{"id":81156,"date":"2019-04-10T00:00:50","date_gmt":"2019-04-11T06:46:45","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/81156\/"},"modified":"2019-04-11T14:46:45","modified_gmt":"2019-04-11T06:46:45","slug":"1985b47730","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/81156\/","title":{"rendered":"\u836f\u54c1\u56fd\u9645\u6ce8\u518c\uff5c\u5404\u56fd\u7533\u62a5\u8d44\u6599\u4e4b\u5dee\u5f02"},"content":{"rendered":"
\n

\u4e00\u3001<\/span>\u4e3b\u8981\u5dee\u5f02\u5bf9\u6bd4\u5206\u6790<\/span><\/strong><\/p>\n

\u3000\u3000\u5404\u56fd\u5bf9\u836f\u54c1\u4e0a\u5e02\u9500\u552e\u5747\u91c7\u53d6\u4e86\u975e\u5e38\u4e25\u683c\u7684\u6ce8\u518c\u7ba1\u7406\uff0c\u6ce8\u518c\u7684\u5177\u4f53\u7a0b\u5e8f\u5404\u4e0d\u76f8\u540c\uff0c\u4f46\u76ee\u6807\u53ea\u6709\u4e00\u4e2a\uff0c\u5c31\u662f\u5728\u5404\u56fd\u56fd\u60c5\u4e0b\uff0c\u5c3d\u6700\u5927\u52aa\u529b\u786e\u4fdd\u672c\u56fd\u516c\u6c11\u7528\u836f\u7684\u5b89\u5168\u3001\u6709\u6548\u548c\u8d28\u91cf\u3002\u76ee\u524d\uff0c\u9664\u4e86\u6b27\u7f8e\u65e5\u7b49\u53d1\u8fbe\u56fd\u5bb6\uff0c\u6211\u56fd\u662f\u5c11\u6570\u5f3a\u5236\u5b9e\u65bd\u836f\u54c1\u751f\u4ea7<\/span>GMP<\/span>\u7ba1\u7406\u7684\u56fd\u5bb6\u4e4b\u4e00\u3002\u6211\u56fd\u4e0e\u6b27\u7f8e\u65e5\u7b49\u4e3b\u6d41\u56fd\u5bb6\u76f8\u6bd4\uff0c\u4e3b\u8981\u5728\u6ce8\u518c\u6587\u4ef6\u683c\u5f0f\u3001\u7533\u62a5\u7a0b\u5e8f\u3001\u6ce8\u518c\u4ea7\u54c1\u5206\u7c7b\u7b49\u65b9\u9762\u6709\u7740\u4e0d\u540c\u3002<\/span>CTD<\/span>\uff08\u836f\u54c1\u6ce8\u518c\u901a\u7528\u6280\u672f\u6587\u4ef6\uff09\u4f5c\u4e3a\u7f8e\u6b27\u65e5\u4e09\u65b9\u4eba\u7528\u836f\u6ce8\u518c\u7edf\u4e00\u7684\u6587\u4ef6\u683c\u5f0f\uff0c\u5341\u5206\u6ce8\u91cd\u7814\u7a76\u7ed3\u679c\u8868\u8ff0\u7684\u5177\u4f53\u5316\u548c\u89c4\u8303\u5316\u3002<\/span><\/p>\n

1.1 <\/span>\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u5dee\u5f02<\/span><\/strong><\/p>\n

\u3000\u3000\uff08\u4e00\uff09\u6b27\u76df\u65b0\u836f\u6ce8\u518c\u7279\u70b9<\/span><\/p>\n

\u3000\u3000\u6b27\u76df\u65b0\u836f\u6ce8\u518c\u7533\u8bf7\u662f\u4e00\u6b21\u7533\u8bf7\u4e00\u6b21\u6279\u51c6\u5f62\u5f0f\uff0c\u5728\u65b0\u836f\u6ce8\u518c\u7533\u8bf7\u7684<\/span>CTD<\/span>\u7533\u62a5\u8d44\u6599\u4e2d\u5e94\u5305\u62ec\u4e34\u5e8a\u7814\u7a76\u5728\u5185\u7684\u6240\u6709\u7533\u8bf7\u6587\u4ef6\u548c\u8d44\u6599\u3002\u6b27\u76df\u8fdb\u884c\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\uff0c\u867d\u7136\u9700\u8981\u76f8\u5173\u5b66\u672f\u53ca\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u540c\u610f\uff0c\u4f46\u4e0d\u9700\u8981\u4e3b\u7ba1\u836f\u54c1\u884c\u653f\u90e8\u95e8\u7684\u6279\u51c6\u3002<\/span><\/p>\n

\u3000\u3000\uff08\u4e8c\uff09\u4e2d\u56fd\u65b0\u836f\u6ce8\u518c\u7279\u70b9<\/span><\/p>\n

\u3000\u3000\u6211\u56fd\u65b0\u836f\u7684\u7533\u8bf7\u5206\u4e3a\u65b0\u836f\u4e34\u5e8a\u548c\u65b0\u836f\u751f\u4ea7\u4e24\u6b21\u7533\u8bf7\u548c\u5ba1\u6279\uff08\u4e24\u62a5\u4e24\u6279\uff09\uff0c\u5373\u8981\u6c42\u7533\u8bf7\u4eba\u6309\u7167\u76f8\u5173\u89c4\u5b9a\u5b8c\u6210\u65b0\u836f\u4e34\u5e8a\u524d\u7814\u7a76\u3002\u7ecf<\/span>CFDA<\/span>\u5ba1\u6279\u83b7\u5f97\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u6279\u4ef6\uff0c\u518d\u5b8c\u6210\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\uff0c\u7ecf<\/span>CFDA<\/span>\u5ba1\u6279\u83b7\u5f97\u836f\u54c1\u6ce8\u518c\u6279\u4ef6\uff0c\u6279\u51c6\u65b0\u836f\u751f\u4ea7\u548c\u4e0a\u5e02\u3002<\/span><\/p>\n

\u3000\u3000\u5728\u6211\u56fd\uff0c\u65b0\u7a76\u9700\u8981\u4e00\u6b21\u6027\u5b8c\u6210\u7533\u62a5\u4e34\u5e8a\u7814\u7a76\u7684\u6240\u6709\u836f\u5b66\u3001\u836f\u6548\u5b66\u3001\u6bd2\u7406\u5b66\u7b49\u8d44\u6599\uff0c\u5f85<\/span>CFDA<\/span>\u6279\u51c6\u540e\u624d\u80fd\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u3002\u7f8e\u56fd<\/span>FDA<\/span>\u5219\u8981\u6c42\u63d0\u4ea4\u4e34\u5e8a\u7814\u7a76\u7533\u8bf7\u540e\uff0c\u5c31\u53ef\u8fdb\u884c\u521d\u59cb\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e76\u6839\u636e\u4e34\u5e8a\u8fdb\u5c55\u60c5\u51b5\u548c\u9636\u6bb5\u7684\u4e0d\u540c\u6765\u51b3\u5b9a\u8865\u5145\u54ea\u4e9b\u8bd5\u9a8c\u7814\u7a76\u8d44\u6599\u548c\u6570\u636e\u3002<\/span><\/p>\n

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

1.2 <\/span>\u4ea7\u54c1\u7533\u8bf7\u6ce8\u518c\u5206\u7c7b\u4e0d\u540c<\/span><\/strong><\/p>\n

