Enforcement record

立入検査 disclosure naming 株式会社メディファーマ

株式会社メディファーマ (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和35年法律第145号）)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和35年法律第145号）Ministry of Health, Labour and WelfareGovernment disclosure29 August 2023

Action type

立入検査

Law

医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和35年法律第145号）

Authority

Ministry of Health, Labour and Welfare

Action date

29 August 2023

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: Apr 28, 2026, 03:02 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: 株式会社メディファーマJapanese only
Original: 株式会社メディファーマ
Governing law: 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和35年法律第145号）
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和35年法律第145号）
Action type: 立入検査
立入検査
Action date: 29 August 2023
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品治験支援

Violation

Machine-translated summary — verify against original

Falsification of clinical trial data, improper conduct of respiratory function tests, sharing of ID passwords among doctors, facility staff, and CRCs, unauthorized training attendance, and concealment of storage deficiencies of the investigational drug.

Show original Japanese text

治験データの改竄、呼吸機能検査の不適切な実施、医師・施設スタッフ・CRCのIDパスワード共有、トレーニング代理受講、治験薬保管不備の隠蔽

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、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和35年法律第145号）.

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: 2026-04-28T06:02:00.715+00:00
Evidence checked: 2026-04-28T06:02:00.715+00:00
Archive captured: 2026-04-28T06:02:06.794656+00:00

Show audit JSON

{
  "record": {
    "id": "9e93d5b6-f979-4887-8e8b-7bac522521d9",
    "url": "https://regbase.jp/en/enforcement/other-medeihuama-20230829",
    "company_name_original": "株式会社メディファーマ",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和35年法律第145号）",
      "en": "医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和35年法律第145号）"
    },
    "action_type": {
      "ja": "立入検査",
      "en": "立入検査"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": "The linked company profile has not been verified under the current identity policy."
  },
  "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、医療機器等の品質、有効性及び安全性の確保等に関する法律（昭和35年法律第145号）."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-medeihuama-20230829",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_35815.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/9335a5c284i7y08x",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_35815.html",
    "archiveCapturedAt": "2026-04-28T06:02:06.794656+00:00",
    "extractedAt": "2026-04-28T06:02:00.715+00:00",
    "translatedAt": "2026-05-01T09:44:07.314+00:00",
    "evidenceCheckedAt": "2026-04-28T06:02:00.715+00:00",
    "generatedAt": "2026-09-18T20:01:14.060Z"
  },
  "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.