FDA公布制药公司清楚识别指南

一沙一叶

FDA issues Guidance for a clear Identification of pharmaceutical Companies

FDA公布制药公司明确识别指南

In our GMP News from September 2013 you learned about a draft of a FDA Guidance for Industry entitled "Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration". This document's goal was to clearly identify pharmaceutical sites. The draft comprised (manageable) five pages - including the cover page. And in terms of volume this didn't change. However, some of the alternatives still mentioned in the draft, are not stated any longer - as one can find out when contacting the authority in these cases. The method now wanted is a registration by a D-U-N-S- (Data Universal Numbering System) number. This number - which is a 9-digit code - is supplied by the company Dun & Bradstreet.

在2013年9月的GMP新闻中，你已经知道FDA题为“用于药物注册登记的唯一厂区识号UFI系统的标准”的行业指南起草的消息。该文件的目的是为了对制药场所进行清楚的识别。草案包括封面在内仅有5页。这次正式版里内容的多少没有变化，但是有些在草案中还提及的替代方式在这里没有再提起了，这种情况在联系官方时可以发现。现在所期望的方法是登记DUNS号。该登记号为9位代码，由邓白氏公司提供。

To find out more please see the complete Guidance for Industry "Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration".  

更多信息请参见行业指南完整版本。

gumupai

FDA公布制药公司明确识别指南（Julia翻译）
https://www.ouryao.com/forum.php? ... &fromuid=182390
撞车了

一沙一叶

gumupai 发表于 2014-12-19 21:35
FDA公布制药公司明确识别指南（Julia翻译）
https://www.ouryao.com/forum.php?mod=viewthread&tid=262550& ...

处理了一下。  

孙艳红

学习了解

baldrian

学习了解。

995966201

谢谢分享，学习中

syhorchid

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