{"id":4838,"date":"2019-01-07T20:11:56","date_gmt":"2019-01-07T12:11:56","guid":{"rendered":"https:\/\/www.eamar.com.cn\/?p=4838"},"modified":"2019-01-07T20:12:58","modified_gmt":"2019-01-07T12:12:58","slug":"%e5%bb%ba%e7%ab%8b%e8%8d%af%e5%93%81%e4%bf%a1%e6%81%af%e5%8c%96%e8%bf%bd%e6%ba%af%e4%bd%93%e7%b3%bb%ef%bc%8c%e4%be%9d%e7%8e%9b%e5%96%b7%e7%a0%81%e6%9c%ba%e6%ac%a7%e7%9b%9ffmd%e7%bb%8f%e9%aa%8c","status":"publish","type":"post","link":"https:\/\/www.eamar.com.cn\/archives\/4838","title":{"rendered":"\u5efa\u7acb\u836f\u54c1\u4fe1\u606f\u5316\u8ffd\u6eaf\u4f53\u7cfb\uff0c\u4f9d\u739b\u55b7\u7801\u673a\u6b27\u76dfFMD\u7ecf\u9a8c\u53ef\u501f\u9274"},"content":{"rendered":"\n<p>2018\u5e7410\u670831\u65e5\u56fd\u5bb6\u836f\u76d1\u5c40\u53d1\u5e03\u7684\u300a\u5173\u4e8e\u836f\u54c1\u4fe1\u606f\u5316\u8ffd\u6eaf\u4f53\u7cfb\u7684\u6307\u5bfc\u610f\u89c1\u300b\uff1a<strong>\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u548c\u751f\u4ea7\u4f01\u4e1a\u5e94\u5c65\u884c\u836f\u54c1\u4fe1\u606f\u5316\u8ffd\u6eaf\u7ba1\u7406\u8d23\u4efb\uff0c\u6309\u7167\u7edf\u4e00\u836f\u54c1\u8ffd\u6eaf\u7f16\u7801\u8981\u6c42\uff0c\u5bf9\u4ea7\u54c1\u5404\u7ea7\u9500\u552e\u5305\u88c5\u5355\u5143\u8d4b\u4ee5\u552f\u4e00\u8ffd\u6eaf\u6807\u8bc6\u4ee5\u5b9e\u73b0\u4fe1\u606f\u5316\u8ffd\u6eaf\u3002\u751f\u4ea7\u836f\u54c1\u7684\u6d41\u901a\u3001\u4f7f\u7528\u7b49\u5168\u8fc7\u7a0b\u4fdd\u6301\u4fe1\u606f\u6e20\u9053\u7684\u7545\u901a\uff0c\u786e\u4fdd\u4efb\u4f55\u76f8\u5173\u65b9\u80fd\u53ca\u65f6\u3001\u51c6\u786e\u83b7\u53d6\u4fe1\u606f\u3002<\/strong>\u518d\u4e00\u6b21\u5c06\u836f\u4f01\u4f5c\u4e3a\u836f\u54c1\u8ffd\u6eaf\u4f53\u7cfb\u7684\u7b2c\u4e00\u8d23\u4efb\u65b9\u8fdb\u884c\u4e86\u4e00\u756a\u201c\u7d27\u9523\u5bc6\u9f13\u201d\u3002<\/p>\n\n\n\n<figure 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class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/vipkshttps6.wiz.cn\/ks\/note\/view\/a0e55156-3d19-4262-b75f-7967eb357a68\/45da1d06-c606-4873-8507-186c796541f2\/index_files\/640_2.jpg\" alt=\"\"\/><\/figure>\n\n\n\n<p><strong>\u836f\u54c1\u5e8f\u5217\u5316\u4e0e\u672c\u6b21\u836f\u76d1\u7801\u7684\u5b9a\u4e49\u5e76\u65e0\u4e8c\u81f4\uff0c<\/strong>\u662f<strong>\u6307\u901a\u8fc7\u836f\u54c1\u5404\u7ea7\u5305\u88c5\u4e0a\u552f\u4e00\u6807\u8bc6\u7801\uff08\u5e8f\u5217\u53f7\u7f16\u7801\uff0c\u5373\u836f\u54c1\u201c\u8eab\u4efd\u201d\u4ee3\u7801\uff09\u6765\u786e\u4fdd\u6d41\u901a\u4e2d\u836f\u54c1\u7684\u771f\u5b9e\u6027<\/strong>\uff0c\u9996\u5148\u9488\u5bf9\u7684\u662f\u5c61\u7981\u4e0d\u6b62\u7684\u5047\u836f\u73b0\u8c61\u30022011\u5e74\u6b27\u76df\u901a\u8fc7\u53cd\u4f2a\u9020\u836f\u54c1\u6307\u4ee4FMD\uff08Falsified Medicine