{"id":98284,"date":"2019-03-13T00:00:50","date_gmt":"2019-05-17T08:13:51","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98284\/"},"modified":"2019-05-17T16:13:54","modified_gmt":"2019-05-17T08:13:54","slug":"27c2797acb","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98284\/","title":{"rendered":"\u6d45\u6790\u56fd\u5185\u5916\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u7684\u76d1\u7ba1\u53ca\u6280\u672f\u8bc4\u4ef7\u8003\u8651"},"content":{"rendered":"
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\u4e0a\u8ff0\u5bf9\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\uff08investigational <\/span>medicinal product\uff0cIMP\uff09\u8fdb\u884c\u7684\u76f8\u5173\u8d28\u91cf\u6539\u8fdb\uff0c<\/span>\u5728\u672c\u6587\u4e2d\u7edf\u79f0\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u7684\u836f\u5b66\u53d8\u66f4\u3002<\/span><\/p>\n

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1<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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FDA \u53caEMA \u5747\u8981\u6c42\u7533\u8bf7\u4eba\u5728\u5f00\u5c55\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u524d\u5411\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\uff08National Regulatory Administration\uff0c<\/span>NRA\uff09\u63d0\u51fa\u7533\u8bf7\uff08investigational new drug\uff0cIND\uff1b<\/span>clinical trial authorization\uff0cCTA\uff09\u3002<\/span><\/p>\n

FDA \u91cd\u89c6\u836f\u54c1\u81ea\u7533\u8bf7\u5f00\u59cb\u540e\u6574\u4e2a\u7814\u53d1\u8fc7\u7a0b\u7684\u7eed<\/span>\u8d2f\u6027\uff0c\u5728\u836f\u54c1\u7684\u9996\u6b21\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u65f6\u4f1a\u7ed9\u4e88\u5176\u5728\u6574\u4e2a<\/span>\u4e34\u5e8a\u7814\u7a76\u91cc\u6301\u7eed\u53ef\u6eaf\u6e90\u7684\u7279\u5b9a\u7f16\u53f7\uff08IND number\uff09\uff0c<\/span>\u5355\u4e2aIND \u53ef\u5bf9\u5e94\u591a\u9879\u62df\u9002\u5e94\u75c7\u6216\u62df\u5f00\u5c55\u7684\u4e34\u5e8a\u8bd5<\/span>\u9a8c\u3002<\/span><\/p>\n

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\u7f8e<\/span>\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u6750\u6599\u4e3b\u8981\u5305\u62ec\uff1a\u7533\u8bf7\u8868\u3001\u7efc\u8ff0\u8d44\u6599\u3001<\/span>\u7814\u7a76\u8ba1\u5212\u3001\u65b9\u6848\u3001\u7814\u7a76\u8005\u624b\u518c\u3001\u836f\u5b66\uff08Chemical\uff0cManu<\/span>facturing and Control\uff0cCMC\uff09\u8d44\u6599\u3001\u4e34\u5e8a\u524d\u8d44\u6599\u3001\u5df2\u6709<\/span>\u7684\u4e34\u5e8a\u8d44\u6599\u7b49\uff3b4\uff3d\u3002<\/span><\/p>\n

EMA \u9488\u5bf9\u7533\u8bf7\u4eba\u5f00\u5c55\u7684\u4e0d\u540c\u9002\u5e94\u8bc1\u8fdb\u884c\u6bcf\u9879\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5355\u72ec\u7ba1\u7406\uff0c\u5373\u5355\u4e2a\u836f\u54c1\u53ef\u5305\u62ec\u591a\u4e2aCTA\uff0c<\/span>\u4f46\u6bcf\u4e2aCTA \u4ec5\u5bf9\u5e94\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u2160\uff0f \u2161 \uff0f \u2162 \uff0f \u2163\u671f<\/span>\u4e34\u5e8a\u8bd5\u9a8c\u5747\u53ef\u5206\u522b\u56f4\u7ed5\u5176\u7279\u5b9a\u76ee\u7684\u3001\u7279\u5b9a\u4eba\u7fa4\u3001\u7279\u5b9a<\/span>\u89c4\u683c\u3001\u7279\u5b9a\u5de5\u827a\u7248\u672c\u5206\u522b\u7533\u8bf7CTA\u3002<\/span><\/p>\n

EMA \u4e34\u5e8a\u8bd5\u9a8c<\/span>\u7533\u8bf7\u6750\u6599\u4e3b\u8981\u5305\u62ec\uff1a\u6b27\u6d32\u4e34\u5e8a\u8bd5\u9a8c\u7f16\u53f7\uff08EudraCT <\/span>number\uff09\u3001\u7533\u8bf7\u8868\u3001\u65b9\u6848\u3001\u7814\u7a76\u8005\u624b\u518c\u3001\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\u7533\u62a5\u8d44\u6599\uff08investigationnal medicinal producs dossier\uff0c<\/span>IMPD\uff09\uff1b\u6b64\u5916\uff0c\u7531\u4e8e\u6b27\u76df\u6d89\u53ca\u591a\u4e2a\u6210\u5458\u56fd\u7684\u7ba1\u7406\uff0c\u7533<\/span>\u62a5\u8d44\u6599\u8fd8\u9700\u5305\u62ec\u9488\u5bf9\u6240\u6d89\u53ca\u6210\u5458\u56fd\u7684\u4e13\u5c5e\u8d44\u6599\uff3b5\uff3d\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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

