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
Queued for preservation
Captured: Jul 12, 2026, 03:35 PM JST

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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.

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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.