{"id":56955,"date":"2018-09-26T01:00:00","date_gmt":"2018-09-30T02:21:13","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e6%ac%a7%e7%be%8e%e4%b8%8a%e5%b8%82%e8%8d%af%e7%89%a9%e4%bf%a1%e6%81%af%e6%9d%83%e5%a8%81%e5%8f%91%e5%b8%83%e6%95%b0%e6%8d%ae%e5%ba%93%e5%8f%8a%e5%85%b6%e5%ba%94%e7%94%a8\/"},"modified":"2018-09-30T10:21:14","modified_gmt":"2018-09-30T02:21:14","slug":"%e6%ac%a7%e7%be%8e%e4%b8%8a%e5%b8%82%e8%8d%af%e7%89%a9%e4%bf%a1%e6%81%af%e6%9d%83%e5%a8%81%e5%8f%91%e5%b8%83%e6%95%b0%e6%8d%ae%e5%ba%93%e5%8f%8a%e5%85%b6%e5%ba%94%e7%94%a8","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/56955\/","title":{"rendered":"\u6b27\u7f8e\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u6743\u5a01\u53d1\u5e03\u6570\u636e\u5e93\u53ca\u5176\u5e94\u7528"},"content":{"rendered":"
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\u4f5c\u8005\u89c2\u70b9\u4e0d\u4ee3\u8868\u672c\u516c\u4f17\u53f7\u7684\u89c2\u70b9\uff0c\u5982\u60a8\u5bf9\u6587\u7ae0\u6709\u7591\u60d1\uff0c\u8bf7\u68c0\u7d22\u539f\u6587\uff0c\u4e0e\u539f\u4f5c\u8005\u8054\u7cfb<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u6b27\u7f8e\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u6743\u5a01\u53d1\u5e03\u6570\u636e\u5e93\u53ca\u5176\u5e94\u7528<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

The official databases of marketed drug information <\/strong>in the USA and Europe and their applications<\/strong><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e2d\u56fd\u533b\u5b66\u79d1\u5b66\u9662\u5317\u4eac\u534f\u548c\u533b\u5b66\u9662\u836f\u7269\u7814\u7a76\u6240<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u901a\u8fc7\u5bf9\u6b27\u7f8e\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u6743\u5a01\u6570\u636e\u5e93Drugs@ FDA \u548c\u6b27\u76df\u516c\u4f17\u8bc4\u4f30\u62a5\u544a( EPAR) \u7684\u4fe1\u606f\u67e5\u8be2\u65b9\u6cd5\u3001\u8be6\u7ec6\u5185\u5bb9\u53ca\u5176\u5e94\u7528\u7684\u4ecb\u7ecd\uff0c\u4e3a\u836f\u54c1\u4f7f\u7528\u548c\u7814\u53d1\u4eba\u5458\u83b7\u5f97\u514d\u8d39\u548c\u9ad8\u8d28\u91cf\u7684\u836f\u7269\u4fe1\u606f\u63d0\u4f9b\u6307\u5bfc\u3002\u901a\u8fc7\u5177\u4f53<\/span>\u5b9e\u4f8b\u8bf4\u660eDrugs@ FDA \u548cEPAR \u6570\u636e\u5e93\u4e2d\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u67e5\u8be2\u7684\u65b9\u6cd5\u3001\u5177\u4f53\u5185\u5bb9\u53ca\u5176\u5e94\u7528\u3002<\/span>
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\u4ecb\u7ecd\u4e86Drugs@<\/span>FDA \u548cEPAR\u6570\u636e\u5e93\u4e2d\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u5305\u62ec\u65b0\u836f\u7814\u53d1\u6574\u4e2a\u8fc7\u7a0b\u4ea7\u751f\u7684\u4fe1\u606f\u8d44\u6599; \u5176\u4e30\u5bcc\u7684\u5185\u5bb9\u548c\u5e9e\u5927\u7684\u6570\u636e<\/span>\u91cf\u4e3a\u836f\u7269\u76f8\u5173\u5927\u6570\u636e\u7684\u6316\u6398\u548c\u5176\u4ed6\u7c7b\u578b\u6570\u636e\u5e93\u7684\u5efa\u7acb\u5960\u5b9a\u4e86\u4fe1\u606f\u57fa\u7840\u3002Drugs@ FDA \u6570\u636e\u5e93\u548cEPAR\u6570\u636e<\/span>\u5e93\u91cc\u7684\u4fe1\u606f\u4e30\u5bcc\u6743\u5a01\uff0c\u68c0\u7d22\u754c\u9762\u7b80\u6d01\u6613\u7528\uff0c\u662f\u836f\u54c1\u4f7f\u7528\u548c\u5f00\u53d1\u4eba\u5458\u9887\u4e3a\u5f97\u529b\u7684\u4fe1\u606f\u52a9\u624b\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


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Patridege \u7b49\uff3b1\uff3d\u901a\u8fc7\u603b\u4f53\u5206\u6790\u53d1\u73b0\uff0c52% \u7684\u65b0\u5206\u5b50\u5b9e\u4f53( new molecular entity\uff0cNME) \u6765\u6e90\u4e8e\u5317\u7f8e<\/span>39%\u6765\u6e90\u4e8e\u6b27\u6d32\uff0c8<\/span>% \u6765\u6e90\u4e8e\u4e9a\u6d32\uff0c\u5728\u6765\u6e90\u4e8e\u4e9a\u6d32\u7684<\/span>NME \u4e2d\uff0c94% \u6765\u6e90\u4e8e\u65e5\u672c\u3002\u56e0\u6b64\uff0c\u8fd93 \u4e2a\u56fd\u5bb6\u6216\u5730<\/span>\u533a\u7684\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u7684\u67e5\u8be2\u548c\u4f7f\u7528\uff0c\u5bf9\u836f\u7269\u7814\u7a76\u673a\u6784<\/span>\u79d1\u7814\u4eba\u5458\u7684\u836f\u7269\u7814\u7a76\u4e0e\u5f00\u53d1\u81f3\u5173\u91cd\u8981; \u5bf9\u4e8e\u533b\u7597\u4eba<\/span>\u5458\u6765\u8bf4\uff0c\u83b7\u5f97\u51c6\u786e\u7684\u836f\u54c1\u8bf4\u660e\u4e66\u4fe1\u606f\u548c\u836f\u7269\u5b89\u5168\u4fe1<\/span>\u606f\uff0c\u6b63\u786e\u6307\u5bfc\u60a3\u8005\u7528\u836f\u4e5f\u81f3\u5173\u91cd\u8981\uff3b2\uff3d\u3002\u65e5\u672c\u7684\u4e0a\u5e02<\/span>\u836f\u7269\u4fe1\u606f\u4ee5\u65e5\u8bed\u4e3a\u4e3b\uff0c\u672c\u6587\u6682\u4e0d\u505a\u8bf4\u660e\u548c\u8ba8\u8bba\u3002<\/span>
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\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u90fd\u5305\u62ec\u54ea\u4e9b\u5185\u5bb9\u5462? \u836f\u7269\u4ece\u4e00\u4e2a\u6709\u6f5c\u529b\u7684\u65b0\u5206\u5b50\u5b9e\u4f53\u6216\u751f\u7269\u5236\u54c1\u5230\u6700\u7ec8\u6279\u51c6\u4e0a\u5e02\uff0c<\/span>\u5176\u5386\u7a0b\u8270\u8f9b\u800c\u6f2b\u957f\uff0c\u4ea7\u751f\u7684\u6570\u636e\u6216\u8d44\u6599\u6d89\u53ca\u65b9\u65b9\u9762<\/span>\u9762\uff0c\u8fd9\u4e9b\u8d44\u6599\u5c06\u6309\u7167\u8981\u6c42\u6574\u7406\u62a5\u9001\u81f3\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\uff0c<\/span>\u5373\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u90e8\u95e8\u3002\u836f\u54c1\u6ce8\u518c\u4fe1\u606f\u662f\u7531\u65b0\u836f\u7814\u7a76<\/span>\u90e8\u95e8\u5bf9\u836f\u7269\u7814\u7a76\u7684\u6574\u4e2a\u8fc7\u7a0b\u4ee5\u7533\u62a5\u8d44\u6599\u5f62\u5f0f\u5411\u836f\u76d1<\/span>\u90e8\u95e8\u62a5\u9001\uff0c\u5185\u5bb9\u5305\u62ec\u836f\u54c1\u7684\u4e34\u5e8a\u524d\u7814\u7a76\u548c\u4e34\u5e8a\u7814\u7a76<\/span>2 \u4e2a\u9636\u6bb5\u3002\u65b0\u836f\u7684\u4e34\u5e8a\u524d\u7814\u7a76\u5305\u62ec\u836f\u5b66\u7814\u7a76\u3001\u836f\u7406<\/span>\u5b66\u7814\u7a76\u548c\u6bd2\u7406\u5b66\u7814\u7a76\u3002\u5728\u836f\u54c1\u7684\u4e34\u5e8a\u7814\u7a76\u8fc7\u7a0b\u4e2d\uff0c<\/span>\u901a\u8fc7\u60a3\u8005\u6216\u5065\u5eb7\u5fd7\u613f\u8005\u8fdb\u884c\u7684\u836f\u7269\u7cfb\u7edf\u6027\u7814\u7a76\uff0c\u8bc1<\/span>\u5b9e\u836f\u7269\u9884\u9632\u3001\u6cbb\u7597\u75be\u75c5\u7684\u4f5c\u7528\u673a\u5236\uff0c\u836f\u54c1\u7684\u4e0d\u826f\u53cd\u5e94<\/span>\u53ca\u4ee3\u8c22\u7279\u5f81\uff0c\u660e\u786e\u836f\u54c1\u6cbb\u7597\u7684\u9002\u5e94\u8bc1\uff0c\u53cd\u6620\u836f\u54c1\u7684\u6709<\/span>\u6548\u6027\u548c\u5b89\u5168\u6027\u4fe1\u606f\uff3b3\uff3d\u3002<\/span><\/p>\n