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\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u53d8\u66f4\u7684\u98ce\u9669\u9ad8\u5ea6\u4f9d\u8d56\u4e8e\u53d8\u66f4\u6240\u5904\u7684\u7814\u53d1\u9636\u6bb5\u3002\u867d\u7136\u6b27\u7f8e\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u62df\u5b9a\u7684\u7533\u8bf7<\/span>\u67b6\u6784\u4e0d\u540c\uff0c\u4f46\u4e24\u8005\u5747\u4ee5\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u7684\u63d0\u51fa\u4f5c\u4e3a\u836f<\/span>\u54c1\u6b63\u5f0f\u8fdb\u5165\u76d1\u7ba1\u8003\u5bdf\u7684\u8d77\u59cb\u3002<\/span><\/p>\n

\u836f\u54c1\u5728\u4e34\u5e8a\u8bd5\u9a8c\u5f00\u5c55<\/span>\u524d\u5747\u5904\u4e8e\u65e9\u671f\u7814\u53d1\u9636\u6bb5\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u5f00\u5c55\u524d\u7684\u836f\u5b66\u53d8<\/span>\u66f4\u5e76\u672a\u7eb3\u5165\u6cd5\u89c4\u548c\u76d1\u7ba1\u4f53\u7cfb\u7684\u7ea6\u675f\uff0c\u7533\u8bf7\u4eba\u5177\u6709\u8f83<\/span>\u9ad8\u7684\u63a2\u7d22\u7075\u6d3b\u6027\uff0c\u4ee5\u5168\u9762\u63a2\u7d22\u548c\u7814\u7a76\u4ea7\u54c1\u7684\u836f\u5b66\u53ca<\/span>\u8d28\u91cf\u5c5e\u6027\u7279\u5f81\u3002<\/span><\/p>\n

\u800c\u5728\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u540e\u7684\u836f\u5b66\u53d8\u66f4<\/span>\uff08\u5305\u62ec\u4e0a\u5e02\u7533\u8bf7\u671f\u95f4\u7684\u836f\u5b66\u53d8\u66f4\u548c\u5df2\u4e0a\u5e02\u4ea7\u54c1\u7684\u836f<\/span>\u5b66\u53d8\u66f4\uff09\uff0c\u7533\u8bf7\u4eba\u5fc5\u987b\u6309\u7167\u76f8\u5e94\u6307\u5bfc\u539f\u5219\u5f00\u5c55\u4e0e\u4e34\u5e8a<\/span>\u8bd5\u9a8c\u7528\u836f\u7684\u5168\u9762\u53ef\u6bd4\u6027\u7814\u7a76\uff0c\u4ee5\u5145\u5206\u8bc1\u660e\u836f\u5b66\u53d8\u66f4<\/span>\u540e\u4ea7\u54c1\u7684\u5b89\u5168\u6709\u6548\u548c\u8d28\u91cf\u53ef\u63a7\u6027\u4e0e\u53d8\u66f4\u524d\u4e00\u81f4\uff0c\u5426<\/span>\u5219\u53ef\u80fd\u9700\u8865\u5145\u6216\u91cd\u65b0\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/span><\/p>\n

\u76ee\u524d\uff0c\u4ece\u901a\u884c\u7684\u56fd\u9645\u7ba1\u7406\u6765\u770b\uff0c\u5df2\u79ef\u7d2f\u8f83\u591a\u836f\u54c1\u7814\u53d1\u6210\u719f\u7ecf\u9a8c\u7684\u7533\u8bf7\u4eba\u503e\u5411\u4e8e\u5728\u4e34\u5e8a\u8bd5\u9a8c\u7684\u65e9<\/span>\u671f\uff08\u2160\uff0f \u2161\u671f\uff09\u901a\u8fc7\u53d8\u66f4\u5e45\u5ea6\u8f83\u5927\u7684\u836f\u5b66\u53d8\u66f4\uff0c\u5728\u2162<\/span>\u671f\u4e34\u5e8a\u8bd5\u9a8c\u524d\u9501\u5b9a\u4ea7\u54c1\u76f8\u5173\u5de5\u827a\u53ca\u8d28\u91cf\uff0c\u800c\u5bf9\u2162\u671f<\/span>\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\u53ca\u4ee5\u540e\u7684\u836f\u5b66\u53d8\u66f4\u6301\u8c28\u614e\u548c\u4fdd\u5b88\u7684<\/span>\u6001\u5ea6\u3002<\/span><\/p>\n

\u56e0\u6b64\uff0c\u65e0\u8bba\u662f\u4ece\u53d8\u66f4\u7684\u9891\u7387\u8fd8\u662f\u7406\u8bba\u4e0a\u7684\u53ef<\/span>\u63a5\u53d7\u5ea6\u6765\u8bf4\uff0c\u5747\u662f\u4e34\u5e8a\u8bd5\u9a8c\u5f00\u5c55\u524d\u7684\u836f\u5b66\u53d8\u66f4\uff1e \u4e34<\/span>\u5e8a\u8bd5\u9a8c\u671f\u95f4\u7684\u836f\u5b66\u53d8\u66f4\uff1e \u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u540e\u7684\u836f\u5b66<\/span>\u53d8\u66f4\u3002<\/span><\/p>\n

\u4e0d\u540c\u9636\u6bb5\u7684\u836f\u5b66\u53d8\u66f4\u7533\u62a5\u8981\u6c42\u80fd\u591f\u53cd\u6620\u51fa\u76d1\u7ba1\u65b9\u57fa\u4e8e\u98ce\u9669\u8bc4\u4ef7\u7684\u6574\u4f53\u601d\u8def\u3002<\/span><\/p>\n