\u3000\u3000\u7f8e\u56fd\u3001\u6b27\u76df\u548c\u65e5\u672c\u5bf9\u5316\u5b66\u836f\u54c1\u7684\u6ce8\u518c\u5206\u4e3a\u65b0\u836f\u7533\u8bf7\uff08<\/span>NDA<\/span>\uff09\u3001\u4eff\u5236\u836f\u7533\u8bf7\uff08<\/span>ANDA<\/span>\uff09\u3002\u5404\u56fd\u5bf9\u751f\u7269\u5236\u54c1\u7684\u7ba1\u7406\u4e00\u822c\u91c7\u53d6\u8f83\u4e3a\u4e25\u683c\u7684\u4e0a\u5e02\u8bb8\u53ef\u5236\u5ea6\u3002\u5bf9\u4e8e\u8349\u836f\u4ea7\u54c1\uff0c\u7f8e\u56fd\u4e3b\u8981\u6309\u7167\u690d\u7269\u836f\u8fdb\u884c\u6ce8\u518c\u7ba1\u7406\uff0c\u4e00\u4e9b\u4f7f\u7528\u5e74\u9650\u8f83\u957f\u3001\u5b89\u5168\u6027\u8f83\u9ad8\u7684\u8349\u836f\u4ea7\u54c1\u6309\u7167<\/span>OTC<\/span>\u836f\u54c1\u91c7\u53d6\u51cf\u514d\u6ce8\u518c\u7684\u7ba1\u7406\u6a21\u5f0f\uff1b\u6b27\u76df\u4f20\u7edf\u8349\u836f\u836f\u54c1\u53ef\u4ee5\u91c7\u7528\u7b80\u5316\u6ce8\u518c\u7533\u8bf7\uff0c\u7b80\u5316\u7533\u8bf7\u8d44\u6599\u9879\u76ee\uff0c\u975e\u4f20\u7edf\u8349\u836f\u836f\u54c1\u5219\u9700\u6309<\/span>CTD<\/span>\u8981\u6c42\u62a5\u9001\u5168\u90e8\u7533\u8bf7\u8d44\u6599\u9879\u76ee\uff1b\u65e5\u672c\u5bf9\u8349\u836f\u4ea7\u54c1\u5206\u4e3a\u6c49\u65b9\u836f\u548c\u751f\u836f\u5236\u5242\uff0c\u6c49\u65b9\u836f\u7684\u7ec4\u65b9\u4ec5\u5c40\u9650\u4e8e\u300a\u4f24\u5bd2\u6742\u75c5\u8bba\u300b<\/span>210<\/span>\u4e2a\u7ecf\u5178\u65b9\uff0c\u5bf9\u4e8e\u751f\u836f\u5236\u5242\u5219\u53c2\u7167\u65b0\u836f\u7533\u8bf7\u7ba1\u7406\uff0c\u6781\u5c11\u6709\u514d\u505a\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6848\u4f8b\uff0c\u7533\u8bf7\u8d39\u7528\u4e5f\u6bd4\u8f83\u9ad8\u3002<\/span><\/p>\n

\u3000\u3000\u6309\u7167<\/span>2007<\/span>\u5e74<\/span>10<\/span>\u6708<\/span>1<\/span>\u65e5\u8d77\u5b9e\u65bd\u7684\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u5c40\u4ee4\u7b2c<\/span>28<\/span>\u53f7\uff09\uff0c\u6211\u56fd\u5c06\u836f\u54c1\u6ce8\u518c\u5206\u4e3a\u4e2d\u836f\u4e0e\u5929\u7136\u836f\u7269\uff0c\u5316\u5b66\u836f\u54c1\u548c\u751f\u7269\u5236\u54c1\u4e09\u5927\u7c7b\u522b\uff0c\u5176\u4e2d\uff0c\u4e2d\u836f\u548c\u5929\u7136\u836f\u7269\u9879\u4e0b\u7ec6\u5206\u4e3a<\/span>9<\/span>\u7c7b\u4ea7\u54c1\uff0c\u5316\u5b66\u836f\u54c1\u9879\u4e0b\u5206\u4e3a<\/span>6<\/span>\u7c7b\u4ea7\u54c1\uff08CFDA2016\u5e744\u6708\u6700\u65b0\u836f\u54c1\u6ce8\u518c\u5206\u7c7b\uff0c\u5c06\u5316\u5b66\u836f\u5206\u4e3a5\u4e2a\u7c7b\u522b\uff09\uff0c\u751f\u7269\u5236\u54c1\u9879\u4e0b\u5206\u4e3a<\/span>15<\/span>\u7c7b\u4ea7\u54c1\uff0c\u4e0d\u540c\u7684\u7c7b\u522b\u6709\u4e0d\u540c\u6ce8\u518c\u7ba1\u7406\u6a21\u5f0f\uff0c\u5bf9\u7533\u62a5\u8d44\u6599\u7684\u8981\u6c42\u4e5f\u4e0d\u5c3d\u76f8\u540c\u3002<\/span><\/p>\n

1.3 <\/span>\u7533\u62a5\u8d44\u6599\u7ed3\u6784\u548c\u5185\u5bb9<\/span><\/strong><\/p>\n

1.3.1 ICH<\/span>\u7533\u62a5\u6587\u4ef6\u683c\u5f0f\u8981\u6c42<\/span><\/strong><\/p>\n

\u3000\u3000\u6309<\/span>ICH CTD<\/span>\u8981\u6c42\uff0c\u7f8e\u56fd\u3001\u6b27\u76df\u548c\u65e5\u672c\u7684\u65b0\u836f\u7533\u62a5\u8d44\u6599\u987b\u6309\u6a21\u5757<\/span>1-5<\/span>\u7684\u683c\u5f0f\u7533\u62a5\uff0c\u5bf9\u7533\u8bf7\u6587\u4ef6\u7f16\u5199\u89c4\u8303\u7684\u8981\u6c42\u8f83\u4e3a\u4e25\u683c\uff0c\u5bf9\u8349\u836f\u836f\u54c1\u8d28\u91cf\u7814\u7a76\u7684\u8981\u6c42\u6781\u4e3a\u4e25\u683c\uff0c\u51e0\u4e4e\u5b8c\u5168\u7b49\u540c\u4e8e\u5316\u5b66\u836f\u54c1\u3002<\/span><\/p>\n

\u3000\u3000\u6a21\u5757<\/span>1-5<\/span>\u5206\u522b\u4e3a\uff1a\u5730\u533a\u6027\u884c\u653f\u7ba1\u7406\u8d44\u6599\uff0c\u7814\u7a76\u5185\u5bb9\u6982\u8981\u548c\u7efc\u8ff0\uff0c\u8d28\u91cf\u7814\u7a76\u62a5\u544a\uff0c\u975e\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\uff0c\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\u3002\u6a21\u5757<\/span>1<\/span>\u6709\u5730\u533a\u7279\u5f02\u6027\uff0c\u6a21\u5757<\/span>2-4<\/span>\u5219\u662f\u5728\u5404\u5730\u533a\u76f8\u540c\u3001\u7edf\u4e00\u7684\u3002<\/span><\/p>\n

