{"id":178,"date":"2014-08-19T10:56:45","date_gmt":"2014-08-19T02:56:45","guid":{"rendered":"http:\/\/its.juan.tw\/?p=178"},"modified":"2014-08-19T17:50:33","modified_gmt":"2014-08-19T09:50:33","slug":"u-s-fda-esubmiiter-%e5%af%a6%e5%8b%99%e4%b9%8b%e4%b8%80-webtrader-test-account-%e7%94%b3%e8%ab%8b","status":"publish","type":"post","link":"https:\/\/its.juan.tw\/?p=178","title":{"rendered":"U.S. FDA eSubmitter \u5be6\u52d9\u4e4b\u4e00 &#8211; WebTrader test account \u7533\u8acb"},"content":{"rendered":"<p>U.S. FDA \u5f9e2009\u5e746\u67081\u65e5\u8d77\uff0c \u9664\u7279\u5225\u8a31\u53ef\u5916\uff0c\u4e0d\u518d\u63a5\u53d7\u7d19\u672c\u7684\u5de5\u5ee0\u8a3b\u518a\uff08Drug Establishment Registration\uff09\u53ca\u7522\u54c1\u767b\u8a18\uff08Drug Listing\uff09\u3002<\/p>\n<p>\u53c3\u8003\u7db2\u9801: <a href=\"http:\/\/www.fda.gov\/ForIndustry\/ElectronicSubmissionsGateway\/ucm114831.htm\">http:\/\/www.fda.gov\/ForIndustry\/ElectronicSubmissionsGateway\/ucm114831.htm<\/a><\/p>\n<p>1, \u5bc4\u9001\u7d19\u672c\u7684Non-Repudiation Agreement Letter \u5230FDA, \u540c\u610fFDA\u63a5\u53d7\u96fb\u5b50\u7c3d\u540d\u7684\u7533\u8acb\uff09\u3002\u6b64\u4fe1\u9700\u7528\u516c\u53f8\u62ac\u982d\uff0c\u624b\u5beb\u7c3d\u540d\uff0c\u5bc4\u81f3<\/p>\n<p><strong>\u00a0\u00a0\u00a0 Michael Fauntleroy<\/strong><br \/>\n<strong>\u00a0\u00a0\u00a0 Food and Drug Administration<\/strong><br \/>\n<strong>\u00a0\u00a0\u00a0 Center for Biologics Evaluation and Research<\/strong><br \/>\n<strong>\u00a0\u00a0\u00a0 11820 Parklawn Drive, Suite 300<\/strong><br \/>\n<strong>\u00a0\u00a0\u00a0 Rockville, MD 20852<\/strong><\/p>\n<p>\u6587\u4ef6\u7bc4\u672c\u53ca\u5b98\u65b9\u8aaa\u660e\u53ef\u4ee5\u53c3\u8003FDA\u7db2\u7ad9: <a href=\"http:\/\/www.fda.gov\/ForIndustry\/ElectronicSubmissionsGateway\/ucm113964.htm\">http:\/\/www.fda.gov\/ForIndustry\/ElectronicSubmissionsGateway\/ucm113964.htm<\/a><\/p>\n<p>2, \u767c\u9001 email \u5230 esgprep@fda.hhs.gov \u7533\u8acbWebTrader \u6e2c\u8a66\u5e33\u865f\uff0c\u4e26\u63d0\u4f9b\u4ee5\u4e0b\u8cc7\u6599:<\/p>\n<p><strong>\u00a0\u00a0\u00a0 Company name<\/strong><br \/>\n<strong>\u00a0\u00a0\u00a0 First and Last Name<\/strong><br \/>\n<strong>\u00a0\u00a0\u00a0 Phone Number<\/strong><br \/>\n<strong>\u00a0\u00a0\u00a0 Submission Method: (WebTrader)<\/strong><br \/>\n<strong>\u00a0\u00a0\u00a0 Indicate if you would like a WebTrader Hosted Solution (WTHS) account in addition to your WebTrader account. (For more information on WTHS accounts please click here26).<\/strong><\/p>\n<p><!--more--><\/p>\n<p>3, \u6839\u64da FDA \u7684\u56de\u51fd\u63d0\u4f9b\u7684\u8cc7\u6599, \u767b\u5165 <a href=\"https:\/\/esgtest.fda.gov\">https:\/\/esgtest.fda.gov<\/a><\/p>\n<p>Username: webtrader<br \/>\nPassword: (email\u88e1\u6709)<\/p>\n<p><img decoding=\"async\" style=\"display: inline;\" src=\"http:\/\/its.juan.tw\/wp-content\/plugins..\/..