\u7531\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u5f00\u5c55\u524d<\/span>\u6216\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u7684\u836f\u5b66\u53d8\u66f4\u4ecd\u6709\u673a\u4f1a\u7ecf\u8fc7\u540e\u671f<\/span>\u5927\u8303\u56f4\u7684\u4e34\u5e8a\u8bd5\u9a8c\u9a8c\u8bc1\uff0c\u5176\u4eba\u4f53\u5b89\u5168\u6709\u6548\u6027\u7684\u4e0d\u786e<\/span>\u5b9a\u6027\u76f8\u5bf9\u53ef\u63a7\uff0c\u76d1\u7ba1\u65b9\u5bf9\u4ea7\u54c1\u98ce\u9669\u7684\u53ef\u8bc6\u522b\u6027\u76f8\u5bf9<\/span>\u66f4\u9ad8\u3002<\/span><\/p>\n

\u56e0\u6b64\uff0c\u4ece\u98ce\u9669\u9ad8\u4f4e\u548c\u8bc4\u4ef7\u91cd\u89c6\u7a0b\u5ea6\u6765\u770b\uff0c\u5219\u662f<\/span>\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u540e\u7684\u836f\u5b66\u53d8\u66f4\uff1e \u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u7684\u836f<\/span>\u5b66\u53d8\u66f4\uff1e \u4e34\u5e8a\u5f00\u5c55\u524d\u7684\u836f\u5b66\u53d8\u66f4\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

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

\n
\n

\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u7684\u836f\u5b66\u53d8\u66f4\u4e8b\u9879<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5e38\u89c1\u7684\u836f\u5b66\u53d8\u66f4\u4e3b\u8981\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u4ee5\u4e0b\u65b9\u9762\uff1a<\/span><\/p>\n

\u2460\u4ea7\u54c1\u5236\u5242\u5904\u65b9\u7684\u53d8\u66f4\uff1b<\/span><\/p>\n

\u2461\u8d77\u59cb\u539f\u6750\u6599<\/span>\u6216\u7269\u6599\u7684\u53d8\u66f4\uff1b<\/span><\/p>\n

\u2462\u751f\u4ea7\u76f8\u5173\u7684\u53d8\u66f4\uff08\u539f\u6599\u836f\uff0f \u539f\u6db2\u3001<\/span>\u4e2d\u95f4\u4ea7\u7269\u3001\u5236\u5242\u7b49\uff09\uff1b<\/span><\/p>\n

\u2463\u8d28\u91cf\u6807\u51c6\u53ca\u68c0\u6d4b\u65b9\u6cd5\u7684\u53d8\u66f4<\/span>\uff08\u539f\u8f85\u6599\u3001\u539f\u6599\u836f\uff0f \u539f\u6db2\u3001\u4e2d\u95f4\u4ea7\u7269\u3001\u5236\u5242\u3001\u53c2\u6bd4\u54c1\u7b49\uff09\uff1b<\/span><\/p>\n

\u2464\u7a33\u5b9a\u6027\u8003\u5bdf\u53ca\u6709\u6548\u671f\u7684\u53d8\u66f4\uff08\u539f\u6599\u836f\uff0f \u539f\u6db2\u3001\u4e2d\u95f4\u4ea7\u7269\u3001\u5236\u5242\u7b49\uff09\uff1b<\/p>\n

\u2465\u6d89\u53ca\u5305\u88c5\u76f8\u5173\u7684\u53d8\u66f4\u3002<\/p>\n

\u4ea7\u54c1\u5236\u5242\u5904\u65b9\u5305\u62ec\u5c0f\u5230pH \u7f13\u51b2\u6db2\u7ec4\u5206\u7684\u5fae\u8c03\uff0c\u5927\u5230\u8c03\u6574\u836f\u54c1\u6d3b\u6027\u7ec4\u5206\u7684\u542b\u91cf\u3001\u53d8\u66f4\u5242\u578b\u3001\u589e\u52a0<\/span>\u6216\u51cf\u5c11\u529f\u80fd\u6027\u7ec4\u5206\uff08\u9632\u8150\u5242\u3001\u4f50\u5242\uff09\u7b49\uff0c\u8003\u5bdf\u91cd\u70b9\u5728\u4e8e<\/span>\u662f\u5426\u5bfc\u81f4\u6d3b\u6027\u6210\u5206\u7684\u8d28\u91cf\u5c5e\u6027\u6539\u53d8\u3002<\/span><\/p>\n

\u8fd9\u7c7b\u53d8\u66f4\u8f83\u96be<\/span>\u4ec5\u901a\u8fc7\u836f\u5b66\u8d28\u91cf\u53ef\u6bd4\u6027\u7814\u7a76\u5373\u53ef\u5168\u9762\u8bba\u8bc1\u53d8\u66f4\u524d\u540e<\/span>\u4ea7\u54c1\u53ef\u6bd4\u6027\uff0c\u6709\u65f6\u53ef\u80fd\u5bfc\u81f4\u5fc5\u8981\u7684\u6865\u63a5\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\uff0c\u5747\u9700\u7ecf\u8fc7\u5ba1\u614e\u7684\u9a8c\u8bc1\u53ca\u8bc4\u4ef7\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u8d77\u59cb\u539f\u6750\u6599\u6216\u7269\u6599\u7684\u53d8\u66f4\uff0c\u4e0d\u540c\u53d8\u66f4\u60c5\u51b5\u5bf9\u5e94\u7684\u98ce\u9669\u7b49\u7ea7\u4e5f\u4e0d\u540c\uff0c\u5982\u539f\u6750\u6599\u6216\u8f85\u6599\u4f9b\u5e94\u5546\u7684<\/span>\u6539\u53d8\u3001\u66f4\u6362\u751f\u4ea7\u83cc\u79cd\u6216\u7ec6\u80de\u7b49\u3002<\/span><\/p>\n

