"监管复兴"的开始:将监管覆盖范围定位在人类专业知识和数字支持的接口上
James Jones1, Robert M Califf2
1U.S. Food and Drug Administration, White Oak Campus 10903 New Hampshire Ave, Silver Spring, Maryland, MD, 20993, USA.
Therapeutic innovation & regulatory science
|March 12, 2025
概括
美国食品和药物管理局 (FDA) 正通过使用多种数据源和人工智能等先进技术来现代化监管监督. 这种"监管复兴"旨在确保全球供应链中的产品质量和安全.
科学领域:
- 监管科学 监管科学
- 公共卫生政策 公共卫生政策
- 供应链管理 供应链管理
背景情况:
- 美国食品和药物管理局 (FDA) 正在进行最大规模的重组,以现代化监管监督.
- 全球供应链在确保产品质量和安全方面存在复杂的挑战.
- 美国食品和药物管理局的重组提供了一个独特的机会,可以创新其监管战略.
研究的目的:
- 检查FDA制定定量,全面的监管监督方法的战略.
- 探索FDA如何在全球数字环境中确保FDA监管商品的安全和质量.
- 引入"监管复兴"的概念,以加强产品质量保证.
主要方法:
- 利用FDA内部数据和第三方审计信息.
- 利用来自外国监管机构和国家/地方检查机构的数据.
- 应用复杂的数据技术,包括人工智能 (AI) 系统.
主要成果:
- 美国食品和药物管理局 (FDA) 正在开发一种多方面的监管覆盖方法.
- 多种数据源的整合旨在优化产品质量 (安全性,有效性,制造可靠性).
- 该战略涵盖了整个产品生命周期,包括分销和使用说明.
结论:
- "监管复兴"正在进行中,专注于监管行动的数据驱动决策.
- 成功取决于广泛的认可和跨行业,机构和学术界的合作.
- 该方法旨在提高FDA监管产品的安全性,有效性和可靠性.
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