\/uploads\/media\/esubmitter-flow\/image1.png\" alt=\"\" \/><\/p>\n<p>4, \u767b\u5165\u7db2\u7ad9\u5f8c\uff0c\u958b\u59cb\u9032\u884c\u6e2c\u8a66\u5e33\u865f\u7684\u7533\u8acb\u3002\u8a73\u7d30\u8cc7\u6599\u53ef\u4ee5\u53c3\u8003FDA\u7db2\u7ad9\u8aaa\u660e:<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/ForIndustry\/ElectronicSubmissionsGateway\/\">http:\/\/www.fda.gov\/ForIndustry\/ElectronicSubmissionsGateway\/<\/a><\/p>\n<p>a, \u767b\u5165\u5f8c\u51fa\u73fe\u6b61\u8fce\u756b\u9762<\/p>\n<p><img decoding=\"async\" style=\"display: inline;\" src=\"http:\/\/its.juan.tw\/wp-content\/plugins..\/..\/uploads\/media\/esubmitter-flow\/image2.png\" alt=\"\" \/><\/p>\n<p>b, \u76f4\u63a5\u6309 Next<\/p>\n<p><img decoding=\"async\" style=\"display: inline;\" src=\"http:\/\/its.juan.tw\/wp-content\/plugins..\/..\/uploads\/media\/esubmitter-flow\/image3.png\" alt=\"\" \/><\/p>\n<p>c, community \u53ea\u6709\u4e00\u500b FDATEST \u53ef\u4ee5\u9078, \u76f4\u63a5\u6309 Next<\/p>\n<p><img decoding=\"async\" style=\"display: inline;\" src=\"http:\/\/its.juan.tw\/wp-content\/plugins..\/..\/uploads\/media\/esubmitter-flow\/image4.png\" alt=\"\" \/><\/p>\n<p>d, \u7136\u5f8c\u8f38\u5165\u516c\u53f8\u7684\u540d\u7a31\u5f8c, \u6309 Next<\/p>\n<p><img decoding=\"async\" style=\"display: inline;\" src=\"http:\/\/its.juan.tw\/wp-content\/plugins..\/..\/uploads\/media\/esubmitter-flow\/image5.png\" alt=\"\" \/><\/p>\n<p>e, \u7136\u5f8c\u4e0a\u50b3\u4f60\u7684 Digital Certificate, \u9019\u88e1\u6211\u5011\u5148\u4f7f\u7528 Self-Sign\u7684\u5c31\u53ef\u4ee5<\/p>\n<p><img decoding=\"async\" style=\"display: inline;\" src=\"http:\/\/its.juan.tw\/wp-content\/plugins..\/..\/uploads\/media\/esubmitter-flow\/image6.png\" alt=\"\" \/><\/p>\n<p>f, \u4e0a\u50b3\u5f8c, \u7db2\u7ad9\u6703\u986f\u793a\u4f60\u7684\u57fa\u672c\u8cc7\u6599, \u6c92\u554f\u984c\u5f8c\u5c31\u6309 Next<\/p>\n<p><img decoding=\"async\" style=\"display: inline;\" src=\"http:\/\/its.juan.tw\/wp-content\/plugins..\/..\/uploads\/media\/esubmitter-flow\/image7.png\" alt=\"\" \/><\/p>\n<p>g, \u63a5\u4e0b\u4f86\u624d\u662f\u771f\u6b63\u958b\u59cb\u6e2c\u8a66\u5e33\u865f\u7684\u5efa\u7acb\u3002\u9019\u88e1\u4f60\u5fc5\u9808\u81ea\u5df1\u9078\u64c7\u4e00\u500b\u5e33\u865f\u540d, \u9577\u5ea6\u70ba\u4e94\u500b\u6587\u6578\u5b57\u4ee5\u4e0a\uff0c\u4ee5\u53ca\u806f\u7d61\u4eba\u7684\u8cc7\u6599\u3002\u6b64\u5916\uff0c\u9084\u53ef\u4ee5\u518d\u63d0\u4f9b\u4e00\u540d\u806f\u7d61\u4eba\u3002<\/p>\n<p><img decoding=\"async\" style=\"display: inline;\" src=\"http:\/\/its.juan.tw\/wp-content\/plugins..\/..\/uploads\/media\/esubmitter-flow\/image8.png\" alt=\"\" \/><\/p>\n<p>h, \u8f38\u5165\u5b8c\u7562\u5f8c\uff0c\u7cfb\u7d71\u6703\u6839\u64da\u4e4b\u524d\u586b\u5beb\u7684\u8cc7\u6599, \u8b93\u60a8\u78ba\u8a8d:<\/p>\n<p><img decoding=\"async\" style=\"display: inline;\" src=\"http:\/\/its.juan.tw\/wp-content\/plugins..\/..