Enforcement record

先駆け審査指定制度対象品目の募集 disclosure naming シスメックス株式会社

シスメックス株式会社 (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.

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, 03:35 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: シスメックス株式会社Japanese only
Original: シスメックス株式会社
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

A cancer-related gene panel testing system that detects gene abnormalities (mutations, amplifications, or fusions) in tumor tissue DNA from solid cancer patients to perform genetic abnormality profiling and assist in treatment decision-making.

Show original Japanese text

がん関連遺伝子パネル検査システム固形がん患者の腫瘍組織中のDNAにおける遺伝子の異常（変異、増幅又は融合）を一括検出することで、がん患者の遺伝子異常プロファイリングを行い、診療方針決定の補助に用いる

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: 2026-04-24T23:38:30.053+00:00
Evidence checked: 2026-04-24T23:38:30.053+00:00
Archive captured: 2026-07-12T06:35:06.810541+00:00

Show audit JSON

{
  "record": {
    "id": "eb6d119b-1a60-4e54-9a74-d1748fddd746",
    "url": "https://regbase.jp/en/enforcement/other-sisumetukusu-20171005",
    "company_name_original": "シスメックス 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 (シスメックス株式会社). 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-sisumetukusu-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": "2026-04-24T23:38:30.053+00:00",
    "translatedAt": "2026-05-01T06:52:21.448+00:00",
    "evidenceCheckedAt": "2026-04-24T23:38:30.053+00:00",
    "generatedAt": "2026-09-18T20:58:47.895Z"
  },
  "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.