Possible Administrative Guidance against 臨床薬理協会（臨薬協）
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/api/v1/enforcements?company=%E8%87%A8%E5%BA%8A%E8%96%AC%E7%90%86%E5%8D%94%E4%BC%9A%EF%BC%88%E8%87%A8%E8%96%AC%E5%8D%94%EF%BC%89&limit=10Action summary
- Company
- 臨床薬理協会（臨薬協）Japanese originalOriginal: 臨床薬理協会（臨薬協）
- Entity match
- Possible entity match60/100Machine extractedCompany name extracted from the Japanese public disclosure
- 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
- 1 September 2024
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Reviewing the scope of adverse event reporting in clinical trials, promoting international joint clinical trials, improving the reliability of registries, coordinating GCP inspections internationally, harmonizing regulations, promoting electronic submissions and digitization, and implementing work style reforms and IT system adoption.
Show original Japanese text
治験不具合報告範囲の見直し、国際共同治験の推進、レジストリの信頼性向上、GCP調査の国際調整、規制の国際整合、電子申請・電子化推進、働き方改革とITシステムの導入。
Compliance context
Low-mediumAdministrative 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
- Extracted at
- 2026-04-27T00:01:32.723+00:00
- Evidence checked
- 2026-04-27T00:01:32.723+00:00
- Archive captured
- 2026-04-27T00:01:33.211+00:00
Show audit JSON
{
"record": {
"id": "5ce63840-8021-4e8d-81db-a3b68a643fe6",
"url": "https://regbase.jp/en/enforcement/yakkiho-lin-chuang-yao-li-xie-huilin-yao-xie-20240901",
"company_name_original": "臨床薬理協会（臨薬協）",
"company_name_registry": "臨床薬理協会（臨薬協）",
"corporate_number": null,
"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": "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": "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-lin-chuang-yao-li-xie-huilin-yao-xie-20240901",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_13968.html",
"archiveUrl": "https://kiroku.today/view/9512ba6ebbgfmie5",
"archiveCapturedAt": "2026-04-27T00:01:33.211+00:00",
"extractedAt": "2026-04-27T00:01:32.723+00:00",
"translatedAt": "2026-05-01T09:42:27.064+00:00",
"evidenceCheckedAt": "2026-04-27T00:01:32.723+00:00",
"generatedAt": "2026-06-19T09:18:42.015Z"
},
"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.