Possible Administrative Guidance against 医薬・生活衛生局
For developers: integration details
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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&limit=10Action summary
- Company
- 医薬・生活衛生局Japanese originalOriginal: 医薬・生活衛生局
- 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
- 27 August 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Explanation of the holding of regular opinion exchange meetings regarding approval reviews and safety measures for medical devices and in vitro diagnostics, and efforts toward system improvements and enhancements.
Show original Japanese text
医療機器・体外診断薬の承認審査や安全対策等に関する定期意見交換会の開催と、制度の改良・改善に向けた取組についての説明。
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
- 2026-04-25T00:20:37.241+00:00
- Evidence checked
- 2026-04-25T00:20:37.241+00:00
- Archive captured
- 2026-04-10T00:00:45.913+00:00
Show audit JSON
{
"record": {
"id": "6befaf78-8645-4eef-a963-3ecf3b182567",
"url": "https://regbase.jp/en/enforcement/yakkiho-yi-yao-sheng-huo-wei-sheng-ju-20210827",
"company_name_original": "医薬・生活衛生局",
"company_name_registry": "医薬・生活衛生局",
"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-yi-yao-sheng-huo-wei-sheng-ju-20210827",
"officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
"archiveUrl": "https://kiroku.today/view/2077ea6711ijow9q",
"archiveCapturedAt": "2026-04-10T00:00:45.913+00:00",
"extractedAt": "2026-04-25T00:20:37.241+00:00",
"translatedAt": "2026-05-01T07:08:50.142+00:00",
"evidenceCheckedAt": "2026-04-25T00:20:37.241+00:00",
"generatedAt": "2026-05-21T23:35:36.229Z"
},
"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.