美国食品和药物管理局 (FDA) 全球药品检查:对制造业设施的监控仍然远低于COVID-19前的水平
Emily Cuddy1, Yun Peng Lu2, David B Ridley3
1Emily Cuddy, Duke University, Durham, North Carolina.
Health affairs (Project Hope)
|December 4, 2023
概括
美国食品和药物管理局 (FDA) 在COVID-19期间大幅减少了药物制造业的检查. 尽管检查减少并增加了每个地点的资源,但药物制造和进口并没有减少,这凸显了需要新的安全策略.
科学领域:
- 制药科学 制药科学
- 监管事务 监管事务
- 公共卫生政策 公共卫生政策
背景情况:
- 随着COVID-19大流行,全球供应链和监管运作受到破坏.
- 美国食品和药物管理局 (FDA) 在通过检查确保药品质量和安全方面发挥着至关重要的作用.
- 疫情前的检查水平为评估监管影响提供了基准.
研究的目的:
- 在COVID-19大流行期间分析FDA药品制造检查 (国内外) 的趋势.
- 评估减少检查对药物制造和进口量的影响.
- 评估与FDA检查相关的资源,人员和引用率的变化.
主要方法:
- 对2012年至2022年FDA检查数据的分析.
- 检查频率,资源分配和疫情前和疫情期间的引用率的比较.
- 检查水平与药物制造/进口数据之间的相关性分析.
主要成果:
- 到2022年,与2019年水平相比,FDA对外国 (79%) 和国内 (35%) 检查的急剧下降.
- 在整个研究期间,检查人数仍然远低于大流行前的水平.
- 尽管检查减少,但药品制造和进口并没有出现相应的下降.
- 每次检查的资源增加了,而引用率也大幅上升,即使提前通知.
结论:
- 该研究强调,在大流行期间,FDA对药物制造的监督显著减少.
- 调查结果表明,目前的检查范式可能不足以确保药物安全,监管活动减少.
- 迫切需要开发和实施替代或补充方法来维持药物安全和质量保证.
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