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风险管理计划系统是否影响了日本包装插件修订的速度?

Natsuko Kameyama1,2, Aoi Hosaka3, Hideki Maeda1,3

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

Frontiers in medicine
|November 13, 2024
PubMed
概括

2013年实施的日本风险管理计划 (J-RMP) 系统没有加速临床显著不良反应 (CSARs) 的识别,如包装插件修订所示. 将CSAR添加到包装插件的速度在J-RMP实施后保持不变.

关键词:
不良反应不良反应不良反应药物安全 药物安全包装插件 修订 修订 修订药物监督和药物监督风险管理计划 风险管理计划日本的风险管理计划.

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