{"id":31206,"date":"2018-08-04T01:00:00","date_gmt":"2018-08-09T04:14:22","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/09\/%e3%80%90%e9%87%8d%e7%a3%85%e3%80%91%e5%b9%b4%e4%b8%adcgmp%e5%ae%a1%e6%9f%a5%e5%9b%9e%e9%a1%be%ef%bc%9a%e8%be%89%e7%91%9e%e3%80%81%e6%8b%9c%e8%80%b3%e5%9b%a0%e4%bd%95%e9%81%adfda%e8%ad%a6%e5%91%8a\/"},"modified":"2018-08-09T12:14:24","modified_gmt":"2018-08-09T04:14:24","slug":"%e3%80%90%e9%87%8d%e7%a3%85%e3%80%91%e5%b9%b4%e4%b8%adcgmp%e5%ae%a1%e6%9f%a5%e5%9b%9e%e9%a1%be%ef%bc%9a%e8%be%89%e7%91%9e%e3%80%81%e6%8b%9c%e8%80%b3%e5%9b%a0%e4%bd%95%e9%81%adfda%e8%ad%a6%e5%91%8a","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/31206\/","title":{"rendered":"\u3010\u91cd\u78c5\u3011\u5e74\u4e2dcGMP\u5ba1\u67e5\u56de\u987e\uff1a\u8f89\u745e\u3001\u62dc\u8033\u56e0\u4f55\u906dFDA\u8b66\u544a\uff0c\u68af\u74e6\u91cd\u78c5\u504f\u5934\u75db\u836f\u4e0a\u5e02\u63a8\u8fdf\u56e0\u8d5b\u5c14\u7fa4&#8230;"},"content":{"rendered":"<div 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100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;vertical-align: middle;display: inline-block;word-wrap: break-word !important;\"><img    class=\"\"  style=\"box-sizing: border-box;vertical-align: middle;word-wrap: break-word !important;width: auto !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/08\/beepress10-1533788063.jpeg\" alt=\"\u3010\u91cd\u78c5\u3011\u5e74\u4e2dcGMP\u5ba1\u67e5\u56de\u987e\uff1a\u8f89\u745e\u3001\u62dc\u8033\u56e0\u4f55\u906dFDA\u8b66\u544a\uff0c\u68af\u74e6\u91cd\u78c5\u504f\u5934\u75db\u836f\u4e0a\u5e02\u63a8\u8fdf\u56e0\u8d5b\u5c14\u7fa4...\" title=\"\u3010\u91cd\u78c5\u3011\u5e74\u4e2dcGMP\u5ba1\u67e5\u56de\u987e\uff1a\u8f89\u745e\u3001\u62dc\u8033\u56e0\u4f55\u906dFDA\u8b66\u544a\uff0c\u68af\u74e6\u91cd\u78c5\u504f\u5934\u75db\u836f\u4e0a\u5e02\u63a8\u8fdf\u56e0\u8d5b\u5c14\u7fa4...\"  \/><\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;line-height: 2;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">\u56de\u987e\u4e0a\u534a\u5e74\u5168\u7403\u533b\u836f\u754c\uff0c\u5404\u836f\u4f01\u51fa\u73b0\u7684\u8fd9\u4e9b\u95ee\u9898\u4e00\u5ea6\u5360\u636e\u5404\u5927\u65b0\u95fb\u7684\u5934\u6761\u3002\u5176\u4e2d\uff0c\u4e0d\u4e4f\u6709\u8f89\u745e(Pfizer)\u3001\u62dc\u8033(Bayer)\u548cAkorn\u7b49\u56fd\u9645\u5927\u578b\u5236\u836f\u516c\u53f8\uff0c\u63a5\u4e0b\u6765\u4e3a\u5927\u5bb6\u56de\u987e\u4e0a\u534a\u5e74\u6bd4\u8f83\u53d7\u5173\u6ce8\u7684\u4e8b\u4ef6\u3002<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"margin-top: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"padding-left: 5px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 677px;border-style: solid;border-width: 0px 0px 0px 10px;border-left-color: rgb(0, 80, 136);border-right-color: rgb(0, 80, 