草药安全使用的历史 - - 记录证据的方法
D B Anantha Narayana1, N B Brindavanam2, Sabina Shirsekar3
1Ayurvidye Trust, 1101, 1 F Main, 2 Stage, Girinagar, Bangalore, 560085, India.
Journal of Ayurveda and integrative medicine
|January 9, 2024
概括
记录草药使用历史对于国际贸易批准至关重要. 本文旨在指导制定监管提交的标准化文件准则.
科学领域:
- 民族植物学 民族植物学
- 监管科学 监管科学
- 草药是一种草药.
背景情况:
- 国际草药贸易需要监管部门的批准,包括有关质量,安全性和有效性的大量数据.
- 传统草药使用的记录历史越来越被认为是全球监管提交的重要证据.
- 现有的法规,如欧盟指令和印度食品法规,强调了需要历史使用数据的必要性.
研究的目的:
- 为了解决缺乏全面的指导方针来记录草药使用的历史,以达到监管目的.
- 建议制定一个框架,为传统草药证据制定标准化的文档实践.
- 促进更广泛的协商,以制定可行的指导方针.
主要方法:
- 对草药产品现有监管要求的文献综述.
- 对提交历史使用数据的当前做法进行分析.
- 确定可靠文档所需的关键元素.
主要成果:
- 在记录历史草药使用的标准化方法中存在很大的差距.
- 当前的文档实践往往不一致,缺乏统一的结构.
- 显然需要国际公认的指导方针.
结论:
- 记录草药使用历史的标准化指南对于简化国际贸易至关重要.
- 制定这些准则将需要监管机构,研究人员和行业利益相关者之间的协作努力.
- 本文作为未来指导方针开发的基础输入.
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