{"id":81072,"date":"2019-03-08T00:00:50","date_gmt":"2019-04-11T06:45:38","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/81072\/"},"modified":"2019-04-11T14:45:40","modified_gmt":"2019-04-11T06:45:40","slug":"09849dcd13","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/81072\/","title":{"rendered":"\u836f\u54c1\u6ce8\u518c\u7701\u7ea7\u521d\u5ba1\u53d6\u6d88\uff0c\u5168\u90e8\u7531\u56fd\u5bb6\u836f\u76d1\u5c40\u76f4\u63a5\u53d7\u7406"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"max-width: 100%;min-height: 1em;font-size: 16px;letter-spacing: 0.544px;line-height: 25.6px;white-space: normal;widows: 1;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;font-size: 16px;letter-spacing: 0.544px;line-height: 25.6px;white-space: normal;widows: 1;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"              style=\"border-width: 1px;border-style: solid;border-color: rgb(238, 237, 235);background-color: rgb(238, 237, 235);background-size: 22px;background-position: 50% 50%;background-repeat: no-repeat;box-sizing: border-box !important;word-wrap: break-word !important;width: 451px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/10-1554965140.jpeg\" alt=\"\u836f\u54c1\u6ce8\u518c\u7701\u7ea7\u521d\u5ba1\u53d6\u6d88\uff0c\u5168\u90e8\u7531\u56fd\u5bb6\u836f\u76d1\u5c40\u76f4\u63a5\u53d7\u7406\" title=\"\u836f\u54c1\u6ce8\u518c\u7701\u7ea7\u521d\u5ba1\u53d6\u6d88\uff0c\u5168\u90e8\u7531\u56fd\u5bb6\u836f\u76d1\u5c40\u76f4\u63a5\u53d7\u7406\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-size: 16px;letter-spacing: 0.544px;line-height: 25.6px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box 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&nbsp;\u54c1\u6ce8\u518c\u521d\u5ba1\u662f\u6839\u636e\u6839\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u54c1\u7ba1\u7406\u6cd5\u300b\uff08\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u4e3b\u5e2d\u4ee4\u7b2c\u56db\u5341\u4e94\u53f7\uff09 \u3001\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u54c1\u7ba1\u7406\u6cd5\u5b9e\u65bd\u6761\u4f8b\u300b\uff08\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u56fd\u52a1\u9662\u4ee4\u7b2c\u4e09\u767e\u516d\u5341\u53f7\uff09\u3001\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u4ee4\u7b2c17\u53f7\uff09\u800c\u5236\u5b9a\u7684\u836f\u54c1\u6ce8\u518c\u5de5\u4f5c\u6cd5\u3002<\/p>\n<section break-word=\"break-word\" neue=\"neue\" sc=\"sc\" gb=\"gb\" ui=\"ui\" helvetica=\"helvetica\" sans=\"sans\" yahei=\"yahei\" px=\"px\" normal=\"normal\" important=\"important\" rgb=\"rgb\"  border-box=\"border-box\" style=\"max-width: 100%;font-size: 16px;letter-spacing: 0.544px;line-height: 25.6px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section   class=\"\" style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section  style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u6b64\u4e4b\u524d\uff0c\u6211\u56fd\u836f\u54c1\u7533\u8bf7\u7684\u5ba1\u6279\u6d41\u7a0b\u5982\u4e0b\uff1a<\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word 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!important;\">2\u3001\u7701\u3001\u81ea\u6cbb\u533a\u3001\u76f4\u8f96\u5e02\u836f\u54c1\u68c0\u9a8c\u6240\u6309\u836f\u54c1\u5ba1\u6279\u5404\u9879\u6280\u672f\u8981\u6c42\u5b8c\u6210\u5bf9\u7533\u62a5\u8d44\u6599\u7684\u5ba1\u67e5\u548c\u6837\u54c1\u7684\u68c0\u9a8c\u3002\u836f\u68c0\u6240\u7684\u5ba1\u6838\u7cfb\u6307\u5bf9\u836f\u54c1\u7684\u836f\u5b66\uff08\u5305\u62ec\u836f\u7406\u3001\u6bd2\u7406\uff09\u7814\u7a76\u8d44\u6599\u8fdb\u884c\u5ba1\u67e5\u548c\u5bf9\u6837\u54c1\u8fdb\u884c\u5b9e\u9a8c\u68c0\u9a8c\uff1b\u4e0d\u5305\u62ec\u4e3a\u7533\u62a5\u5355\u4f4d\u8fdb\u884c\u65b0\u7684\u68c0\u6d4b\u65b9\u6cd5\u7684\u7814\u7a76\u3002\u836f\u68c0\u6240\u5ba1\u6838\u5b8c\u6bd5\u540e\uff0c\