\u3000\u3000\u5176\u4e2d\uff0c\u6a21\u5757<\/span>1<\/span>\u660e\u786e\u8981\u6c42\u6309\u76f8\u5173\u683c\u5f0f\u8981\u6c42\u63d0\u4f9b\u5185\u5bb9\u8be6\u5b9e\u7684<\/span>“<\/span>\u4ea7\u54c1\u7279\u6027\u6982\u8981\uff08<\/span>SPC<\/span>\uff09<\/span>” “<\/span>\u4e13\u5bb6\u8d44\u6599<\/span>” “<\/span>\u73af\u5883\u98ce\u9669\u8bc4\u4ef7<\/span>” “<\/span>\u5b64\u513f\u836f\u54c1\u5e02\u573a\u72ec\u5360\u6027\u7684\u76f8\u5173\u8d44\u6599<\/span>“<\/span>\u56db\u90e8\u5206\u6587\u4ef6\u5185\u5bb9\uff0c\u800c\u56fd\u5185\u7533\u8bf7\u5c1a\u672a\u8981\u6c42\u63d0\u4f9b\u6b64\u7c7b\u76f8\u5173\u5185\u5bb9\u7684\u6587\u4ef6\u6216\u8d44\u6599\u3002<\/span><\/p>\n

\u3000\u3000\u6a21\u5757<\/span>1<\/span>\u5bf9\u4e8e\u836f\u54c1\u6807\u7b7e\u548c\u5305\u88c5\u8bf4\u660e\u4e66\u7684\u683c\u5f0f\u548c\u5185\u5bb9\u5747\u6709\u4e25\u683c\u8981\u6c42\uff0c\u5e76\u8981\u6c42\u63d0\u4f9b\u5e73\u9762\u8bbe\u8ba1\u6837\u7a3f\u3001\u5b9e\u9645\u5370\u5237\u6837\u54c1\u53ca\u5176\u53ef\u8bfb\u6027\u6d4b\u8bd5\u8bf4\u660e\u3002<\/span><\/p>\n

\u3000\u3000\u6a21\u5757<\/span>3<\/span>\u4e2d\u5c06\u539f\u6599\u836f\u548c\u836f\u54c1\uff08\u5236\u5242\uff09\u5206\u5f00\uff0c\u5206\u522b\u63d0\u4f9b\u8d44\u6599\u3002<\/span><\/p>\n

\u3000\u3000\u6b27\u76df\u89c4\u5b9a\u63d0\u53d6\u7269\u53ef\u4ee5\u5b9e\u73b0\u4e13\u4e1a\u5316\u751f\u4ea7\uff0c\u901a\u8fc7\u63a7\u5236\u63d0\u53d6\u7269\u7684\u8d28\u91cf\u53ef\u4ee5\u66f4\u52a0\u6709\u6548\u7684\u63a7\u5236\u836f\u54c1\u7684\u8d28\u91cf\u3002\u8fd9\u6837\u66f4\u9002\u5408\u4e8e\u5de5\u4e1a\u5316\u751f\u4ea7\u548c\u836f\u54c1\u8d28\u91cf\u7684\u63a7\u5236\uff0c\u503c\u5f97\u6211\u56fd\u501f\u9274\u3002<\/span><\/p>\n

CTD<\/span>\u975e\u5e38\u91cd\u89c6\u8f85\u6599\u7684\u517c\u5bb9\u6027\u548c\u706d\u83cc\u65b9\u5f0f\u7684\u7814\u7a76\uff0c\u8981\u6c42\u63d0\u4f9b\u8f85\u6599\u7684\u517c\u5bb9\u6027\u548c\u706d\u83cc\u65b9\u5f0f\u7684\u7814\u7a76\u8d44\u6599\u3002\u5bf9\u751f\u4ea7\u5de5\u827a\u7684\u5173\u952e\u73af\u8282\u548c\u4e2d\u95f4\u4f53\u7684\u63a7\u5236\u4e5f\u975e\u5e38\u91cd\u89c6\uff0c\u8981\u6c42\u63d0\u4f9b\u63a7\u5236\u65b9\u6cd5\u3001\u6807\u51c6\u53ca\u5176\u7814\u7a76\u8d44\u6599\uff0c\u5e76\u5236\u5b9a\u5173\u952e\u6b65\u9aa4\u548c\u5173\u952e\u70b9\u3002\u540c\u65f6\uff0c\u5728\u751f\u4ea7\u5de5\u827a\u4e2d\u8981\u6c42\u63d0\u4f9b\u8bbe\u5907\u540d\u79f0\u53ca\u5176\u578b\u53f7\u3002<\/span><\/p>\n

CTD<\/span>\u7684\u7a33\u5b9a\u6027\u8bd5\u9a8c\u4e0e\u6211\u56fd\u6709\u8f83\u5927\u7684\u533a\u522b\uff0c\u9664\u8981\u6c42\u8fdb\u884c\u5e38\u6e29\u653e\u7f6e\u7a33\u5b9a\u6027\u8bd5\u9a8c\u5916\uff0c\u8fd8\u8981\u6c42\u8fdb\u884c\u5f3a\u5236\u964d\u89e3\u3001\u5e94\u6fc0\u72b6\u6001\u548c\u5149\u5f71\u54cd\u7b49\u8bd5\u9a8c\uff0c\u5fc5\u8981\u65f6\u8fd8\u8981\u6c42\u8fdb\u884c\u534a\u8870\u671f\u8ba8\u8bba\uff1b\u540c\u65f6\uff0c\u8981\u6c42\u4ea7\u54c1\u6279\u51c6\u540e\u8fdb\u884c\u8fdb\u4e00\u6b65\u7684\u7a33\u5b9a\u6027\u8bd5\u9a8c\uff0c\u5e76\u63d0\u51fa\u5bf9\u7a33\u5b9a\u6027\u7684\u627f\u8bfa\u3002<\/span><\/p>\n

CTD<\/span>\u5bf9\u975e\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\u7684\u5185\u5bb9\u8981\u6c42\u4e0e\u6211\u56fd\u5929\u7136\u836f\u7269\u6ce8\u518c\u4e2d\u7684\u76f8\u5173\u5185\u5bb9\u8981\u6c42\u6709\u4e00\u5b9a\u7684\u5dee\u5f02\uff0c<\/span>CTD<\/span>\u5728\u836f\u7406\u5b66\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u548c\u6bd2\u7406\u5b66\u4e09\u65b9\u9762\u5bf9\u836f\u7269\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u505a\u51fa\u4e00\u4e2a\u66f4\u4e3a\u5168\u9762\u3001\u5408\u7406\u7684\u8bc4\u4ef7\u3002\u836f\u7406\u5b66\u65b9\u9762\uff0c<\/span>CTD<\/span>\u8981\u6c42\u63d0\u4f9b\u6b21\u8981\u836f\u6548\u5b66\u548c\u836f\u7269\u76f8\u4e92\u4f5c\u7528\u836f\u6548\u5b66\u7684\u7814\u7a76\u5185\u5bb9\u3002<\/span><\/p>\n

CTD<\/span>\u5bf9\u4e8e\u4e34\u5e8a\u7efc\u8ff0\u3001\u6982\u8981\u548c\u7814\u7a76\u62a5\u544a\u7684\u5185\u5bb9\u548c\u5f62\u5f0f\u5747\u505a\u51fa\u4e86\u660e\u786e\u7684\u89c4\u5b9a\uff0c\u5bf9\u6240\u6709\u76f8\u5173\u836f\u54c1\u7684\u751f\u7269\u836f\u5242\u5b66\u3001\u4e34\u5e8a\u836f\u7406\u5b66\u3001\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u4ee5\u53ca\u4e34\u5e8a\u5b9e\u8df5\u4e2d\u836f\u54c1\u4f7f\u7528\u7684\u4f18\u52bf\u548c\u98ce\u9669\u8bc4\u4ef7\u7b49\u65b9\u9762\u90fd\u63d0\u51fa\u4e86\u8be6\u5c3d\u7684\u8981\u6c42\u3002<\/span><\/p>\n

