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目前的情况和有关日本风险管理计划终止的问题

Natsuko Kameyama1, Aoi Hosaka2, Hideki Maeda1,2

  • 1Department of Regulatory Science, Graduate School of Pharmaceutical Science, Meiji Pharmaceutical University, Tokyo, Japan.

Frontiers in medicine
|June 14, 2024
PubMed
概括

在日本,大多数药物的风险管理计划 (RMP) 在重新审查后被终止. 然而,一些已终止的RMP仍然存在未列出的风险,这凸显了关于终止后药物安全性的更明确指导方针的需要.

关键词:
日本的药物监管体系是日本的药物监管体系.在RMP中终止RMP终止.药物安全 药物安全药物监督和药物监督审查系统的重新审查.风险管理计划 风险管理计划有关安全的担忧是安全问题.

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