Administrative Guidance against Ri Ben Noyi Yao Pin Yi Liao Ji Qi Zong He Ji Gou(pmda)
日本の医薬品医療機器総合機構（ＰＭＤＡ） (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareJune 30, 2022
Action summary
- Company
- Original: 日本の医薬品医療機器総合機構（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
- June 30, 2022
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Show original Japanese text
日本のＰＭＤＡを医薬品審査システムが確立している規制当局（参照規制当局）とみなし、フィリピンにおける新医薬品（ワクチン及び生物製剤を含む）の登録審査において、ＰＭＤＡの審査報告書を利用して簡略的な審査を実施できるようになる
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
- Ri Ben Noyi Yao Pin Yi Liao Ji Qi Zong He Ji Gou(pmda) Romanized
- Japanese name
- 日本の医薬品医療機器総合機構（ＰＭＤＡ）
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.