对CBRN医疗对策的监管批准:当前情景和未来的路径
Manan Grover1, Mansi Sharma1, Vikesh Kumar Shukla1
1Manan Grover, MPharm, and Mansi Sharma, MPharm, are Research Scholars, Regulatory Affairs; Vikesh Kumar Shukla, PhD, MPharm, is a Professor and Centre Head, Industrial Pharmacy and Regulatory Affairs; and Navneet Sharma, PhD, MPharm, PGDRA, is an Assistant Professor; all at the Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India. Sudeep Ranjan Nayak, PhD, is a Scientist-E, Division of CBRN Defence, Institute of Nuclear Medicine and Allied Sciences, Defence Research and Development Organization, New Delhi, India.
本综述审查了2014-2024年美国对化学,生物,放射和核 (CBRN) 医学对策 (MCM) 的规定. 它强调了紧急使用授权 (EUA) 和动物规则,确定了在平衡速度和安全方面需要改进的领域.
科学领域:
- 监管科学 监管科学
- 公共卫生政策 公共卫生政策
- 应急准备情况 应急准备情况
背景情况:
- 美国已经建立了针对化学,生物,放射和核 (CBRN) 威胁的医疗对策 (MCM) 的监管框架.
- 像FDA,NIH,DHS和CDC这样的关键机构在MCM监管过程中发挥着至关重要的作用.
- 根据联邦食品,药物和化品法案第564条的紧急使用授权 (EUA) 是在公共卫生紧急情况下快速获得MCM的主要机制.
研究的目的:
- 审查和分析2014年至2024年美国CBRN MCM的监管格局.
- 确定当前的监管挑战和在MCM的审批过程中需要改进的领域.
- 在CBRN MCM开发和部署的背景下讨论伦理和安全方面的考虑.
主要方法:
- 审查有关CBRN MCM的现有美国法规,包括 EUA 和动物规则.
- 分析主要监管机构 (FDA,NIH,DHS,CDC) 的角色和流程.
- 讨论政策机制,如优先审查券及其对MCM发展的影响.
主要成果:
- 目前的监管框架,包括 EUA 和动物规则,提供了应对 CBRN 威胁的机制.
- 快速通道存在,但速度和安全之间的关键平衡至关重要.
- 在适应创新,预测政策转变和促进全球合作方面存在增强的机会.
结论:
- 虽然目前的政策已经发挥了作用,但有必要改善CBRN MCM的监管框架.
- 解决伦理和安全问题对于保持公众信任至关重要.
- 未来的努力应集中在加强监管灵活性,促进全球合作,并确保MCM的安全性和有效性的强有力的证明.
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