Enforcement record

先駆け審査指定制度対象品目の募集 disclosure naming 小野薬品工業 株式会社

小野薬品工業 株式会社 (Pharmaceutical Affairs Act)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Pharmaceutical Affairs ActMinistry of Health, Labour and WelfareGovernment disclosure5 October 2017

Action type

先駆け審査指定制度対象品目の募集

Law

Pharmaceutical Affairs Act

Authority

Ministry of Health, Labour and Welfare

Action date

5 October 2017

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

Save the disclosure record naming 小野薬品工業 株式会社

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Preserved evidence by Kiroku

Review the preserved source for 小野薬品工業 株式会社

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack
For developers: JSON integration details

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/api/v1/enforcements?company=%E5%B0%8F%E9%87%8E%E8%96%AC%E5%93%81%E5%B7%A5%E6%A5%AD%20%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Action summary

Company
小野薬品工業 株式会社Japanese only
Original: 小野薬品工業 株式会社
Governing law
Pharmaceutical Affairs Act
薬事法
Action type
先駆け審査指定制度対象品目の募集
先駆け審査指定制度対象品目の募集
Action date
5 October 2017
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Nivolumab (genetically modified) for biliary tract cancer

Show original Japanese text

ニボルマブ(遺伝子組換え)胆道癌

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 Pharmaceutical Affairs Act.

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 source (Japanese)Open preserved source and evidence pack
Extracted at
2026-04-24T23:38:29.018+00:00
Evidence checked
2026-04-24T23:38:29.018+00:00
Archive captured
2026-07-12T06:35:06.810541+00:00
Show audit JSON
{
  "record": {
    "id": "7e2aa30e-3916-4280-80e8-6f1e0fd4d7e7",
    "url": "https://regbase.jp/en/enforcement/other-xiao-ye-yao-pin-gong-ye-20171005",
    "company_name_original": "小野薬品工業 株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬事法",
      "en": "Pharmaceutical Affairs Act"
    },
    "action_type": {
      "ja": "先駆け審査指定制度対象品目の募集",
      "en": "先駆け審査指定制度対象品目の募集"
    },
    "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 (小野薬品工業株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "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 Pharmaceutical Affairs Act."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-xiao-ye-yao-pin-gong-ye-20171005",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000179802.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/ceb343f564hf0jc8",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000179802.html",
    "archiveCapturedAt": "2026-07-12T06:35:06.810541+00:00",
    "extractedAt": "2026-04-24T23:38:29.018+00:00",
    "translatedAt": "2026-05-01T06:52:15.359+00:00",
    "evidenceCheckedAt": "2026-04-24T23:38:29.018+00:00",
    "generatedAt": "2026-08-04T16:44:12.436Z"
  },
  "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.

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.