20150617 ECA新闻：草药制品各论系统审核HMPC文件更新 （分享）

20150617 ECA新闻：草药制品各论系统审核HMPC文件更新  

GMP News
17/06/2015

HMPC Document on the systematic Review of Monographs Herbal Medicinal Products updated

草药制品各论系统审核HMPC文件更新

On 28 January 2015 the EMA's HMPC (Committee on Herbal Medicinal Products) has updated the procedure which defines the systematic review of the monographs for herbal medicinal products of the European Union and the list entries of the European Union as well as their supporting documentation.

在2015年1月28日，EMA的HMPC（草药制品委员会）对欧盟草药制品各论系统审核的程序进行了更新，同时还更新了欧盟的清单以及其支持性文件。

The legal basis for this is the EMA/HMPC reflection paper about the reasons and time periods for the revision of monographs and list entries. Every 5 years it has to be checked whether a monograph or a list entry is still up-to-date.

更新所依据的法规是EMA/HMPC关于各论和清单修订理由和时间段的概念文件。每5年必须要检查一份各论或清单是否需要更新。

The HMPC review document deals with the following aspects:

HMPC审核文件包括以下方面：

• Scope of the revisions
• 修订范围
• Timelines
• 时间限制
• Documentation of the review / revision
• 审核/修订的文件记录
  

With regard to the last point it is mentioned that the extent of the changes made in each document must be transparent.

关于最后一点，它讲到在每份文件中所做的变更的程度必须是透明的。

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