Enforcement record
Recommendation disclosure naming 臨薬協、AMDD、EBC
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Recommendation
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
Unknown
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
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Public-source and preservation status
- Publishing authority
- Ministry of Health, Labour and Welfare
- Official source URL
- Recorded by RegBase
- Entity match
- Not confirmed; shown under the published name
- Kiroku preservation
- Queued for preservation
- Captured: May 4, 2026, 09:02 PM JST
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Action summary
- Company
- 臨薬協、AMDD、EBCJapanese onlyOriginal: 臨薬協、AMDD、EBC
- 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
- Industry context
- 体外診断薬
Violation
The recommendation involves reviewing the classification of in vitro diagnostics, the approach to supporting documentation, digitization of package inserts, discussions for regulatory harmonization, revising qualification requirements for managers, improving the operation of responsible persons, and aligning the QMS inspection system internationally.
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
MediumA 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.
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.