{"id":35784,"date":"2018-08-23T01:00:00","date_gmt":"2018-09-17T05:56:32","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e6%ac%a7%e7%9b%9f%e6%8b%92%e7%bb%9d%e5%b7%b2%e8%8e%b7fda%e6%89%b9%e5%87%86%e7%9a%84%e4%b8%a4%e7%a7%8d%e8%8d%af%e5%93%81%e4%b8%8a%e5%b8%82-%ef%bc%81\/"},"modified":"2018-09-17T13:56:33","modified_gmt":"2018-09-17T05:56:33","slug":"%e6%ac%a7%e7%9b%9f%e6%8b%92%e7%bb%9d%e5%b7%b2%e8%8e%b7fda%e6%89%b9%e5%87%86%e7%9a%84%e4%b8%a4%e7%a7%8d%e8%8d%af%e5%93%81%e4%b8%8a%e5%b8%82-%ef%bc%81","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/35784\/","title":{"rendered":"\u6b27\u76df\u62d2\u7edd\u5df2\u83b7FDA\u6279\u51c6\u7684\u4e24\u79cd\u836f\u54c1\u4e0a\u5e02 \uff01"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section class=\"\"   >\n<section style=\"margin:10px auto;\">\n<section style=\"margin: 3px;padding: 15px;color: rgb(62, 62, 62);line-height: 24px;box-shadow: rgb(170, 170, 170) 0px 0px 3px;border-width: 2px;border-style: solid;border-color: rgb(240, 240, 240);\">\n<p style=\"text-align: justify;text-indent: 2em;\">2018\u5e743\u670823\u65e5\uff0cEMA\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08CHMP\uff09\u5426\u51b3\u4e86\u4e24\u79cd\u836f\u54c1\u7684\u7533\u8bf7\uff1aDexxience\uff08betrixaban\uff0c\u8d1d\u66f2\u6c99\u73ed\uff0c\u7528\u4e8e\u9884\u9632\u9759\u8109\u8840\u6813\u6813\u585e\uff09\u548cEladynos\uff08abaloparatid\uff0c\u963f\u5df4\u5e15\u80bd\uff0c\u7528\u4e8e\u6cbb\u7597\u9ad8\u9aa8\u6298\u98ce\u9669\u7684\u5973\u6027\u7edd\u7ecf\u540e\u9aa8\u8d28\u758f\u677e\u75c7\u60a3\u8005\uff09\u3002\u800c\u8fd9\u4e24\u79cd\u836f\u54c1\u5206\u522b\u4e8e2017\u5e746\u6708\u548c5\u6708\u5df2\u7ecf\u901a\u8fc7\u4e86FDA\u7684\u6279\u51c6\u3002<\/p>\n<p><br  \/><\/p>\n<p style=\"text-align: justify;text-indent: 2em;\">CHMP\u62d2\u7edd\u6279\u51c6\u8d1d\u66f2\u6c99\u73ed\u7684\u7406\u7531\u662f\uff1a\u65e0\u6cd5\u786e\u5b9a\u83b7\u76ca\u5927\u4e8e\u98ce\u9669\u3002\u4e3b\u8981\u7814\u7a76\u672a\u80fd\u4ee4\u4eba\u6ee1\u610f\u7684\u8bc1\u660e\uff0c\u56e0\u8fd1\u671f\u60a3\u75c5\u800c\u4f4f\u9662\u7684\u60a3\u8005\u5e94\u7528\u8d1d\u66f2\u6c99\u73ed\u9884\u9632\u8840\u6813\u6813\u585e\u65f6\u7684\u83b7\u76ca\u5927\u4e8e\u98ce\u9669\u3002\u6b64\u5916\uff0c\u7814\u7a76\u7684\u7ed3\u679c\u88ab\u8ba4\u4e3a\u662f\u4e0d\u53ef\u9760\u7684\uff0c\u56e0\u4e3a\u672a\u83b7\u5f97\u67d0\u4e9b\u8840\u6813\u76f8\u5173\u68c0\u67e5\u7684\u7ed3\u679c\u3002\u8d1d\u66f2\u6c99\u73ed\u6cbb\u7597\u7ec4\u60a3\u8005\u7684\u51fa\u8840\u4e8b\u4ef6\u591a\u4e8e\u5bf9\u7167\u7ec4\u3002\u8003\u8651\u5230\u8be5\u836f\u9884\u8ba1\u5c06\u7528\u4e8e\u4f34\u6709\u4e25\u91cd\u57fa\u7840\u75be\u75c5\u7684\u60a3\u8005\uff0c\u8fd9\u4e00\u70b9\u662f\u5f88\u91cd\u8981\u7684\u5b89\u5168\u6027\u95ee\u9898\u3002<\/p>\n<p><br  \/><\/p>\n<p style=\"text-align: justify;text-indent: 2em;\">CHMP\u62d2\u7edd\u6279\u51c6\u963f\u5df4\u5e15\u80bd\u7684\u7406\u7531\u662f\uff1a\u65e0\u6cd5\u786e\u5b9a\u83b7\u76ca\u5927\u4e8e\u98ce\u9669\u3002\u4e3b\u8981\u7814\u7a76\u672a\u80fd\u4ee4\u4eba\u6ee1\u610f\u7684\u8bc1\u660e\uff0c\u5728\u7edd\u7ecf\u540e\u5973\u6027\u4e2d\u963f\u5df4\u5e15\u80bd\u53ef\u6709\u6548\u9884\u9632\u975e\u690e\u9aa8\u9aa8\u6298\u3002\u6709\u4e24\u4e2a\u7814\u7a76\u4e2d\u5fc3\u56e0\u4e3a\u672a\u9075\u5faaGCP\uff0c\u83b7\u5f97\u7684\u6570\u636e\u4e0d\u53ef\u9760\uff0c\u9700\u8981\u4ece\u7814\u7a76\u4e2d\u5254\u9664\u3002\u6b64\u5916\uff0c\u4ece\u5b89\u5168\u7684\u89d2\u5ea6\uff0c\u56e0\u4e3a\u7edd\u7ecf\u540e\u5973\u6027\u7684\u5fc3\u810f\u75be\u75c5\u98ce\u9669\u5347\u9ad8\uff0cCHMP\u62c5\u5fc3\u8be5\u836f\u4f1a\u589e\u52a0\u5fc3\u810f\u98ce\u9669\u3002<\/p>\n<p><br  \/><\/p>\n<p style=\"text-align: justify;text-indent: 2em;\">\u5f53\u7136\uff0c\u8fd9\u5e76\u4e0d\u662f\u7b2c\u4e00\u6b21EMA\u4e0eFDA\u7684\u5ba1\u8bc4\u610f\u89c1\u76f8\u5de6\u30022018\u5e742\u670822\u65e5\uff0cCHMP\u5c31\u5426\u51b3\u8fc7FDA\u5df2\u4e8e2017\u5e747\u6708\u6279\u51c6\u7684\u4e73\u817a\u764c\u836f\u7269Nerlynx \uff08neratinib\uff0c\u6765\u90a3\u66ff\u5c3c\uff09\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"   >\n<section class=\"\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"width: 100%;transform: rotate(0deg);-webkit-transform: rotate(0deg);-moz-transform: rotate(0deg);-o-transform: rotate(0deg);box-sizing: border-box;\">\n<section class=\"\" style=\"background-color:rgb(46, 167, 224);box-sizing:border-box;height:4px;width:50px;\" ><\/section>\n<\/section>\n<section style=\"background-color:rgb(239, 239, 239);box-sizing:border-box;margin-top:-4px;padding:10px;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"text-align: justify;\"><strong><span style=\"font-size: 14px;\">\u6765\u6e90\uff1a<\/span><\/strong><\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"font-size: 14px;\">https:\/\/www.raps.org\/news-and-articles\/news-articles\/2018\/3\/ema%E2%80%99s-chmp-rejects-two-drugs-approved-by-us-fda-in<\/span><\/strong><\/p>\n<p><br  \/><\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"font-size: 14px;\">\u539f\u6587\u520a\u767b\u4e8e\u300a\u56fd\u9645\u836f\u54c1\u68c0\u67e5\u52a8\u6001\u7814\u7a76\u300b\u7b2c3\u5377 \u7b2c2\u671f \uff08\u603b\u7b2c11\u520a\uff09\uff0c2018\uff0cP6<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<hr  \/>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 15px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><br  \/><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><span style=\"font-size: 15px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u4ee5\u4e0b\u4e3a\u5546\u52a1\u63a8\u5e7f\uff0c\u4e0e\u6587\u7ae0\u65e0\u5173\u3002<\/span><br  \/><\/p>\n<h2 class=\"\" style=\"margin-bottom: 14px;font-size: 22px;max-width: 100%;color: rgb(51, 51, 51);\"><strong><span style=\"max-width: 100%;font-size: 15px;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;\">\u67cf\u864e\u79d1\u6280\u52a9\u529b\u4e2d\u56fd\u5b9e\u9a8c\u5ba4\u5efa\u8bbe\u2014\u6253\u9020\u4e00\u4f53\u5316\u5b9e\u9a8c\u5ba4\u5de5\u7a0b\u670d\u52a1\u5e73\u53f0<\/span><\/strong><\/h2>\n<p><strong><span style=\"font-size: 15px;color: rgb(2, 30, 170);\">\u8054\u7cfb\u4eba\uff1a\u4f55\u7ecf\u7406&nbsp;&nbsp;<\/span><\/strong><span style=\"color: rgb(217, 33, 66);\"><strong><span style=\"font-size: 15px;\">13913118411<\/span><\/strong><\/span><strong><span style=\"font-size: 15px;color: rgb(2, 30, 170);\">\uff08\u5fae\u4fe1\u540c\u53f7\uff09<\/span><\/strong><\/p>\n<p><br  \/><\/p>\n<p><img class=\"\"      style=\"width: 677px !important;height: auto !important;visibility: visible !important;\"  src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/8-1537163793.jpeg\" alt=\"\u6b27\u76df\u62d2\u7edd\u5df2\u83b7FDA\u6279\u51c6\u7684\u4e24\u79cd\u836f\u54c1\u4e0a\u5e02 \uff01\" title=\"\u6b27\u76df\u62d2\u7edd\u5df2\u83b7FDA\u6279\u51c6\u7684\u4e24\u79cd\u836f\u54c1\u4e0a\u5e02 \uff01\"  \/><\/p>\n<p><br  \/><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>2018\u5e743\u670823\u65e5\uff0cEMA\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08CHMP\uff09\u5426\u51b3\u4e86\u4e24\u79cd\u836f\u54c1\u7684\u7533\u8bf7\uff1aDexxience\uff08betrixa [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":35785,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/35784"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=35784"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/35784\/revisions"}],"predecessor-version":[{"id":35787,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/35784\/revisions\/35787"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/35785"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=35784"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=35784"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=35784"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}