136);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u4e2d\u56fd:\u539f\u6599\u836f\u542b\u6709\u81f4\u764c\u6027\u6742\u8d28\u3001\u75ab\u82d7\u4e11\u95fb\u3001\u8fdd\u53cd\u6570\u636e\u7684\u5b8c\u6574\u6027<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"margin-bottom: 8px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;height: 1px;background-color: rgb(0, 80, 136);word-wrap: break-word !important;\"><\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;line-height: 2;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<span style=\"max-width: 100%;box-sizing: border-box;text-indent: 2em;letter-spacing: 0px;line-height: 2;word-wrap: break-word !important;\">\u4e2d\u56fd\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a(Zhejiang Huahai Pharmaceuticals)\u4f9b\u5e94\u7684\u6d3b\u6027\u836f\u7269\u6210\u5206valsartan\u88ab\u67e5\u51fa\u542b\u6709\u53ef\u80fd\u81f4\u764c\u6027\u6742\u8d28\u2014\u2014\u4e9a\u785d\u57fa\u4e8c\u7532\u57fa\u80faNDMA\u3002\u5b83\u5728\u6d59\u6c5f\u534e\u6d77\u8fdb\u884c\u7684\u5e38\u89c4\u68c0\u6d4b\u4e2d\u5e76\u672a\u88ab\u53d1\u73b0\uff0c\u56e0\u6b64\uff0c\u8be5\u4f01\u4e1a\u79f0\u5b83\u7684\u5b58\u5728\u662f\u610f\u6599\u4e4b\u5916\u7684\u4e8b\u3002\u73b0\u5982\u4eca\uff0c\u6b27\u76df\u3001\u7f8e\u56fd\u548c\u4e9a\u6d32\u56fd\u5bb6\u5f53\u5c40\u6b63\u5728\u5bf9\u6d59\u6c5f\u534e\u6d77\u63d0\u4f9b\u7684valsartan\u836f\u54c1\u8fdb\u884c\u53ec\u56de\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u6d59\u6c5f\u534e\u6d77\u662f\u5411\u6b27\u76df\u548c\u7f8e\u56fd\u751f\u4ea7\u7f2c\u6c99\u5766\u836f\u7269\u7684\u4e3b\u8981\u4f9b\u5e94\u5546\uff0c\u5176\u751f\u4ea7\u7684\u539f\u6599valsartan\u57282017\u5e74\u9500\u552e\u91cf\u5df2\u8d85\u8fc75000\u4e07\u7f8e\u5143\u3002<\/span><\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">\u957f\u751f\u751f\u7269\u56e0\u5728\u56fd\u5bb6\u836f\u76d1\u5c40\u98de\u884c\u68c0\u67e5\u4e2d\u88ab\u53d1\u73b0\u4f2a\u9020\u72c2\u72ac\u75c5\u75ab\u82d7\u7684\u751f\u4ea7\u6570\u636e\uff0c\u5176\u884c\u4e3a\u4e25\u91cd\u8fdd\u53cd\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\u884c\u4e3a\u3002\u5f53\u5730\u836f\u76d1\u5c40\u6536\u56deGMP\u8bc1\u4e66\uff0c\u516c\u5b89\u673a\u5173\u5bf9\u6d89\u6848\u4eba\u5458\u7acb\u6848\u8c03\u67e5\uff0c\u63d0\u8bf7\u6279\u6355\u7b49\u3002\u6574\u4e2a\u4e8b\u4ef6\u53d1\u751f\u81f3\u4eca\uff0c\u56fd\u6c11\u9707\u60ca\u3001\u58f0\u8ba8\u4e0d\u65ad\uff0c\u4f01\u4e1a\u5168\u9762\u505c\u4ea7\uff0c\u8bc1\u76d1\u4f1a\u5927\u4fee\u9000\u5e02\u5236\u5ea6\uff0c\u56fd\u5bb6\u9886\u5bfc\u4eba\u5f3a\u8c03\u4e00\u67e5\u5230\u5e95\u4e25\u8083\u95ee\u8d23\uff0c\u56fd\u52a1\u9662\u603b\u7406\u8981\u6c42\u5bf9\u5bf9\u4e00\u5207\u5371\u5bb3\u4eba\u6c11\u751f\u547d\u5b89\u5168\u7684\u8fdd\u6cd5\u72af\u7f6a\u884c\u4e3a\u575a\u51b3\u91cd\u62f3\u6253\u51fb\uff0c\u5bf9\u4e0d\u6cd5\u5206\u5b50\u575a\u51b3\u4f9d\u6cd5\u4e25\u60e9\uff0c\u5bf9\u76d1\u7ba1\u5931\u804c\u6e0e\u804c\u884c\u4e3a\u575a\u51b3\u4e25\u5389\u95ee\u8d23\u3002<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">\u4e2d\u56fd\u6cb3\u5357\u7acb\u534e\u836f\u4e1a(Henan