\u751f\u4ea7\u76f8\u5173\u7684\u53d8\u66f4\u60c5\u51b5\u590d\u6742\uff0c\u6d89\u53ca\u9762\u5e7f\uff0c\u5982\u7533\u8bf7\u4eba\u7ed3\u5408\u81ea\u8eab\u5546\u4e1a\u5316\u8003\u8651\u8fdb\u884c\u751f\u4ea7\u89c4\u6a21\u7684\u9010\u7ea7\u653e\u5927\u3001\u4e0d<\/span>\u540c\u9636\u6bb5\u5382\u5730\u53d8\u8fc1\u3001\u57fa\u4e8e\u6539\u5584\u836f\u54c1\u8d28\u91cf\u6216\u51cf\u5c11\u635f\u8017\u7b49\u76ee<\/span>\u7684\u4f18\u5316\u751f\u4ea7\u5de5\u827a\u3001\u9488\u5bf9\u4ea7\u54c1\u751f\u4ea7\u7279\u6027\u7684\u9010\u6b65\u8ba4\u8bc6\u8c03<\/span>\u6574\u8fc7\u7a0b\u63a7\u5236\u7b49\uff0c\u5747\u53ef\u7b3c\u7edf\u5730\u5f52\u4e8e\u6b64\u9879\u3002<\/span><\/p>\n

\u8d28\u91cf\u6807\u51c6\u53ca\u68c0\u6d4b\u65b9\u6cd5\u7684\u53d8\u66f4\uff0c\u53ef\u80fd\u6d89\u53ca\u589e\u51cf\u653e\u884c\u68c0\u5b9a\u9879\u76ee\u3001\u6536\u7d27\u6216\u653e\u5bbd\u6807\u51c6\u8303\u56f4\u3001\u6539\u53d8\u68c0\u6d4b\u65b9\u6cd5\uff0f<\/span>\u8bd5\u5242\u7b49\u3002<\/span><\/p>\n

\u968f\u7740\u79d1\u5b66\u6280\u672f\u7684\u53d1\u5c55\uff0c\u66f4\u52a0\u7cbe\u51c6\u4fbf\u6377\u7684\u68c0<\/span>\u6d4b\u65b9\u6cd5\u66ff\u4ee3\u539f\u6709\u8001\u65e7\u68c0\u6d4b\u65b9\u6cd5\u662f\u5fc5\u7136\u8d8b\u52bf\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u68c0<\/span>\u6d4b\u65b9\u6cd5\u7684\u53d8\u66f4\uff0c\u901a\u5e38\u4e5f\u4f34\u968f\u7740\u76f8\u5e94\u8d28\u91cf\u6807\u51c6\u7684\u53d8\u66f4\uff0c<\/span>\u9700\u5173\u6ce8\u76f8\u540c\u6837\u54c1\u5728\u53d8\u66f4\u524d\u540e\u7684\u7ed3\u679c\u4e00\u81f4\u6027\u5206\u6790\u3002<\/span><\/p>\n

\u7a33\u5b9a\u6027\u8003\u5bdf\u53ca\u6709\u6548\u671f\u7684\u53d8\u66f4\u53ef\u80fd\u5305\u542b\u8ba1\u5212\u5185\u53d8<\/span>\u66f4\u53ca\u8ba1\u5212\u5916\u53d8\u66f4\uff0c\u524d\u8005\u901a\u5e38\u662f\u7533\u8bf7\u4eba\u5728\u524d\u671f\u63d0\u4ea4\u7684<\/span>\u8d44\u6599\u4e2d\u5df2\u62df\u5b9a\u7a33\u5b9a\u6027\u8003\u5bdf\u8ba1\u5212\uff0c\u4f46\u4ec5\u63d0\u4f9b\u4e86\u6709\u9650\u7684<\/span>\u8003\u5bdf\u7ed3\u679c\uff0c\u968f\u7740\u540e\u7eed\u6309\u8ba1\u5212\u68c0\u6d4b\u7ed3\u679c\u4e0d\u65ad\u5145\u5b9e\uff0c\u8865\u5145<\/span>\u66f4\u65b0\u4e86\u7a33\u5b9a\u6027\u7ed3\u679c\u5e76\u5ef6\u957f\u6709\u6548\u671f\u3002<\/span><\/p>\n

\u540e\u8005\u5219\u53ef\u80fd\u7531\u4e8e<\/span>\u4f34\u968f\u5176\u4ed6\u53d8\u66f4\u5bfc\u81f4\u7a33\u5b9a\u6027\u7ed3\u679c\u4e0e\u9884\u671f\u4e0d\u4e00\u81f4\u800c\u4e34\u65f6<\/span>\u63d0\u51fa\u53d8\u66f4\u6709\u6548\u671f\u3002<\/span><\/p>\n

