00

Show audit JSON

{
  "record": {
    "id": "c76d4fcf-c042-4ae9-ac8e-1e1f77168f09",
    "url": "https://regbase.jp/en/enforcement/other-zhu-you-chong-ji-jie-gong-ye-20170228",
    "company_name_original": "住友重機械工業株式会社",
    "company_name_registry": "住友重機械工業 株式会社",
    "corporate_number": "9010701005032",
    "law": {
      "ja": "薬事法",
      "en": "薬事法"
    },
    "action_type": {
      "ja": "指定",
      "en": "指定"
    },
    "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 薬事法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-zhu-you-chong-ji-jie-gong-ye-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveUrl": "https://kiroku.today/view/60d0baf7afokk4is",
    "archiveCapturedAt": "2026-04-07T12:02:05.779+00:00",
    "extractedAt": "2026-04-25T00:13:58.578+00:00",
    "translatedAt": "2026-05-01T07:03:39.215+00:00",
    "evidenceCheckedAt": "2026-04-25T00:13:58.578+00:00",
    "generatedAt": "2026-06-19T13:10:17.333Z"
  },
  "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: Sumitomo Heavy Industries, Ltd. Official
Japanese name: 住友重機械工業株式会社
Corporate Number: 9010701005032
Registered address: 東京都品川区大崎２丁目１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.