非洲生物等价中心:当前状况和增长机会
Bakani Mark Ncube1, Sarah Muthuri1, Olawale Ajose1
1Market Access Africa, Geneva, Switzerland.
Journal of pharmaceutical policy and practice
|November 24, 2025
概括
生物等价性研究确保仿制药是安全有效的. 非洲面临当地研究中心的挑战,增加制造商的成本并影响监管标准.
科学领域:
- 制药科学 制药科学
- 监管事务 监管事务
- 非洲卫生系统 非洲卫生系统
背景情况:
- 对仿制药的批准而言,生物等价性研究至关重要,它确保了与创新产品相比的质量,安全性和有效性.
- 非洲对生物等价性要求的监管执法不一致,一些国家基于不完整的数据授予营销许可.
- 对当地生物等效中心的有限访问迫使非洲制造商承担高成本的国际研究,主要是在印度和中东.
研究的目的:
- 审查非洲生物等价性研究和设施的现状.
- 识别阻碍当地生物等效能力发展的挑战.
- 为促进非洲地区生物等效设施的增长提出建议.
主要方法:
- 进行了对非洲生物等价性景观的审查.
- 分析了非洲各个国家的生物等价性研究中心的运行状况.
- 为非洲制药厂商确定与生物等价性研究相关的挑战和机会.
主要成果:
- 目前只有五个非洲国家拥有运营中的生物等价性研究中心,而两个国家渴望建立它们.
- 非洲制造商面临的一个重大挑战是,在国外进行生物等价性研究的可访问性有限,成本高.
- 非洲缺乏生物等效设施,导致监管不一致,并阻碍了仿制药的及时批准.
结论:
- 建议在具有临床试验能力的学术医院建立生物等效设施.
- 为监管机构和制造商开发认可的培训计划对于提高劳动力的技能至关重要.
- 强制要求对所有仿制药应用进行生物等价证明,无论其来源如何,对于确保公共卫生和监管协调至关重要.
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