关于草药产品的新HMPC概念稿公布

20150826 ECA新闻：关于草药产品的新HMPC概念稿公布  

GMP News
26/08/2015
New HMPC Concept Papers published on Herbal Medicinal Products
关于草药产品的新HMPC概念稿公布
EMA's HMPC (Committee on Herbal Medicinal Products) published two new concept papers on 1 June 2015.
EMA的HMPC（草药制品委员会）在2015年7月1日公布了2份新的概念稿。
One is on the revision of the guideline on specifications, test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products.
一份是对草药物质、草药制剂和草药药品/传统草药药品质量标准、检测方法和可接受标准的指南的修订。
The revision is required in order to take into consideration the updated Q&A document on the quality of herbal medicinal products. And new guidance from the European Pharmacopoeia must be considered.
修订是为了考虑更新的草药制品问答文件的内容。另外也必须考虑欧洲药典中新的指南。
The other one is a revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal products.
另一份是对草药制品/传统草药制品的质量指南的修订。
Here again, it is important to adapt to the European Pharmacopoeia and to the updated Q&A document. Furthermore, the Guideline on declaration of herbal substances and herbal preparations has to be taken into account.
同样，这份文件的修订也是为了采纳欧洲药典的内容和更新的问答文件。另外，也必须考虑草药物质和草药制剂的声明指南。
Deadline for comments for both documents is the 31 August 2015.
两份文件征求意见的截止时间都是2015年8月31日。
For more detailed information please see the complete Concept Paper on the revision of the guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products as well as the second Concept Paper on the revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal products.

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