低收入和中等收入国家的良好制造实践:合规性的挑战和解决方案
Pelden Chejor1, Thinley Dorji2, Ngawang Dema3
1Centre for Research in Aged Care Edith Cowan University Joondalup Western Australia Australia.
Public health challenges
|June 11, 2025
概括
确保低收入和中等收入国家获得优质药品需要加强良好制造实践 (GMP) 的遵守. 对制药制造商和国家监管机构来说,解决资源,基础设施和监管障碍至关重要.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 全球卫生公平性全球卫生公平性
- 监管科学是一种监管科学.
背景情况:
- 在全球范围内,对必需药物的有限获取影响了20亿人,在低收入和中等收入国家 (LMICs) 不成比例.
- 低质量和假冒的药物在LMICs有助于抗菌素耐药性和治疗失败.
- 良好的制造实践 (GMP) 对于确保药品质量,安全性和有效性至关重要,有利于制造商和政府.
研究的目的:
- 确定低收入和中等收入国家 (LMICs) 遵守良好制造实践 (GMP) 的障碍.
- 探索加强GMP标准和LMIC监管监管的战略.
- 强调国际合作和资源分配对药品质量的重要性.
主要方法:
- 分析现有的文献和关于LMICs制药制造和监管的报告.
- 审查世界卫生组织 (WHO) 的GMP指导方针及其在LMICs中的采用.
- 确定国家监管机构 (NRA) 和LMIC制造商面临的共同挑战.
主要成果:
- 主要障碍包括资源不足,监管体系薄弱,以及LMIC中技术人员短缺.
- 在LMIC国家,国家监管机构 (NRA) 往往缺乏独立性,难以利用国际合作.
- 在LMICs中,制药厂商在实施和维护GMP标准方面面临着挑战.
结论:
- 加强LMICs的GMP合规性需要对NRA和制造商提供强有力的支持,包括能力建设和资源分配.
- 赋予国家监管机构功能独立的权力和促进机构间合作是必不可少的.
- 利用世卫组织的GMP标准和优先考虑资源优化,可以提高LMICs的药品质量和市场准入.
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