{"id":40781,"date":"2018-03-06T08:38:51","date_gmt":"2018-03-06T13:38:51","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/drug-establishments-must-use-ectd-format-for-u-s-fda-drug-master-file-dmf-submissions-beginning-may-5-2018\/"},"modified":"2020-02-07T19:24:27","modified_gmt":"2020-02-07T19:24:27","slug":"drug-establishments-must-use-ectd-format-for-u-s-fda-drug-master-file-dmf-submissions-beginning-may-5-2018","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/drug-establishments-must-use-ectd-format-for-u-s-fda-drug-master-file-dmf-submissions-beginning-may-5-2018\/","title":{"rendered":"2018\u5e745\u67085\u65e5\u8d77\u6240\u6709DMF\u5fc5\u987b\u4ee5eCTD\u683c\u5f0f\u5411FDA\u9012\u4ea4"},"content":{"rendered":"

2018\u5e745\u67085\u65e5\u8d77\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u5c06\u4f1a\u8981\u6c42\u6240\u6709\u7684\u4f01\u4e1a\u4ee5\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\uff08eCTD\uff09\u683c\u5f0f\u5411FDA\u9012\u4ea4\u6240\u6709\u65b0\u7684\u836f\u7269\u7ba1\u7406\u6863\u6848\uff08DMF\uff09\u8d44\u6599\uff0c\u5305\u62ec\u5e74\u5ea6\u62a5\u544a\u548c\u4fee\u6b63\u6587\u6863\u3002FDA\u8868\u660e\uff0c\u81ea\u8be5\u65e5\u671f\u8d77\u5176\u5c06\u4f1a\u62d2\u6536\u6240\u6709\u975eeCTD\u683c\u5f0f\u7684DMF\u7533\u8bf7\u8d44\u6599\u3002<\/p>\n

What is eCTD?<\/strong> \u4f55\u4e3a<\/strong>eCTD<\/strong>\uff1f<\/strong><\/p>\n

eCTD\u662fFDA\u76ee\u524d\u6807\u51c6\u5316\u7684\u7533\u8bf7\u683c\u5f0f\u3002\u65b0\u836f\u7533\u8bf7\uff08NDAs\uff09\uff0c\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7(INDs)\uff0c\u7b80\u7565\u65b0\u836f\u7533\u8bf7\uff08ANDAs\uff09\uff0c\u4ee5\u53ca\u67d0\u4e9b\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7(BLAs)\u5747\u9700\u4ee5\u8be5\u683c\u5f0f\u5411FDA\u9012\u4ea4\u3002FDA\u8868\u793a\uff0c\u6839\u636e\u300a\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u53ca\u5316\u5986\u54c1(FD&C) \u6cd5\u6848\u300b\u7684\u8981\u6c42\uff0cDMF\u901a\u5e38\u662f\u4e3a\u4e86\u652f\u6491\u524d\u8ff0\u7533\u8bf7\u7684\u76ee\u7684\u800c\u9012\u4ea4\u7684\uff0c\u56e0\u6b64\uff0cDMF\u4e5f\u7406\u5e94\u8981\u901a\u8fc7eCTD\u683c\u5f0f\u6765\u9012\u4ea4\u3002<\/p>\n