\/uploads\/media\/esubmitter-flow\/image9.png\" alt=\"\" \/><\/p>\n<p>i, \u78ba\u8a8d\u6c92\u554f\u984c\u5f8c\uff0c\u5728I hereby certify that the information provided herein is true and that I am authorized to register with the FDA. \u524d\u7684checkbox \u6253v\uff0c\u7136\u5f8c\u6309 Finish registration \u5c31\u53ef\u4ee5\u9001\u4ef6\u4e86\u3002<\/p>\n<p>5, \u7533\u8acb\u904e\u7a0b\u4e2d\uff0c\u5fc5\u9808\u63d0\u4f9b\u6548\u671f\u70ba1~3\u5e74\u7684Digital Certificate\uff0cFDA\u7db2\u9801\u6709\u8a73\u7d30\u7684\u8aaa\u660e:<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/forindustry\/electronicsubmissionsgateway\/ucm334781.htm\">http:\/\/www.fda.gov\/forindustry\/electronicsubmissionsgateway\/ucm334781.htm<\/a> \u5176\u4e2d\uff0cFDA\u5efa\u8b70\u4e86\u4e09\u500b\u7db2\u7ad9\u53ef\u4ee5\u7533\u8acb:<\/p>\n<p>Comodo:<a href=\"%20https:\/\/secure.instantssl.com\/products\/frontpage?area=SecureEmailCertificate\"> https:\/\/secure.instantssl.com\/products\/frontpage?area=SecureEmailCertificate<\/a><br \/>\nGeoTrust: <a href=\"http:\/\/www.geotrust.com\/signing-products\/secure-email\/index.html\">http:\/\/www.geotrust.com\/signing-products\/secure-email\/index.html<\/a><br \/>\nGlobalSign: <a href=\"http:\/\/www.globalsign.com\/digital_certificate\/personalsign\/index.htm#2\">http:\/\/www.globalsign.com\/digital_certificate\/personalsign\/index.htm#2<\/a><\/p>\n<p>\u5176\u4e2d Comodo \u514d\u8cbb\u63d0\u4f9b\u6548\u671f\u70ba\u4e00\u5e74\u7684Digital ID\uff0c\u53ef\u4ee5\u76f4\u63a5\u7dda\u4e0a\u7533\u8acb\uff0c\u7acb\u523b\u53d6\u5f97\u3002<\/p>\n<p>5, \u5728\u7533\u8acb\u904e\u7a0b\u4e2d\uff0c\u9047\u5230\u7684\u4efb\u4f55\u554f\u984c\u90fd\u53ef\u4ee5\u900f\u904e<a href=\"mailto:ESGHelpDesk@fda.hhs.gov\"><span style=\"text-decoration: underline;\">ESGHelpDesk@fda.hhs.gov<\/span><\/a><\/p>\n<div class=\"pvc_clear\"><\/div>\n<p id=\"pvc_stats_178\" class=\"pvc_stats all  \" data-element-id=\"178\" style=\"\"><i class=\"pvc-stats-icon medium\" aria-hidden=\"true\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"far\" data-icon=\"chart-bar\" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\" class=\"svg-inline--fa fa-chart-bar fa-w-16 fa-2x\"><path fill=\"currentColor\" d=\"M396.8 352h22.4c6.4 0 12.8-6.4 12.8-12.8V108.8c0-6.4-6.4-12.8-12.8-12.8h-22.4c-6.4 0-12.8 6.4-12.8 12.8v230.4c0 6.4 6.4 12.8 12.8 12.8zm-192 0h22.4c6.4 0 12.8-6.4 12.8-12.8V140.8c0-6.4-6.4-12.8-12.8-12.8h-22.4c-6.4 0-12.8 6.4-12.8 12.8v198.4c0 6.4 6.4 12.8 12.8 12.8zm96 0h22.4c6.4 0 12.8-6.4 12.8-12.8V204.8c0-6.4-6.4-12.8-12.8-12.8h-22.4c-6.4 0-12.8 6.4-12.8 12.8v134.4c0 6.4 6.4 12.8 12.8 12.8zM496 400H48V80c0-8.84-7.16-16-16-16H16C7.16 64 0 71.16 0 80v336c0 17.67 14.33 32 32 32h464c8.84 0 16-7.16 16-16v-16c0-8.84-7.16-16-16-16zm-387.2-48h22.4c6.4 0 12.8-6.4 12.8-12.8v-70.4c0-6.4-6.4-12.8-12.8-12.8h-22.4c-6.4 0-12.8 6.4-12.8 12.8v70.4c0 6.4 6.4 12.8 12.8 12.8z\" class=\"\"><\/path><\/svg><\/i> <img