\u6d89\u53ca\u5305\u88c5\u76f8\u5173\u7684\u53d8\u66f4\uff0c\u4e3b\u8981\u5305\u62ec\u539f\u6599\u836f\uff0f \u539f\u6db2\u3001\u4e2d\u95f4\u4ea7\u7269\u3001\u5236\u5242\u7684\u5305\u88c5\u6750\u6599\u6539\u53d8\u6216\u5305\u88c5\u5f62\u5f0f\u53d1\u751f\u53d8<\/span>\u5316\u7b49\u3002<\/span><\/p>\n

\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u4ee5\u4e0a\u7684\u5404\u79cd\u836f\u5b66\u53d8\u66f4\u53ef\u80fd\u540c\u65f6\u4ea7\u751f\u5e76\u4e92\u76f8\u4ea4\u53c9\uff0c\u5bfc\u81f4\u590d\u5408\u578b\u7684\u836f\u5b66\u53d8\u66f4\u51fa\u73b0\uff0c\u4f7f\u5f97<\/span>\u836f\u54c1\u5728\u5b89\u5168\u6709\u6548\u3001\u8d28\u91cf\u53ef\u63a7\u4e0a\u7684\u98ce\u9669\u5448\u5173\u8054\u6027\u7684\u653e<\/span>\u5927\uff0c\u5982\u56e0\u751f\u4ea7\u83cc\u6bd2\u682a\u53d1\u751f\u53d8\u66f4\u800c\u4f34\u968f\u6539\u53d8\u751f\u4ea7\u5de5\u827a<\/span>\u6b65\u9aa4\u7684\u60c5\u51b5\u7b49\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

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

\n
\n

FDA \u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4CMC \u53d8\u66f4\u7684\u7ba1\u7406<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

\u6839\u636eFDA \u7684\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406\u7406\u5ff5\u53ca\u7533\u8bf7\u67b6\u6784\uff0c\u65e0\u8bba\u4f55\u79cd\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\u53d1\u751f\u7684\u53d8\u66f4\uff0c\u5747\u66f4\u65b0\u5728\u540c\u4e00<\/span>IND \u9879\u76ee\u4e0b\u3002FDA \u6839\u636e\u836f\u5b66\u53d8\u66f4\u7684\u9636\u6bb5\u6027\u8ba4\u8bc6\uff0c\u8981<\/span>\u6c42\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u836f\u5b66\u8d44\u6599\u7740\u91cd\u4e8e\u63d0\u4f9b\u4e0e\u53d7\u8bd5\u8005\u5b89<\/span>\u5168\u6027\u8bc4\u4ef7\u76f8\u5173\u7684\u5185\u5bb9\uff3b6-7\uff3d\u3002<\/span><\/p>\n

\u540c\u65f6\uff0c\u5728\u2161 \uff0f \u2162\u671f\u836f\u5b66\u8d44<\/span>\u6599\u7684\u6570\u636e\u6536\u96c6\u65b9\u9762\u4e5f\u7ed9\u4e88\u7533\u8bf7\u4eba\u8f83\u5927\u7684\u7075\u6d3b\u7a7a\u95f4\uff3b8\uff3d\u3002<\/span><\/p>\n

\u7533\u8bf7\u4eba\u80fd\u591f\u4ee5\u65b9\u6848\u4fee\u8ba2\uff08protocol amendments\uff09\u3001\u4fe1\u606f\u4fee\u8ba2\uff08information amendments\uff09\u3001\u5b89\u5168\u62a5\u544a\uff08safety <\/span>reports\uff09\u3001\u5e74\u5ea6\u62a5\u544a\uff08annual reports\uff09\u8fd9\u56db\u79cd\u5f62\u5f0f\u9012\u4ea4<\/span>\u4e34\u5e8a\u671f\u95f4\u53d8\u66f4\u6750\u6599\u3002<\/span><\/p>\n

\u800c\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u7684\u836f\u5b66\u53d8\u66f4\u7684<\/span>\u9012\u4ea4\uff0c\u4e3b\u8981\u91c7\u7528\u4fe1\u606f\u4fee\u8ba2\u53ca\u5e74\u5ea6\u62a5\u544a\u8fd9\u4e24\u79cd\u5f62\u5f0f\u3002<\/span><\/p>\n

\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u7684\u836f\u5b66\u53d8\u66f4\u53ef\u6309\u7167\u5bf9\u5b89\u5168\u6027\u5f71\u54cd\u7684\u98ce\u9669\u8fdb\u884c\u533a\u5206\uff0c\u5373\u4e0e\u5b89\u5168\u6027\u6709\u5173\u7684\u836f\u5b66\u53d8\u66f4\u548c\u4e0e<\/span>\u5b89\u5168\u6027\u65e0\u5173\u7684\u836f\u5b66\u53d8\u66f4\u3002\u524d\u8005\u4e3aCMC \u5b89\u5168\u6027\u4fe1\u606f<\/span>\uff08CMC safety information\uff09\uff0c\u901a\u5e38\u4ee5\u4fe1\u606f\u4fee\u8ba2\uff08information <\/span>amendments\uff09\u7684\u65b9\u5f0f\u5411FDA \u8fdb\u884c\u9012\u4ea4\uff3b9\uff3d\u3002<\/span><\/p>\n

\u540e\u8005<\/span>\u60ef\u4f8b\u4e0a\u79f0\u4e3a\u786e\u8bc1\u4fe1\u606f\uff08corroborating information\uff09\uff0c\u53ef<\/span>\u5728\u5e74\u5ea6\u62a5\u544a\u4e2d\u5448\u73b0\u3002<\/p>\n