\u81ea\u4e0a\u8ff0\u65e5\u671f\u8d77\uff0cFDA\u5c06\u4f1a\u8981\u6c42\u7528\u6237\u901a\u8fc7FDA\u300a\u6570\u636e\u6807\u51c6\u76ee\u5f55\u300b\u652f\u6301\u7684eCTD\u683c\u5f0f\u6765\u9012\u4ea4\u6240\u6709\u7684DMF\u3002\u6b64\u5916\uff0c\u5728FDA 2017\u5e744\u6708\u4efd\u53d1\u5e03\u7684\u4e00\u4efd\u6307\u5357\u4e2d\u4e5f\u786e\u7acb\u4e86\u76f8\u5173\u7684\u6280\u672f\u89c4\u683c\uff0c\u4f8b\u5982\u6587\u6863\u7ed3\u6784\uff0c \u6587\u4ef6\u683c\u5f0f\u53ca\u7248\u672c\uff0c\u540c\u65f6\u8fd8\u8981\u6c42\u7528\u6237\u63d0\u4f9b\u6570\u636e\u96c6\u7684\u5b9a\u4f4d\u53ca\u7814\u7a76\u4fe1\u606f\u3002<\/p>\n

\u4e4b\u524d\u4ee5\u975eCTD\u683c\u5f0f\uff0c\u5305\u62ec\u7eb8\u8d28\u683c\u5f0f\u9012\u4ea4\u7684DMF\u5907\u6848\u65e0\u9700\u4ee5eCTD\u7684\u65b9\u5f0f\u91cd\u65b0\u9012\u4ea4\u3002\u4f46\u662f\u540e\u7eed\u82e5\u8981\u5bf9\u8fd9\u4e9bDMF\u9012\u4ea4\u4efb\u4f55\u7684\u8d44\u6599\uff0c\u5982\u5e74\u5ea6\u62a5\u544a\u3001\u8865\u5145\u62a5\u544a\u4ee5\u53ca\u4fee\u6539\u8d44\u6599\u7b49\u90fd\u5fc5\u987b\u4ee5eCTD\u683c\u5f0f\u901a\u8fc7ESG\u901a\u9053\u9012\u4ea4\u3002\u82e5\u4f01\u4e1a\u9009\u62e9\u81ea\u613f\u5c06\u5176\u76ee\u524d\u7684\u7eb8\u8d28DMF\u8f6c\u6362\u4e3aeCTD\u683c\u5f0f\uff0c\u90a3\u4e48DMF\u53f7\u7801\u4f1a\u4fdd\u6301\u4e0d\u53d8\u3002\u9009\u62e9\u5c06\u5176\u7eb8\u8d28DMF\u8f6c\u6362\u4e3aeCTD\u683c\u5f0f\u7684\u4f01\u4e1a\u4e3b\u8981\u662f\u4e3a\u4e86\u52a0\u5feb\u5f15\u7528\u5176DMF\u7684NDA\u6216\u8005ANDA\u7684\u5ba1\u6838\u901f\u5ea6\u3002<\/p>\n

\u6211\u8be5\u5982\u4f55\u9012\u4ea4<\/strong>eCTD<\/strong>\u683c\u5f0f\u7684<\/strong>DMF<\/strong>\u6587\u6863\uff1f<\/strong><\/p>\n

\u4e0d\u8d85\u8fc710GB\u7684eCTD\u6587\u6863\u5fc5\u987b\u901a\u8fc7FDA\u7684\u7535\u5b50\u9012\u4ea4\u901a\u9053\uff08ESG\uff09\u6765\u9012\u4ea4\u3002\u5728\u4f7f\u7528ESG\u7cfb\u7edf\u4e4b\u524d\uff0c\u7528\u6237\u5fc5\u987b\u5411FDA\u7533\u8bf7\u4e00\u4e2a\u7f16\u7801\uff0c\u6ce8\u518c\u4e00\u4e2aESG\u8d26\u6237\uff0c\u5e76\u4e14\u5c06\u5176\u7535\u8111\u8bbe\u7f6e\u4e3aESG\u7cfb\u7edf\u4f7f\u7528\u7684\u8bed\u8a00\u3002FDA\u5efa\u8bae\u7528\u6237\u5728\u771f\u6b63\u9012\u4ea4\u4e4b\u524d\u5148\u591a\u6d4b\u8bd5\u51e0\u904d\u3002\u7528\u6237\u53ef\u80fd\u9700\u8981\u82b1\u4e0a\u6570\u5468\u624d\u80fd\u6210\u529f\u767b\u5f55ESG\u7cfb\u7edf\u3002<\/p>\n