\u3000\u3000\u5728\u751f\u7269\u836f\u5242\u5b66\u65b9\u9762\uff0c<\/span>CTD<\/span>\u8981\u6c42\u4e0d\u4ec5\u8981\u63d0\u4f9b\u4f53\u5185\u5916\u5242\u578b\u6027\u80fd\u3001\u751f\u7269\u5229\u7528\u5ea6\uff08<\/span>BA<\/span>\uff09\u3001\u76f8\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u3001\u751f\u7269\u7b49\u6548\u6027\uff08<\/span>BE<\/span>\uff09\u7814\u7a76\u62a5\u544a\uff0c\u8fd8\u8981\u63d0\u4f9b\u4f53\u5916<\/span>–<\/span>\u4f53\u5185\u76f8\u5173\u6027\u7814\u7a76\u62a5\u544a\uff1b\u5728\u4e34\u5e8a\u836f\u7406\u5b66\u65b9\u9762\uff0c<\/span>CTD<\/span>\u4e0d\u4ec5\u8981\u6c42\u63d0\u4f9b\u836f\u52a8\u5b66\u3001\u836f\u6548\u5b66\u7814\u7a76\u62a5\u544a\uff0c\u8fd8\u8981\u6c42\u63d0\u4f9b\u514d\u75ab\u539f\u6027\u7814\u7a76\u3001\u4e34\u5e8a\u5fae\u751f\u7269\u5b66\u7814\u7a76\u6216\u5176\u4ed6\u7c7b\u836f\u54c1\u7279\u6b8a<\/span>PD<\/span>\u7814\u7a76\u7684\u7ed3\u679c\u548c\u542b\u4e49\uff1b\u5728\u8bc4\u4ef7\u5229\u76ca\u548c\u98ce\u9669\u65b9\u9762\uff0c\u4e0d\u4ec5\u8981\u5168\u9762\u8bc4\u4ef7\u836f\u54c1\u9488\u5bf9\u67d0\u4e00\u4e34\u5e8a\u9002\u5e94\u75c7\u7684\u6cbb\u7597\u4e2d\u6240\u5904\u7684\u5730\u4f4d\uff0c\u8fd8\u8981\u8ba8\u8bba\u8be5\u836f\u54c1\u5bf9\u4e8e\u5176\u4ed6\u672a\u670d\u836f\u4e2a\u4f53\u5b58\u5728\u7684\u98ce\u9669\u3002<\/span><\/p>\n

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

1.3.2 <\/span>\u4e2d\u56fd\u7533\u62a5\u8d44\u6599\u683c\u5f0f\u8981\u6c42<\/span><\/strong><\/p>\n

1<\/span>\u3001\u4e2d\u836f\u3001\u5929\u7136\u836f\u7269\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u8981\u6c42<\/span><\/p>\n

\u3000\u3000\u6211\u56fd\u4e2d\u836f\u3001\u5929\u7136\u836f\u7269\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u5206\u56db\u5927\u90e8\u5206\uff1a\u7efc\u8ff0\u8d44\u6599\u3001\u836f\u5b66\u7814\u7a76\u8d44\u6599\u3001\u836f\u7406\u6bd2\u7406\u7814\u7a76\u8d44\u6599\u548c\u4e34\u5e8a\u5b9e\u9a8c\u8d44\u6599\uff1b\u91c7\u7528\u7f16\u53f7<\/span>1-33<\/span>\u7684\u8054\u53f7\u65b9\u5f0f\u3002\u5176\u4e2d\uff0c\u7efc\u8ff0\u8d44\u6599\u90e8\u5206\u5305\u62ec<\/span>6<\/span>\u4e2a\u9879\u76ee\uff0c\u7f16\u53f7\u4e3a<\/span>1-6<\/span>\uff1b\u836f\u5b66\u7814\u7a76\u8d44\u6599\u5305\u62ec<\/span>12<\/span>\u4e2a\u9879\u76ee\uff0c\u7f16\u53f7\u4e3a<\/span>7-18<\/span>\uff1b\u836f\u7406\u6bd2\u7406\u7814\u7a76\u8d44\u6599\u5305\u62ec<\/span>10<\/span>\u4e2a\u9879\u76ee\uff0c\u7f16\u53f7\u4e3a<\/span>19-28<\/span>\uff1b\u4e34\u5e8a\u5b9e\u9a8c\u8d44\u6599\u5305\u62ec<\/span>5<\/span>\u4e2a\u9879\u76ee\uff0c\u7f16\u53f7\u4e3a<\/span>29-33<\/span>\u3002<\/span><\/p>\n

2<\/span>\u3001\u5316\u5b66\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u8981\u6c42<\/span><\/p>\n

\u3000\u3000\u5173\u4e8e\u6211\u56fd\u5316\u5b66\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u7684\u8981\u6c42\uff0c\u6211\u4eec\u4e0d\u518d\u8be6\u7ec6\u8d58\u8ff0\uff0c\u8bf7\u53c2\u8003CFDA\u672c\u6708\u521d\u53d1\u5e03\u7684\u6700\u65b0\u6587\u4ef680\u53f7\u6587\u3002<\/span><\/p>\n

3<\/span>\u3001\u751f\u7269\u5236\u54c1\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u8981\u6c42<\/span><\/p>\n

\u3000\u3000\u751f\u7269\u5236\u54c1\u7684\u7533\u62a5\u9879\u76ee\u8d44\u6599\u8981\u6c42\u4e3a\uff1a\u7efc\u8ff0\u8d44\u6599\u3001\u836f\u5b66\u7814\u7a76\u8d44\u6599\u3001\u836f\u7406\u6bd2\u7406\u7814\u7a76\u8d44\u6599\u3001\u4e34\u5e8a\u8bd5\u9a8c\u8d44\u6599\u3001\u5176\u4ed6\u4e94\u90e8\u5206\uff0c\u540c\u6837\u91c7\u7528\u7f16\u53f7<\/span>1-38<\/span>\u9879\u3002\u5176\u4e2d\uff0c\u7efc\u8ff0\u8d44\u6599\u90e8\u5206\u5305\u62ec<\/span>6<\/span>\u4e2a\u9879\u76ee\uff0c\u7f16\u53f7\u4e3a<\/span>1-6<\/span>\uff1b\u836f\u5b66\u7814\u7a76\u8d44\u6599\u5305\u62ec<\/span>9<\/span>\u4e2a\u9879\u76ee\uff0c\u7f16\u53f7\u4e3a<\/span>7-15<\/span>\uff1b\u836f\u7406\u6bd2\u7406\u7814\u7a76\u8d44\u6599\u5305\u62ec<\/span>12<\/span>\u4e2a\u9879\u76ee\uff0c\u7f16\u53f7\u4e3a<\/span>16-28<\/span>\uff1b\u4e34\u5e8a\u5b9e\u9a8c\u8d44\u6599\u5305\u62ec<\/span>5<\/span>\u4e2a\u9879\u76ee\uff0c\u7f16\u53f7\u4e3a<\/span>29-33<\/span>\uff1b\u5176\u4ed6\u5305\u62ec<\/span>5<\/span>\u4e2a\u9879\u76ee\uff0c\u7f16\u53f7\u4e3a<\/span>34-38<\/span>\u3002<\/span><\/p>\n

