在巴西获得先进治疗药品的挑战和机会
Camile Giaretta Sachetti1, Augusto Barbosa2, Antonio Carlos Campos de Carvalho3
1Graduate Program for Collective Health, Faculty of Health Sciences, University of Brasilia (UnB), Brasilia, Brazil; Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, Brazil.
Cytotherapy
|April 19, 2024
概括
工业发现巴西
科学领域:
- 先进疗法药物 (ATMPs) 是一种先进疗法药物.
- 监管科学 监管科学
- 卫生经济学 卫生经济学
背景情况:
- 巴西对ATMP的营销许可是最近的发展.
- 对于开发人员来说,ATMP的专业化性质带来了独特的挑战.
- 了解行业经验对于改善监管框架至关重要.
研究的目的:
- 评估行业对巴西ATMP临床开发的看法.
- 评估ATMPs的营销许可程序.
- 确定ATMP在统一卫生系统 (SUS) 中获得的挑战和机会.
主要方法:
- 一项调查分发给商业化ATMP的公司.
- 包括来自10家外国制药公司的参与者.
- 对调查数据进行了描述性分析.
主要成果:
- 巴西的监管体系,特别是安维萨的卫生登记,在确保质量,安全性和有效性方面被认为是积极的.
- 强项包括安维萨与行业的互动以及与国际标准的协调.
- 主要挑战包括缺乏具体的定价法规以及使用当前的医疗技术评估 (HTA) 方法进行高成本ATMP的SUS补偿方面的困难.
结论:
- 建议行业和政府之间继续进行对话,以加强监管,重点关注定价和HTA.
- 为国家卫生经济工业综合体制定政策至关重要.
- 需要创新的融资模式,包括风险共享和共同融资,以实现SUS可持续和公平的ATMP接入.
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