先駆け審査指定制度対象品目の募集 against ステラファーマ株式会社

ステラファーマ株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareConfirmed entity match5 October 2017

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Action summary

Company: ステラファーマ株式会社Japanese original
Original: ステラファーマ株式会社
Corporate Number: 5120001124194
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: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
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

The Ministry of Health, Labour and Welfare established the 'Designated Fast-Track Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, etc., with the aim of accelerating their practical application in Japan.

Show original Japanese text

厚生労働省は、革新的医薬品・医療機器・再生医療等製品を日本で早期に実用化することを目的として、その開発を促進するために、平成27年４月１日に「先駆け審査指定制度」を創設しました。

Compliance context

Context needed

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

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

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: 2026-04-27T18:02:29.646+00:00
Evidence checked: 2026-04-27T18:02:29.646+00:00
Archive captured: 2026-04-27T18:02:30.195+00:00

Show audit JSON

{
  "record": {
    "id": "6ea44d3d-d610-49eb-9ff5-14e4683e498e",
    "url": "https://regbase.jp/en/enforcement/yakkiho-suterahuama-20171005",
    "company_name_original": "ステラファーマ株式会社",
    "company_name_registry": "ステラファーマ株式会社",
    "corporate_number": "5120001124194",
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "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": "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": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-suterahuama-20171005",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000179802.html",
    "archiveUrl": "https://kiroku.today/view/ceb343f564hi8gdl",
    "archiveCapturedAt": "2026-04-27T18:02:30.195+00:00",
    "extractedAt": "2026-04-27T18:02:29.646+00:00",
    "translatedAt": "2026-05-01T09:43:32.19+00:00",
    "evidenceCheckedAt": "2026-04-27T18:02:29.646+00:00",
    "generatedAt": "2026-06-19T09:10:20.924Z"
  },
  "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: ステラファーマ株式会社 Japanese original
Japanese name: ステラファーマ株式会社
Corporate Number: 5120001124194
Registered address: 大阪府大阪市中央区高麗橋３丁目２番７号ＯＲＩＸ高麗橋ビル

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