Possible 指定 against 株式会社セルシード

株式会社セルシード (薬事法)

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

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/api/v1/enforcements?company=%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE%E3%82%BB%E3%83%AB%E3%82%B7%E3%83%BC%E3%83%89&limit=10

Open API response API docs

Action summary

Company: 株式会社セルシードJapanese original
Original: 株式会社セルシード
Entity match: Possible entity match60/100Machine extracted
Company name extracted from the Japanese public disclosure
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

The product is a cell sheet cultured from the patient's own oral mucosal epithelial cells, intended to prevent stenosis and shorten the time to re-epithelialization after endoscopic submucosal dissection (ESD) for esophageal cancer. Two clinical studies in Japan (19 cases) have been conducted, showing promising results with a high non-stenosis rate of 64%.

Show original Japanese text

患者自身の口腔粘膜から採取した上皮細胞を培養した細胞シートであり、食道がんにおける広範囲内視鏡的粘膜下層剥離術（ESD）後の狭窄の抑制及び再上皮化までの日数の短縮目的とするものである。国内で2つの臨床研究（19例）が実施されており、高い有効性を示唆する結果（本品の使用による高い非狭窄率64％）が得られた。

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: 2026-04-25T00:13:59.368+00:00
Evidence checked: 2026-04-25T00:13:59.368+00:00
Archive captured: 2026-04-07T12:02:09.628+00:00

Show audit JSON

{
  "record": {
    "id": "c2e33dfb-6e30-46f1-bf14-45a97b3744de",
    "url": "https://regbase.jp/en/enforcement/other-serusido-20170228",
    "company_name_original": "株式会社セルシード",
    "company_name_registry": "株式会社 セルシード",
    "corporate_number": null,
    "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": "possible",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": null
  },
  "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-serusido-20170228",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000153128.html",
    "archiveUrl": "https://kiroku.today/view/60d0baf7afokk4is",
    "archiveCapturedAt": "2026-04-07T12:02:09.628+00:00",
    "extractedAt": "2026-04-25T00:13:59.368+00:00",
    "translatedAt": "2026-05-01T07:03:44.147+00:00",
    "evidenceCheckedAt": "2026-04-25T00:13:59.368+00:00",
    "generatedAt": "2026-06-19T10:27:44.621Z"
  },
  "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: 株式会社セルシード Japanese original
Japanese name: 株式会社セルシード

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.

Possible 指定 against 株式会社 セルシード