FDA \u5bf9\u4e8e\u4eba\u7528\u836f\uff08human drugs\uff09CMC \u5b89\u5168\u6027\u4fe1\u606f\u6574\u4f53\u4e3e\u4f8b\u89c1\u88681\uff3b8\uff3d\uff0c\u9700\u8981\u5f3a\u8c03\u7684\u662f\uff0c\u8be5\u8868\u4e3e\u4f8b\u5e76\u4e0d<\/span>\u80fd\u7b80\u5355\u5957\u7528\u81f3\u6240\u6709\u836f\u54c1\u7684\u5b9e\u9645\u53d8\u66f4\u4e2d\uff0c\u5982\u690d\u7269\u836f\u6216<\/span>\u751f\u7269\u5236\u54c1\u7531\u4e8e\u5176\u672c\u8eab\u7684\u5929\u7136\u6027\u548c\u590d\u6742\u6027\uff0c\u7533\u8bf7\u4eba\u5e94<\/span>\u53c2\u7167\u5177\u4f53\u95ee\u9898\u5177\u4f53\u5206\u6790\uff08case by case\uff09\u7684\u7406\u5ff5\uff0c\u5bf9\u836f<\/span>\u54c1\u53d8\u66f4\u60c5\u51b5\u8fdb\u884c\u6570\u636e\u79ef\u7d2f\u548c\u5145\u5206\u8bc4\u4f30\uff0c\u4ece\u800c\u51b3\u5b9a\u5982<\/span>\u4f55\u8fdb\u884c\u7533\u62a5\u3002\u7533\u8bf7\u4eba\u6bcf\u6b21\u9012\u4ea4\u9700\u81f3\u5c11\u95f4\u969430 d\u3002<\/span><\/p>\n

\"\u6d45\u6790\u56fd\u5185\u5916\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u7684\u76d1\u7ba1\u53ca\u6280\u672f\u8bc4\u4ef7\u8003\u8651\"<\/p>\n

FDA<\/span>\u5728\u6536\u5230\u7533\u8bf7\u4eba\u7684\u4fe1\u606f\u4fee\u8ba2\u8d44\u6599\u540e\uff0c\u5c06\u6309\u7167\u60ef\u4f8b\u89c4\u8303<\/span>\u7684\u76f8\u5e94\u7c7b\u522b\u8fdb\u884c\u5ba1\u8bc4\uff3b 10\uff3d\u3002<\/span><\/p>\n

\u56e0\u6b64\uff0c\u4e00\u822c\u6765\u8bf4\uff0c\u7533\u8bf7\u4eba\u901a\u5e38\u5747\u4f1a\u5728\u9012\u4ea4\u540e\u9009\u62e9\u7b49\u5f8530 d\uff0c\u786e\u5b9aFDA \u65e0\u4efb\u4f55<\/span>\u56de\u590d\u6216\u6c9f\u901a\u8981\u6c42\u540e\u518d\u5f00\u59cb\u8fdb\u884c\u540e\u7eed\u5b9e\u65bd\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u786e\u8bc1\u4fe1\u606f\uff0c\u7533\u8bf7\u4eba\u91c7\u7528\u5e74\u5ea6\u62a5\u544a\u7684\u65b9\u5f0f\u5411FDA \u62a5\u5907\u3002\u5e74\u5ea6\u62a5\u544a\u662f\u7533\u8bf7\u4eba\u5728\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u6bcf\u5e74<\/span>\u4e00\u6b21\u7684\u603b\u7ed3\u6982\u8ff0\uff0c\u4e3b\u8981\u56f4\u7ed5\u672c\u5e74\u4e34\u5e8a\u7814\u7a76\u8fdb\u5c55\u548c\u4e0b<\/span>\u4e00\u6b65\u8ba1\u5212\uff0c\u603b\u7ed3\u5e74\u5ea6\u5185\u4e34\u5e8a\u5b89\u5168\u76f8\u5173\u4fe1\u606f\uff0c\u5982\u4e0a\u6587\u6240<\/span>\u8ff0\u7684CMC \u5b89\u5168\u4fe1\u606f\u4fee\u8ba2\u4e5f\u9700\u4ee5\u603b\u7ed3\u6982\u8ff0\u7684\u5f62\u5f0f\u5728<\/span>\u5e74\u5ea6\u62a5\u544a\u4e2d\u4f53\u73b0\uff1b\u6b64\u5916\uff0c\u66f4\u65b0\u7684\u4e34\u5e8a\u524d\u8bd5\u9a8c\u7ed3\u679c\u6216\u53d8<\/span>\u66f4\u4fee\u8ba2\u4e5f\u53ef\u5728\u5e74\u5ea6\u62a5\u544a\u4e2d\u6c47\u603b\u3002<\/span><\/p>\n

\u5e74\u5ea6\u62a5\u544a\u9700\u5728\u6bcf\u5e74<\/span>IND \u751f\u6548\u65e5\u671f\u768460 d \u5185\u5411FDA \u63d0\u4ea4\uff0c\u5e76\u7eb3\u5165\u8be5\u836f\u54c1<\/span>\u7684IND \u8d44\u6599\u5907\u6848\u3002\u5982\u65e0\u7279\u6b8a\u60c5\u51b5\uff0cFDA \u5c06\u4e0d\u518d\u5bf9\u7533<\/span>\u8bf7\u4eba\u7684\u5e74\u5ea6\u62a5\u544a\u8fdb\u884c\u53cd\u9988\uff3b8\uff0c1<\/span>1\uff3d\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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5<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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EMA \u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b9e\u8d28\u6027\u53d8\u66f4\u7684\u7ba1\u7406<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

