Administrative Guidance against PMDA
Action summary
- Company
- PMDARomanizedOriginal: PMDA
- Governing law
- 不明不明
- Action type
- Administrative Guidance行政指導
- Action date
- March 9, 2016
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
PMDA will host a pilot seminar as a Good Practice training center for the Multi-Regional Clinical Trial / GCP Inspection Roadmap and the Pharmaceuticals and Medical Devices Safety Surveillance Roadmap. PMDA will play a central role in training regulatory authorities and related personnel in the APEC region in these areas.
Show original Japanese text
PMDAが多地域臨床試験/GCP査察ロードマップ及び医薬品・医療機器安全性監視ロードマップの優良トレーニングセンターとしてパイロットセミナーを主催します。PMDAはこれらの分野におけるAPEC地域の規制当局者等の研修に中心的な役割を担うことになります。
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.