Directive)\uff0c\u5f15\u5165\u66f4\u4e3a\u4e25\u683c\u7684\u89c4\u5219\u4ee5\u53ca\u7edf\u4e00\u7684\u3001\u6cdb\u6b27\u76df\u7684\u63aa\u65bd\u6765\u786e\u4fdd\u836f\u54c1\u7684\u5b89\u5168\u548c\u836f\u54c1\u8d38\u6613\u7684\u4e25\u683c\u7ba1\u7406\u3002FMD\u89c4\u5b9a\u5bf9\u51e0\u4e4e\u6240\u6709\u5904\u65b9\u836f\u4f7f\u7528\u5e26\u6709\u552f\u4e00\u5e8f\u5217\u53f7\u7f16\u7801\u7684\u5305\u88c5\uff0c\u7528\u4e8e\u6574\u4e2a\u4f9b\u5e94\u94fe\u4e2d\u5bf9\u836f\u54c1\u7684\u8ffd\u8e2a\uff0c\u9632\u6b62\u5047\u836f\u8fdb\u5165\u5408\u6cd5\u4f9b\u5e94\u94fe\uff0c\u8bc6\u522b\u4f9b\u5e94\u94fe\u4f53\u7cfb\u4e2d\u53ef\u80fd\u5b58\u5728\u7684\u5047\u836f\uff0c\u4fdd\u62a4\u60a3\u8005\u5b89\u5168\u3002<br><\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/vipkshttps6.wiz.cn\/ks\/note\/view\/a0e55156-3d19-4262-b75f-7967eb357a68\/45da1d06-c606-4873-8507-186c796541f2\/index_files\/640_3.jpg\" alt=\"\"\/><\/figure>\n\n\n\n<p>&nbsp;<br>\u5728FMD\u6846\u67b6\u4e0b\uff0c\u627f\u62c5\u9a8c\u8bc1\u529f\u80fd\u7684\u8bc6\u522b\u7801\u7531\u4f01\u4e1a\u81ea\u4e3b\u751f\u6210\u5e76\u8d4b\u7801\uff0c\u968f\u4e4b\u4ea7\u751f\u7684\u5927\u5bb9\u91cf\u7684\u6570\u636e\u7ba1\u7406\u5de5\u4f5c\u540c\u6837\u9700\u8981\u4f01\u4e1a\u81ea\u4e3b\u5b8c\u6210\u3002\u8fd9\u5bf9\u836f\u54c1\u751f\u4ea7\u5546\u7684\u4ea7\u7ebf\u63d0\u51fa\u4e86\u65b0\u7684\u8981\u6c42\uff0c\u5728\u4fdd\u8bc1\u751f\u4ea7\u901f\u5ea6\u7684\u524d\u63d0\u4e0b\uff0c\u751f\u4ea7\u5546\u5728FMD\u9650\u5b9a\u7684\u65f6\u95f4\u5185\u8fd0\u7528\u5404\u81ea\u7684\u8d4b\u7801\u539f\u5219\uff0c\u5347\u7ea7\u4ea7\u7ebf\u914d\u5907\u7cbe\u5bc6\u7684\u8d4b\u7801\u53ca\u8bfb\u7801\u7cfb\u7edf\u3002\u636e\u7edf\u8ba1\uff0c\u9ad8\u8fbe80%\u5236\u836f\u4f01\u4e1a\u4f7f\u7528\u7684\u8d4b\u7801\u65b9\u6848\u65e0\u6cd5\u5b8c\u6210FMD\u8981\u6c42\u7684\u8d4b\u7801\u89c4\u8303\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/vipkshttps6.wiz.cn\/ks\/note\/view\/a0e55156-3d19-4262-b75f-7967eb357a68\/45da1d06-c606-4873-8507-186c796541f2\/index_files\/640_4.jpg\" alt=\"\"\/><\/figure>\n\n\n\n<p><strong>\u836f\u54c1\u5e8f\u5217\u5316\u6210\u529f\u7ecf\u9a8c<\/strong><\/p>\n\n\n\n<p>\u51ed\u501f\u5728\u53ef\u53d8\u6570\u636e\u8d4b\u7801\u6280\u672f\u7684\u4f18\u52bf\uff0c\u591a\u7c73\u8bfa\u4e00\u76f4\u81f4\u529b\u4e8e\u8d28\u91cf\u8ffd\u8e2a\u8ffd\u6eaf\u4f53\u7cfb\u7684\u7814\u53d1\u4e0e\u5e94\u7528\uff0c\u5728\u8fd9\u4e00\u9886\u57df\u79ef\u7d2f\u4e86\u4e30\u5bcc\u7684\u7ecf\u9a8c\u3002\u5728\u5236\u836f\u884c\u4e1a\u62e5\u6709\u8d85\u8fc720\u5e74\u7684\u8d4b\u7801\u5e94\u7528\u7ecf\u9a8c\uff0c\u591a\u7c73\u8bfa\u751f\u547d\u79d1\u5b66\uff08Life Science\uff09\u90e8\u95e8\u4e00\u76f4\u5173\u6ce8\u836f\u54c1\u5e8f\u5217\u5316\u8981\u6c42\u7684\u66f4\u65b0\uff0c\u5e76\u5168\u7a0b\u53c2\u4e0e\u6b27\u6d32FMD\u6807\u8bc6\u6807\u51c6\u7684\u5236\u5b9a\u3002\u4ece\u6ee1\u8db3FMD\u5408\u89c4\u7684\u6838\u5fc3\u8981\u6c42\uff0c\u5230\u5404\u56fd\u76f8\u5e94\u6cd5\u89c4\u89c4\u8303\u3001GAMP\u81ea\u52a8\u5316\u8ba4\u8bc1\uff0c\u4ee5\u53ca\u4e00\u7cfb\u5217\u5168\u7403\u6807\u51c6\uff0c\u591a\u7c73\u8bfa\u53ca\u5176\u8bbe\u5907\u59cb\u7ec8\u4fdd\u6301\u4e0e\u65f6\u4ff1\u8fdb\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/vipkshttps6.wiz.cn\/ks\/note\/view\/a0e55156-3d19-4262-b75f-7967eb357a68\/45da1d06-c606-4873-8507-186c796541f2\/index_files\/640_5.jpg\" alt=\"\"\/><\/figure>\n\n\n\n<p>\u5728\u5e94\u5bf9\u5168\u7403\u4e3b\u8981\u6cd5\u89c4\u89c4\u5b9a\uff0c\u5982<strong>CIP13\u3001ITS\u3001<\/strong><strong>GAMP5\u3001EU Annex 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