FDA对草药制品研发的新要求

20150930 ECA新闻：FDA对草药制品研发的新要求  

New FDA Requirements for the Development of Herbal Medicinal Products
FDA对草药制品研发的新要求
In August 2015, the FDA has published a draft of the guideline "Botanical Drug Development". This guideline addresses issues arising from the particular nature of herbal medicinal products. After its finalization it is supposed to replace the previous guideline from June 2004.
2015年8月，FDA公布了指南草案“植物学药品研发”指南草案。该指南中解释了草药制品特殊属性引出的问题。如果定稿，这份指南将替代之前2004年6月的指南。
The general approach in the development of herbal medicinal products remained unchanged since 2004. But due to the better understanding of herbal medicinal products and the experience gained during the review of the approval documents for herbals (NDAs/New Drug Applications and INDs/Investigational New Drug Applications), specific recommendations could be adjusted. Still, new sections will be supplemented to better address the late development phase.
草药制品常规研发方法自2004年以来保持没有变化。但是因为对草药制品有了更好的了解，以及在对草药（NDA/新药申请和IND/研发新药申请）批准文件的审核过程中获得的经验，现在可以调整这些特定建议。新的部分将会对研发阶段后期提供更好的建议。
The draft guideline also covers the following topics:
指南草案还包括以下主题：
General, regulatory requirements
通用的，法规的要求
INDs for phase 1-3 clinical trials
1-3期临床试验阶段的IND
NDAs for herbal medicinal products
草药制品NDA
For further information please see the full FDA document 'Botanical Drug Development'.
更多信息参见FDA文件“植物药品研发”。

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015999529387/

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