印尼草药法规的基于证据的生产框架
Mohamad Kashuri1,2, Taruna Ikrar2, Sutriyo1
1Faculty of Pharmacy Universitas Indonesia, Depok, West Java, Indonesia.
Frontiers in pharmacology
|January 19, 2026
概括
本综述概述了草药的基于证据的生产 (EBP),使用先进的技术和omics来保证质量. 它提出了一个框架,让印尼的FDA监管草药产品,确保安全性和一致性.
科学领域:
- 草药生产 草药生产
- 药理学是指药理学,即药理学是指药理学.
- 监管科学是一种监管科学.
背景情况:
- 草药生产面临的一致性和供应变化的挑战.
- 先进的技术和omics提供了质量控制和认证的解决方案.
- 监管协调对于草药的全球接受至关重要.
研究的目的:
- 从2015年到2025年,审查基于证据的草药生产 (EBP).
- 探索先进的生产技术,支持omics的身份验证,设计质量 (QbD) 和监管协调.
- 为印度尼西亚监管机构 (BPOM) 提出一个框架,使EBP.
主要方法:
- 科学文献的叙事综述 (2015-2025年).
- 分析先进的生产技术 (体外培养,生物反应器,纳米技术).
- 评估omics方法 (DNA条形码,代谢学) 和QbD原则.
- 评估监管协调倡议 (东盟,世卫组织).
主要成果:
- 先进的技术提高了草药的一致性,解决了供应变化.
- 欧米克的方法确保了同一性和化学可重复性.
- 监管倡议促进协调,同时尊重传统的多样性.
- 建议采用一个双关键批量释放规范 (基因组x代谢物).
结论:
- 实施EBP需要整合先进技术,omics和QbD.
- 根据良好的实验室实践 (GLP) 验证的omics工作流对于可追溯性至关重要.
- 一个可行的框架可以使印度尼西亚成为基于证据的草药监管的区域枢纽.
- 数字药物监测和现实世界的证据提高了市场后的安全监测.
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