Administrative Guidance against Baiozienziyapan K.K.
Action summary
- Company
- Baiozienziyapan K.K.RomanizedOriginal: バイオジェン・ジャパン株式会社Corporate Number: 7010401046394
- 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
Five additional pharmaceutical products were designated as target items under the system. For innovative new drugs that meet certain criteria such as severity of the target disease, the system designates these products from early development stages and prioritizes consultations and reviews related to drug approval to shorten approval review periods.
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
- Baiozienziyapan K.K. Romanized
- Japanese name
- バイオジェン・ジャパン株式会社
- Corporate Number
- 7010401046394
- Registered address
- 東京都中央区日本橋１丁目４番１号日本橋一丁目三井ビルディング１４Ｆ
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.