Enforcement record
Administrative Guidance disclosure naming 日本臨床検査薬協会
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Administrative Guidance
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
29 July 2019
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: Apr 27, 2026, 09:00 AM JST
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Action summary
- Company
- 日本臨床検査薬協会Japanese onlyOriginal: 日本臨床検査薬協会
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices医薬品医療機器等法
- Action type
- Administrative Guidance行政指導
- Action date
- 29 July 2019
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 体外診断薬
Violation
Proposed recommendations on the digitization and operation of package inserts, the provision of paper package inserts, international harmonization, regulatory streamlining, and the rationalization of pre-approval testing.
Show original Japanese text
添付文書の電子化運用、紙の添付文書提供の運用、国際整合、規制の合理化、承認前試験の合理化などについて提言。
Compliance context
Low-mediumAdministrative guidance or supervision was publicly disclosed by the authority.
Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.
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.
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.