Possible Recommendation against 臨薬協、AMDD、EBC

臨薬協、AMDD、EBC (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfarePossible entity match
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/api/v1/enforcements?company=%E8%87%A8%E8%96%AC%E5%8D%94%E3%80%81AMDD%E3%80%81EBC&limit=10

Action summary

Company
臨薬協、AMDD、EBCJapanese original
Original: 臨薬協、AMDD、EBC
Entity match
Possible entity match60/100Machine extracted
Company 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
Recommendation
勧告
Action date
Unknown
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Show original Japanese text

体外診のクラス分類の見直し、根拠資料の考え方、添付文書の電子化、規制調和のための協議、管理者資格要件の見直し、責任者の運用改善、QMS調査制度の国際整合化など。

Compliance context

Medium

A regulator issued a recommendation or formal request for corrective action.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

Review the facts and follow-up status. This is usually less severe than a suspension or revocation, but still a public enforcement signal.

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 announcement (Japanese)Archived source snapshot
Extracted at
2026-05-04T12:02:36.94+00:00
Evidence checked
2026-05-04T12:02:36.94+00:00
Archive captured
2026-05-04T12:02:37.429+00:00
Show audit JSON
{
  "record": {
    "id": "27c18343-7347-45ae-bfe8-cef50f29d1bf",
    "url": "https://regbase.jp/en/enforcement/yakkiho-lin-yao-xieamddebc-unknown",
    "company_name_original": "臨薬協、AMDD、EBC",
    "company_name_registry": "臨薬協、AMDD、EBC",
    "corporate_number": null,
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "勧告",
      "en": "Recommendation"
    },
    "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": "Medium",
    "actionMeaning": "A regulator issued a recommendation or formal request for corrective action.",
    "practicalNote": "Review the facts and follow-up status. This is usually less severe than a suspension or revocation, but still a public enforcement signal.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-lin-yao-xieamddebc-unknown",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_65484.html",
    "archiveUrl": "https://kiroku.today/view/8869646b79r5gtgk",
    "archiveCapturedAt": "2026-05-04T12:02:37.429+00:00",
    "extractedAt": "2026-05-04T12:02:36.94+00:00",
    "translatedAt": null,
    "evidenceCheckedAt": "2026-05-04T12:02:36.94+00:00",
    "generatedAt": "2026-06-19T10:28:11.486Z"
  },
  "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.

Company info

English name
臨薬協、AMDD、EBC Japanese original
Japanese name
臨薬協、AMDD、EBC
See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.