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\u4ece\u4e0a\u8ff0\u63cf\u8ff0\u53ef\u4ee5\u770b\u51fa\uff0c\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u638c\u63e1\u6240\u6709\u4e0a\u62a5\u7684\u836f\u54c1\u6ce8\u518c\u4fe1\u606f\u3002\u65b0\u836f\u4e0a\u5e02\u4ee5\u540e\uff0c\u4fe1\u606f\u62ab<\/span>\u9732\u662f\u5176\u5de5\u4f5c\u804c\u8d23\u7684\u4e00\u90e8\u5206\u3002\u5bf9\u4e8e\u7f8e\u56fd\u4e0a\u5e02\u836f\u7269\u4fe1<\/span>\u606f\uff0c\u7531\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40( Food and Drug <\/span>Administration\uff0cFDA) \u5728Drugs@ FDA \u6570\u636e\u5e93\u7f51\u7ad9\u516c<\/span>\u5e03( \u7f51\u5740\u4e3ahttps: \/ \/www.accessdata.fda.gov \/scripts \/<\/span>cder \/daf \/index.cfm) \uff0c\u7528\u4e8e\u4fe1\u606f\u67e5\u8be2; \u5bf9\u4e8e\u6b27\u76df\u4e0a\u5e02<\/span>\u836f\u7269\u4fe1\u606f\uff0c\u7531\u6b27\u76df\u533b\u836f\u7ba1\u7406\u5c40( European Medicines <\/span>Agency\uff0cEMA) \u5728\u5176\u7f51\u7ad9\u516c\u5e03\uff3b\u6570\u636e\u5e93\u7684\u540d\u79f0\u4e3a\u6b27\u76df<\/span>\u516c\u4f17\u8bc4\u4f30\u62a5\u544a( European Public Assessment Report\uff0c<\/span>EPAR) \uff0c\u7f51\u5740\u4e3ahttp: \/ \/www.ema.europa.eu \/ema\uff0c\u4ee5<\/span>\u4e0b\u7b80\u79f0EPAR\u6570\u636e\u5e93\uff3d\u3002<\/span><\/p>\n

\u8fd92 \u4e2a\u6570\u636e\u5e93\u91cc\u7684\u4fe1\u606f\u5747<\/span>\u514d\u8d39\u9762\u5411\u516c\u4f17\u5f00\u653e\uff0c\u4fe1\u606f\u6765\u6e90\u53ef\u9760\u4e14\u5185\u5bb9\u4e30\u5bcc\uff3b4\uff3d\uff0c<\/span>\u4f46\u5c1a\u672a\u89c1\u6587\u7ae0\u7cfb\u7edf\u4ecb\u7ecd\u6b27\u7f8e\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u7684\u67e5\u8be2\u65b9<\/span>\u6cd5\u3001\u516c\u5f00\u5185\u5bb9\u53ca\u5176\u5e94\u7528\uff0c\u672c\u6587\u5c06\u56f4\u7ed5\u8fd9\u4e2a\u8bdd\u9898\u5c55\u5f00<\/span>\u8bba\u8ff0\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Drugs@FDA \u6570\u636e\u5e93<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n


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FDA \u6210\u7acb\u4e8e1906 \u5e74\uff0c\u5386\u53f2\u975e\u5e38\u60a0\u4e45\u3002\u5176\u4f7f\u547d\u662f\u786e\u4fdd\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u548c\u98df\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u4ee5\u4fdd\u62a4\u516c\u4f17\u5065\u5eb7\u3002\u800c\u836f\u54c1\u4fe1\u606f\u7684\u516c\u5f00\u662f\u4f53\u73b0\u5176\u4f7f\u547d\u7684\u4e00\u4e2a\u91cd\u8981\u65b9\u9762\uff0c\u4ee5\u786e\u4fdd\u4e0a\u5e02\u836f\u7269\u5b89\u5168\u6709\u6548\u5730\u4f7f\u7528\uff3b5\uff3d\u3002FDA \u5b98\u7f51\u4e0a\u67e5\u8be2\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u7684\u6570\u636e\u5e93\u4e3aDrugs@ FDA\u3002<\/p>\n

\u5728Drugs@ FDA \u6570\u636e\u5e93\u4e2d\u8fdb\u884c\u836f\u7269\u4fe1\u606f\u67e5\u8be2\u65f6\uff0c\u53ef\u8f93\u5165\u836f\u54c1\u540d\u79f0\u3001\u6709\u6548\u6210\u5206\u6216\u7533\u8bf7\u53f7\u5373\u53ef\u67e5\u5230\u76f8\u5173\u4fe1\u606f\u3002<\/p>\n

\u4ee5\u836f\u7269\u5361\u57f9\u4ed6\u6ee8\u7684\u539f\u7814\u836f\u7269\u5e0c\u7f57\u8fbe\u4e3a\u4f8b\uff0c \u5176\u6709\u6548\u6210\u5206apecitabine\uff0c\u5546\u54c1\u540d\u4e3aXeloda\u3002\u67e5\u8be2\u7ed3\u679c\u7684\u5de6\u4e0a\u89d2\u663e\u793a\u4e86\u65b0\u836f\u7533\u8bf7\u53f7\u7801( 020896) \u548c\u836f\u54c1\u7814\u53d1\u516c\u53f8( Hoffmann La \uff32oche) \uff0c\u7ed3\u679c\u5206\u4e3a4 \u90e8\u5206\uff0c\u5747\u4ee5\u8868\u683c\u5f62\u5f0f\u5c55\u73b0\uff0c\u6e05\u6670\u660e\u4e86\u3002<\/p>\n

\u7b2c1 \u90e8\u5206\u4e3a\u836f\u54c1\u7684\u5177\u4f53\u4fe1\u606f<\/strong><\/span><\/p>\n

( products on NDA 020896) \uff0c\u5728\u8868\u683c\u91cc\u53ef\u4ee5\u770b\u5230\u836f\u54c1\u540d\u79f0\uff3bdrug name( s ) \uff3d\u3001\u6709\u6548\u6210\u5206\uff3bactive ingredient ( s ) \uff3d\u3001\u89c4\u683c( strength) \u3001\u5242\u578b\/\u7ed9\u836f\u9014\u5f84( dosage form\/route) \u7b49\u5b57\u6bb5\u3002\u4ece\u4e0a\u8ff0\u4fe1\u606f\u53ef\u4ee5\u770b\u51fa\uff0c\u4e0e\u4e00\u822c\u7684\u9759\u8109\u6ce8\u5c04\u6297\u764c\u836f\u7269\u4e0d\u540c\uff0c\u5e0c\u7f57\u8fbe\u662f\u53e3\u670d\u7684\u7247\u5242\u3002<\/p>\n

\u7b2c2 \u90e8\u5206\u5305\u62ec\u6279\u51c6\u65e5\u671f\u548c\u5386\u53f2<\/span><\/strong><\/p>\n