\u4e8c\u3001 <\/span>\u7533\u62a5\u7a0b\u5e8f\u5dee\u5f02<\/span><\/strong><\/p>\n

2.1 <\/span>\u7f8e\u56fd\u7684\u65b0\u836f\u7533\u8bf7<\/span><\/strong><\/p>\n

\u3000\u3000\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u7533\u8bf7<\/span>(IND)<\/span>\uff1a\u4e00\u4e2a\u65b0\u836f\u5f53\u51b3\u5b9a\u8fdb\u5165\u4e34\u5e8a\u8bd5\u9a8c\u65f6<\/span>,<\/span>\u5219\u8981\u5411<\/span>FDA<\/span>\u63d0\u4ea4\u65b0\u7a76\u7684\u7533\u8bf7<\/span>,<\/span>\u540c\u65f6\u62a5\u9001\u6240\u6709\u7814\u7a76\u8d44\u6599\u3002<\/span>FDA<\/span>\u5728\u6536\u5230<\/span>IND<\/span>\u4ee5\u540e<\/span>,<\/span>\u5728\u4e00\u4e2a\u6708\u5185\u5fc5\u987b\u7ed9\u4e88\u7b54\u590d\u3002\u5982\u679c\u7533\u8bf7\u4eba\u5728\u4e00\u4e2a\u6708\u5185\u5f97\u4e0d\u5230<\/span>FDA<\/span>\u7684\u7b54\u590d\uff0c\u5373\u8868\u793a\u5df2\u7ecf\u6279\u51c6\u8fdb\u5165\u4eba\u4f53\u8bd5\u9a8c<\/span>,<\/span>\u53ef\u81ea\u52a8\u8fdb\u5165\u4e34\u5e8a\u7814\u7a76\u3002\u65b0\u836f\u7533\u8bf7<\/span>(NDA)<\/span>\uff1a\u65b0\u836f\u5728\u4e09\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u540e\uff0c\u7533\u8bf7\u4eba\u5c31\u53ef\u4ee5\u5411<\/span>FDA<\/span>\u8fdb\u884c\u65b0\u836f\u7533\u8bf7\u3002\u5728\u7533\u8bf7\u4eba\u63d0\u4ea4<\/span>NDA<\/span>\u4e4b\u524d\uff0c<\/span>FDA<\/span>\u65b0\u836f\u5ba1\u8bc4\u90e8\u95e8\u901a\u5e38\u4f1a\u548c\u7533\u8bf7\u4eba\u4e3e\u884c\u4e00\u6b21\u4f1a\u8bae\uff0c\u5728\u4f1a\u8bae\u4e0a\u7533\u8bf7\u4eba\u63d0\u4ea4\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6982\u8ff0\u62a5\u544a\uff0c\u8ba9<\/span>FDA<\/span>\u53ca\u8bc4\u5ba1\u4eba\u5458\u4e86\u89e3\u6240\u7533\u8bf7\u65b0\u836f\u7684<\/span>NDA<\/span>\u683c\u5f0f\u548c\u5185\u5bb9\u3002\u65b0\u836f\u7533\u8bf7\u7684\u5ba1\u8bc4\u7a0b\u5e8f\u5305\u62ec\u7533\u8bf7\u4e66\u7684\u53d7\u7406\u3001\u65b0\u836f\u6280\u672f\u5ba1\u8bc4\u3001\u73b0\u573a\u8003\u5bdf\u3001\u901a\u77e5\u5ba1\u8bc4\u7ed3\u679c\u3001\u53cc\u65b9\u7684\u4ea4\u6d41\uff08\u4e2d\u671f\u4f1a\u8bae\u3001\u5ba1\u8bc4\u7ec8\u7ed3\u4f1a\u8bae\u548c\u5176\u4ed6\u4f1a\u8bae\uff09\u7b49\u3002<\/span><\/p>\n

2.2 <\/span>\u6b27\u76df\u7684\u65b0\u836f\u7533\u8bf7<\/span><\/strong><\/p>\n

1<\/span>\u3001\u836f\u54c1\u5ba1\u8bc4\u7a0b\u5e8f<\/span><\/p>\n

\u3000\u3000\u6b27\u76df\u5c06\u836f\u54c1\u4e0a\u5e02\u7533\u8bf7\u7a0b\u5e8f\u5206\u6210\u56db\u79cd\uff0c\u5373<\/span>“<\/span>\u96c6\u4e2d\u7533\u8bf7\u7a0b\u5e8f\uff08<\/span>CP<\/span>\uff09<\/span>” “<\/span>\u975e\u96c6\u4e2d\u7533\u8bf7\u7a0b\u5e8f\uff08<\/span>DCP<\/span>\uff09<\/span>” “<\/span>\u4e92\u8ba4\u7533\u8bf7\u7a0b\u5e8f\uff08<\/span>MRP<\/span>\uff09<\/span>“<\/span>\u548c<\/span>“<\/span>\u6210\u5458\u56fd\u7533\u8bf7\u7a0b\u5e8f\uff08<\/span>NP<\/span>\uff09<\/span>“<\/span>\u3002\u524d\u4e09\u79cd\u7a0b\u5e8f\u662f\u57fa\u4e8e\u6b27\u76df\u7edf\u4e00\u6cd5\u89c4\u8981\u6c42\u6216\u6210\u5458\u56fd\u4e4b\u95f4\u7684<\/span>“<\/span>\u4e92\u8ba4\u534f\u8bae\uff08<\/span>MRA<\/span>\uff09<\/span>“<\/span>\u4e3a\u51cf\u5c11\u7533\u8bf7\u4eba\u7684\u91cd\u590d\u7533\u8bf7\u8d1f\u62c5\u3001\u6d88\u9664\u6210\u5458\u56fd\u4e4b\u95f4\u7684\u4e0a\u5e02\u6838\u51c6\u7ed3\u679c\u4e92\u4e0d\u627f\u8ba4\u548c\u836f\u54c1\u8d38\u6613\u7684\u969c\u788d\u4e3a\u76ee\u6807\u7684\uff0c\u4e00\u4e2a\u836f\u54c1\u65e0\u8bba\u54ea\u4e00\u4e2a\u7533\u8bf7\u7a0b\u5e8f\u83b7\u5f97\u6279\u51c6<\/span>,<\/span>\u6839\u636e\u6cd5\u89c4\u8981\u6c42\u6216\u4e92\u8ba4\u534f\u8bae\u89c4\u5b9a\uff0c\u6709\u5173\u6210\u5458\u56fd\u5fc5\u987b\u627f\u8ba4\u8fd9\u79cd\u6838\u51c6\u7ed3\u679c<\/span>,<\/span>\u5e76\u5141\u8bb8\u8be5\u836f\u54c1\u5728\u672c\u56fd\u4e0a\u5e02\u3002<\/span><\/p>\n

2<\/span>\u3001\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7<\/span><\/p>\n

