药物的紧急使用许可:历史和道德困境
Mamta Bishnoi1, Aniket Sonker2
1Department of Pharmaceutical Sciences, Faculty of Life Sciences, Gurugram University, Gurugram, Haryana, India.
Perspectives in clinical research
|June 16, 2023
概括
像美国FDA和欧盟这样的监管机构为新型疗法提供了加快的途径. 本综述比较了全球紧急药物批准流程,包括印度的加速途径,并列出了批准的产品.
科学领域:
- 药品监管事务 药品监管事务
- 药物开发和批准 药物开发和批准
- 全球卫生政策 全球卫生政策
背景情况:
- 美国食品和药物管理局 (FDA) 和欧盟 (EU) 对新疗法有严格的监管批准程序.
- 紧急使用授权 (EUA) 和有条件的营销授权 (CMA) 等加速批准途径存在于危急情况下.
- 印度于2019年建立了"加速审批流程",以解决未满足的医疗需求,特别是在COVID-19大流行期间.
研究的目的:
- 为了比较和理解各种全球紧急药物批准流程.
- 分析与这些快速通道相关的条件和索赔.
- 根据这些紧急/加速框架确定和列出已批准的治疗剂.
主要方法:
- 系统审查全球监管机构官方网站的信息.
- 对加速和加速药物批准流程的比较分析.
- 在紧急情况下使用的批准产品的编制和分类.
主要成果:
- 详细概述美国和欧盟的加速批准机制.
- 解释印度的加速审批流程及其实施.
- 在紧急情况下通过这些途径批准的特定新疗法的识别.
结论:
- 全球监管机构采用快速通道,以确保及时获得关键药物.
- 了解这些过程的细微差别对于制药开发和公共卫生准备至关重要.
- 该审查提供了对健康危机期间新疗法监管格局的见解.
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