RegBase
日本語

Possible 業務改善指示 against ギリアド・サイエンシズ インク

ギリアド・サイエンシズ インク (医薬品医療機器法)
医薬品医療機器法Ministry of Health, Labour and WelfarePossible entity match13 February 2015
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/api/v1/enforcements?company=%E3%82%AE%E3%83%AA%E3%82%A2%E3%83%89%E3%83%BB%E3%82%B5%E3%82%A4%E3%82%A8%E3%83%B3%E3%82%B7%E3%82%BA%20%E3%82%A4%E3%83%B3%E3%82%AF&limit=10
Open API responseAPI docs

Action summary

Company
ギリアド・サイエンシズ インクJapanese original
Original: ギリアド・サイエンシズ インク
Entity match
Possible entity match60/100Machine extracted
Company name extracted from the Japanese public disclosure
Governing law
医薬品医療機器法
医薬品医療機器法
Action type
業務改善指示
業務改善指示
Action date
13 February 2015
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

During the clinical trial commissioned by the company, the company did not report adverse reactions that occurred post-marketing abroad within the specified deadline.

Show original Japanese text

同社が依頼を行った治験の実施中に、国外で市販後に発生した副作用を定められた期限内に報告しなかった

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 医薬品医療機器法.

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
2026-04-25T00:04:48.953+00:00
Evidence checked
2026-04-25T00:04:48.953+00:00
Archive captured
2026-04-04T06:01:09.843+00:00
Show audit JSON
{
  "record": {
    "id": "ea126e0c-c802-4e76-8ca4-9c5ae7cf8a8d",
    "url": "https://regbase.jp/en/enforcement/other-giriadosaiensizuinku-20150213",
    "company_name_original": "ギリアド・サイエンシズ インク",
    "company_name_registry": "ギリアド・サイエンシズ インク",
    "corporate_number": null,
    "law": {
      "ja": "医薬品医療機器法",
      "en": "医薬品医療機器法"
    },
    "action_type": {
      "ja": "業務改善指示",
      "en": "業務改善指示"
    },
    "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 医薬品医療機器法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-giriadosaiensizuinku-20150213",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000073914.html",
    "archiveUrl": "https://kiroku.today/view/e89e3e0c36jxcgim",
    "archiveCapturedAt": "2026-04-04T06:01:09.843+00:00",
    "extractedAt": "2026-04-25T00:04:48.953+00:00",
    "translatedAt": "2026-05-01T06:55:05.707+00:00",
    "evidenceCheckedAt": "2026-04-25T00:04:48.953+00:00",
    "generatedAt": "2026-05-20T23:50:44.981Z"
  },
  "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
ギリアド・サイエンシズ インク Japanese original
Japanese name
ギリアド・サイエンシズ インク
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.