Administrative Guidance against 小野薬品工業 株式会社
Action summary
- Company
- 小野薬品工業 株式会社Japanese onlyOriginal: 小野薬品工業株式会社Corporate Number: 7120001077374
- 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
- April 21, 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
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 early-stage development, consultations, and reviews related to drug approval, thereby shortening 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。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- 小野薬品工業 株式会社 Japanese only
- Japanese name
- 小野薬品工業 株式会社
- Corporate Number
- 7120001077374
- Registered address
- 大阪府大阪市中央区道修町２丁目１番５号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.