Business Suspension Order against K.K. Medeihuama
株式会社メディファーマ (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律)
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律Ministry of Health, Labour and WelfareOctober 17, 2023
Action summary
- Company
- K.K. MedeihuamaRomanizedOriginal: 株式会社メディファーマ
- Governing law
- 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律
- Action type
- Business Suspension Order業務停止命令
- Action date
- October 17, 2023
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Machine-translated summary — verify against original
Falsification of clinical trial data, improper conduct of respiratory function tests, sharing of ID passwords among doctors, facility staff, and CRCs, proxy attendance at training sessions, and concealment of storage deficiencies of the investigational drug.
Show original Japanese text
治験データの改竄、呼吸機能検査の不適切な実施、医師・施設スタッフ・CRCのIDパスワード共有、トレーニング代理受講、治験薬保管不備の隠蔽
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)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.