\u6216\u8005\uff0c\u60a8\u4e5f\u53ef\u4ee5\u9009\u62e9\u4e00\u4e2a\u4e13\u4e1a\u7684\u6cd5\u89c4\u4e13\u5bb6\uff0c\u5982Registrar Corp\u6765\u534f\u52a9\u8d35\u53f8\u66f4\u52a0\u4fbf\u6377\u5feb\u901f\u5730\u5b8c\u6210\u4e0a\u8ff0\u64cd\u4f5c\u3002Registrar Corp\u53ef\u4ee5\u534f\u52a9\u8d35\u53f8\u5c06DMF\u8f6c\u6362\u6210eCTD\u683c\u5f0f\u5e76\u4e14\u5feb\u901f\u5730\u901a\u8fc7FDA\u7684ESG\u7cfb\u7edf\u9012\u4ea4\u8d35\u53f8\u7684DMF\u3002\u60f3\u8981\u4e86\u89e3\u66f4\u591aFDA\u5173\u4e8eDMF\u7684eCTD\u65b9\u9762\u7684\u76f8\u5173\u8981\u6c42\uff0c\u60a8\u4e5f\u53ef\u4ee5\u81f4\u7535+1-757-224-0177\u4e0e\u6211\u4eec\u8054\u7cfb\uff0c\u6216\u8005\u901a\u8fc7\u767b\u5f55www.registrarcorp.com\/livehelp\u4e0e\u6211\u4eec\u5168\u5929\u5019\u5728\u7ebf\u7684\u6cd5\u89c4\u4e13\u5458\u5b9e\u65f6\u8054\u7edc\uff01<\/p>\n","protected":false},"excerpt":{"rendered":"

2018\u5e745\u67085\u65e5\u8d77\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u5c06\u4f1a\u8981\u6c42\u6240\u6709\u7684\u4f01\u4e1a\u4ee5\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\uff08eCTD\uff09\u683c\u5f0f\u5411FDA\u9012\u4ea4\u6240\u6709\u65b0\u7684\u836f\u7269\u7ba1\u7406\u6863\u6848\uff08DMF\uff09\u8d44\u6599\uff0c\u5305\u62ec\u5e74\u5ea6\u62a5\u544a\u548c\u4fee\u6b63\u6587\u6863\u3002FDA\u8868\u660e\uff0c\u81ea\u8be5\u65e5\u671f\u8d77\u5176\u5c06\u4f1a\u62d2\u6536\u6240\u6709\u975eeCTD\u683c\u5f0f\u7684DMF\u7533\u8bf7\u8d44\u6599\u3002 What is eCTD? \u4f55\u4e3aeCTD\uff1f eCTD\u662fFDA\u76ee\u524d\u6807\u51c6\u5316\u7684\u7533\u8bf7\u683c\u5f0f\u3002\u65b0\u836f\u7533\u8bf7\uff08NDAs\uff09\uff0c\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7(INDs)\uff0c\u7b80\u7565\u65b0\u836f\u7533\u8bf7\uff08ANDAs\uff09\uff0c\u4ee5\u53ca\u67d0\u4e9b\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7(BLAs)\u5747\u9700\u4ee5\u8be5\u683c\u5f0f\u5411FDA\u9012\u4ea4\u3002FDA\u8868\u793a\uff0c\u6839\u636e\u300a\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u53ca\u5316\u5986\u54c1(FD&C) \u6cd5\u6848\u300b\u7684\u8981\u6c42\uff0cDMF\u901a\u5e38\u662f\u4e3a\u4e86\u652f\u6491\u524d\u8ff0\u7533\u8bf7\u7684\u76ee\u7684\u800c\u9012\u4ea4\u7684\uff0c\u56e0\u6b64\uff0cDMF\u4e5f\u7406\u5e94\u8981\u901a\u8fc7eCTD\u683c\u5f0f\u6765\u9012\u4ea4\u3002 \u81ea\u4e0a\u8ff0\u65e5\u671f\u8d77\uff0cFDA\u5c06\u4f1a\u8981\u6c42\u7528\u6237\u901a\u8fc7FDA\u300a\u6570\u636e\u6807\u51c6\u76ee\u5f55\u300b\u652f\u6301\u7684eCTD\u683c\u5f0f\u6765\u9012\u4ea4\u6240\u6709\u7684DMF\u3002\u6b64\u5916\uff0c\u5728FDA 2017\u5e744\u6708\u4efd\u53d1\u5e03\u7684\u4e00\u4efd\u6307\u5357\u4e2d\u4e5f\u786e\u7acb\u4e86\u76f8\u5173\u7684\u6280\u672f\u89c4\u683c\uff0c\u4f8b\u5982\u6587\u6863\u7ed3\u6784\uff0c \u6587\u4ef6\u683c\u5f0f\u53ca\u7248\u672c\uff0c\u540c\u65f6\u8fd8\u8981\u6c42\u7528\u6237\u63d0\u4f9b\u6570\u636e\u96c6\u7684\u5b9a\u4f4d\u53ca\u7814\u7a76\u4fe1\u606f\u3002 \u4e4b\u524d\u4ee5\u975eCTD\u683c\u5f0f\uff0c\u5305\u62ec\u7eb8\u8d28\u683c\u5f0f\u9012\u4ea4\u7684DMF\u5907\u6848\u65e0\u9700\u4ee5eCTD\u7684\u65b9\u5f0f\u91cd\u65b0\u9012\u4ea4\u3002\u4f46\u662f\u540e\u7eed\u82e5\u8981\u5bf9\u8fd9\u4e9bDMF\u9012\u4ea4\u4efb\u4f55\u7684\u8d44\u6599\uff0c\u5982\u5e74\u5ea6\u62a5\u544a\u3001\u8865\u5145\u62a5\u544a\u4ee5\u53ca\u4fee\u6539\u8d44\u6599\u7b49\u90fd\u5fc5\u987b\u4ee5eCTD\u683c\u5f0f\u901a\u8fc7ESG\u901a\u9053\u9012\u4ea4\u3002\u82e5\u4f01\u4e1a\u9009\u62e9\u81ea\u613f\u5c06\u5176\u76ee\u524d\u7684\u7eb8\u8d28DMF\u8f6c\u6362\u4e3aeCTD\u683c\u5f0f\uff0c\u90a3\u4e48DMF\u53f7\u7801\u4f1a\u4fdd\u6301\u4e0d\u53d8\u3002\u9009\u62e9\u5c06\u5176\u7eb8\u8d28DMF\u8f6c\u6362\u4e3aeCTD\u683c\u5f0f\u7684\u4f01\u4e1a\u4e3b\u8981\u662f\u4e3a\u4e86\u52a0\u5feb\u5f15\u7528\u5176DMF\u7684NDA\u6216\u8005ANDA\u7684\u5ba1\u6838\u901f\u5ea6\u3002 \u6211\u8be5\u5982\u4f55\u9012\u4ea4eCTD\u683c\u5f0f\u7684DMF\u6587\u6863\uff1f \u4e0d\u8d85\u8fc710GB\u7684eCTD\u6587\u6863\u5fc5\u987b\u901a\u8fc7FDA\u7684\u7535\u5b50\u9012\u4ea4\u901a\u9053\uff08ESG\uff09\u6765\u9012\u4ea4\u3002\u5728\u4f7f\u7528ESG\u7cfb\u7edf\u4e4b\u524d\uff0c\u7528\u6237\u5fc5\u987b\u5411FDA\u7533\u8bf7\u4e00\u4e2a\u7f16\u7801\uff0c\u6ce8\u518c\u4e00\u4e2aESG\u8d26\u6237\uff0c\u5e76\u4e14\u5c06\u5176\u7535\u8111\u8bbe\u7f6e\u4e3aESG\u7cfb\u7edf\u4f7f\u7528\u7684\u8bed\u8a00\u3002FDA\u5efa\u8bae\u7528\u6237\u5728\u771f\u6b63\u9012\u4ea4\u4e4b\u524d\u5148\u591a\u6d4b\u8bd5\u51e0\u904d\u3002\u7528\u6237\u53ef\u80fd\u9700\u8981\u82b1\u4e0a\u6570\u5468\u624d\u80fd\u6210\u529f\u767b\u5f55ESG\u7cfb\u7edf\u3002 \u6216\u8005\uff0c\u60a8\u4e5f\u53ef\u4ee5\u9009\u62e9\u4e00\u4e2a\u4e13\u4e1a\u7684\u6cd5\u89c4\u4e13\u5bb6\uff0c\u5982Registrar