Lihua Pharmaceutical)\u4e3b\u8981\u751f\u4ea7\u50cf\u6c22\u5316\u53ef\u7684\u677e(hydrocortisone)\u548c\u6cfc\u5c3c\u677e(prednisone)\u76f8\u4f3c\u7684\u7c7b\u56fa\u9187\u539f\u6599\u836f\u3002FDA\u8c03\u67e5\u5458\u5728\u68c0\u67e5\u8fc7\u7a0b\u4e2d\uff0c\u53d1\u73b0\u8be5\u516c\u53f8\u5236\u9020\u8f66\u95f4\u529e\u516c\u5ba4\u7684\u4e00\u4e2a\u5f00\u653e\u67dc\u4e2d\u5b58\u5728\u5927\u91cf\u7684\u7a7a\u767d\u7684\u6279\u751f\u4ea7\u8bb0\u5f55\uff0c\u5176\u4e2d\u591a\u4e2a\u7a7a\u767d\u7684\u4ea7\u54c1\u53d1\u5e03\u8868\u683c\u4e0a\u9762\u5747\u6807\u6709\u201c\u5141\u8bb8\u51fa\u5382\u201d\u7684\u7ea2\u8272\u8d28\u91cf\u4fdd\u8bc1\u53d1\u5e03\u7ae0\u3002\u56e0\u6b64\uff0c\u5176\u5728\u4eca\u5e74\u6536\u5230\u4e86FDA\u53d1\u51fa\u7684\u8b66\u544a\u4fe1\uff0c\u5e76\u4e14\u4fe1\u4e2d\u6307\u51fa\u5bf9\u6570\u636e\u5b8c\u6574\u6027\u7684\u5904\u7406\u4e0d\u5408\u89c4\u3002\u8fd9\u4e00\u5c01\u8b66\u544a\u4fe1\u4e5f\u8ba9\u6cb3\u5357\u7acb\u534e\u836f\u4e1a\u4e8e2018\u5e743\u6708\u201c\u767b\u4e0a\u4e86\u201dFDA\u7684\u8fdb\u53e3\u9884\u8b66\u540d\u5355\u3002<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"margin-top: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"padding-left: 5px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 677px;border-style: solid;border-width: 0px 0px 0px 10px;border-left-color: rgb(0, 80, 136);border-right-color: rgb(0, 80, 136);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u7f8e\u56fd:\u8f89\u745e\u5236\u836f\u516c\u53f8\u7684\u751f\u4ea7\u95ee\u9898\u5bfc\u81f4\u6570\u767e\u79cd\u836f\u54c1\u77ed\u7f3a<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"margin-bottom: 8px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;height: 1px;background-color: rgb(0, 80, 136);word-wrap: break-word !important;\"><\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;line-height: 2;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">\u5236\u836f\u5de8\u5934\u8f89\u745e\u7684\u751f\u4ea7\u95ee\u9898\u4ecd\u7136\u662f\u4eca\u5e74\u5404\u5927\u5934\u7248\u62a5\u9053\u7684\u7126\u70b9\u3002\u300a\u8d22\u5bcc\u300b(Fortune)\u6742\u5fd7\u7684\u4e00\u7bc7\u6587\u7ae0\u201c\u6307\u8d23\u201d\u8f89\u745e\u516c\u53f8(Pfizer)\u57282015\u5e74\u4ee5170\u4ebf\u7f8e\u5143\u6536\u8d2d\u4e86Hospira\uff0c\u8fd9\u540c\u65f6\u4e5f\u7ed9\u7f8e\u56fd\u957f\u671f\u836f\u7269\u77ed\u7f3a\u7684\u73b0\u72b6\u96ea\u4e0a\u52a0\u971c\u3002\u6839\u636e\u8fd9\u7bc7\u6587\u7ae0\uff0c\u8f89\u745e\u516c\u53f8\u2014\u2014\u4e16\u754c\u4e0a\u6700\u5927\u7684\u65e0\u83cc\u6ce8\u5c04\u836f\u7269\u5236\u9020\u5546\u2014\u2014\u622a\u6b622018\u5e74 