欧洲对精油的未来质量要求

GmpForEver · 发表于 2013-4-5 05:58:16

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In January, EMA's HMPC (Committee on Herbal Medicinal Products) published a "Reflection Paper" on the quality of essential oils for use in the manufacture of herbal medicinal products / traditional herbal medicinal products.

With this "Reflection Paper" aspects related to the nature and the specific production processes of essential oils should be taken into account.

Products made of essential oils belong to herbal preparations. So far, requirements on essential oils haven't been addressed enough in the existing guidelines.

Moreover, the existing HMPC guidelines on quality don't take into account the definitions laid down in the Pharmacopoeia Europea (Ph.Eur.) monograph on essential oils.

From a regulatory point of view, essential oils used as APIs in herbal products raise a broad range of questions which are emphasized by the fact that the current guidelines don't fully address the specific aspects of essential oils.

The new "Reflection Paper" calls on interested parties to provide concrete examples and comments on the whole manufacturing processes of essential oils. The feedbacks will be the basis for further discussions. Depending on them, a new guideline will be developed.

The deadline for comments is the 15th May 2013.

皇后 · 发表于 2013-4-5 06:38:46

很期待欧盟的指南。

yyl19851204 · 发表于 2013-4-5 07:57:44

谁能翻译过来呀

残伤 · 发表于 2013-4-5 08:42:47

谢谢分享。

freeman132 · 发表于 2013-4-5 10:20:26

本帖最后由 freeman132 于 2013-4-5 10:36 编辑

老兄，你英语蛮牛啊，我看不懂

syhorchid · 发表于 2013-4-5 10:30:11

谢谢分享

GmpForEver · 发表于 2013-4-5 11:46:33

本帖最后由 GmpForEver 于 2013-4-5 14:09 编辑

In January, EMA's HMPC (Committee on Herbal Medicinal Products) published a "Reflection Paper" on the quality of essential oils for use in the manufacture of herbal medicinal products / traditional herbal medicinal products.
1月，EMA的草药协会发布了关于草药/传统草药生产中使用到的精油质量的几点思考
With this "Reflection Paper" aspects related to the nature and the specific production processes of essential oils should be taken into account.
这个“思考”内容应当考虑精油的天然性和特定生产工艺
Products made of essential oils belong to herbal preparations. So far, requirements on essential oils haven't been addressed enough in the existing guidelines.
精油制作的产品属于草药制剂。到目前为止，还没有指南说明精油的要求
Moreover, the existing HMPC guidelines on quality don't take into account the definitions laid down in the Pharmacopoeia Europea (Ph.Eur.) monograph on essential oils.
再者，现有的HMPC质量指南未考虑关于精油在欧洲药典中规定的定义
From a regulatory point of view, essential oils used as APIs in herbal products raise a broad range of questions which are emphasized by the fact that the current guidelines don't fully address the specific aspects of essential oils.
从法规的观点看，生产草药用到作为原料药的精油会产品很多的问题，这已经被当前指南未完全说明精油的特定方面这个事实所强调
The new "Reflection Paper" calls on interested parties to provide concrete examples and comments on the whole manufacturing processes of essential oils. The feedbacks will be the basis for further discussions. Depending on them, a new guideline will be developed.
这个新“思考”呼吁相关方对精油的整个生产过程提供实际的例子和建议，这个反馈是将来讨论最近基本的信息。根据这些，将会开发出新的指南
The deadline for comments is the 15th May 2013.
这个建议的截止时间2013年5月15日

GmpForEver · 发表于 2013-4-5 11:47:17

freeman132 发表于 2013-4-5 10:20
老兄，你英语蛮牛啊，我看不懂

呵呵，简单翻译了一下，看7楼

GmpForEver · 发表于 2013-4-5 11:47:28

yyl19851204 发表于 2013-4-5 07:57
谁能翻译过来呀

简单翻译了一下，看7楼

freeman132 · 发表于 2013-4-5 12:20:23

GmpForEver 发表于 2013-4-5 11:47
呵呵，简单翻译了一下，看7楼

谢谢分享

，你真是个好人。

yijinjun123 · 发表于 2013-4-5 14:08:34

门槛又高了，赚钱又难了

aze0212 · 发表于 2019-7-30 14:12:57

GmpForEver 发表于 2013-4-5 11:46
In January, EMA's HMPC (Committee on Herbal Medicinal Products) published a "Reflection Paper" on th ...

感谢分享，学习了。。。

Q_Q虫 · 发表于 2019-11-13 15:48:57

感谢分享，感谢翻译，学习了。。。

欧洲对精油的未来质量要求

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