Administrative Guidance against PMDA（医薬品医療機器総合機構）
PMDA（医薬品医療機器総合機構） (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfareJuly 29, 2019
Action summary
- Company
- PMDA（医薬品医療機器総合機構）Japanese onlyOriginal: PMDA（医薬品医療機器総合機構）
- Governing law
- 医薬品医療機器等法医薬品医療機器等法
- Action type
- Administrative Guidance行政指導
- Action date
- July 29, 2019
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Machine-translated summary — verify against original
Discussed revision of review fees, system review, promotion of electronic applications and UDI, and utilization of real-world evidence.
Show original Japanese text
審査手数料の改定、制度の見直し、電子申請やUDIの推進、リアルワールドエビデンスの活用促進などについて議論。
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
- PMDA（医薬品医療機器総合機構） Japanese only
- Japanese name
- PMDA（医薬品医療機器総合機構）
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.