5\u670811\u65e5\uff0c\u8be5\u516c\u53f8\u5df2\u7ecf\u6709370\u4e2a\u4ea7\u54c1\u5c06\u6d88\u8017\u6b86\u5c3d\uff0c\u5e02\u573a\u4f9b\u5e94\u6781\u5176\u6709\u9650\uff0c\u5176\u4e2d102\u4e2a\u4ea7\u54c1\u8981\u52302019\u5e74\u624d\u80fd\u4e0a\u5e02\u3002\u6587\u7ae0\u8fd8\u8bf4\u9053:\u201c\u7f8e\u56fd\u76ee\u524d\u901a\u7528\u65e0\u83cc\u6ce8\u5c04\u9488\u5242\u532e\u4e4f\u7684\u4e3b\u8981\u539f\u56e0\u662f\u7f8e\u56fd\u9886\u5148\u7684\u9488\u5242\u836f\u54c1\u751f\u4ea7\u5546\u4e0d\u751f\u4ea7\u5b83\u4eec\u4e86\u3002\u201d<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">\u4e0e\u6b64\u540c\u65f6\uff0cMylan\u7684\u65d7\u8230\u4ea7\u54c1EpiPen\uff08\u80be\u4e0a\u817a\u7d20\u81ea\u52a8\u6ce8\u5c04\u4ea7\u54c1\uff09\u4e5f\u53ef\u80fd\u56e0\u8f89\u745e\u7684\u751f\u4ea7\u95ee\u9898\u800c\u9762\u4e34\u77ed\u7f3a\u3002Mylan\u62e5\u6709EpiPen\uff08\u80be\u4e0a\u817a\u7d20\u81ea\u52a8\u6ce8\u5c04\u4ea7\u54c1\uff09\u7684\u6240\u6709\u6743\uff0c\u4f46\u5b83\u5c06\u81ea\u52a8\u6ce8\u5c04\u5668\u7684\u5236\u9020\u8f6c\u5305\u7ed9\u8f89\u745e\u65d7\u4e0b\u7684Meridian\u533b\u7597\u6280\u672f\u516c\u53f8\u3002\u800c\u5728\u53bb\u5e749\u6708\uff0cFDA\u5c31\u8be5\u516c\u53f8\uff08Meridian\u533b\u7597\u6280\u672f\u516c\u53f8\uff09\u5236\u9020\u73af\u8282\u5b58\u5728\u4e25\u91cd\u7684\u8fdd\u89c4\u60c5\u51b5\u53ca\u5bfc\u81f4\u90e8\u5206\u60a3\u8005\u53d1\u751f\u6b7b\u4ea1\u6848\u4f8b\u53d1\u51fa\u8b66\u544a\u51fd\u3002Mylan\u533b\u836f\u4e5f\u56e0\u6b64\u5728\u5168\u7403\u591a\u4e2a\u56fd\u5bb6\uff08\u5305\u62ec\u7f8e\u56fd\uff09\u53ec\u56de\u4e86\u6570\u4e07\u53f0\u7684\u8bbe\u5907\u3002\u73b0\u76ee\u524d\uff0cFDA\u5df2\u5c06<span style=\"max-width: 100%;line-height: 32px;text-indent: 32px;box-sizing: border-box !important;word-wrap: break-word !important;\">EpiPen\uff08\u80be\u4e0a\u817a\u7d20\u81ea\u52a8\u6ce8\u5c04\u4ea7\u54c1\uff09<\/span>\u5217\u5165\u5b98\u65b9\u836f\u54c1\u77ed\u7f3a\u540d\u5355\u3002<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"margin-top: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"padding-left: 5px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 677px;border-style: solid;border-width: 0px 0px 0px 10px;border-left-color: rgb(0, 80, 136);border-right-color: rgb(0, 80, 136);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u5fb7\u56fd:FDA\u5f3a\u8c03\u62dc\u8033\u8bbe\u65bd\u7684\u6c61\u67d3\u548c\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"margin-bottom: 8px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;height: 1px;background-color: rgb(0, 80, 136);word-wrap: break-word !important;\"><\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;line-height: 2;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">FDA\u5411\u5fb7\u56fd\u52d2\u6c83\u5e93\u68ee\u62dc\u8033\u5236\u836f(Bayer