“<\/span>\u65b0\u836f<\/span>“<\/span>\u7533\u8bf7\u591a\u5c5e<\/span>“<\/span>\u96c6\u4e2d\u5ba1\u8bc4\u7a0b\u5e8f\uff08<\/span>CP<\/span>\uff09<\/span>“<\/span>\u3002\u7533\u8bf7\u9012\u4ea4\u786e\u8ba4\u540e<\/span>,<\/span>\u5373\u542f\u52a8\u96c6\u4e2d\u5ba1\u8bc4\u7a0b\u5e8f\u3002\u5728\u5ba1\u8bc4\u4e2d\uff0c\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08<\/span>CHMP<\/span>\uff09\u4e0d\u4ec5\u5bf9\u96c6\u4e2d\u5ba1\u8bc4\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7<\/span>\/<\/span>\u53d8\u66f4\u51fa\u5177\u610f\u89c1<\/span>,<\/span>\u8fd8\u5bf9\u6b27\u76df\u6210\u5458\u56fd\u95f4\u5728\u53d1\u751f\u4ee5\u4e0b\u95ee\u9898\u65f6\uff0c\u8fdb\u884c\u534f\u8c03\u5e76\u63d0\u51fa\u610f\u89c1\uff1a\u5728<\/span>“<\/span>\u975e\u96c6\u4e2d\u7a0b\u5e8f\uff08<\/span>DCP<\/span>\uff09<\/span>“<\/span>\u548c<\/span>“<\/span>\u4e92\u8ba4\u7a0b\u5e8f\uff08<\/span>MRP<\/span>\uff09<\/span>“<\/span>\u4e2d\uff0c\u4e00\u4e2a\u6210\u5458\u56fd\u51fa\u4e8e\u516c\u4f17\u5065\u5eb7\u98ce\u9669\u7684\u539f\u56e0\u4e0d\u8ba4\u53ef<\/span>DCP<\/span>\u7a0b\u5e8f\u4e2d<\/span>“<\/span>\u4e3b\u5ba1\u6210\u5458\u56fd\uff08<\/span>RS<\/span>\uff09<\/span>“<\/span>\u6216<\/span>MRP<\/span>\u7a0b\u5e8f\u4e2d\u539f\u5ba1\u6210\u5458\u56fd\u7684\u4e0a\u5e02\u8bb8\u53ef\uff1b\u5bf9\u4efb\u4e00\u4ea7\u54c1\u5728\u6210\u5458\u56fd\u51b3\u5b9a\u51fa\u73b0\u5206\u6b67\uff1b\u5728\u6d89\u53ca\u5171\u540c\u4f53\u5229\u76ca\u7684\u7279\u6b8a\u60c5\u51b5\u4e0b\uff1b\u5728\u4e3a\u4fdd\u62a4\u516c\u4f17\u5065\u5eb7\u800c\u8003\u8651\u662f\u5426\u6388\u4e88\u3001\u6682\u65f6\u6216\u64a4\u6d88\u8bb8\u53ef\u7684\u60c5\u51b5\u4e0b\u3002<\/span><\/p>\n

2.3 <\/span>\u65e5\u672c\u7684\u65b0\u836f\u7533\u8bf7<\/span><\/strong><\/p>\n

\u3000\u3000\u5728\u65e5\u672c\uff0c\u65b0\u836f\u7533\u8bf7\u62a5\u544a\u62a5\u539a\u751f\u52b3\u52a8\u7701\uff0c\u6280\u672f\u8d44\u6599\u7531<\/span>“<\/span>\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u5c40\uff08<\/span>Pharmaceuticals and Medical Devices Agency, PMDA<\/span>\uff09<\/span>“<\/span>\u53d7\u7406\u548c\u5ba1\u67e5\u3002\u4e00\u822c\u60c5\u51b5\u4e0b\u5148\u8fdb\u884c\u5b9e\u9a8c\u8d44\u6599\u53ef\u4fe1\u6027\u5ba1\u67e5\u53ca\u5b9e\u9a8c\u7814\u7a76\u7684\u89c4\u8303\u6027\uff08<\/span>GLP\/GCP<\/span>\uff09\u68c0\u67e5\u3002\u5f53\u5b9e\u9a8c\u8d44\u6599\u6570\u636e\u53ca\u5b9e\u9a8c\u6761\u4ef6\u5f97\u5230\u786e\u8ba4\u540e\uff0c<\/span>PMDA<\/span>\u65b9\u8fdb\u5165\u5b9e\u8d28\u6027\u6280\u672f\u5ba1\u67e5\u3002<\/span>PMDA<\/span>\u65b0\u836f\u5ba1\u67e5\u7a0b\u5e8f\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u6b65\u9aa4\uff1a<\/span><\/p>\n

\u3000\u3000\u5728\u5f00\u59cb\u5bf9\u7533\u62a5\u8d44\u6599\u6280\u672f\u5ba1\u67e5\u524d\uff0c\u5148\u4e0e\u7533\u62a5\u8005\u9762\u8c08\uff1b\u7136\u540e\u8fdb\u884c\u6280\u672f\u5ba1\u8bc4\uff0c\u5f62\u6210\u5ba1\u67e5\u62a5\u544a\uff1b\u53ec\u5f00\u5ba1\u67e5\u610f\u89c1\u534f\u8c03\u4f1a\uff0c\u5404\u4e13\u5bb6\u5bf9\u54c1\u79cd\u7684\u4e3b\u8981\u95ee\u9898\u8fdb\u884c\u7814\u7a76\u8ba8\u8bba\uff1b\u7531\u7533\u8bf7\u8005\u3001<\/span>PMDA<\/span>\u5ba1\u67e5\u5b98\u53ca\u5ba1\u67e5\u4f1a\u76f8\u5173\u4e13\u5bb6\u4e09\u65b9\u4eba\u5458\u4e3e\u884c\u5ba1\u67e5\u4f1a\uff0c\u5bf9\u7533\u8bf7\u8005\u5b58\u5728\u7684\u4e3b\u8981\u95ee\u9898\u8fdb\u884c\u8ba8\u8bba\u3001\u7814\u7a76\uff0c\u518d\u6b21\u8ba8\u8bba\u5e76\u534f\u8c03<\/span>PMDA<\/span>\u5ba1\u67e5\u610f\u89c1\uff0c\u5f97\u51fa\u57fa\u672c\u5ba1\u67e5\u7ed3\u8bba\uff0c\u5f62\u6210\u7efc\u5408\u5ba1\u67e5\u62a5\u544a\uff1b\u5c06\u5ba1\u67e5\u62a5\u544a\u5448\u62a5\u539a\u751f\u52b3\u52a8\u7701<\/span>\u00b7<\/span>\u533b\u836f\u98df\u54c1\u5c40<\/span>\u00b7<\/span>\u5ba1\u67e5\u7ba1\u7406\u8bfe\uff0c\u5e76\u53ec\u5f00\u9ad8\u5c42\u5ba1\u67e5\u4f1a\u4e13\u5bb6\u4f1a\u8bae\uff0c\u4e13\u5bb6\u4ece\u793e\u4f1a\u5b66\u3001\u4f26\u7406\u5b66\u3001\u4fdd\u9669\u8d54\u507f\u53ca\u793e\u4f1a\u9700\u6c42\u89d2\u5ea6\u505a\u51fa\u6700\u7ec8\u7ed3\u8bba\uff0c\u539a\u751f\u7701\u52b3\u52a8\u5927\u81e3\u4ee5\u6b64\u4e3a\u4f9d\u636e\uff0c\u6279\u51c6\u65b0\u836f\u4e0a\u5e02\u3002<\/span><\/p>\n

2.4<\/span>\u6211\u56fd\u7684\u65b0\u836f\u7533\u62a5\u4e0e\u5ba1\u6279<\/span><\/strong><\/p>\n

1<\/span>\u3001\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u7684\u5ba1\u6279<\/span><\/p>\n

\u3000\u3000\u7533\u8bf7\u4eba\u5b8c\u6210\u4e34\u5e8a\u524d\u7814\u7a76\u540e\uff0c\u5411\u6240\u5728\u5730\u7701\u3001\u81ea\u6cbb\u533a\u3001\u76f4\u8f96\u5e02\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5982\u5b9e\u62a5\u9001\u6709\u5173\u8d44\u6599\uff0c\u7ecf\u7701\u7ea7\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u521d\u5ba1\u540e\uff0c\u62a5<\/span>CFDA<\/span>\u5ba1\u8bc4\u548c\u5ba1\u6279\uff0c\u5f85<\/span>CFDA<\/span>\u6279\u51c6\u540e\u5373\u53ef\u8fdb\u884c\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u3002<\/span><\/p>\n

2<\/span>\u3001\u65b0\u836f\u751f\u4ea7\u7684\u5ba1\u6279<\/span><\/p>\n

\u3000\u3000\u7533\u8bf7\u4eba\u5b8c\u6210\u836f\u7269\u4e34\u5e8a\u7814\u7a76\u540e\uff0c\u5411\u6240\u5728\u5730\u7701\u3001\u81ea\u6cbb\u533a\u3001\u76f4\u8f96\u5e02\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u62a5\u9001\u4e34\u5e8a\u7814\u7a76\u8d44\u6599\u53ca\u5176\u4ed6\u53d8\u66f4\u548c\u8865\u5145\u8d44\u6599\uff0c\u540c\u65f6\u5411\u4e2d\u56fd\u836f\u54c1\u751f\u7269\u5236\u54c1\u68c0\u5b9a\u6240\u62a5\u9001\u5236\u5907\u6807\u51c6\u54c1\u7684\u539f\u6750\u6599\u3002\u7ecf<\/span>CFDA<\/span>\u5ba1\u8bc4\u5ba1\u6279\u7b26\u5408\u89c4\u5b9a\u7684\uff0c\u53d1\u7ed9<\/span>“<\/span>\u65b0\u836f\u8bc1\u4e66<\/span>“<\/span>\uff0c\u5177\u5907\u836f\u54c1\u751f\u4ea7\u8bb8\u53ef\u8bc1\u548c\u8be5\u836f\u54c1\u76f8\u5e94\u751f\u4ea7\u6761\u4ef6\u7684\uff0c\u540c\u65f6\u53d1\u7ed9<\/span>“<\/span>\u836f\u54c1\u6279\u51c6\u6587\u53f7<\/span>“<\/span>\u3002<\/span><\/p>\n

2.5 <\/span>\u52a0\u62ff\u5927\u65b0\u836f\u7533\u8bf7<\/span><\/strong><\/p>\n

1<\/span>\u3001\u5929\u7136\u836f\u54c1\uff08\u6216\u4f20\u7edf\u836f\uff09\u7684\u7533\u8bf7\u9014\u7ecf<\/span><\/p>\n

\u3000\u3000\u4e3b\u8981\u6709\u4e13\u518c\u3001\u4f20\u7edf\u3001\u975e\u4f20\u7edf\u7533\u8bf7\u7b49\u591a\u79cd\u9014\u5f84\u3002\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/span><\/p>\n

\u3000\u3000\uff08<\/span>1<\/span>\uff09\u8d28\u91cf\u5ba1\u67e5\u8981\u6c42<\/span><\/p>\n

\u3000\u3000\u5305\u62ec\u4e86\u5bf9\u539f\u6750\u6599\uff08\u836f\u6750\uff09\u3001\u4e2d\u95f4\u4ea7\u7269\u548c\u6700\u7ec8\u5236\u5242\u7684\u8d28\u91cf\u63a7\u5236\u4e09\u4e2a\u65b9\u9762\uff0c\u5747\u9700\u9075\u5faa\u6216\u53c2\u7167<\/span>ICH<\/span>\u548c\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08<\/span>WHO<\/span>\uff09\u7b49\u6709\u5173\u8d28\u91cf\u6280\u672f\u6307\u5357\u8981\u6c42\u548c\u6807\u51c6\u3002<\/span><\/p>\n

\u3000\u3000\uff08<\/span>2<\/span>\uff09\u5b89\u5168\u6027\u5ba1\u67e5\u8981\u6c42<\/span><\/p>\n

\u3000\u3000\u5305\u62ec\u4ea7\u54c1\u53ca\u6210\u5206\u7684\u4f7f\u7528\u7981\u5fcc\u3001\u5df2\u77e5\u6216\u672a\u77e5\u7684\u4e0d\u826f\u53cd\u5e94\u6216\u4f7f\u7528\u98ce\u9669\u4fe1\u606f\u3001\u836f\u7406\u548c\u6bd2\u7406\u8bd5\u9a8c\u7814\u7a76\uff08\u4e0d\u5177\u5f3a\u5236\u6027\uff09\u3001\u4e0e\u836f\u54c1<\/span>\/<\/span>\u98df\u54c1\u76f8\u4e92\u4f5c\u7528\u7684\u7814\u7a76\uff08\u4e0d\u5177\u5f3a\u5236\u6027\uff09\u3001\u836f\u6548\u5b66<\/span>\/<\/span>\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\uff08\u4e0d\u5177\u5f3a\u5236\u6027\uff09\u3001\u5176\u4ed6\u8981\u6c42\u7684\u5b89\u5168\u6027\u7814\u7a76\u6570\u636e\u7b49\u3002<\/span><\/p>\n

\u3000\u3000\uff08<\/span>3<\/span>\uff09\u6709\u6548\u6027\u5ba1\u67e5\u8981\u6c42<\/span><\/p>\n

\u3000\u3000\u5305\u62ec\u53ef\u63d0\u4ea4\u4e94\u4e2a\u8bc1\u636e\u7ea7\u522b\u7684\u4e34\u5e8a\u6709\u6548\u6027\u6570\u636e\u3001\u662f\u5426\u9700\u8981\u5f00\u5c55\u4e34\u5e8a\u7814\u7a76\u5219\u53d6\u51b3\u4e8e\u4ea7\u54c1\u7684\u7533\u62a5\u9014\u5f84\u548c\u9012\u4ea4\u7684\u8bc1\u636e\u7ea7\u522b\uff08\u5982\u975e\u4f20\u7edf\u7533\u8bf7\uff09\u3002<\/span><\/p>\n

\u3000\u3000\uff08<\/span>4<\/span>\uff09<\/span>GMP<\/span>\u8981\u6c42<\/span><\/p>\n

