Possible Administrative Guidance against 医薬・生活衛生局総務課 国際薬事規制室
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/api/v1/enforcements?company=%E5%8C%BB%E8%96%AC%E3%83%BB%E7%94%9F%E6%B4%BB%E8%A1%9B%E7%94%9F%E5%B1%80%E7%B7%8F%E5%8B%99%E8%AA%B2%E5%9B%BD%E9%9A%9B%E8%96%AC%E4%BA%8B%E8%A6%8F%E5%88%B6%E5%AE%A4&limit=10Action summary
- Company
- 医薬・生活衛生局総務課 国際薬事規制室Japanese originalOriginal: 医薬・生活衛生局総務課国際薬事規制室
- Entity match
- Possible entity match60/100Machine extractedCompany name extracted from the Japanese public disclosure
- Governing law
- 不明不明
- Action type
- Administrative Guidance行政指導
- Action date
- Unknown
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Show original Japanese text
厚生労働省が策定した「国際薬事規制調和戦略」及び同日にPMDAが策定した「PMDA国際戦略2015」に資するものであり、日本がAPEC地域の薬事規制当局者に対して、当該分野の研修に中心的な役割を担うとともに、ICHガイドラインの普及などに貢献することとなります。
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Japanese regulatory disclosure under 不明.
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
- 2026-05-02T00:01:37.303+00:00
- Evidence checked
- 2026-05-02T00:01:37.303+00:00
- Archive captured
- 2026-05-02T00:01:38.317+00:00
Show audit JSON
{
"record": {
"id": "7938f267-c527-4c97-9106-b49824f08682",
"url": "https://regbase.jp/en/enforcement/other-yi-yao-sheng-huo-wei-sheng-ju-zong-wu-ke-guo-ji-yao-shi-gui-zhi-shi-unknown",
"company_name_original": "医薬・生活衛生局総務課国際薬事規制室",
"company_name_registry": "医薬・生活衛生局総務課 国際薬事規制室",
"corporate_number": null,
"law": {
"ja": "不明",
"en": "不明"
},
"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": "Japanese regulatory disclosure under 不明."
},
"evidence": {
"recordUrl": "https://regbase.jp/en/enforcement/other-yi-yao-sheng-huo-wei-sheng-ju-zong-wu-ke-guo-ji-yao-shi-gui-zhi-shi-unknown",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000135446.html",
"archiveUrl": "https://kiroku.today/view/4079c3a148nkty6h",
"archiveCapturedAt": "2026-05-02T00:01:38.317+00:00",
"extractedAt": "2026-05-02T00:01:37.303+00:00",
"translatedAt": null,
"evidenceCheckedAt": "2026-05-02T00:01:37.303+00:00",
"generatedAt": "2026-06-19T10:33:32.952Z"
},
"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
- 医薬・生活衛生局総務課 国際薬事規制室 Japanese original
- Japanese name
- 医薬・生活衛生局総務課 国際薬事規制室
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.