Enforcement record

指定 disclosure naming 株式会社ヘリオス

株式会社ヘリオス (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

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

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure28 February 2017

Action type

指定

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

28 February 2017

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: Completed archive verified; Captured: May 2, 2026, 09:01 PM JST

“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.

Open the official source links in the section below to review the original disclosure.

Action summary

Company: 株式会社ヘリオスJapanese only
Original: 株式会社ヘリオス
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: 指定
指定
Action date: 28 February 2017
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医療用幹細胞

Violation

Machine-translated summary — verify against original

On February 28, 2017, the Ministry of Health, Labour and Welfare designated a stem cell product derived from donor bone marrow, which is intended for the treatment of acute ischemic stroke within 18-36 hours of onset. The product consists of adult adherent stem cells used for medical purposes. The company involved is Helios Corporation. The product was classified as a regulated medical stem cell product under the Pharmaceutical and Medical Device Act.

Show original Japanese text

急性期（発症後18～36時間）の脳梗塞の治療を目的とした、ドナーの骨髄から採取して増殖させた成人接着性幹細胞に由来する幹細胞製品。

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.

Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-05-02T12:01:57.095+00:00
Evidence checked: 2026-05-02T12:01:57.095+00:00
Archive captured: 2026-05-02T12:01:57.351371+00:00

Show audit JSON

{
  "record": {
    "id": "b230971f-1bba-4142-9cc1-21cbae664e61",
    "url": "https://regbase.jp/en/enforcement/yakkiho-heriosu-20170228",
    "company_name_original": "株式会社ヘリオス",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "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": "unresolved",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": "The linked company profile has not been verified under the current identity policy."
  },
  "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-heriosu-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/60d0baf7afoak2ny",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveCapturedAt": "2026-05-02T12:01:57.351371+00:00",
    "extractedAt": "2026-05-02T12:01:57.095+00:00",
    "translatedAt": "2026-07-06T07:52:00.859+00:00",
    "evidenceCheckedAt": "2026-05-02T12:01:57.095+00:00",
    "generatedAt": "2026-09-18T20:14:25.194Z"
  },
  "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)

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