\u3000\u3000\u5bf9\u6b64\u7c7b\u4ea7\u54c1<\/span>GMP<\/span>\u7684\u8981\u6c42\u5305\u62ec\u4e86\u4ea7\u54c1\u3001\u6807\u7b7e\u3001\u5305\u88c5\u548c\u8fdb\u53e3<\/span>4<\/span>\u4e2a\u65b9\u9762\uff0c\u6db5\u76d6\u4e86<\/span>GMP<\/span>\u7684\u5404\u9879\u6280\u672f\u8981\u6c42\u3002\u540c\u65f6\u83b7\u5f97\u573a\u5730\u8bb8\u53ef\uff08<\/span>GMP<\/span>\uff09\u662f\u4ea7\u54c1\u80fd\u591f\u5408\u6cd5\u4e0a\u5e02\u7684\u524d\u63d0\u3002\u5bf9\u4e8e<\/span>PIC\/S<\/span>\u6210\u5458\u56fd\u7684<\/span>GMP<\/span>\u8bc1\u4e66\u6216\u7ecf\u5ba1\u6838\u8bb8\u53ef\u7684\u7b2c\u4e09\u65b9<\/span>GMP<\/span>\u73b0\u573a\u5ba1\u67e5\u7ed3\u679c\uff0c\u53ef\u514d\u53bb\u73b0\u573a\u68c0\u67e5\u73af\u8282\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u8868<\/span>1-1<\/span>\uff1a\u52a0\u62ff\u5927\u4e0e\u7f8e\u56fd\u3001\u6b27\u76df\u690d\u7269\u836f\u6ce8\u518c\u7ba1\u7406\u6bd4\u8f83\u8868<\/span><\/p>\n\n\n\n\n\n\n\n

<\/td>\n		\n

\u52a0\u62ff\u5927<\/span><\/p>\n<\/td>\n

\n

\u7f8e\u56fd<\/span><\/p>\n<\/td>\n

\n

\u6b27\u76df<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4e0a\u5e02\u524d\u5ba1\u6279<\/span><\/p>\n<\/td>\n

\n

\u662f<\/span><\/p>\n<\/td>\n

\n

\u5426<\/span><\/p>\n<\/td>\n

\n

\u662f<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7533\u8bf7\u4e0a\u5e02\u9014\u5f84<\/span><\/p>\n<\/td>\n

\n

\u4f20\u7edf\u7533\u8bf7\uff08<\/span>50<\/span>\u5e74\uff09\u3001\u975e\u4f20\u7edf\u7533\u8bf7\u3001\u4e13\u8bba\u7533\u8bf7\u7b49<\/span><\/p>\n<\/td>\n

\n

\u65e0\u9700\u7533\u8bf7\uff0c\u5907\u6848\u5236<\/span><\/p>\n<\/td>\n

\n

\u4f20\u7edf\u7533\u8bf7\uff08<\/span>30<\/span>\u5e74\u3001<\/span>15<\/span>\u5e74\uff09\u3001\u4e13\u8bba\u8bc4\u4f30\uff08\u4e0d\u8db3<\/span>30<\/span>\u5e74\uff09<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

GMP<\/span>\u8981\u6c42<\/span><\/p>\n<\/td>\n

\n

\u5929\u7136\u5065\u5eb7\u4ea7\u54c1<\/span>GMP\/<\/span>\u8ba4\u53ef\u836f\u54c1<\/span>GMP<\/span><\/p>\n<\/td>\n

\n

\u81b3\u98df\u8865\u5145\u5242<\/span>GMP<\/span><\/p>\n<\/td>\n

\n

\u836f\u54c1<\/span>GMP<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4e13\u8bba\u8981\u6c42<\/span><\/p>\n<\/td>\n

\n

\u6709<\/span><\/p>\n<\/td>\n

\n

—<\/span><\/p>\n<\/td>\n

\n

\u6709<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u8d44\u6599\u6765\u6e90\uff1a\u5929\u6d25\u5929\u58eb\u529b\u62a5\u544a<\/span><\/p>\n

 <\/span><\/p>\n

2<\/span>\u3001\u52a0\u62ff\u5927\u5316\u5b66\u836f\u5b8c\u6574\u7533\u8bf7<\/span><\/p>\n

\u3000\u3000\uff08<\/span>1<\/span>\uff09\u5b89\u5168\u6027\u5ba1\u67e5\u8981\u6c42<\/span><\/p>\n

\u3000\u3000\u4ee5\u4e0b\u7814\u7a76\u5185\u5bb9\u7686\u5177\u6709\u5f3a\u5236\u6027\uff0c\u5305\u62ec\u4ea7\u54c1\u53ca\u6210\u5206\u7684\u4f7f\u7528\u7981\u5fcc\u3001\u5df2\u77e5\u6216\u672a\u77e5\u7684\u4e0d\u826f\u53cd\u5e94\u3001\u836f\u7406\u548c\u6bd2\u7406\u8bd5\u9a8c\u62a5\u544a\u3001\u4e0e\u836f\u54c1<\/span>\/<\/span>\u98df\u54c1\u7684\u76f8\u4e92\u4f5c\u7528\u7814\u7a76\u3001\u836f\u6548\u5b66<\/span>\/<\/span>\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u3001\u5176\u4ed6\u8981\u6c42\u7684\u5b89\u5168\u6027\u7814\u7a76\u6570\u636e\u7b49\u3002<\/span><\/p>\n

\u3000\u3000\uff08<\/span>2<\/span>\uff09\u6709\u6548\u6027\u5ba1\u67e5\u8981\u6c42<\/span><\/p>\n

\u3000\u3000\u81f3\u5c11\u4e24\u9879\u826f\u597d\u8bbe\u8ba1\u7684\u968f\u673a\u5bf9\u7167\u7684\u4e34\u5e8a\u7814\u7a76\uff08\u5fc5\u987b\u662f\u591a\u4e2d\u5fc3\u7814\u7a76\uff09<\/span><\/p>\n

\u3000\u3000\uff08<\/span>3<\/span>\uff09<\/span>GMP<\/span>\u8981\u6c42<\/span><\/p>\n

\u5bf9\u836f\u54c1\u7684<\/span>GMP<\/span>\u7684\u8981\u6c42\u5305\u62ec\u5382\u623f\u3001\u8bbe\u5907\u3001\u4eba\u5458\u3001\u536b\u751f\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u7a33\u5b9a\u6027\u3001\u6587\u4ef6\u8bb0\u5f55\u548c\u4ea7\u54c1\u53ec\u56de\u7b49\u591a\u9879\u5185\u5bb9\u3002\u4ea7\u54c1\u4e0a\u5e02\u524d\u53ef\u53c2\u7167\u8003\u8651<\/span>PIC\/S<\/span>\u6210\u5458\u56fd\u7684<\/span>GMP<\/span>\u5ba1\u6838\u7ed3\u679c\uff0c\u4f46\u4ecd\u9700\u5bf9\u751f\u4ea7\u73b0\u573a\u8fdb\u884c\u5f3a\u5236\u6027\u68c0\u67e5\uff0c\u4ee5\u5ba1\u6838<\/span>GMP<\/span>\u7684\u7b26\u5408\u6027\u3002<\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u4e00\u3001\u4e3b\u8981\u5dee\u5f02\u5bf9\u6bd4\u5206\u6790 \u3000\u3000\u5404\u56fd\u5bf9\u836f\u54c1\u4e0a\u5e02\u9500\u552e\u5747\u91c7\u53d6\u4e86\u975e\u5e38\u4e25\u683c\u7684\u6ce8\u518c\u7ba1\u7406\uff0c\u6ce8\u518c\u7684\u5177\u4f53\u7a0b\u5e8f\u5404\u4e0d\u76f8\u540c\uff0c\u4f46\u76ee\u6807\u53ea\u6709\u4e00\u4e2a […]<\/p>\n","protected":false},"author":1,"featured_media":81157,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81156"}],"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=81156"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81156\/revisions"}],"predecessor-version":[{"id":81158,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/81156\/revisions\/81158"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/81157"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=81156"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=81156"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=81156"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}