EMA \u5728Reg\uff0e\uff08EU\uff09No536 \uff0f 2014 \u4e2d\u4f53\u73b0\u7684\u91cd\u8981\u6846\u67b6\u539f\u5219\u4e4b\u4e00\u5373\u662f\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u540e\u9488\u5bf9\u5b9e\u8d28\u6027\u53d8\u66f4<\/span>\u7684\u4fee\u8ba2\uff08substantial modification\uff09\uff3b12\uff3d\u3002<\/span><\/p>\n

\u6cd5\u89c4\u4e2d\u660e\u786e\u4e86<\/span>\u5b9e\u8d28\u6027\u53d8\u66f4\u7684\u5b9a\u4e49\uff0c\u5373\u4e34\u5e8a\u8bd5\u9a8c\u83b7\u6279\u540e\u53d1\u751f\u7684\u4efb\u4f55<\/span>\u53ef\u80fd\u5bf9\u53d7\u8bd5\u8005\u5b89\u5168\u548c\u83b7\u76ca\u6216\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u53ef\u9760\u7a33\u5065\u6027\u4ea7\u751f\u5b9e\u8d28\u6027\u5f71\u54cd\u7684\u53d8\u66f4\uff3b5\uff3d\u3002<\/span><\/p>\n

\u5728\u5224\u65ad\u67d0\u9879\u4e34\u5e8a\u8bd5<\/span>\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u662f\u5426\u9700\u8981\u63d0\u4ea4\u5b9e\u8d28\u6027\u53d8\u66f4\u901a\u544a\uff08the <\/span>notification of a substantial amendment\uff09\u65f6\uff0c\u5e94\u91cd\u70b9\u8003<\/span>\u8651\u5176\u5bf9\u53d7\u8bd5\u8005\u5b89\u5168\u6027\u3001\u4e34\u5e8a\u8bd5\u9a8c\u5177\u4f53\u5b9e\u65bd\u3001\u4e34\u5e8a\u8bd5\u9a8c<\/span>\u7528\u836f\u8d28\u91cf\u7b49\u591a\u89d2\u5ea6\u7684\u5f71\u54cd\uff3b13-14\uff3d\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u5b9e\u8d28\u6027\u53d8\u66f4\uff0cEMA \u672a\u660e\u786e\u89c4\u5b9a\u63d0\u4ea4\u7684\u95f4\u9694<\/span>\u671f\uff0c\u4f46\u5f3a\u8c03\u5e76\u975e\u6bcf\u9879\u53d8\u66f4\u5747\u4e3a\u5b9e\u8d28\u6027\u53d8\u66f4\uff0c\u7533\u8bf7\u4eba\u5e94<\/span>\u5728\u8fdb\u884c\u5145\u5206\u8bc4\u4f30\u57fa\u7840\u4e0a\u5c3d\u91cf\u907f\u514d\u9891\u7e41\u53d8\u66f4\u548c\u63d0\u4ea4\u3002<\/span><\/p>\n

\u5728\u6536\u5230\u6709\u6548\u7684\u5b9e\u8d28\u6027\u53d8\u66f4\u901a\u544a\u540e\uff0c\u4f26\u7406\u59d4\u5458\u4f1a\u53ca\u56fd<\/span>\u5bb6\u76d1\u7ba1\u673a\u6784\u901a\u5e38\u4f1a\u572835 \u4e2a\u81ea\u7136\u65e5\u5185\u4f5c\u51fa\u56de\u590d\uff08\u7279\u6b8a<\/span>\u60c5\u51b5\u53ef\u5ef6\u957f\uff09\uff0c\u5982\u4f26\u7406\u59d4\u5458\u4f1a\u652f\u6301\u4e14\u56fd\u5bb6\u76d1\u7ba1\u673a\u6784\u672a<\/span>\u53cd\u5bf9\uff0c\u5219\u7533\u8bf7\u4eba\u53ef\u81ea\u884c\u5b9e\u65bd\u53d8\uff3b14\uff3d\u3002<\/span><\/p>\n

\u82e5\u4e3a\u975e\u5b9e\u8d28\u6027\u53d8\u66f4\uff0cEMA \u5219\u672a\u5f3a\u5236\u8981\u6c42\u7533\u8bf7\u4eba\u5411\u4f26\u7406\u59d4\u5458\u4f1a\u6216\u56fd\u5bb6\u76d1\u7ba1\u673a\u6784\u63d0\u4ea4\u53d8\u66f4\u901a\u544a\uff0c\u4f46\u9700<\/span>\u5c06\u975e\u5b9e\u8d28\u6027\u53d8\u66f4\u8bb0\u5f55\u7eb3\u5165\u540e\u7eed\u63d0\u4ea4\u7684\u6587\u4ef6\u4e2d\uff0c\u5982\u53ef<\/span>\u5728\u540e\u7eed\u5b9e\u8d28\u6027\u53d8\u66f4\u63d0\u4ea4\u65f6\u4e00\u5e76\u63d0\u4f9b\uff3b14\uff3d\u3002<\/span><\/p>\n

\u90e8\u5206EMA \u6307\u5bfc\u539f\u5219\u4e2d\u5bf9\u5b9e\u8d28\u6027\uff0f \u975e\u5b9e\u8d28\u6027\u836f\u5b66\u53d8\u66f4\u7684\u5217\u4e3e\u89c1\u88682\uff3b13\uff0c 15\uff3d\u3002<\/span><\/p>\n