u63d0\u51fa\u8d28\u91cf\u6807\u51c6\u548c\u5bf9\u836f\u5b66\uff08\u5305\u62ec\u836f\u7406\u3001\u6bd2\u7406\uff09\u65b9\u9762\u7684\u7efc\u5408\u5ba1\u67e5\u610f\u89c1\uff0c\u9001\u7701\u7ea7\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\">3\u3001\u7701\u7ea7\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u521d\u5ba1\u901a\u8fc7\u540c\u610f\u4e0a\u62a5\u7684\uff0c\u5728\u836f\u54c1\u4e34\u5e8a\u7814\u7a76\uff08\u6216\u751f\u4ea7\uff09\u7533\u8bf7\u8868\u7b7e\u7f72\u610f\u89c1\uff0c\u8fde\u540c\u7533\u62a5\u7684\u6280\u672f\u8d44\u6599\u4e00\u5f0f5\u4efd\u62a5\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6ce8\u518c\u53f8\u8fdb\u884c\u5f62\u5f0f\u5ba1\u67e5\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word 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break-word !important;\">6\u3001\u529e\u7406\u836f\u54c1\u4e34\u5e8a\u7814\u7a76\u7533\u8bf7\u6279\u4ef6\uff0c\u62a5\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6ce8\u518c\u53f8\u53f8\u957f\u5ba1\u6279\u3002\u7533\u62a5\u5355\u4f4d\u5728\u53d6\u5f97\u4e34\u5e8a\u7814\u7a76\u6279\u4ef6\u4ee5\u540e\uff0c\u5728\u9009\u62e9\u7684\u4e34\u5e8a\u7814\u7a76\u8d1f\u8d23\u548c\u627f\u62c5\u5355\u4f4d\u4e2d\uff0c\u8fdb\u884c\u836f\u54c1\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\">7\u3001\u529e\u7406\u836f\u54c1\u751f\u4ea7\u7533\u8bf7\u6279\u4ef6\uff0c\u62a5\u6ce8\u518c\u53f8\u53f8\u957f\u5ba1\u6838\uff0c\u518d\u8f6c\u62a5\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5c40\u957f\u5ba1\u6279\u3002\u836f\u54c1\u8d28\u91cf\u6807\u51c6\u4e0e\u8f6c\u6b63\u6280\u672f\u5ba1\u67e5\u5de5\u4f5c\u7531\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a\u8d1f\u8d23\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\">8.\u5c06\u7533\u8bf7\u6279\u4ef6\u53d1\u9001\u7533\u62a5\u5355\u4f4d\u7b49\u3002<\/p>\n<p style=\"margin-top: 20px;margin-bottom: 20px;padding-right: 10px;padding-left: 10px;max-width: 100%;min-height: 1em;font-size: 14px;line-height: 2em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"     style=\"color: rgb(62, 62, 62);font-family: &quot;Microsoft YaHei&quot;, -apple-system-font, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, sans-serif;font-size: 16px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;width: auto !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/04\/9-1554965140.jpeg\" alt=\"\u836f\u54c1\u6ce8\u518c\u7701\u7ea7\u521d\u5ba1\u53d6\u6d88\uff0c\u5168\u90e8\u7531\u56fd\u5bb6\u836f\u76d1\u5c40\u76f4\u63a5\u53d7\u7406\" title=\"\u836f\u54c1\u6ce8\u518c\u7701\u7ea7\u521d\u5ba1\u53d6\u6d88\uff0c\u5168\u90e8\u7531\u56fd\u5bb6\u836f\u76d1\u5c40\u76f4\u63a5\u53d7\u7406\"  \/><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<h2 style=\"white-space: normal;max-width: 100%;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<p class=\"\" style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;font-size: 17px;letter-spacing: 0.544px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u5b8b\u4f53;font-size: 28px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(136, 136, 136);font-size: 12px;letter-spacing: 0.544px;widows: 1;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ee5\u4e0a\u56fe\u6587\uff0c\u5982\u6d89\u53ca\u7248\u6743\u95ee\u9898\uff0c<\/span><span style=\"max-width: 100%;font-size: 12px;widows: 1;color: rgb(38, 38, 38);font-family: Optima-Regular, PingFangTC-light, \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 0.5px;text-align: start;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8bf7\u4e0e\u5c0f\u7f16\u8054\u7cfb\u6211\u4eec\u4f1a\u59a5\u5584\u5904\u7406<\/span><\/span><\/strong><\/strong><\/span><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 24px;\">\u836f\u54c1\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863eCTD\u7533\u62a5<\/span><\/strong><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 