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 1, 2020
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Efforts include rapid approval related to COVID-19, collaboration with overseas regulatory authorities, providing training to Asian countries, promoting international joint clinical trials, harmonizing review processes internationally, improving the reliability of registry data, aligning GCP investigations internationally, and promoting work style reforms and the use of IT systems.
Show original Japanese text
新型コロナウイルスに関する迅速承認、海外規制当局との連携、アジア諸国への研修提供、国際共同治験の推進、審査の国際調和、レジストリデータの信頼性向上、GCP調査の国際整合、働き方改革とITシステムの活用促進など。
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.