偶看新闻日语识别扫描软件在线:如何将NDC号码通过ESG提交FDA？
来源：百度文库 编辑：偶看新闻 时间：2024/05/02 07:39:42
来源：http://pharmaregulatory.blog.hexun.com/ 对于ESG的问题：在FDA的指南中已经讲的很清楚了： http://www.accessdata.fda.gov/esg/userguide/webhelp/default.htm.这个里面详细的讲述了准备工作。 1. 包括申请检测，建立测试帐号，发送检测申请，以及一些完整的使用ESG的步骤。 Ø 值得注意的是通过FDA给的第一个商业的数字证书链接网站，可以免费的下载到使用期限是一年的数字证书。下载安装完成之后，需要进行导出数字证书： 2. 在导出数字证书的私匙和公匙的时候，参见上面给出的指南，请千万注意，如果你导出的证书的位置一定是在“个人”的标签下面的，而不是像“中级证书颁发机构，其他人”中的，在这个过程中是可以查看证书的有效时间的，否则不要进行下一步操作，（本人吃过亏的），成功导出之后应该是有三个文件（.cer, p7b,pfx）的，这个在以后你跟FDA提交文件的过程中会用到。 3. 下载和安装JRE：通过网址https://cds.sun.com/is-bin/INTERSHOP.enfinity/WFS/CDS-CDS_Developer-Site/en_US/-/USD/ViewProductDetail-Start?ProductRef=jre-1.5.0_15-oth-JPR@CDS-CDS_Developer ，下载并且安装，之后要通过控制面板来限制其升级，注意只有1.5的版本才能是ESG接受的，自动升级之后的1.6是传不了文件的。 Ø 下面是JRE的禁止升级步骤：开始》》控制面板》》Java（如果安装成功的话，是可以找到Java的，找不到则显示安装不成功）右手键单击，选择“更新”选项卡 4. SPL文件的编写： ² Here is a link to the SPL Xforms: http://www.fda.gov/ForIndustry/DataStandards/XForms/default.htm. ² 在下载SPL文件完成之后，要按照网站上的提示完成internet explorer 的升级(下载http://sourceforge.net/projects/mozzie/files/MozzIE%201.8/，并且安装)，也就是升级成为explorer 8 (可以使6，7或者8)，这样一来，才可以看见想要的XML文件显示出来的效果。 ² 在装好explorer之后，通过 ....\SPL_Xform\SPL\XForms中找到：SPLForm_DrugListing.xhtml, 接着按照指南，Here is link to a web page with more details on creating and submitting SPL documents: http://spl-work-group.wikispaces.com/SPL+eBooks+-+Graphic+Guides 编写文件，其中基本上给出了每一个空怎么填的情况。 a. 其中的Duns码是可以通过FDA的网站链接免费申请到的，只不过时间比较长而已（40天左右），如果出钱，这个会快一些，具体见：DUNS Numbers can be obtained through D&B using the basic service (no cost) http://www.dnbgov.com/federal_compliance/fda/DUNSrequest/requestGuide.html or using the expedited service (nominal fee) at http://www.dnbgov.com/federal_compliance/fda/DUNSrequest/ b. 如何编写SPL总的指南见：Step-by-step instructions document: http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM162027.pdf. 5. SPL编写完成之后，可以通过FDA的给定的网站来提交后验证 ² 先提交一个很小的txt文件，这时的acknowledgement等两分钟会显示出来，请注意中心的选择，然后就是SPL文件的提交，注意要选择“OC”中心，也是等两分钟，（这时候提交的SPL应该是经过 http://validator.pragmaticdata.com/validator-lite/validator/spl/网站验证过的，如果发现没有错误，就可以提交）。等两分钟acknowledgement会显示出来。提交完成之后在ESG的页面上呈现的是： Submission name Size Center Type Status Date NDC.tar.gz 51.8 KB OCPP SPL Backup found Receipt No acknowledgement Backup found Receipt 1.txt 6 KB GWTEST Connect Test Acknowledgement New ² 在添加一个NDC码的时候，是要将标签的照片扫描好之后，处理的小一点：（<1MB）,同时必须是jpg的文件，不能大写？然后跟创建好的XML文件一起打包成.ZIP（桌面上右手键-->点击新建-->点击winRAR ZIP 压缩文件，然后将jpg文件和xml文件拖进去。）文件之后提交。 ² 接下来等待获得production system account。 在收到的FDA以下email范本的时候，提交txt文件和SPL文件，完成提交之后即等待production system account： Cc: ESG REG Sent: Friday, June 11, 2010 11:33 PM Subject: WebTrader self registration in FDA ESG test system approved Hello ***, Your WebTrader self registration "Zhejiang Jiuzhou Pharmaceutical.,Ltd." for the FDA Electronic Submissions Gateway test system has been approved. Please do the following to complete your account configuration. If these steps are not performed correctly the submission will fail: 1. Make sure the correct JRE and JCE is installed. Refer to Appendix D of the FDA ESG User Guide for more information: JRE: https://cds.sun.com/is-bin/INTERSHOP.enfinity/WFS/CDS-CDS_Developer-Site/en_US/-/USD/ViewProductDetail-Start?ProductRef=jre-1.5.0_18-oth-JPR@CDS-CDS_Developer JCE: https://cds.sun.com/is-bin/INTERSHOP.enfinity/WFS/CDS-CDS_Developer-Site/en_US/-/USD/ViewProductDetail-Start?ProductRef=jce_policy-1.5.0-oth-JPR@CDS-CDS_Developer For more details on the steps involved in the JRE/JCE install, please see: http://www.accessdata.fda.gov/esg/userguide/webhelp/Java_Runtime_Edition.htm 2. Make sure your firewall is configured to allow you to connect to IP address 150.148.2.66 on port 3080. 3. Login to your ESG test account at https://esgtest.fda.gov/ using the credentials you requested when you registered. If your ESG account will be used to register tobacco products or facilities, then you should send your test file to the "Center for Tobacco Products", Please send a very small (20KB or so) text file. This will be the only test you have to complete. Otherwise, when you send your first test, use a very small (20KB or so) text file and please send it to the "Testing" (or "GWTEST") center. This center is used purely for connectivity and load testing, and the files are not reviewed by FDA personnel for compliance. After you have succeeded at sending this basic test and have received the 2nd ACK, you should send an FDA-compliant submission to whatever center is appropriate (CBER, CDER, etc.) for that submission. Then, FDA personnel will review the submission for compliance. This can take 1-2 weeks. Information about center specific submission guidelines is available at the following page: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm113200.htm While they are reviewing, you can use that time to send the load test submission (if required). This submission does not have to be FDA-compliant, and should also be sent to the "Testing" center. Please contact esgreg@gnsi.com if you have any questions. Thank you and have a nice day Pamela E Gallion Help Desk Technician GlobalNet Services, Inc. For faster service, please send all ESG technical support requests to esgreg@gnsi.com