Administrative Guidance against 臨床薬理協会（臨薬協）
Action summary
- Company
- 臨床薬理協会（臨薬協）Japanese onlyOriginal: 臨床薬理協会（臨薬協）
- 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, 2024
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Reviewing the scope of adverse event reporting in clinical trials, promoting international joint clinical trials, improving the reliability of registries, coordinating GCP inspections internationally, harmonizing regulations, promoting electronic submissions and digitization, and implementing work style reforms and IT system adoption.
Show original Japanese text
治験不具合報告範囲の見直し、国際共同治験の推進、レジストリの信頼性向上、GCP調査の国際調整、規制の国際整合、電子申請・電子化推進、働き方改革とITシステムの導入。
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.