24px;\">\u8981\u6c42<\/span><\/strong><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 24px;\">\u4e13\u9898\u57f9\u8bad\u73ed<\/span><\/strong><\/p>\n<\/h2>\n<section class=\"\" style=\"white-space: normal;max-width: 100%;box-sizing: border-box;letter-spacing: 0.544px;word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;line-height: 25.6px;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-bottom: -8px;max-width: 100%;box-sizing: border-box;border-width: 8px;border-style: solid;border-color: rgb(249, 110, 87);border-radius: 0.5em;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;background-color: rgb(249, 110, 87);word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px 5px;max-width: 100%;box-sizing: border-box;border-radius: 1em;border-width: 1px;border-style: solid;border-color: rgb(249, 110, 87);background-color: rgb(255, 255, 255);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;text-align: left;word-wrap: break-word !important;\">\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e00\u3001CTD\u4e0e<span style=\"font-family: &quot;Times New Roman&quot;\">eCTD<\/span>\u7684\u76f8\u4e92\u5173\u7cfb<\/span><\/strong><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">1eCTD&nbsp;\u7684\u524d\u4e16\u4eca\u751f<span style=\"font-family: &quot;Times New Roman&quot;\">&#8212;-eCTD&nbsp;<\/span>\u6280\u672f\u89c4\u8303\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u8bb2\u89e3<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">2CTD&nbsp;\u4e0e<span style=\"font-family: &quot;Times New Roman&quot;\">eCTD:<\/span>\u7eb8\u8d28\u6750\u6599\u548c\u7535\u5b50\u6750\u6599\u95f4\u7684\u5dee\u5f02<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">3eCTD\u7533\u62a5\u8d44\u6599\u7684\u7ed3\u6784\u8bb2\u89e3<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\uff08\u4ec0\u4e48\u662feCTD\u9012\u4ea4\u7684\u7533\u8bf7\u53f7\uff0c\u5e8f\u5217\u53f7\u4ee5\u53ca\u6587\u4ef6\u7684\u751f\u547d\u5468\u671f\uff1f\uff09<\/span><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e8c\u3001ICH-CTD-eCTD\u6574\u5408\u4e0e\u5408\u89c4\u51c6\u5907\u6ce8\u518c\u6587\u6863<\/span><\/strong><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">1eCTD&nbsp;\u5404\u7c7b\u57fa\u672c\u6587\u4ef6\u7684\u7f16\u5236<\/span><\/strong><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">a)&nbsp;\u884c\u653f\u7ba1\u7406\u4fe1\u606f<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">b)&nbsp;\u603b\u7ed3\u4e0e\u7efc\u8ff0<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">c)&nbsp;\u8d28\u91cf\u8d44\u6599\uff08\u836f\u5b66\uff09<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">d)&nbsp;\u975e\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\uff08\u836f\u7406\u6bd2\u7406\u5b66\uff09<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">e)&nbsp;\u4e34\u5e8a\u7814\u7a76\u62a5\u544a<\/span><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">2eCTD\u64b0\u5199\u7ba1\u7406<\/span><\/strong><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e09\u3001\u836f\u54c1\u7814\u53d1\u4e0d\u540c\u65f6\u671f\u63d0\u4ea4\u7684\u6587\u4ef6<\/span><\/strong><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u56db\u3001\u7533\u62a5\u8d44\u6599\u4e0e\u6570\u636e\u53ef\u9760\u6027<\/span><\/strong><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e94\u3001\u836f\u54c1\u6ce8\u518c\u751f\u547d\u5468\u671f\u7ba1\u7406<\/span><\/strong><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e3b\u8bb2\u4eba\uff1a\u6881\u8001\u5e08&nbsp;&nbsp;\u4e2d\u56fd\u836f\u79d1\u5927\u5b66\u56fd\u9645\u533b\u836f\u5546\u5b66\u9662\u836f\u54c1\u56fd\u5185\u5916\u6ce8\u518c\u548c\u8d28\u91cf\u8ba4\u8bc1\u836f\u4e8b\u6cd5\u89c4\u8d44\u6df1\u6559\u6388\uff0c\u6df1\u523b\u89e3\u8bfbeCTD\u7684\u6e0a\u6e90\u548c\u539f\u7406\uff0c<span