loading=\"lazy\" decoding=\"async\" width=\"16\" height=\"16\" alt=\"Loading\" src=\"https:\/\/its.juan.tw\/wp-content\/plugins\/page-views-count\/ajax-loader-2x.gif\" border=0 \/><\/p>\n<div class=\"pvc_clear\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>U.S. FDA \u5f9e2009\u5e746\u67081\u65e5\u8d77\uff0c \u9664\u7279\u5225\u8a31\u53ef\u5916\uff0c\u4e0d\u518d\u63a5\u53d7\u7d19\u672c\u7684\u5de5\u5ee0\u8a3b\u518a\uff08Drug Establish [&hellip;]<\/p>\n<div class=\"pvc_clear\"><\/div>\n<p id=\"pvc_stats_178\" class=\"pvc_stats all  \" data-element-id=\"178\" style=\"\"><i class=\"pvc-stats-icon medium\" aria-hidden=\"true\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"far\" data-icon=\"chart-bar\" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\" class=\"svg-inline--fa fa-chart-bar fa-w-16 fa-2x\"><path fill=\"currentColor\" d=\"M396.8 352h22.4c6.4 0 12.8-6.4 12.8-12.8V108.8c0-6.4-6.4-12.8-12.8-12.8h-22.4c-6.4 0-12.8 6.4-12.8 12.8v230.4c0 6.4 6.4 12.8 12.8 12.8zm-192 0h22.4c6.4 0 12.8-6.4 12.8-12.8V140.8c0-6.4-6.4-12.8-12.8-12.8h-22.4c-6.4 0-12.8 6.4-12.8 12.8v198.4c0 6.4 6.4 12.8 12.8 12.8zm96 0h22.4c6.4 0 12.8-6.4 12.8-12.8V204.8c0-6.4-6.4-12.8-12.8-12.8h-22.4c-6.4 0-12.8 6.4-12.8 12.8v134.4c0 6.4 6.4 12.8 12.8 12.8zM496 400H48V80c0-8.84-7.16-16-16-16H16C7.16 64 0 71.16 0 80v336c0 17.67 14.33 32 32 32h464c8.84 0 16-7.16 16-16v-16c0-8.84-7.16-16-16-16zm-387.2-48h22.4c6.4 0 12.8-6.4 12.8-12.8v-70.4c0-6.4-6.4-12.8-12.8-12.8h-22.4c-6.4 0-12.8 6.4-12.8 12.8v70.4c0 6.4 6.4 12.8 12.8 12.8z\" class=\"\"><\/path><\/svg><\/i> <img loading=\"lazy\" decoding=\"async\" width=\"16\" height=\"16\" alt=\"Loading\" src=\"https:\/\/its.juan.tw\/wp-content\/plugins\/page-views-count\/ajax-loader-2x.gif\" border=0 \/><\/p>\n<div class=\"pvc_clear\"><\/div>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[34,32,8,33],"class_list":["post-178","post","type-post","status-publish","format-standard","hentry","category-7","tag-drug-establishment-registration","tag-esubmitter","tag-fda","tag-webtrader"],"_links":{"self":[{"href":"https:\/\/its.juan.tw\/index.php?rest_route=\/wp\/v2\/posts\/178","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/its.juan.tw\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/its.juan.tw\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/its.juan.tw\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/its.juan.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=178"}],"version-history":[{"count":5,"href":"https:\/\/its.juan.tw\/index.php?rest_route=\/wp\/v2\/posts\/178\/revisions"}],"predecessor-version":[{"id":185,"href":"https:\/\/its.juan.tw\/index.php?rest_route=\/wp\/v2\/posts\/178\/revisions\/185"}],"wp:attachment":[{"href":"https:\/\/its.juan.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/its.juan.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/its.juan.tw\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}