Cease and Desist Order against Ministry of Health, Labour and Welfare
Action summary
- Company
- Original: 厚生労働省Corporate Number: 6000012070001
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Cease and Desist Order措置命令
- Action date
- September 1, 2024
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Preparation for enforcement and operational adjustments related to the revision of the Pharmaceuticals and Medical Devices Act, issuance of notifications, review of regulations, designation of specific-use medical devices, introduction of a conditional approval system, extrapolation of clinical data, implementation of the IDATEN system, rationalization of medical device regulations, promotion of digitization, review of adverse event reporting scope in clinical trials, promotion of international harmonization, advancement of international joint clinical trials for regulatory harmonization, and strengthening cooperation with overseas regulatory authorities.
Show original Japanese text
薬機法の改正に伴う施行準備と運用の調整、通知の発出、規制の見直し、特定用途医療機器の指定、条件付き承認制度の導入、臨床データの外挿、IDATEN制度の導入、医療機器の規制の合理化、電子化推進、治験の不具合報告範囲の見直し、国際整合の推進、規制調和のための国際共同治験の推進、海外の規制当局との連携強化。
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
- Ministry of Health, Labour and Welfare Official
- Japanese name
- 厚生労働省
- Corporate Number
- 6000012070001
- Registered address
- 東京都千代田区霞が関１丁目２－２
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.