Enforcement record
Administrative Guidance disclosure naming 第一三共株式会社
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
21 April 2017
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Source verification
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 28, 2026, 03:03 AM JST
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Action summary
- Company
- 第一三共株式会社Japanese onlyOriginal: 第一三共株式会社
- 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
- 21 April 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医薬品
Violation
Designated five additional pharmaceuticals as target items, including innovative new drugs that meet certain criteria such as severity of the target disease. The system was applied to prioritize consultation and review related to drug approval from early development stages, aiming to shorten the approval review period.
Show original Japanese text
新たに５品目の医薬品を指定し、対象疾患の重篤性など一定の要件を満たす画期的な新薬について、開発の早期段階から対象品目に指定し、薬事承認に関する相談・審査で優先的な取扱いをすることで、承認審査の期間を短縮する制度を適用。
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.
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.