style=\"font-family: &quot;Times New Roman&quot;\">CFDA<\/span>\u5173\u4e8e<span style=\"font-family: &quot;Times New Roman&quot;\">eCTD<\/span>\u7ba1\u7406\u53ca\u5176\u6307\u5bfc\u539f\u5219\u7684\u7cbe\u795e\u5b9e\u8d28\u3002<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin: auto;max-width: 100%;box-sizing: border-box;width: 200.391px;height: 8px;vertical-align: top;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><br class=\"\" style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/section>\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;letter-spacing: 0.544px;text-align: justify;word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;line-height: 25.6px;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-bottom: -8px;max-width: 100%;box-sizing: border-box;border-width: 8px;border-style: solid;border-color: rgb(249, 110, 87);border-radius: 0.5em;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: -8px;margin-right: auto;margin-left: auto;max-width: 100%;box-sizing: border-box;width: 195.594px;height: 8px;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><\/section>\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;background-color: rgb(249, 110, 87);word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px 5px;max-width: 100%;box-sizing: border-box;border-radius: 1em;border-width: 1px;border-style: solid;border-color: rgb(249, 110, 87);background-color: rgb(255, 255, 255);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;text-align: left;word-wrap: break-word !important;\">\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e00\u3001eCTD\u539f\u7406\u3001\u4e2d\u56fd\u4e0e\u6b27\u7f8e<span style=\"font-family: &quot;Times New Roman&quot;\">eCTD<\/span>\u5f02\u540c<\/span><\/strong><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e8c\u3001eCTD\u89e3\u51b3\u65b9\u6848<span style=\"font-family: &quot;Times New Roman&quot;\">&#8212;&#8211;<\/span>\u5916\u5305\u8fd8\u662f\u8d2d\u4e70\u8f6f\u4ef6<\/span><\/strong><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e09\u3001eCTD\u6587\u4ef6\u7684\u7ec4\u6210\u4e0e<span style=\"font-family: &quot;Times New Roman&quot;\">eCTD<\/span>\u4e2d\u7684\u4e3b\u8981\u6982\u5ff5<\/span><\/strong><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u56db\u3001\u5236\u4f5ceCTD\u9700\u8981\u7684\u6280\u80fd\u4e0e\u5de5\u5177<\/span><\/strong><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">1.\u4ec0\u4e48\u662f<span style=\"font-family: &quot;Times New Roman&quot;\">XML<\/span>\uff1f\u4e3a\u4ec0\u4e48<span style=\"font-family: &quot;Times New Roman&quot;\">eCTD<\/span>\u8981\u91c7\u7528<span style=\"font-family: &quot;Times New Roman&quot;\">XML<\/span>\u8bed\u8a00\uff1f\u4f01\u4e1a<span style=\"font-family: &quot;Times New Roman&quot;\">IT<\/span>\u4eba\u5458\u53ef\u4ee5\u81ea\u884c\u5236\u4f5c\u5417\uff1f<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">2\u5236\u4f5c<span style=\"font-family: &quot;Times New Roman&quot;\">ectd<\/span>\u6587\u4ef6\u65f6\u9700\u8981\u638c\u63e1\u7684\u6280\u80fd\uff0c\u4ee5\u53ca\u5982\u4f55\u63d0\u9ad8<span style=\"font-family: &quot;Times New Roman&quot;\">ectd<\/span>\u6587\u4ef6\u7684\u5236\u4f5c\u6548\u7387<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">3\u7f16\u5199\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u51fa\u73b0\u7684\u95ee\u9898\u53ca\u89e3\u51b3<\/span><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e94\u3001\u89e3\u8bfb\uff1a\u4e2d\u56fd\u836f\u54c1\u8bc4\u5ba1\u4e2d\u5fc3\uff08CDE\uff09\u53d1\u5e03\u7684<span style=\"font-family: &quot;Times New Roman&quot;\">eCTD<\/span>\u6280\u672f\u89c4\u8303\u5f81\u6c42\u610f\u89c1\u7a3f\u3001<span style=\"font-family: &quot;Times New