( approval date and history) \u3001\u4fe1\u4ef6( letters) \u3001\u8bf4\u660e\u4e66( labels) \u548c\u7efc\u8ff0( reviews) \u3002\u8fd9\u90e8\u5206\u5185\u5bb9\u5f88\u4e30\u5bcc\uff0c\u5305\u62ec2 \u4e2a\u8868\u683c\u3002\u7b2c1 \u4e2a\u8868\u683c\u663e\u793a\u5e0c\u7f57\u8fbe\u4e8e1998 \u5e744 \u670830 \u65e5\u83b7\u5f97\u6279\u51c6\uff0c\u5c5e\u4e8e\u4f18\u5148\u5ba1\u8bc4\u7684\u5c0f\u5206\u5b50\u5b9e\u4f53\u3002\u5e76\u4e14\u9644\u4e0a\u4e86\u5f53\u521d\u6279\u51c6\u7684\u8bf4\u660e\u4e66\u3001\u4fe1\u4ef6\u548c\u7efc\u8ff0\u3002\u7b2c2 \u90e8\u5206\u8868\u683c\u5217\u51fa\u4e86\u8865\u5145( supplements ) \u4fe1\u606f\uff0c\u5305\u62ec\u6267\u884c\u65e5\u671f( action date) \u3001\u9012\u4ea4\u8d44\u6599( submission ) \u3001\u9012\u4ea4\u8d44\u6599\u7684\u5206\u7c7b ( submission classification) \u53ca\u8bf4\u660e\u4e66\u3001\u4fe1\u4ef6\u3001\u7efc\u8ff0\u3001\u4e13 \u5229\u7b49\u9644\u4ef6( labels\uff0cletters\uff0creviews\uff0cpatient package insert) \u3002\u503c\u5f97\u4e00\u63d0\u7684\u662f\u836f\u54c1\u8bf4\u660e\u4e66\uff0c\u5176\u5bf9\u533b\u751f\u5f00\u5177 \u5904\u65b9\u5177\u6709\u91cd\u8981\u53c2\u8003\u610f\u4e49\u3002\u70b9\u51fb\u9644\u4ef6\u4e2d\u7684\u201c\u8bf4\u660e\u4e66 ( label) \u201d\uff0c\u53ef\u4ee5\u5728\u7ebf\u67e5\u770b\u548c\u4e0b\u8f7d\u3002\u5b8c\u6574\u7684\u5904\u65b9\u4fe1\u606f\u603b\u8ba1\u5305\u62ec17 \u4e2a\u65b9\u9762\u7684\u5185\u5bb9\uff0c\u5305\u62ec\u9002\u5e94\u8bc1\u548c\u7528\u9014\u3001\u7528\u6cd5\u7528\u91cf\u3001\u5242\u578b\u548c\u89c4\u683c\u3001\u7981\u5fcc\u8bc1\u7b49\u4fe1\u606f\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u5728\u5e0c\u7f57\u8fbe\u7684\u836f\u54c1\u8bf4\u660e\u4e66\u4e2d\uff0c\u5728\u5b8c\u6574\u7684\u5904\u65b9\u4fe1\u606f\u524d\u6709\u4e00\u4e2a\u9ed1\u6846\u8b66\u544a\uff0c\u63d0\u793a\u201c\u5bf9\u4e8e\u540c\u65f6\u670d\u7528\u5361\u57f9\u4ed6\u6ee8\u548c\u9999\u8c46\u7d20\u7c7b\u884d\u751f\u7269\u6297\u51dd\u836f\u5982\u534e\u6cd5\u4ee4\u548c\u82ef\u4e19\u9999\u8c46\u7d20\u7684\u60a3\u8005\uff0c\u5e94\u8be5\u9891\u7e41\u76d1\u6d4b\u6297\u51dd\u53cd\u5e94\u6307\u6807\uff0c\u5982\u56fd\u9645\u6807\u51c6\u5316\u6bd4\u503c( IN\uff32) \u6216\u51dd\u8840\u9176\u539f\u65f6\u95f4\uff0c\u4ee5\u8c03\u6574\u6297\u51dd\u5242\u7684\u7528\u91cf\u3002\u5728\u5408\u5e76\u7528\u836f\u671f\u95f4\uff0c\u66fe\u6709\u51dd\u8840\u53c2\u6570\u6539\u53d8\u548c\/\u6216\u51fa\u8840\uff0c\u5305\u62ec\u6b7b\u4ea1\u62a5\u544a\u201d\u3002\u70b9\u51fb\u8868\u683c\u91cc\u9762\u7684\u201c\u7efc\u8ff0( review) \u201d\uff0c\u8fdb\u5165\u5230\u836f\u7269\u6279\u51c6\u4fe1\u606f\u5305\u8fd9\u4e00\u754c\u9762\uff0c\u5176\u4e2d\u5305\u542b\u65b0\u836f\u7533\u62a5\u8d44\u6599\uff0c\u6bd4\u5982\u5316\u5b66\u7efc\u8ff0\u3001\u533b\u5b66\u7efc\u8ff0\u3001\u4e34\u5e8a\u836f\u7406\u5b66\u548c\u751f\u7269\u836f\u5242\u5b66\u7efc\u8ff0\u7b49\u3002\u5bf9\u4e8e\u505a\u4eff\u5236\u836f\u5236\u5242\u9879\u76ee\u7684\u7814\u7a76\u4eba\u5458\u6765\u8bf4\uff0c\u901a\u8fc7\u67e5\u770b\u7efc\u8ff0\u91cc\u7684\u5185\u5bb9\u53ef\u4ee5\u83b7\u5f97\u5f88\u591a\u91cd\u8981\u4fe1\u606f\uff0c\u5982\u5904\u65b9\u91cc\u7684\u8f85\u6599\u3001\u6eb6\u51fa\u5ea6\u76f8\u5173\u6570\u636e\uff0c\u6709\u65f6\u8fd8\u6709\u5236\u5907\u5de5\u827a\u3001\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u548c\u5173\u952e\u5de5\u827a\u53c2\u6570\u7b49\u3002<\/p>\n

\u7b2c3 \u90e8\u5206\u5217\u51fa\u4e86\u836f\u54c1\u7684\u6bcf\u4e2a\u7248\u672c\u7684\u8bf4\u660e\u4e66\u3001\u6267\u884c\u65e5\u671f\u548c\u8bf4\u660e\u4e66\u53d8\u66f4\u7684\u539f\u56e0\u3002<\/span><\/strong><\/p>\n

\u7b2c4 \u90e8\u5206\u662f\u201c\u65b0\u836f\u6cbb\u7597\u7b49\u6548\u6027<\/strong><\/span><\/p>\n

(therapeutic equivalents for NDA 020896) \u201d\uff0c\u8fdb\u5165\u9875\u9762\u53ef\u4ee5\u770b\u5230\u5e0c\u7f57\u8fbe\u7684\u4eff\u5236\u836f\u4fe1\u606f\uff0c\u5982\u6709\u6548\u6210\u5206\u3001\u751f\u4ea7\u5382\u5bb6\u3001\u7533\u8bf7\u53f7\u3001\u89c4\u683c\u548c\u5242\u578b\u7b49\u3002\u7528Drugs@ FDA \u67e5\u8be2\u4e0a\u5e02\u836f\u7269\u606f\uff0c\u503c\u5f97\u6ce8\u610f\u7684\u662f: Drugs@ FDA \u5305\u542b\u4e86\u81ea1939 \u5e74\u6279\u51c6\u4e0a\u5e02\u7684\u5927\u90e8\u5206\u836f\u7269\uff0c\u81ea1998 \u5e74\u83b7\u5f97\u6279\u51c6\u7684\u836f\u7269\u5927\u90e8\u5206\u53ef\u4ee5\u770b\u5230\u5176\u8bf4\u660e\u4e66\u3001\u6279\u51c6\u6587\u4ef6\u3001\u7efc\u8ff0\u53ca\u5176\u4ed6\u4fe1\u606f\uff3b6\uff3d; \u6709\u4e9bOTC \u836f\u7269\u548c\u90e8\u5206\u751f\u7269\u5236\u54c1\u672a\u5728\u6b64\u6570\u636e\u5e93\u4e2d\u6536\u5f55\uff0c\u6240\u6709\u81b3\u98df\u8865\u5145\u5242\u548c\u517d\u836f\u4e5f\u5747\u672a\u6536\u5f55\u5728\u5185\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

2<\/span><\/p>\n<\/section>\n

\n

EPAR \u6570\u636e\u5e93<\/strong><\/p>\n<\/section>\n<\/section>\n


<\/p>\n

EMA \u6210\u7acb\u4e8e1995 \u5e74\uff0c\u662f\u8d1f\u8d23\u9488\u5bf9\u6b27\u76df\u5f00\u53d1\u4f7f\u7528\u7684\u836f\u54c1\u8fdb\u884c\u79d1\u5b66\u8bc4\u4f30\u7684\u673a\u6784\u3002\u6240\u6709\u6b27\u76df\u6210\u5458\u5fc5\u987b<\/span>\u63a5\u53d7EMA \u5bf9\u65b0\u65e7\u836f\u7269\u7684\u9002\u5e94\u8bc1\u6539\u53d8\u3001\u6279\u51c6\u3001\u6682\u505c\u6216<\/span>\u8005\u9000\u5e02\u7684\u51b3\u5b9a\uff3b7\uff3d\u3002<\/span>
<\/p>\n

