葡萄牙的营销后监管行动 - - 2013年至2023年间的回顾性分析
Vítor Silva1, João Joaquim2, Cristiano Matos2,3
1Unidade Local de Saúde de Coimbra, EPE, Coimbra, Portugal.
The International journal of risk & safety in medicine
|February 20, 2025
概括
葡萄牙 葡萄牙 葡萄牙
科学领域:
- 药监和药物安全 药监和药物安全
- 监管科学 监管科学
- 公共卫生政策 公共卫生政策
背景情况:
- 在药物的整个生命周期中,对药物安全性的持续监测至关重要.
- 葡萄牙的制药行业经历了来自INFARMED,IP的监管变化. 在过去的十年里.
- 在通知,ip. 确保药物的安全性,有效性和质量.
研究的目的:
- 从2013年到2023年,分析葡萄牙因安全问题而采取的监管行动.
- 确定药物安全和质量警报的趋势.
- 了解监管干预的原因和模式.
主要方法:
- 通过INFARMED,I.P.发布的安全警报的回顾性分析. (2013年至2023年) 的时间.
- 专注于营销状态的变化,药物类型,原因和年度模式.
- 将警报分类为安全和质量问题.
主要成果:
- 发出了602个警报 (41个安全,561个质量).
- 2018年监管行动的峰值 (172个案例).
- 一般药物占主导地位 (72.19%),批量召回 (76.65%) 是主要的质量行动,通常是由于杂质或稳定性问题 (65.42%).
- 所有安全警报都源于不利的风险/收益比率.
结论:
- 强有力的监督和制造和监管流程的持续评估对于药物安全至关重要.
- 监管机构,行业和医疗保健专业人员之间的有效合作是必不可少的.
- 确保药物的益处始终超过风险是一个重要的公共卫生目标.
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