Corp\u6765\u534f\u52a9\u8d35\u53f8\u66f4\u52a0\u4fbf\u6377\u5feb\u901f\u5730\u5b8c\u6210\u4e0a\u8ff0\u64cd\u4f5c\u3002Registrar Corp\u53ef\u4ee5\u534f\u52a9\u8d35\u53f8\u5c06DMF\u8f6c\u6362\u6210eCTD\u683c\u5f0f\u5e76\u4e14\u5feb\u901f\u5730\u901a\u8fc7FDA\u7684ESG\u7cfb\u7edf\u9012\u4ea4\u8d35\u53f8\u7684DMF\u3002\u60f3\u8981\u4e86\u89e3\u66f4\u591aFDA\u5173\u4e8eDMF\u7684eCTD\u65b9\u9762\u7684\u76f8\u5173\u8981\u6c42\uff0c\u60a8\u4e5f\u53ef\u4ee5\u81f4\u7535+1-757-224-0177\u4e0e\u6211\u4eec\u8054\u7cfb\uff0c\u6216\u8005\u901a\u8fc7\u767b\u5f55www.registrarcorp.com\/livehelp\u4e0e\u6211\u4eec\u5168\u5929\u5019\u5728\u7ebf\u7684\u6cd5\u89c4\u4e13\u5458\u5b9e\u65f6\u8054\u7edc\uff01<\/p>\n","protected":false},"author":2,"featured_media":40103,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[68],"tags":[],"class_list":{"0":"post-40781","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-zh","8":"entry"},"yoast_head":"\n2018\u5e745\u67085\u65e5\u8d77\u6240\u6709DMF\u5fc5\u987b\u4ee5eCTD\u683c\u5f0f\u5411FDA\u9012\u4ea4 - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"2018\u5e745\u67085\u65e5\u8d77\u6240\u6709DMF\u5fc5\u987b\u4ee5eCTD\u683c\u5f0f\u5411FDA\u9012\u4ea4\" \/>\n<meta property=\"og:description\" content=\"2018\u5e745\u67085\u65e5\u8d77\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u5c06\u4f1a\u8981\u6c42\u6240\u6709\u7684\u4f01\u4e1a\u4ee5\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\uff08eCTD\uff09\u683c\u5f0f\u5411FDA\u9012\u4ea4\u6240\u6709\u65b0\u7684\u836f\u7269\u7ba1\u7406\u6863\u6848\uff08DMF\uff09\u8d44\u6599\uff0c\u5305\u62ec\u5e74\u5ea6\u62a5\u544a\u548c\u4fee\u6b63\u6587\u6863\u3002FDA\u8868\u660e\uff0c\u81ea\u8be5\u65e5\u671f\u8d77\u5176\u5c06\u4f1a\u62d2\u6536\u6240\u6709\u975eeCTD\u683c\u5f0f\u7684DMF\u7533\u8bf7\u8d44\u6599\u3002 What is eCTD? \u4f55\u4e3aeCTD\uff1f eCTD\u662fFDA\u76ee\u524d\u6807\u51c6\u5316\u7684\u7533\u8bf7\u683c\u5f0f\u3002\u65b0\u836f\u7533\u8bf7\uff08NDAs\uff09\uff0c\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7(INDs)\uff0c\u7b80\u7565\u65b0\u836f\u7533\u8bf7\uff08ANDAs\uff09\uff0c\u4ee5\u53ca\u67d0\u4e9b\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7(BLAs)\u5747\u9700\u4ee5\u8be5\u683c\u5f0f\u5411FDA\u9012\u4ea4\u3002FDA\u8868\u793a\uff0c\u6839\u636e\u300a\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u53ca\u5316\u5986\u54c1(FD&C) \u6cd5\u6848\u300b\u7684\u8981\u6c42\uff0cDMF\u901a\u5e38\u662f\u4e3a\u4e86\u652f\u6491\u524d\u8ff0\u7533\u8bf7\u7684\u76ee\u7684\u800c\u9012\u4ea4\u7684\uff0c\u56e0\u6b64\uff0cDMF\u4e5f\u7406\u5e94\u8981\u901a\u8fc7eCTD\u683c\u5f0f\u6765\u9012\u4ea4\u3002 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Corp\u53ef\u4ee5\u534f\u52a9\u8d35\u53f8\u5c06DMF\u8f6c\u6362\u6210eCTD\u683c\u5f0f\u5e76\u4e14\u5feb\u901f\u5730\u901a\u8fc7FDA\u7684ESG\u7cfb\u7edf\u9012\u4ea4\u8d35\u53f8\u7684DMF\u3002\u60f3\u8981\u4e86\u89e3\u66f4\u591aFDA\u5173\u4e8eDMF\u7684eCTD\u65b9\u9762\u7684\u76f8\u5173\u8981\u6c42\uff0c\u60a8\u4e5f\u53ef\u4ee5\u81f4\u7535+1-757-224-0177\u4e0e\u6211\u4eec\u8054\u7cfb\uff0c\u6216\u8005\u901a\u8fc7\u767b\u5f55www.registrarcorp.com\/livehelp\u4e0e\u6211\u4eec\u5168\u5929\u5019\u5728\u7ebf\u7684\u6cd5\u89c4\u4e13\u5458\u5b9e\u65f6\u8054\u7edc\uff01\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/zh\/drug-establishments-must-use-ectd-format-for-u-s-fda-drug-master-file-dmf-submissions-beginning-may-5-2018\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2018-03-06T13:38:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-02-07T19:24:27+00:00\" \/>\n<meta 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Registrar","robots":{"index":"noindex","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"og_locale":"zh_CN","og_type":"article","og_title":"2018\u5e745\u67085\u65e5\u8d77\u6240\u6709DMF\u5fc5\u987b\u4ee5eCTD\u683c\u5f0f\u5411FDA\u9012\u4ea4","og_description":"2018\u5e745\u67085\u65e5\u8d77\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u5c06\u4f1a\u8981\u6c42\u6240\u6709\u7684\u4f01\u4e1a\u4ee5\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\uff08eCTD\uff09\u683c\u5f0f\u5411FDA\u9012\u4ea4\u6240\u6709\u65b0\u7684\u836f\u7269\u7ba1\u7406\u6863\u6848\uff08DMF\uff09\u8d44\u6599\uff0c\u5305\u62ec\u5e74\u5ea6\u62a5\u544a\u548c\u4fee\u6b63\u6587\u6863\u3002FDA\u8868\u660e\uff0c\u81ea\u8be5\u65e5\u671f\u8d77\u5176\u5c06\u4f1a\u62d2\u6536\u6240\u6709\u975eeCTD\u683c\u5f0f\u7684DMF\u7533\u8bf7\u8d44\u6599\u3002 What is eCTD? \u4f55\u4e3aeCTD\uff1f 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