\n
\n
\n

\u6b27\u76df\u7684\u60c5\u51b5\u6bd4\u7f8e\u56fd\u76f8\u5bf9\u590d\u6742\u4e9b\uff0c\u6b27\u76df\u836f\u54c1\u7684\u5ba1\u6279\u7a0b\u5e8f\u65e2\u6709\u9488\u5bf9\u6574\u4e2a\u6b27\u76df\u5e02\u573a\u7684\u96c6\u4e2d\u5ba1\u6279\u7a0b\u5e8f<\/span>( centralized procedure) \uff0c\u53c8\u53ef\u540c\u65f6\u5728\u591a\u4e2a\u6b27\u76df\u6210\u5458<\/span>\u56fd\u4e0a\u5e02\u7684\u975e\u96c6\u4e2d\u5ba1\u6279\u7a0b\u5e8f( decentralized procedure)<\/span>\u53ca\u5404\u6210\u5458\u56fd\u81ea\u4e3b\u7684\u201c\u6210\u5458\u56fd\u5ba1\u6279\u7a0b\u5e8f( national procedure)<\/span>\u201d\u548c\u5404\u6210\u5458\u56fd\u4e4b\u95f4\u7684\u201c\u4e92\u8ba4\u7a0b\u5e8f( mutualrecognized <\/span>procedure\uff0cMRP) \u201d\u3002\u751f\u7269\u5236\u54c1\u3001\u6cbb\u7597\u764c\u75c7\u3001\u7cd6<\/span>\u5c3f\u75c5\u7b49\u91cd\u5927\u75be\u75c5\u7684\u836f\u54c1\u548c\u5b64\u513f\u836f\u5fc5\u987b\u7ecf\u8fc7\u96c6\u4e2d\u5ba1\u6279<\/span>\u7a0b\u5e8f\uff3b8\uff3d\u3002<\/span><\/p>\n

EMA \u7f51\u7ad9\u4e0a\u7684\u4e0a\u5e02\u836f\u7269\u5747\u4e3a\u901a\u8fc7\u96c6\u4e2d\u5ba1<\/span>\u6279\u7a0b\u5e8f\u800c\u83b7\u5f97\u6279\u51c6\u7684\u836f\u54c1\u3002<\/span>\u4e00\u65e6EMA \u7ed9\u4e88\u4e00\u4e2a\u836f\u7269\u4e0a\u5e02\u8bb8\u53ef\uff0c\u5c06\u53d1\u5e03\u4e00\u4efd<\/span>EPAR\u7684\u79d1\u5b66\u8bc4\u4f30\u3002EPAR \u662f\u4e0e\u751f\u4ea7\u4f01\u4e1a\u8fbe\u6210\u4e00\u81f4<\/span>\u800c\u7f16\u5199\u7684\uff0c\u6982\u8ff0\u4e86\u751f\u4ea7\u4f01\u4e1a\u53d1\u5e03\u7684\u6587\u4ef6\u3001\u63cf\u8ff0\u4e86<\/span>EMA \u6279\u51c6\u6b64\u836f\u7684\u7a0b\u5e8f\u3002\u5728\u5546\u4e1a\u4fdd\u5bc6\u4fe1\u606f\u88ab\u5220\u9664\u540e\uff0c<\/span>\u516c\u5e03\u5728EMA \u7684\u7f51\u7ad9\u4e0a\uff3b9\uff3d\u3002\u9664\u4e86\u6709\u5b8c\u6574\u7684\u62a5\u544a\u53ef\u4ee5<\/span>\u4e0b\u8f7d\u5916\uff0c\u7f51\u9875\u4e0a\u8fd8\u5bf9\u8fd9\u4efd\u62a5\u544a\u8fdb\u884c\u6982\u8ff0\u3002EPAR\u662f<\/span>\u516c\u4f17\u53ef\u5f97\u7684\u5173\u4e8e\u6b27\u6d32\u65b0\u836f\u7684\u4e00\u4efd\u91cd\u8981\u7684\u89c4\u8303\u6027\u6587<\/span>\u4ef6\uff0c\u5b83\u53cd\u6620\u4e86\u76f8\u5173EMA \u6210\u5458\u7684\u79d1\u5b66\u7ed3\u8bba\uff0c\u56e0\u6b64\u662f\u836f<\/span>\u7269\u4fe1\u606f\u7684\u4e00\u4e2a\u91cd\u8981\u6765\u6e90\uff3b7\uff3d\u3002\u6839\u636e\u836f\u7269\u6cbb\u7597\u5bf9\u8c61\u7684<\/span>\u4e0d\u540c\uff0cEPAR \u5206\u4e3a3 \u7c7b: \u4eba\u7528\u836f\u7269\u62a5\u544a\u3001\u517d\u7528\u836f\u7269\u62a5<\/span>\u544a\u548c\u4eba\u7528\u4e2d\u8349\u836f\u62a5\u544a\u3002<\/span><\/p>\n

\u4e0b\u9762\u5c06\u4ee5\u4e0a\u5e02\u836f\u7269\u5361\u57f9\u4ed6\u6ee8\u539f\u7814\u836f\u54c1\u5e0c\u7f57\u8fbe\u4e3a\u4f8b\uff0c\u4ecb\u7ecdEPAR\u6570\u636e\u5e93\u7684\u76f8\u5173\u5185\u5bb9\u3002\u9996\u5148\u6253\u5f00EMA<\/span>\u7684\u4e3b\u9875\uff0c\u5728\u4e3b\u9875\u7684\u5de6\u4e0a\u89d2\u201csearch for medicines\u201d\u4e00\u680f<\/span>\u76f4\u63a5\u8f93\u5165\u201ccapecitabine\u201d\u67e5\u8be2\u6216\u8005\u70b9\u51fb\u4e3b\u9875\u4e0a\u7684<\/span>\u201cfind medicine\u201d\u8fdb\u5165\u67e5\u8be2\u9875\u9762\u67e5\u8be2\u3002\u70b9\u51fb\u201cxeloda\u201d\uff0c<\/span>\u6240\u663e\u793a\u7684\u9875\u9762\u5305\u62ec4 \u4e2a\u5206:\u201cabout\u201d\uff0c\u201cauthorisation<\/span>details\u201d\uff0c\u201cproduct information\u201d\u548c\u201cassessment history\u201d<\/span>\u3002\u56e0\u6b64\uff0c\u4e00\u4efd\u5b8c\u6574\u7684EPA\uff32 \u5305\u62ec\u4ea7\u54c1\u6982\u8ff0\u3001\u6279\u51c6<\/span>\u7ec6\u8282\u3001\u4ea7\u54c1\u4fe1\u606f\u548c\u8bc4\u4f30\u5386\u53f24 \u4e2a\u90e8\u5206\u7684\u5185\u5bb9\u3002<\/span><\/p>\n

\u4ea7\u54c1\u6982\u8ff0\u7531\u5e0c\u7f57\u8fbe\u662f\u4ec0\u4e48\u3001\u5e0c\u7f57\u8fbe\u7684\u7528\u9014\u662f\u4ec0\u4e48\u3001\u600e\u6837\u4f7f\u7528\u5e0c\u7f57\u8fbe\u7b4910 \u4e2a\u90e8\u5206\u7684\u5185\u5bb9\u7ec4\u6210\u3002\u7531\u6b64<\/span>\u53ef\u89c1\uff0c\u4ea7\u54c1\u6982\u8ff0\u5bf9\u836f\u7269\u7684\u5404\u65b9\u9762\u4fe1\u606f\u8fdb\u884c\u4e86\u7b80\u8981\u7684<\/span>\u4ecb\u7ecd\uff0c\u516c\u4f17\u53ef\u4e86\u89e3\u5230\u6709\u5173\u8be5\u836f\u7684\u57fa\u672c\u4fe1\u606f\u3002<\/span>\u6279\u51c6\u7ec6\u8282\u516c\u5e03\u4e86\u836f\u7269\u7684\u6709\u6548\u6210\u5206\u3001\u6cbb\u7597\u75be\u75c5\u7b49<\/span>\u4fe1\u606f\uff0c\u4ee5\u53ca\u836f\u7269\u5f00\u53d1\u8005\u7684\u4e00\u4e9b\u4fe1\u606f\u3002<\/span>\u4ea7\u54c1\u4fe1\u606f\u62a5\u544a\u7684\u5185\u5bb9\u4e3b\u8981\u67093 \u4e2a\u65b9\u9762: \u4ea7\u54c1\u7279<\/span>\u5f81\u6982\u8ff0\u3001\u836f\u7269\u4e0a\u5e02\u4e8b\u9879\u3001\u6807\u7b7e\u548c\u5305\u88c5\u8bf4\u660e\u4e66\uff3b8\uff3d\u3002<\/p>\n

\u4ea7\u54c1\u7279\u5f81\u6982\u8ff0\u5305\u62ec\u836f\u7269\u540d\u79f0\u3001\u836f\u54c1\u6210\u5206\u53ca\u542b\u91cf\u3001\u5305\u88c5\u89c4\u683c\u3001\u4e34\u5e8a\u8d44\u6599\u3001\u836f\u7406\u6027\u8d28\u3001\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u8005\u3001\u4e0a\u5e02\u8bb8\u53ef\u6388\u4e88\u8005\u3001\u9996\u6b21\u6388\u6743\u6216\u518d\u6b21\u6388\u6743\u65e5\u671f\u3001\u6587\u6863\u4fee\u8ba2\u65e5\u671f\u7b49<\/span>10 \u4e2a\u65b9\u9762\u3002\u5176\u4e2d\uff0c\u4e34\u5e8a\u8d44\u6599\u548c\u836f\u7406\u6027\u8d28\u7bc7\u5e45\u8f83\u957f\uff0c<\/span>\u662f\u975e\u5e38\u91cd\u8981\u7684\u53c2\u8003\u8d44\u6599\u3002\u836f\u7269\u4e0a\u5e02\u4e8b\u9879\u4e3b\u8981\u4ecb\u7ecd\u4e86\u5e0c\u7f57\u8fbe\u7684\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u8005\u7f57\u6c0f\u516c\u53f8\uff0c\u4e0a\u5e02\u8bb8\u53ef\u89c4\u5b9a<\/span>\u7684\u6709\u5173\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u6761\u4ef6\u548c\u9650\u5236\u7b49\u4fe1\u606f\u8bf4\u660e\u3002<\/span>\u6700\u540e\u662f\u6807\u7b7e\u548c\u5305\u88c5\u8bf4\u660e\u4e66\uff0c\u6807\u7b7e\u89c4\u5b9a\u4e86\u4ea7\u54c1\u5916\u5305\u88c5<\/span>\u4e0a\u5e94\u5305\u542b\u7684\u4fe1\u606f\uff0c\u5305\u88c5\u8bf4\u660e\u4e66\u5305\u62ec\u4ea7\u54c1\u63cf\u8ff0\u3001\u670d\u7528\u524d<\/span>\u987b\u77e5\u3001\u5982\u4f55\u670d\u7528\u3001\u4e0d\u826f\u53cd\u5e94\u3001\u5982\u4f55\u50a8\u5b58\u7b49\u4fe1\u606f\u3002<\/span><\/p>\n

EPAR\u7684\u6700\u540e\u4e00\u90e8\u5206\u2014\u2014\u2014\u8bc4\u4f30\u5386\u53f2\u4e5f\u662f\u975e\u5e38\u6709\u4ef7\u503c\u7684\u4fe1\u606f\u3002\u8bc4\u4f30\u5386\u53f2\u4e2d\u5305\u62ec\u6700\u521d\u6279\u51c6\u7684\u516c\u5f00\u5ba1\u8bc4<\/span>\u62a5\u544a\u3001\u9488\u5bf9\u4ea7\u54c1\u91cd\u5927\u53d8\u66f4\u7684\u516c\u5f00\u5ba1\u8bc4\u62a5\u544a\u53ca\u836f\u7269\u6279<\/span>\u51c6\u524d\u540e\u6b65\u9aa4\u6982\u89c8\u3002\u8fd9\u91cc\u9762\u542b\u6709\u7684\u4fe1\u606f\uff0c\u5bf9\u4e8e\u65b0\u836f\u7684<\/span>\u5f00\u53d1\u6709\u7740\u5f88\u91cd\u8981\u7684\u53c2\u8003\u610f\u4e49\u3002\u5728\u5e0c\u7f57\u8fbe\u6700\u521d\u6279\u51c6\u7684<\/span>\u516c\u5f00\u5ba1\u8bc4\u62a5\u544a\u4e2d\uff0c\u6240\u5305\u542b\u7684\u4fe1\u606f\u4e3b\u8981\u5305\u62ec\u836f\u7269\u6982\u8ff0;<\/span>\u5316\u5b66\u3001\u836f\u5b66\u548c\u751f\u7269\u5b66\u65b9\u9762\u7684\u4fe1\u606f; \u6bd2\u7406\u548c\u836f\u7406\u5b66\u65b9\u9762<\/span>\u7684\u4fe1\u606f; \u4e34\u5e8a\u65b9\u9762\u7684\u4fe1\u606f; \u6574\u4f53\u8ba8\u8bba\u548c\u5229\u76ca-\u98ce\u9669\u8bc4\u4f30<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

3<\/span><\/p>\n<\/section>\n

\n

\u6b27\u7f8e\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u7684\u5e94\u7528<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n


<\/p>\n

\n
\n
\n

\u9664\u4e86\u5bf9\u67d0\u4e2a\u836f\u7269\u5177\u4f53\u4fe1\u606f\u7684\u67e5\u8be2\uff0cDrugs@ FDA\u6570\u636e\u5e93\u4f5c\u4e3a\u4e0a\u5e02\u836f\u7269\u7684\u7efc\u5408\u6570\u636e\u96c6\uff0c\u5176\u4e30\u5bcc\u7684\u5185\u5bb9\u3001\u5e9e\u5927\u7684\u6570\u636e\u91cf\u53ca\u5168\u9762\u7684\u68c0\u7d22\u529f\u80fd\u4e5f\u4e3a\u836f\u7269\u5927\u6570\u636e\u7684\u8fdb\u4e00\u6b65\u6316\u6398\u548c\u5e94\u7528\u5960\u5b9a\u4e86\u6570\u636e\u57fa\u7840\u3002<\/p>\n

\u674e\u8f69\u7b49\uff3b10\uff3d\u901a\u8fc7\u67e5\u9605Drugs@ FDA \u6570\u636e\u5e93\uff0c\u6536\u96c62014 \u5e74FDA \u6279\u51c6\u7684\u65b0\u836f\u4fe1\u606f\uff0c\u4ece\u6279\u51c6\u7684\u65b0\u836f\u6570\u91cf\u3001FDA \u6279\u51c6\u65b0\u836f\u7684\u65b9\u5f0f\u3001FDA \u6279\u51c6\u65b0\u836f\u7684\u6cbb\u7597\u9886\u57df\u4e0e\u5242\u578b\u7b49\u65b9\u9762\u8fdb\u884c\u7edf\u8ba1\u5206\u6790\uff0c\u5176\u5206\u6790\u7ed3\u679c\u4e3a\u533b\u836f\u754c\u548c\u76f8\u5173\u7ba1\u7406\u90e8\u95e8\u63d0\u4f9b\u4e86\u4fe1\u606f\u53c2\u8003\u3002\u5206\u6790\u53d1\u73b0\uff0c2014 \u5e74FDA \u6279\u51c6\u4e8641\u4e2a\u65b0\u836f\uff0c\u5176\u4e2d17 \u4e2a\u4e3a\u5b64\u513f\u836f( orphan product) \uff0c\u5360\u6240\u6709\u6279\u51c6\u65b0\u836f\u768441\uff0e 5%\uff0c\u5176\u6570\u91cf\u662f1983 \u5e74\u5b64\u513f\u836f\u6cd5\u6848\u5b9e\u65bd\u4ee5\u6765\u4e4b\u6700\u3002\u6279\u51c6\u65b0\u836f\u7684\u6cbb\u7597\u9886\u57df\u4ee5\u6297\u5fae\u751f\u7269\u836f( \u76ae\u80a4\u53ca\u76ae\u80a4\u7ec4\u7ec7\u611f\u67d3\u3001\u57fa\u56e01 \u578b\u4e19\u809d\u611f\u67d3\u548c\u8dbe\u7532\u771f\u83cc\u611f\u67d3\u7b49) \u3001\u6297\u80bf\u7624\u836f( \u6dcb\u5df4\u7624\u3001\u9ed1\u8272\u7d20\u7624\u7b49) \u548c\u4ee3\u8c22\u7cfb\u7edf\u7528\u836f( 2 \u578b\u7cd6\u5c3f\u75c5\u7b49) \u4e3a\u4e3b\uff0c\u5242\u578b\u4ee5\u6ce8\u5c04\u5242\u3001\u7247\u5242\u548c\u80f6\u56ca\u5242\u4e3a\u4e3b\u3002\u963f\u4e3d\u5854\u7b49\uff3b11\uff3d\u4ee5Drugs@ FDA \u6570\u636e\u5e93\u4e3a\u6570\u636e\u6765\u6e90\uff0c\u7cfb\u7edf\u68b3\u7406\u4e861984\u20142014 \u5e74\u7f8e\u56fdFDA \u5ba1\u6279\u4e0a\u5e02\u7684\u6cbb\u7597\u6027\u751f\u7269\u836f\u7269\uff0c\u7ed3\u679c\u8868\u660e\u5168\u7403\u751f<\/span>\u7269\u836f\u7269\u57281996 \u5e74\u4ee5\u540e\u5f00\u59cb\u5feb\u901f\u53d1\u5c55\uff0c2001\u20142005<\/span>\u5e74\u662f\u751f\u7269\u836f\u7269\u6210\u679c\u6700\u4e3a\u663e\u8457\u7684\u9636\u6bb5\u3002\u80bf\u7624\u3001\u514d\u75ab\u7cfb<\/span>\u7edf\u75be\u75c5\u3001\u5185\u5206\u6ccc\u548c\u4ee3\u8c22\u75be\u75c5\u3001\u8840\u6db2\u7cfb\u7edf\u75be\u75c5\u3001\u9aa8\u9abc\u808c<\/span>\u7cfb\u7edf\u75be\u75c5\u662f\u751f\u7269\u836f\u7269\u7814\u7a76\u7684\u91cd\u70b9\u9886\u57df\uff0c\u4e0a\u5e02\u836f\u7269\u8f83<\/span>\u591a\u3002\u76ee\u524d\u6297\u4f53\u5df2\u7ecf\u53d1\u5c55\u6210\u4e3a\u6cbb\u7597\u6027\u751f\u7269\u836f\u7269\u7684\u4e3b\u5bb0<\/span>\u836f\u7269\uff0c\u5728\u80bf\u7624\u3001\u6d88\u5316\u3001\u514d\u75ab\u3001\u547c\u5438\u3001\u6ccc\u5c3f\u3001\u9aa8\u9abc\u808c\u75be\u75c5\u3001\u75be<\/span>\u75c5\u8bca\u65ad\u7b49\u4e0d\u540c\u9886\u57df\u5e7f\u6cdb\u5e94\u7528\u3002\u8fd9\u4e9b\u5927\u6570\u636e\u7814\u7a76\u5206\u6790<\/span>\u5bf9\u4e8e\u6211\u56fd\u751f\u7269\u836f\u7269\u4ea7\u4e1a\u53d1\u5c55\u5177\u6709\u91cd\u5927\u53c2\u8003\u610f\u4e49\u3002<\/span><\/p>\n

<\/span><\/p>\n

\u4e0eDrugs@ FDA \u6570\u636e\u5e93\u4e0d\u540c\uff0cEPAR \u6570\u636e\u5e93\u5305\u542b\u4e86\u6ca1\u6709\u83b7\u6279\u7684\u836f\u7269\u548c\u9000\u5e02\u836f\u7269\uff0c\u5e76\u4e14\u7ed9\u51fa\u4e86\u4e0d\u4e88\u6279<\/span>\u51c6\u6216\u8005\u9000\u5e02\u7684\u539f\u56e0\uff3b12\uff3d\u3002Hartmann \u7b49\uff3b13\uff3d\u5229\u7528EPAR<\/span>\u6570\u636e\u5e93\u5206\u6790\u4e862006\u20142011 \u5e74\u83b7\u5f97\u6279\u51c6\u7684\u6297\u80bf\u7624\u836f<\/span>\u7269\uff0c\u53d1\u73b0\u83b7\u6279\u836f\u7269\u5360\u7533\u8bf7\u7684\u6297\u80bf\u7624\u836f\u7269\u6bd4\u4f8b\u4e3a<\/span>63%\uff0c\u4f4e\u4e8e\u975e\u80bf\u7624\u836f\u7269\u7684\u6279\u51c6\u6bd4\u738773%\u3002\u4f5c\u8005\u8fd8\u6bd4<\/span>\u8f83\u4e86\u540c\u4e00\u65f6\u671f\u7f8e\u56fd\u548c\u65e5\u672c\u7684\u4e0a\u5e02\u80bf\u7624\u836f\u7269\u7684\u60c5\u51b5\uff0c<\/span>\u53d1\u73b0\u65b0\u836f\u5728\u7f8e\u56fd\u83b7\u5f97\u6279\u51c6\u7684\u901f\u5ea6\u66f4\u5feb\uff0c\u56e0\u5176\u52a0\u5feb\u5ba1<\/span>\u67e5\u7a0b\u5e8f\u4f7f\u7528\u7684\u66f4\u4e3a\u9891\u7e41\u3002<\/span>
<\/p>\n

\u9664\u4e86\u836f\u7269\u5927\u6570\u636e\u7684\u6316\u6398\u548c\u5e94\u7528\uff0c\u8fd8\u53ef\u4ee5\u5229\u7528Drugs@ FDA \u548cEPA\uff32 \u6570\u636e\u5e93\u4e30\u5bcc\u7684\u6570\u636e\u8d44\u6e90\uff0c\u6784\u5efa<\/span>\u5176\u4ed6\u7528\u9014\u7684\u6570\u636e\u5e93\uff0c\u4f8b\u5982\u6784\u5efa\u7528\u4e8e\u836f\u7269\u91cd\u5b9a\u4f4d\u7684\u6570<\/span>\u636e\u5e93\u3002\u836f\u7269\u91cd\u5b9a\u4f4d( drug repositioning) \u53c8\u79f0\u201c\u8001\u836f\u65b0<\/span>\u7528\u201d\u3001\u201c\u91cd\u5ba1\u65e7\u836f\u201d\uff0c\u662f\u6307\u53d1\u73b0\u5df2\u4e0a\u5e02\u836f\u7269\u7684\u65b0\u9002\u5e94\u8bc1<\/span>\u6216\u65b0\u7528\u9014\u3002\u8bb8\u591a\u5b66\u8005\u8ba4\u4e3a\uff0c\u5728\u5f53\u524d\u6240\u6709\u65b0\u836f\u7814\u53d1\u7b56<\/span>\u7565\u4e2d\uff0c\u836f\u7269\u91cd\u5b9a\u4f4d\u7814\u7a76\u662f\u6700\u4e3a\u5feb\u6377\u3001\u6700\u4e3a\u6709\u6548\u7684\u7b56\u7565<\/span>\u4e4b\u4e00\uff0c\u53d7\u5230\u9ad8\u5ea6\u91cd\u89c6\u30022011 \u5e74\u6709\u7814\u7a76\u8ba4\u4e3a\uff0c\u836f\u7269\u91cd<\/span>\u5b9a\u4f4d\u7814\u7a76\u662f\u4e00\u79cd\u201c\u7eff\u8272\u7684\u836f\u7269\u53d1\u73b0\u201d\uff3b14\uff3d\u3002Huang<\/span>\u7b49\uff3b15\uff3d\u96c6\u5408\u4e86Drugs@ FDA\uff0cEPA\uff32 \u6570\u636e\u5e93\u7b49\u6279\u51c6\u7684\u5c0f<\/span>\u5206\u5b50\u836f\u7269\uff0c\u6784\u5efa\u4e86\u7f51\u7edc\u6570\u636e\u5e93\u548c\u836f\u7269\u5b9e\u4f53\u5e93\uff0c\u7f51\u7edc\u6570<\/span>\u636e\u5e93\u91cc\u7684\u836f\u7269\u53ef\u7528\u4e8e\u865a\u62df\u7b5b\u9009\uff0c\u5b9e\u4f53\u5e93\u91cc\u7684\u5c0f\u5206\u5b50<\/span>\u53ef\u4ee5\u7528\u9ad8\u901a\u91cf\u7b5b\u9009\uff0c\u8fbe\u5230\u836f\u7269\u91cd\u5b9a\u4f4d\u7814\u7a76\u7684\u76ee\u7684\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

4<\/p>\n<\/section>\n

\n

FDA \u548cEMA \u7f51\u7ad9\u4e0a2 \u4e2a\u4e0a\u5e02\u836f\u7269\u6570\u636e\u5e93\u4fe1\u606f\u516c\u5f00\u7684\u5f02\u540c\u6bd4\u8f83<\/span><\/p>\n<\/section>\n<\/section>\n


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FDA \u548cEMA \u4f5c\u4e3a\u5168\u7403\u4e0a\u5e02\u836f\u7269\u5ba1\u6279\u548c\u76d1\u7ba1\u7684\u6743\u5a01\u673a\u6784\uff0c\u836f\u7269\u4fe1\u606f\u516c\u5f00\u4f5c\u4e3a\u5176\u5de5\u4f5c\u5185\u5bb9\u7684\u4e00\u90e8\u5206\uff0c\u65e2\u6709\u5dee\u5f02\u4e5f\u6709\u5171\u540c\u4e4b\u5904\u3002\u5982\u524d\u9762\u6240\u8ff0\uff0cFDA \u6210\u7acb\u4e8e1906 \u5e74\uff0c\u5386\u53f2\u975e\u5e38\u60a0\u4e45; EMA \u6210\u7acb\u4e8e1995 \u5e74\uff0c\u76f8\u5bf9\u6bd4\u8f83\u5e74\u8f7b\uff0c\u56e0\u6b64FDA\u76f8\u5bf9\u4e8eEMA \u79ef\u7d2f\u7684\u6570\u636e\u91cf\u66f4\u591a\u3002FDA \u5728\u65b0\u836f\u5ba1\u6279\u7684\u6001\u5ea6\u4e0a\u66f4\u4e3a\u6fc0\u8fdb\uff0cEMA \u5219\u662f\u7565\u4e3a\u6e29\u548c\u4fdd\u5b88\uff0c\u56e0\u6b64FDA \u7684\u4e0a\u5e02\u836f\u7269\u6570\u91cf\u4e5f\u66f4\u591a\u3002\u6709\u7814\u7a76\u663e\u793a\uff0c\u81ea2011\u20142015 \u5e74\uff0c\u7f8e\u56fd\u76d1\u7ba1\u673a\u6784\u5728\u65b0\u836f\u6279\u51c6\u6570\u91cf\u548c\u5ba1\u67e5\u901f\u5ea6\u4e24\u65b9\u9762\u5747\u5df2\u8d85\u8fc7\u4e86\u5176\u5728\u6b27\u6d32\u7684\u540c\u884c\uff3b16\uff3d\u3002<\/p>\n

\u636e\u8c03\u67e5\u5206\u6790\u663e\u793a\uff0cFDA \u57285 \u5e74\u65f6\u95f4\u5185\u6279\u51c6\u4e86170 \u4e2a\u65b0\u836f\uff0cEMA \u6279\u51c6\u4e86144 \u4e2a\u65b0\u836f\u3002\u53e6\u5916\uff0cFDA \u65b0\u836f\u5ba1\u8bc4\u7684\u65f6\u95f4\u6bd4\u5176\u5728EMA \u5ba1\u8bc4\u7684\u65f6\u95f4\u5e73\u5747\u7f29\u77ed60 d\u3002<\/p>\n

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\u5c3d\u7ba1FDA \u7f51\u7ad9\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u91cf\u8f83\u5927\uff0c\u4f46\u662f\u4e00\u9879\u5bf9\u6bd4\u7814\u7a76\u53d1\u73b0\uff0cEMA \u7684\u836f\u7269\u4fe1\u606f\u67e5\u8be2\u6bd4FDA \u66f4\u7b80\u660e\u597d\u7528\uff0c\u4fe1\u606f\u66f4\u5bb9\u6613\u83b7\u5f97\uff0cEMA \u6240\u6709\u7684\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u90fd\u96c6\u4e2d\u5728EPAR\u91cc\uff0c\u6bcf\u4e2a\u6587\u6863\u7684\u6700\u524d\u9762\u90fd\u6709\u8868\u683c\u5217\u51fa\u4e3b\u8981\u5185\u5bb9\uff0cDrugs@ FDA \u6570\u636e\u5e93\u91cc\u7684\u4fe1\u606f\u6709\u7684\u683c\u5f0f\u5316\u7a0b\u5ea6\u76f8\u5bf9\u8f83\u5dee\uff0c\u6709\u65f6\u96be\u4ee5\u901a\u8fc7\u67e5\u8be2\u83b7\u5f97\u3002\u5728Drugs@ FDA \u6570\u636e\u5e93\u91cc\u5e76\u672a\u5305\u542b\u6ca1\u6709\u83b7\u6279\u7684\u836f\u7269\u548c\u9000\u5e02\u836f\u7269\uff0c\u800c\u5728EMA \u7f51\u7ad9\u4e0a\u662f\u6709\u4e0a\u8ff0\u836f\u7269\u7684\u4fe1\u606f\uff0c\u5e76\u4e14\u7ed9\u51fa\u4e86\u4e0d\u4e88\u6279\u51c6\u6216\u8005\u9000\u5e02\u7684\u539f\u56e0\uff3b11\uff3d\uff0c\u89c1\u88681\u3002<\/p>\n

\"\u6b27\u7f8e\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u6743\u5a01\u53d1\u5e03\u6570\u636e\u5e93\u53ca\u5176\u5e94\u7528\"<\/p>\n

FDA \u548cEMA \u5728\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u516c\u5f00\u4e0a\uff0c\u7531\u4e8e\u6587\u5316\u3001\u6cd5\u89c4\u7b49\u65b9\u9762\u7684\u4e0d\u540c\uff0c\u786e\u5b9e\u5b58\u5728\u4e00\u4e9b\u5dee\u522b\u3002\u4f46\u4e24\u8005\u5747\u4e3a\u4fe1\u606f\u516c\u5f00\u900f\u660e\u800c\u4e0d\u61c8\u52aa\u529b\uff0c\u5305\u62ec\u542c\u53d6\u591a\u65b9\u610f\u89c1\u8fdb\u884c\u8c03\u6574\u6539\u8fdb\u3001\u4e0e\u836f\u7269\u751f\u4ea7\u4f01\u4e1a\u5408\u4f5c\u5b9e\u73b0\u5171\u8d62\u7b49\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u4f5c\u4e3a\u6b27\u7f8e\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u5b98\u65b9\u516c\u5e03\u7684\u5185\u5bb9\uff0cDrugs@ FDA \u6570\u636e\u5e93\u548cEPAR<\/span>\u6570\u636e\u5e93\u91cc\u7684\u4fe1\u606f\u4e30\u5bcc\u6743\u5a01\uff0c\u68c0\u7d22\u754c\u9762\u7b80\u6d01\u6613\u7528\uff0c\u662f\u836f\u54c1\u4f7f\u7528\u548c\u7814\u53d1\u4eba\u5458\u9887\u4e3a\u5f97\u529b\u7684\u4fe1\u606f\u52a9\u624b\u3002Drugs@ FDA \u6570\u636e\u5e93\u548cEPAR\u6570\u636e\u5e93\u5bf9\u6211\u56fd\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u7684\u836f\u7269\u4fe1\u606f\u516c\u5f00\u5177\u6709\u975e\u5e38\u91cd\u8981\u7684\u53c2\u8003\u610f\u4e49\u3002\u968f\u7740\u5927\u6570\u636e\u65f6\u4ee3\u7684\u6765\u4e34\u548c\u56fd\u5bb6\u653f\u7b56\u7684\u4e0d\u65ad\u5b8c\u558417\uff3d\uff0c\u6211\u56fd\u4e0a\u5e02\u836f\u7269\u4fe1\u606f\u7684\u7535\u5b50\u5316\u3001\u900f\u660e\u5ea6\u7b49\u5c06\u4f1a\u5f97\u5230\u8fdb\u4e00\u6b65\u63d0\u9ad8\uff0c\u4ee5\u52a9\u529b\u6211\u56fd\u65b0\u836f\u7814\u53d1\u8fc8\u4e0a\u65b0\u7684\u53f0\u9636\u3002<\/span><\/p>\n


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\u53c2\u8003\u6587\u732e<\/p>\n<\/section>\n

