happyjyl
第1楼2010/04/26
ERN Eritrean Nakfa (ISO currency code)
ERN European Rivers Network
ERN Error-Related Negativity (EEG recording)
ERN Emergency Response Network
ERN Electronic Remittance Notice (US Medicare)
ERN Encyclopedia of Religion and Nature (Continuum International)
ERN Engineering Release Notice
ERN External Recurrent Neural Network
ERN Estação Radionaval (Portugal)
ERN Equipment Revenue Note (New Jersey Health Care Facilities Financing Authority)
ERN Erasure Relay Network (network with binary erasure channels)
你看到的是哪个方面的?
影子
第2楼2010/04/27
关于原料药在美国FDA注册方面的,我们的客户说是在DMF递交前申请的
establishment registration number 可以译为企业注册号码,会不会就是这个?
happyjyl
第4楼2010/04/27
是的。FDA的21 CFR 207.35 - Notification of registrant; drug establishment registration number and drug listing number里有提到:
FDA will provide to the registrant a validated copy of Form FDA2656 (Registration of Drug Establishment) as evidence of registration. This validated copy will be sent to the mailing address shown on the form.
FDA will assign a permanent registration number to each drug establishment registered in accordance with these regulations.
happyjyl
第6楼2010/04/27
FEI = Facility Establishment Identifier 看下面的网页,一张表格上既有FEI又有ERN,应该不是一个意思。
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080872.pdf
我没时间细看,你详细看看下面两个网站吧,另外也可以在google上再搜索一下:
http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm
http://cfr.vlex.com/vid/207-35-notification-number-listing-19708892
天晴了
第7楼2010/04/28
http://elsmar.com/Forums/showthread.php?t=39002 讨论了Is there a difference between Establishment Registration Number and FEI?
FACTS automatically generates a 10-digit FEI number under the firm build screen when a new firm is added. Firms previously in FIS retained their original 7-digit CFN which, in most cases, also became their FEI number. The old CFN can be viewed under the cross-reference viewing screen in FACTS. See Appendix IV, General Rules and Guidance for Assignment of Firm Establishment Identifiers, for assignment rules of FEI numbers.
影子
第8楼2010/04/28
FEI is the Firm Establishment Identifier - FDA database is automatically generates a 10-digit FEI number when a new firm is added.
FEI是公司建立的识别符 – 当增加一个新公司的时候,FDA数据库自动生成一个10位数的FEI号。
看来ERN与FEI确实是不同的,只是对于国内的公司而言,不知道是怎样获取FEI号的?
happyjyl
第10楼2010/04/28
仔细看看这个网站,里面有提到。包括“FACTS automatically generates a 10-digit FEI number under the firm build screen when a new firm is added. Firms previously in FIS retained their original 7-digit CFN which, in most cases, also became their FEI number. The old CFN can be viewed under the cross-reference viewing screen in FACTS. See Appendix IV, General Rules and Guidance for Assignment of Firm Establishment Identifiers, for assignment rules of FEI numbers. “这段话也是从这个网站中引用的。
http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm