Administrative Guidance against DAIICHI SANKYO COMPANY, LIMITED

第一三共株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareConfirmed entity match21 April 2017

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/api/v1/enforcements?corporate_number=1010001095640&limit=10

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Action summary

Company: DAIICHI SANKYO COMPANY, LIMITEDOfficial
Original: 第一三共株式会社
Corporate Number: 1010001095640
Entity match: Confirmed entity match95/100Machine extracted
Normalized Japanese name matched to a company profile with Corporate Number
Matched by normalized Japanese company name to an enriched company profile with a Corporate Number.
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: Administrative Guidance
行政指導
Action date: 21 April 2017
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Designated five additional pharmaceuticals as target items, including innovative new drugs that meet certain criteria such as severity of the target disease. The system was applied to prioritize consultation and review related to drug approval from early development stages, aiming to shorten the approval review period.

Show original Japanese text

新たに５品目の医薬品を指定し、対象疾患の重篤性など一定の要件を満たす画期的な新薬について、開発の早期段階から対象品目に指定し、薬事承認に関する相談・審査で優先的な取扱いをすることで、承認審査の期間を短縮する制度を適用。

Compliance context

Low-medium

Administrative guidance or supervision was publicly disclosed by the authority.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

Use as a monitoring signal. Confirm details before treating it as a formal sanction.

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: 2026-04-27T18:02:54.402+00:00
Evidence checked: 2026-04-27T18:02:54.402+00:00
Archive captured: 2026-04-27T18:02:54.916+00:00

Show audit JSON

{
  "record": {
    "id": "b595af54-f75e-4968-85d0-595a8b0f23b8",
    "url": "https://regbase.jp/en/enforcement/yakkiho-di-yi-san-gong-20170421",
    "company_name_original": "第一三共株式会社",
    "company_name_registry": "第一三共 株式会社",
    "corporate_number": "1010001095640",
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "行政指導",
      "en": "Administrative Guidance"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "confirmed",
    "confidence": 95,
    "method": "normalized_name_with_corporate_number",
    "method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
    "notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Low-medium",
    "actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
    "practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-di-yi-san-gong-20170421",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000162665.html",
    "archiveUrl": "https://kiroku.today/view/27f0c6af56hi96yr",
    "archiveCapturedAt": "2026-04-27T18:02:54.916+00:00",
    "extractedAt": "2026-04-27T18:02:54.402+00:00",
    "translatedAt": "2026-05-01T09:43:44.068+00:00",
    "evidenceCheckedAt": "2026-04-27T18:02:54.402+00:00",
    "generatedAt": "2026-06-19T14:28:46.838Z"
  },
  "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: DAIICHI SANKYO COMPANY, LIMITED Official
Japanese name: 第一三共株式会社
Corporate Number: 1010001095640
Registered address: 東京都中央区日本橋本町３丁目５番１号

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.