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实施10年后日本风险管理计划的描述:2013-2023年
Sono Sawada1, Keiko Asao1, Ryohei Kobayashi1
1Health Economics and Outcomes Research, IQVIA Solutions Japan G.K, Tokyo, Japan.
Therapeutic innovation & regulatory science
|June 3, 2025
概括
日本的风险管理计划 (J-RMP) 通常使用初级数据收集进行营销后研究. 延迟不良事件通常被归类为潜在风险,提供有价值的药监察见解.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 监管科学 监管科学
背景情况:
- 日本十年前的风险管理计划 (RMP) 系统为评估其特征提供了至关重要的机会.
- 分析这些计划可以支持当前和未来的药监工作.
研究的目的:
- 描述日本的风险管理计划 (J-RMP).
- 通过药物分类来确定推销后研究 (PMS) 的类型,并量化安全性和有效性问题.
- 根据安全问题类型分析已识别的和潜在风险的分布.
主要方法:
- 从637个日本风险管理计划 (J-RMP) 和相关包装插件中提取数据.
- 审查了J-RMP特征,包括安全性/有效性问题,PMS类型和药物分类.
- 截至2023年5月,进行了数据收集.
主要成果:
- 每个J-RMP的安全性和有效性问题中位数为8个 (4个确定的风险,2个潜在风险,1个有效性问题).
- 86.5%的患有PMS的J-RMP使用了初级数据收集 (使用结果调查).
- 新生体和妊娠/出生缺陷是常见的重要潜在风险.
结论:
- 日本的营销后研究主要使用初级数据收集方法.
- 有延迟效果的不良事件经常被归类为重要的潜在风险.
- 联合监管计划 (J-RMP) 提供了对日本药物监管活动的重要见解.
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