\uff3b<\/span>1<\/span>\uff3d<\/span> PATRIDGE EV<\/span>\uff0c<\/span>GAREISS PC<\/span>\uff0c<\/span>KINCH MS<\/span>\uff0c<\/span>et al<\/span>\uff0e<\/span> An analysis oforiginal research contributions toward FDA-approved drug<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>Drug Discovery Today<\/span>\uff0c<\/span>2015<\/span>\uff0c<\/span>20( 10) : 1182 <\/span>\uff0d<\/span> 1187<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>2<\/span>\uff3d<\/span>\u9648\u7389\u6587\uff0c\u9648\u8679\uff0e<\/span>\u533b\u751f\u5bf9\u4fe1\u606f\u4f20\u9012\u9014\u5f84\u53ca\u836f\u54c1\u4fe1\u606f\u63a5\u6536\u7a0b\u5ea6\u7684\u8c03\u67e5\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>\u533b\u836f\u5bfc\u62a5\uff0c<\/span>2010<\/span>\uff0c<\/span>29( 6) : 827 <\/span>\uff0d<\/span> 829<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>3<\/span>\uff3d<\/span>\u738b\u7426\uff0c\u5218\u57f9\u4f1f\uff0c\u968b\u5a1c\u5a1c\uff0e<\/span>\u836f\u54c1\u4fe1\u606f\u76d1\u7ba1\u73b0\u72b6\u5206\u6790\u4e0e\u5168\u65b9\u4f4d\u76d1\u7ba1\u5efa\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>\u4e2d\u56fd\u836f\u4e1a\uff0c<\/span>2015<\/span>\uff0c<\/span>24( 10) : 5 <\/span>\uff0d<\/span> 8<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>4<\/span>\uff3d<\/span> COOK GE<\/span>\uff0c<\/span>MADDEN MM<\/span>\uff0e<\/span> The significance of information posted on the US Food andDrug Administration’s website<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>J Manag Care Pharm<\/span>\uff0c<\/span>2013<\/span>\uff0c<\/span>19( 1) : 72 <\/span>\uff0d<\/span> 73<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>5<\/span>\uff3d<\/span> INDSTROM JA<\/span>\uff0e<\/span>Sources of drug information:FDA-approved labeling and other official FDA sources<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>Dermatol Ther<\/span>\uff0c<\/span>2010<\/span>\uff0c<\/span> 22( 3) : 246 <\/span>\uff0d<\/span> 256<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>6<\/span>\uff3d<\/span> MA<\/span>\uff32<\/span>CHAND HC<\/span>\uff0c\uff32<\/span>OS BJ<\/span>\uff0c<\/span>FINE AM<\/span>\uff0c<\/span>et al<\/span>\uff0e<\/span> The U<\/span>\uff0e<\/span> S<\/span>\uff0e<\/span> Food and drugadministration: drug information resource for formulary recommendations<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>J Manag Care Pharm<\/span>\uff0c<\/span>2012<\/span>\uff0c<\/span>18 ( 9 ) : 713 <\/span>\uff0d<\/span> 718<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>7<\/span>\uff3d<\/span> KOHLER M<\/span>\uff0c<\/span>HAAG S<\/span>\uff0c<\/span>BIESTE<\/span>\uff32<\/span> K<\/span>\uff0c<\/span>et al<\/span>\uff0e<\/span> Information onnew drugs at market entry: retrospective analysis of healthtechnology assessment reports versus regulatory reports<\/span>\uff0c<\/span>journal publications<\/span>\uff0c<\/span>andregistry reports<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span> Bri Med J<\/span>\uff0c<\/span>2015<\/span>\uff0c<\/span>350: 796<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>8<\/span>\uff3d<\/span>\u9648\u7389\uff0c\u9ec4\u5e73\uff0e<\/span>\u6b27\u76df\u516c\u4f17\u8bc4\u4f30\u62a5\u544a<\/span>( EPA<\/span>\uff32<\/span>) <\/span>\u4ecb\u7ecd\uff3b<\/span>J<\/span>\uff3d\uff0e\u4e2d\u56fd\u6267\u4e1a\u836f<\/span> <\/span>\u5e08\uff0c<\/span>2011<\/span>\uff0c<\/span>8 ( 1) : 26 <\/span>\uff0d<\/span> 29<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>9<\/span>\uff3d<\/span> BARBUI C<\/span>\uff0c<\/span>BASCHIROTTO C<\/span>\uff0c<\/span>CIPRIANI A<\/span>\uff0e<\/span>EMA mustimprove its quality of clinical trial reports<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span> Bri Med J<\/span>\uff0c<\/span>2011<\/span>\uff0c<\/span> 342: d2291<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>10<\/span>\uff3d<\/span>\u674e\u8f69\uff0c\u90fd\u6653\u6625\uff0c\u5f20\u857e\uff0e<\/span> 2014 <\/span>\u5e74\u7f8e\u56fd<\/span>FDA <\/span>\u6279\u51c6\u7684\u65b0\u836f\u5206\u6790\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span> <\/span>\u4e2d\u56fd\u836f\u4e8b\uff0c<\/span>2015<\/span>\uff0c<\/span>29 ( 6) : 618 <\/span>\uff0d<\/span> 622<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>11<\/span>\uff3d<\/span>\u963f\u4e3d\u5854\uff0c\u7a46\u946b\uff0c\u5510\u5c0f\u5229\uff0c\u7b49\uff0e<\/span> 1984 <\/span>\uff5e<\/span> 2014 <\/span>\u5e74\u6cbb\u7597\u6027\u751f\u7269\u836f\u7269\u53d1\u5c55\u5386\u7a0b\u53ca\u5c55\u671b\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>\u4e2d\u56fd\u836f\u7406\u5b66\u901a\u62a5\uff0c<\/span>2015<\/span>\uff0c<\/span>31 ( 10) : 1356 <\/span>\uff0d<\/span>1362<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>12<\/span>\uff3d<\/span> SCHROLL JB<\/span>\uff0c<\/span>ABDELSATTAR M<\/span>\uff0c<\/span>BERO L<\/span>\uff0e<\/span> The food anddrug administration reports provided more data but were moredifficult to use than the European Medicines Agency reports<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span> J ClinEpidemiol<\/span>\uff0c<\/span>2015<\/span>\uff0c<\/span>68( 1) : 102 <\/span>\uff0d<\/span> 107<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>13<\/span>\uff3d<\/span> HARTMANN M<\/span>\uff0c<\/span>MAYER-NICOLAI C<\/span>\uff0c<\/span>PFAFF O<\/span>\uff0e<\/span>Approval probabilitiesand regulatory review patterns for anticancer drugs in the European Union<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span> Crit Rev Oncol\/Hematol<\/span>\uff0c<\/span>2013<\/span>\uff0c<\/span>87 (2) : 112 <\/span>\uff0d<\/span> 121<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>14<\/span>\uff3d<\/span>\u5f20\u6c38\u7965\uff0c\u7a0b\u8096\u854a\uff0c\u5468\u6587\u971e\uff0e<\/span>\u836f\u7269\u91cd\u5b9a\u4f4d<\/span>\u2014\u2014\u2014<\/span>\u7f51\u7edc\u836f\u7406\u5b66\u7684\u91cd\u8981\u5e94\u7528\u9886\u57df\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>\u4e2d\u56fd\u836f\u7406\u5b66\u4e0e\u6bd2\u7406\u5b66\u6742\u5fd7\uff0c<\/span>2012<\/span>\uff0c<\/span>26( 6) : 779 <\/span>\uff0d<\/span>786<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>15<\/span>\uff3d<\/span> HUANG RL<\/span>\uff0c<\/span>SOUTHALL N<\/span>\uff0c<\/span>WANG YH<\/span>\uff0c<\/span>et al<\/span>\uff0e<\/span> The NCGC Pharmaceutical Collection: a comprehensiveresource of clinically approved drugs enabling repurposing and chemicalgenomics<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>Sci Transl Med<\/span>\uff0c<\/span>2011<\/span>\uff0c<\/span>3( 80) : 80ps16<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>16<\/span>\uff3d<\/span> DOWNING NS<\/span>\uff0c<\/span>ZHANG AD<\/span>\uff0c\uff32<\/span>OSS JS<\/span>\uff0e<\/span>Regulatory reviewof new therapeutic agents\u2014FDA versus EMA<\/span>\uff0c<\/span>2011<\/span>\uff0d<\/span> 2015<\/span>\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span> N Engl J Med<\/span>\uff0c<\/span>2017<\/span>\uff0c<\/span>376( 14) : 1386 <\/span>\uff0d<\/span> 1387<\/span>\uff0e<\/span><\/p>\n

\uff3b<\/span>17<\/span>\uff3d<\/span>\u80e1\u660c\u52e4\uff0c\u6210\u53cc\u7ea2\uff0e<\/span>\u5927\u6570\u636e\u65f6\u4ee3\u836f\u54c1\u8d28\u91cf\u76d1\u7ba1\u4f53\u7cfb\u53d1\u5c55\u8d8b\u52bf\uff3b<\/span>J<\/span>\uff3d\uff0e<\/span>\u4e2d\u56fd\u65b0\u836f\u6742\u5fd7\uff0c<\/span>2016<\/span>\uff0c<\/span>25( 20) : 2281 <\/span>\uff0d<\/span> 2286<\/span>\uff0e<\/span><\/p>\n


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\u51e1\u9ed8\u8c37\u516c\u4f17\u53f7\u5f00\u901a\u5f80\u671f\u6587\u7ae0\u4efb\u610f\u641c\u529f\u80fd\u5566<\/span><\/strong>
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\u516c\u4f17\u53f7\u83dc\u5355\u680f\u4e2d\u8f93\u5165\u201c\u641c\u7d22\u201d\uff0c\u5373\u53ef\u641c\u7d22\u5f80\u671f\u5fae\u4fe1\u5185\u5bb9<\/span><\/strong><\/p>\n

\u6765\u6e90<\/strong>6 \u671f<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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