Administrative Guidance against PMDA
Action summary
- Company
- PMDARomanizedOriginal: PMDA
- 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
- September 14, 2023
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Thank you for your cooperation in the rapid review and post-marketing safety measures for medical devices and in vitro diagnostic drugs. Following last year, all target review periods for medical devices and in vitro diagnostic drugs were achieved.
Show original Japanese text
医療機器・体外診断用医薬品の迅速な承認審査や市販後安全対策への御協力に感謝申し上げます。昨年度に引き続きまして、医療機器・体外診断用医薬品の審査期間につきましては、目標値を全て達成することができました。
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.