Enforcement record

指定 disclosure naming 大日本住友製薬株式会社

大日本住友製薬株式会社 (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 disclosure28 February 2017

Action type

指定

Law

Pharmaceutical Affairs Act

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: Jul 12, 2026, 04:04 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: 大日本住友製薬株式会社Japanese only
Original: 大日本住友製薬株式会社
Governing law: Pharmaceutical Affairs Act
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 concerns Parkinson's disease treatment using non-autologous iPS cell-derived dopamine neural precursor cells, which have a different mechanism of action from conventional treatments. Although there is no clinical experience, non-clinical efficacy evaluations have reported significant symptom improvement (more than 40% in motor symptom scores) from six months after transplantation, as well as dopamine synthesis and reuptake activity (PET imaging) at the transplantation site in the brain.

Show original Japanese text

非自己iPS細胞由来ドパミン神経前駆細胞を用いたパーキンソン病治療であり、従来の治療法とは異なる作用機序を有する。臨床使用経験はないが、非臨床有効性評価により、移植6か月後から症状の有意な改善（運動症状スコア40％以上）と脳内移植部位でドパミン合成及びドパミン再取込み活性（PET画像）が認められたとの報告がある。

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 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.

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: 2026-04-25T00:13:59.624+00:00
Evidence checked: 2026-04-25T00:13:59.624+00:00
Archive captured: 2026-07-12T07:04:38.252332+00:00

Show audit JSON

{
  "record": {
    "id": "3a33e33b-7d77-4993-a812-cb180f702ae2",
    "url": "https://regbase.jp/en/enforcement/other-da-ri-ben-zhu-you-zhi-yao-20170228",
    "company_name_original": "大日本住友製薬株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "薬事法",
      "en": "Pharmaceutical Affairs Act"
    },
    "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": "Japanese regulatory disclosure under Pharmaceutical Affairs Act."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-da-ri-ben-zhu-you-zhi-yao-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/60d0baf7afhg2xss",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveCapturedAt": "2026-07-12T07:04:38.252332+00:00",
    "extractedAt": "2026-04-25T00:13:59.624+00:00",
    "translatedAt": "2026-05-01T07:03:45.884+00:00",
    "evidenceCheckedAt": "2026-04-25T00:13:59.624+00:00",
    "generatedAt": "2026-09-18T21:00:55.968Z"
  },
  "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.