Pharma)\u7684\u5236\u836f\u5de5\u5382\u53d1\u51fa\u4e86\u4e00\u5c01\u8b66\u544a\u4fe1\uff0c\u4fe1\u4e2d\u8868\u660e\uff0c\u8c03\u67e5\u4eba\u5458\u5728\u5ba1\u67e5\u4e00\u9879\u836f\u54c1\u751f\u4ea7\u64cd\u4f5c\u65f6\uff0c\u53d1\u73b0\u5728\u8bbe\u5907\u4e0a\u9057\u7559\u6b8b\u7559\u7269\uff0c\u56e0\u6b64\u8fd9\u4e9b\u8bbe\u5907\u5f88\u53ef\u80fd\u53c2\u4e0e\u8fc7\u5176\u5b83\u836f\u54c1\u7684\u52a0\u5de5\u3002\u800c\u5728\u6b64\u751f\u4ea7\u7ebf\u4e0b\u7684\u4ea7\u54c1\u5c06\u4f1a\u53d7\u5230\u4e25\u91cd\u7684\u4ea4\u53c9\u6c61\u67d3\u3002FDA\u968f\u540e\u5bf9\u836f\u54c1\u751f\u4ea7\u6570\u636e\u8fdb\u884c\u5ba1\u6838\u5ba1\u8ba1\u8ffd\u8e2a\uff0c\u4e2d\u63a7\u7247\u91cd\u68c0\u67e5\u4e2d\u6709\u672a\u62a5\u544a\u7684\u6570\u636e\uff0c\u5373\u751f\u4ea7\u89c4\u7a0b\u89c4\u5b9a\u8f66\u95f4\u8d1f\u8d23\u4e2d\u63a7\u91cd\u91cf\u68c0\u67e5\u4eba\u5458\u4e0d\u9700\u62a5\u544a\u7247\u91cd\u8d85\u8fc7\u76ee\u6807\u7247\u91cd\u7684\u6570\u503c\u3002\u5373\u4e0a\u8ff0\u6240\u8a00\uff0c\u62dc\u8033\u4e8e2018\u5e742\u6708\u56e0\u8bbe\u5907\u3001\u4ea7\u54c1\u6c61\u67d3\u4e0e\u751f\u4ea7\u6570\u636e\u5b8c\u6574\u6027\u51fa\u73b0\u7684\u5408\u89c4\u7f3a\u9677\u95ee\u9898\u800c\u6536\u5230FDA\u7684\u8b66\u544a\u3002<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"margin-top: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"padding-left: 5px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 677px;border-style: solid;border-width: 0px 0px 0px 10px;border-left-color: rgb(0, 80, 136);border-right-color: rgb(0, 80, 136);word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u97e9\u56fd:\u7531\u4e8e\u8d5b\u5c14\u7fa4\uff08Celltrion\uff09\u7684\u95ee\u9898\uff0c\u68af\u74e6\u5236\u836f\uff08Teva\uff09\u6f5c\u5728\u7684\u91cd\u78c5\u836f\u88ab\u63a8\u8fdf\u4e0a\u5e02<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"margin-bottom: 8px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;height: 1px;background-color: rgb(0, 80, 136);word-wrap: break-word !important;\"><\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;color: rgb(51, 51, 51);\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;line-height: 2;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">\u97e9\u56fd\u8fd1\u51e0\u5e74\u6765\u6210\u4e3a\u5168\u7403\u65b0\u5174\u751f\u7269\u4eff\u5236\u836f\u5e02\u573a\u7684\u4e00\u80a1\u529b\u91cf\u5de8\u5927\u7684\u201c\u6697\u6f6e\u201d\u3002\u5c24\u5176\u662f\u8d5b\u5c14\u7fa4\u7a81\u51fa\u7684\u8868\u73b0\uff0c\u8be5\u516c\u53f8\u662f\u97e9\u56fd\u751f\u7269\u4eff\u5236\u836f\u7684\u4e3b\u8981\u5236\u9020\u5546\uff0c\u65d7\u4e0b\u7684Inflectra \u548cRemsima \u4e24\u5927\u4ea7\u54c1\u5206\u522b\u901a\u8fc7\u4e86\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u548c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40(EMA)\u7684\u5ba1\u6279\uff0c\u6210\u4e3a\u5168\u7403\u9996\u4e2a\u901a\u8fc7\u53d1\u8fbe\u56fd\u5bb6\u76d1\u7ba1\u673a\u6784\u5ba1\u6279\u7684\u5355\u514b\u9686\u6297\u4f53\u751f\u7269\u4eff\u5236\u836f\u3002\u4f46\u5728FDA\u8c03\u67e5\u4eba\u5458\u4e8e2017\u5e745\u670822\u65e5\u81f36\u67082\u65e5\u5728\u8fdb\u884c\u8f66\u95f4\u89c4\u8303\u751f\u4ea7\u7684\u68c0\u67e5\u4e2d\uff0c\u53d1\u73b0\u5b89\u88c5\u548c\u704c\u88c5\u8fc7\u7a0b\u51fa\u73b0\u7684\u591a\u79cd\u8fdd\u89c4\u6027\u5730\u65e0\u83cc\u64cd\u4f5c\uff0c\u8fd9\u5c06\u53ef\u80fd\u9020\u6210\u5fae\u751f\u7269\u6c61\u67d3\u7684\u98ce\u9669\u3002\u56e0\u6b64\uff0c\u8d5b\u5c14\u7fa4\u4e0d\u4e45\u6536\u5230\u4e86FDA\u7684\u8b66\u544a\u4fe1\uff0c\u800c\u8fd9\u5c01\u4fe1\u5374\u8ba9\u5176\u906d\u53d7\u4e86\u8f83\u5927\u7684\u91cd\u521b\u3002<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">&nbsp;<\/p>\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-indent: 2em;word-wrap: break-word !important;\">\u8d5b\u5c14\u7fa4\u672c\u662fTeva\u7684\u504f\u5934\u75db\u836f\u7269fremanezumab\uff08\u4e00\u79cd\u6297\u964d\u9499\u7d20\u57fa\u56e0\u76f8\u5173\u80bd\uff08anti-CGRP\uff09\u5355\u514b\u9686\u6297\u4f53\uff0c\u5f00\u53d1\u7528\u4e8e\u504f\u5934\u75db\u7684\u9632\u6cbb\uff09\u7684\u4e3b\u8981\u539f\u6599\u836f\u4f9b\u5e94\u5546\u3002\u7531\u4e8e\u8b66\u544a\u4fe1\u7684\u5f71\u54cd\uff0c\u68af\u74e6\u8bc1\u5b9eFDA\u5df2\u7ecf\u5ef6\u957f\u4e86fremanezumab\u7684\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\u65e5\u671f\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<p><br  \/><\/p>\n<p>\uff08\u6765\u6e90\uff1a\u836f\u667a\u7f51\uff09<\/p>\n<p><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u957f\u6309\u56fe\u7247\u2014\u2014\u8bc6\u522b\u4e8c\u7ef4\u7801\uff0c\u5173\u6ce8\u6211\u4eec<\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;font-size: 16px;line-height: 25.6px;color: rgb(62, 62, 62);font-family: \u5fae\u8f6f\u96c5\u9ed1;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;letter-spacing: 0.544px;white-space: normal;font-size: 16px;line-height: 25.6px;color: rgb(62, 62, 62);font-family: \u5fae\u8f6f\u96c5\u9ed1;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u5173\u6ce8\u201c\u9aa8\u6709\u8c37\u4f9d\u201d\uff0c\u5206\u4eab\u66f4\u591a\u9aa8\u79d1\u4ea7\u54c1\u548c\u75be\u75c5\u77e5\u8bc6&nbsp;<\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;white-space: normal;font-size: 16px;line-height: 25.6px;color: rgb(62, 62, 62);font-family: \u5fae\u8f6f\u96c5\u9ed1;text-align: center;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"     width=\"auto\"  style=\"box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/08\/beepress1-1533788064.jpeg\" 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