20141217 ECA新闻 FDA公布制药公司明确识别指南

20141217 ECA新闻 FDA公布制药公司明确识别指南  

2014-12-18 14:03:45|  分类： ECA新闻

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201411182345473/

GMP News
17/12/2014

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.

在我们2013年9月的GMP新闻中，你已经知道FDA题为“药品设施登记用场所唯一识别号UFI系统的要求”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邓白氏号。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。