印度对人类疫苗的紧急批准机制
Nidhi Mehrotra1, Padmavati Manchikanti2
1Rajiv Gandhi School of Intellectual Property Law, Indian Institute of Technology Kharagpur, Kharagpur, 721302, India. nidhimehrotra11@gmail.com.
Pharmaceutical medicine
|January 24, 2024
概括
印度 印度 印度
科学领域:
- 监管科学 监管科学
- 公共卫生政策 公共卫生政策
- 疫苗开发 疫苗开发
背景情况:
- COVID-19大流行暴露了管理公共卫生紧急情况 (PHE) 的全球脆弱性.
- 在疫情期间,及时获得医疗疗法,特别是疫苗,被证明是至关重要的.
- 印度实施了紧急批准途径,包括滚动和加速审查,以加快疫苗获取.
研究的目的:
- 审查印度2019年新药和临床试验规则在紧急COVID-19疫苗批准方面的使用情况.
- 探索印度PHEs期间紧急疫苗授权的法律基础.
- 为了确定印度现有的"紧急使用"框架中的挑战和复杂性.
主要方法:
- 审查2019年新药和临床试验规则.
- 分析印度药品总监局 (DCGI) 针对COVID-19疫苗的紧急批准流程.
- 评估紧急使用授权的立法基础.
主要成果:
- 2019年新药和临床试验规则为印度的COVID-19疫苗紧急批准提供了一个框架.
- 采用了监管灵活性,数字化整合和适应的统计方法.
- 该研究确定了"紧急使用"范式的关键方面:定义,决策透明度和终止规则.
结论:
- 印度的监管框架在COVID-19 PHE期间表现出适应性.
- 提出了政策建议,以加强"紧急使用"框架,以应对未来的公共卫生威胁.
- 提高紧急使用的定义,决策透明度和终止协议至关重要.
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