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

RegBase evidence report

Japanese public-record enforcement check

Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.

Report ID: RB-EN-ENFORCEMENT-OTHER-MEDEIHUAMA--202608041527
Generated at: 5 August 2026 at 00:27
Record URL: https://regbase.jp/en/enforcement/other-medeihuama-20230829

1. Review Summary

Disclosure name	株式会社メディファーマ	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	29 August 2023	Authority	Ministry of Health, Labour and Welfare
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）	Action type	立入検査
Source status	Preserved public-source archive recorded

This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.

2. Published Information

Published name	株式会社メディファーマ

3. Enforcement Record

Target name in disclosure	株式会社メディファーマ
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	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） / 立入検査
Action / announcement date	Action: 29 August 2023 / Announcement: 28 April 2026
English summary	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.
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
Official source	https://www.mhlw.go.jp/stf/newpage_35815.html
Source archive	https://kiroku.today/a/9335a5c284i7y08x
Extraction / evidence timestamps	Extracted: 28 April 2026 at 15:02 / Evidence checked: 28 April 2026 at 15:02 / Archive captured: 28 April 2026 at 15:02

4. Business Location and Permit Details

No additional structured business-location or permit fields are recorded for this disclosure.

5. Other Confirmed Records for This Company

This report covers the single government disclosure shown on this page.

Reviewer Notes

Reviewer		Team / company
Review purpose
Additional notes

□ Official source URL or archived source was checked.
□ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
□ This document is understood as a public-record evidence file, not a credit decision or legal opinion.

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Free report

Save the disclosure record naming 株式会社メディファーマ

Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.

Preserved evidence by Kiroku

Review the preserved source for 株式会社メディファーマ

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack

For developers: JSON integration details

You do not need this for normal browsing. Use it only when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?company=%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE%E3%83%A1%E3%83%87%E3%82%A3%E3%83%95%E3%82%A1%E3%83%BC%E3%83%9E&limit=10

Open JSON Specs

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.

Evidence pack

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": "2026-08-04T15:27:17.957Z"
  },
  "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.