Roman&quot;\">eCTD<\/span>\u9a8c\u8bc1\u6807\u51c6\u5f81\u6c42\u610f\u89c1\u7a3f\u4ee5\u53ca\u914d\u5957\u6587\u4ef6<\/span><\/strong><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\uff08eCTD\u5982\u4f55\u9a8c\u8bc1\u53ca\u5e38\u89c1\u9a8c\u8bc1\u95ee\u9898\u5206\u6790\uff09<\/span><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u516d\u3001eCTD&nbsp;\u751f\u547d\u5468\u671f\u7ba1\u7406<\/span><\/strong><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">1\u7533\u62a5\u751f\u547d\u5468\u671f\uff0c\u5982\u53d8\u91cf\u548c\u7533\u62a5\u7ebf\u5ef6\u957f<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">2\u6587\u6863\u751f\u547d\u5468\u671f\u6587\u6863\u751f\u547d\u5468\u671f\uff08\u65b0\u5efa\u3001\u66ff\u6362\u3001\u5220\u9664\u3001\u589e\u8865\uff09<\/span><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-weight: bold;font-size: 16px;\">\u4e03\u3001<\/span><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e2d\u56fdeCTD\u5236\u4f5c\u8fc7\u7a0b\u8f85\u5bfc<\/span><\/strong><\/p>\n<p><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u7ed3\u5408\u6b27\u7f8eeCTD\u6210\u529f\u6848\u4f8b\u3001\u7406\u8bba<span style=\"font-family: &quot;Times New Roman&quot;\">+<\/span>\u5b9e\u9645\u64cd\u4f5c\u6f14\u793a\u76f8\u7ed3\u5408<\/span><\/p>\n<p><strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e3b\u8bb2\u4eba\uff1a\u960e\u8001\u5e08\uff1a<\/span><\/strong><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u4e3b\u8bb2\u8fc79\u6b21\u5168\u56fd\u6027\u7684eCTD\u57f9\u8bad\uff0c\u5927\u5927\u52a0\u901f\u4e86\u836f\u4f01\u4eba\u5458\u5b66\u4f1aeCTD\u77e5\u8bc6\u7684\u8fdb\u5ea6\u3001\u4e3a\u4ed6\u4eec\u5927\u5927\u8282\u7ea6\u4e86\u719f\u7ec3\u638c\u63e1eCTD\u6240\u9700\u7684\u65f6\u95f4\u3002<\/span><span style=\"font-family: \u5b8b\u4f53;font-size: 16px;\">\u5728\u6b27\u7f8e\u836f\u54c1\u6cd5\u89c4\u3001\u6ce8\u518c\u548ccGMP\u8ba4\u8bc1\u9886\u57df\uff0c\u62e5\u6709\u591a\u5e74\u54a8\u8be2\u7ecf\u9a8c\uff0c\u5e2e\u52a9\u4f17\u591a\u836f\u5382\u89c4\u5212\u3001\u7f16\u5199\u3001\u7ffb\u8bd1\u548c\u63d0\u4ea4\u4e86\u6570\u5341\u4e2a\u7eb8\u8d28\u7248\u548ceCTD\u683c\u5f0f\u7684DMF\u3001\u83b7\u5f97\u4e86\u591a\u4e2aCEP\u8bc1\u4e66\uff0c\u4e3a\u5f88\u591a\u836f\u5382\u6700\u7ec8\u6210\u529f\u901a\u8fc7FDA\u548c\u6b27\u76dfcGMP\u68c0\u67e5\u505a\u4e86\u5927\u91cf\u5de5\u4f5c\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin: auto;max-width: 100%;box-sizing: border-box;width: 200.391px;height: 8px;vertical-align: top;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;line-height: 25.6px;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-bottom: -8px;max-width: 100%;box-sizing: border-box;border-width: 8px;border-style: solid;border-color: rgb(249, 110, 87);border-radius: 0.5em;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: -8px;margin-right: auto;margin-left: auto;max-width: 100%;box-sizing: border-box;width: 195.594px;height: 8px;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/section>\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;background-color: rgb(249, 110, 87);word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px 5px;max-width: 100%;box-sizing: border-box;border-radius: 1em;border-width: 1px;border-style: solid;border-color: rgb(249, 110, 87);background-color: rgb(255, 255, 255);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;text-align: left;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u4eff\u5b8b_GB2312;font-size: 19px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e00\u3001\u4f1a\u8bae\u65f6\u95f4\u5730\u70b9\uff1a<\/span><\/span><\/strong><span style=\"max-width: 100%;font-family: \u4eff\u5b8b_GB2312;font-size: 19px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/p>\n<p style=\"line-height: 