作者・相关律师 | |
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发行年月日 | 2025年5月 |
业务领域 | |
行业领域 | 医疗、医药、保健、生命科学和生物技术化学食品·饮料 |
时事通讯 "Life Science Newsletter (2025年5月号)" 发布。
Contents
1. Enforcement of the Amended Clinical Trials Act, etc.
1.1 Application of the Clinical Trials Act on observational studies
1.2 Scope of specified clinical trials on the use of off-label pharmaceuticals
1.3 Introduction of “general manager”
1.4 Review of the scope of disease reporting
2. Enactment of the revision bill to the Pharmaceuticals and Medical Devices Act, etc.