28px;\"><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u65f6\u95f4\uff1a201<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">9<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u5e74<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">4<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u6708<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">12<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u65e5-<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">4<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u6708<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">14<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u65e5\uff08<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">12<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u65e5\u5168\u5929\u62a5\u5230\uff09<\/span><\/p>\n<p style=\"line-height: 28px;\"><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u5730\u70b9:&nbsp;<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u4e0a\u6d77<\/span><span style=\"font-family: \u4eff\u5b8b_GB2312;font-size: 19px;\">\u5e02&nbsp;\uff08\u5730\u70b9\u786e\u5b9a\u76f4\u63a5\u901a\u77e5\u62a5\u540d\u8005\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin: auto;max-width: 100%;box-sizing: border-box;width: 200.391px;height: 8px;vertical-align: top;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;line-height: 25.6px;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-bottom: -8px;max-width: 100%;box-sizing: border-box;border-width: 8px;border-style: solid;border-color: rgb(249, 110, 87);border-radius: 0.5em;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: -8px;margin-right: auto;margin-left: auto;max-width: 100%;box-sizing: border-box;width: 195.594px;height: 8px;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><\/section>\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;background-color: rgb(249, 110, 87);word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px 5px;max-width: 100%;box-sizing: border-box;border-radius: 1em;border-width: 1px;border-style: solid;border-color: rgb(249, 110, 87);background-color: rgb(255, 255, 255);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;text-align: left;word-wrap: break-word !important;\">\n<p class=\"\" style=\"max-width: 100%;min-height: 1em;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong class=\"\" style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-family: \u4eff\u5b8b_GB2312;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e8c\u3001\u53c2\u4f1a\u5bf9\u8c61<\/span><\/strong><\/span><\/p>\n<p class=\"\" style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-family: \u5b8b\u4f53;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u3000<span style=\"max-width: 100%;font-family: \u4eff\u5b8b_GB2312;font-size: 14pt;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5236\u836f\u4f01\u4e1a\u548c\u7814\u53d1\u673a\u6784\u4ece\u4e8b\u836f\u54c1\u7814\u53d1\u3001\u5236\u5242\u7814\u53d1\u3001\u8d28\u91cf\u7814\u7a76\u3001<\/span>QA\u3001QC\u3001\u751f\u4ea7\u4eba\u5458\u3001\u5de5\u827a\u4eba\u5458\u548c\u5de5\u7a0b\u4eba\u5458\uff0c\u9662\u6821\u3001\u79d1\u7814\u9662\u6240\u76f8\u5173\u4eba\u5458\u3002<\/span><span style=\"max-width: 100%;font-family: \u4eff\u5b8b_GB2312;font-size: 14pt;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin: auto;max-width: 100%;box-sizing: border-box;width: 200.391px;height: 8px;vertical-align: top;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;line-height: 25.6px;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-bottom: -8px;max-width: 100%;box-sizing: border-box;border-width: 8px;border-style: solid;border-color: rgb(249, 110, 87);border-radius: 0.5em;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: -8px;margin-right: auto;margin-left: auto;max-width: 100%;box-sizing: border-box;width: 195.594px;height: 8px;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><\/section>\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;background-color: rgb(249, 110, 87);word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px 5px;max-width: 100%;box-sizing: border-box;border-radius: 1em;border-width: 1px;border-style: solid;border-color: rgb(249, 110, 87);background-color: rgb(255, 255, 255);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;text-align: left;word-wrap: break-word !important;\">\n<p class=\"\" style=\"max-width: 100%;min-height: 1em;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong class=\"\" style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-family: \u4eff\u5b8b_GB2312;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4e09\u3001\u4f1a\u8bae\u8d39\u7528<\/span><\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<p>\u4f1a\u52a1\u8d39\uff1a2200\u5143\/\u4eba\uff08\u542b2\u5929\u5348\u9910\uff09\u3002\u4f4f\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\" style=\"margin: auto;max-width: 100%;box-sizing: border-box;width: 200.391px;height: 8px;vertical-align: top;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;line-height: 25.6px;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-bottom: -8px;max-width: 100%;box-sizing: border-box;border-width: 8px;border-style: solid;border-color: rgb(249, 110, 87);border-radius: 0.5em;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: -8px;margin-right: auto;margin-left: auto;max-width: 100%;box-sizing: border-box;width: 195.594px;height: 8px;background-color: rgb(254, 255, 255);word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/section>\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;background-color: rgb(249, 110, 87);word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding: 10px 5px;max-width: 100%;box-sizing: border-box;border-radius: 1em;border-width: 1px;border-style: solid;border-color: rgb(249, 110, 87);background-color: rgb(255, 255, 255);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;text-align: left;word-wrap: break-word !important;\">\n<p class=\"\" style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong class=\"\" style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-family: \u4eff\u5b8b_GB2312;box-sizing: border-box !important;word-wrap: break-word !important;\">\u56db\u3001\u8054\u7cfb\u65b9\u5f0f<\/span><span class=\"\" style=\"max-width: 100%;font-family: \u4eff\u5b8b_GB2312;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;<\/span><\/span><\/strong><\/p>\n<p class=\"\" style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 37px;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong class=\"\" style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-size: 19px;font-family: \u4eff\u5b8b_GB2312;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8054<\/span>&nbsp;<span class=\"\" style=\"max-width: 100%;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u7cfb<\/span>&nbsp;<span class=\"\" style=\"max-width: 100%;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4eba\uff1a\u6f58\u6613<\/span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;panyi2010@126.com &nbsp;&nbsp;<\/span><\/span><\/strong><\/p>\n<p class=\"\" style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\"><strong class=\"\" style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span class=\"\" style=\"max-width: 100%;font-family: \u5b8b\u4f53;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp; \u7535&nbsp; \u8bdd\uff1a13522766753 \uff08\u5fae\u4fe1\u540c\u53f7\uff09<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p><br  \/><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; &nbsp; &nbsp; 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