\"\u6d45\u6790\u56fd\u5185\u5916\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u7684\u76d1\u7ba1\u53ca\u6280\u672f\u8bc4\u4ef7\u8003\u8651\"<\/p>\n

\u5bf9\u4e8e\u7269\u8d28\u57fa\u7840\u76f8\u5dee\u8f83\u5927<\/span>\u7684\u4e0d\u540c\u7c7b\u522b\u836f\u54c1\uff0c\u8be5\u8868\u5e76\u4e0d\u80fd\u7edf\u4e00\u5957\u7528\u3002\u5982\u7531\u4e8e\u5316<\/span>\u836f\u7c7b\u548c\u751f\u7269\u7c7b\u4ea7\u54c1\u672c\u8d28\u6027\u4e0d\u540c\uff0c\u4e24\u8005\u5bf9\u4e8e\u751f\u4ea7\u89c4\u6a21\u653e<\/span>\u5927\u53d8\u66f4\u6240\u4f34\u968f\u5f71\u54cd\u7684\u9884\u5224\u548c\u8bc4\u4f30\u662f\u4e0d\u540c\u7684\u3002<\/p>\n

\u5316\u836f\u7c7b\u5728\u8fdb\u884c\u751f\u4ea7\u89c4\u6a21\u653e\u5927\u65f6\uff0c\u6839\u636e\u4ea7\u54c1\u786e\u5b9a\u7684\u5316\u5b66\u7ed3<\/span>\u6784\uff0c\u901a\u5e38\u6709\u6761\u4ef6\u91c7\u7528\u65e2\u5f80\u7ecf\u9a8c\u6216\u53ef\u8861\u91cf\u7684\u6807\u51c6\uff0c\u56e0<\/span>\u6b64\uff0c\u5176\u751f\u4ea7\u89c4\u6a21\u653e\u5927\u5177\u6709\u53ef\u4f5c\u4e3a\u975e\u5b9e\u8d28\u6027\u53d8\u66f4\u7684\u7406<\/span>\u8bba\u57fa\u7840\u3002<\/span><\/p>\n

\u7136\u800c\u751f\u7269\u5236\u54c1\u5728\u8fdb\u884c\u89c4\u6a21\u653e\u5927\u65f6\uff0c\u4ea7\u54c1\u751f<\/span>\u7269\u5b66\u7279\u6027\u6539\u53d8\u662f\u5e38\u6001\u5316\uff0c\u4e14\u8f83\u96be\u5224\u5b9a\uff0c\u56e0\u6b64\uff0c\u8be5\u7c7b\u53d8<\/span>\u66f4\u9700\u7efc\u5408\u8d28\u91cf\u53ef\u6bd4\u6027\u7814\u7a76\u7ed3\u679c\u4ee5\u786e\u5b9a\u662f\u5426\u4f5c\u4e3a\u5b9e<\/span>\u8d28\u6027\u53d8\u66f4\u3002<\/span><\/p>\n

\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u5b9e\u8d28\u6027\u53d8\u66f4\u901a\u544a\u7684\u63d0\u4ea4\u4ec5\u9002\u7528\u4e8e\u67d0\u9879\u6b63\u5728\u8fdb\u884c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u9274\u4e8eEMA \u8981\u6c42\u5355\u4e00<\/span>\u836f\u54c1\u5f00\u5c55\u7684\u591a\u9879\u4e34\u5e8a\u8bd5\u9a8c\u5177\u5907\u72ec\u7acb\u7684\u7533\u8bf7\u53f7\uff0c\u56e0\u6b64\uff0c<\/span>\u5982\u67d0\u9879\u836f\u5b66\u53d8\u66f4\u5c06\u5728\u65b0\u7684\u4e34\u5e8a\u8bd5\u9a8c\u542f\u52a8\u540e\u5b9e\u65bd\uff0c\u5219<\/span>\u5e94\u5728\u63d0\u4ea4\u65b0\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u65f6\u624d\u4e88\u4ee5\u901a\u544a\uff3b 13\uff3d\u3002<\/span><\/p>\n

\u6240<\/span>\u4ee5\uff0c\u7533\u8bf7\u4eba\u53ef\u8003\u8651\u57fa\u4e8e\u4e0d\u540c\u4e34\u5e8a\u8bd5\u9a8c\u9879\u76ee\u7b80\u5316\u5b9e\u8d28<\/span>\u6027\u53d8\u66f4\u901a\u544a\uff0c\u5373\u5728\u4e0b\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08\u5c06\u5305\u542b\u65b0\u7684<\/span>\u4e34\u5e8a\u7814\u7a76\u6279\u6b21\uff09\u4e2d\u56ca\u62ec\u62df\u5b9e\u65bd\u7684\u836f\u5b66\u5b9e\u8d28\u6027\u53d8\u66f4\uff0c\u800c<\/span>\u65e0\u9700\u5bf9\u539f\u4e34\u5e8a\u8bd5\u9a8c\u9879\u76ee\u8fdb\u884c\u5b9e\u8d28\u6027\u53d8\u66f4\u901a\u544a\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
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\n

6<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

\u6b27\u7f8e\u76d1\u7ba1\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u7684\u76f8\u540c\u7406\u5ff5<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

\u901a\u8fc7\u5bf9\u6bd4\u7f8e\u56fdFDA \u4e0e\u6b27\u76dfEMA \u76f8\u5173\u6cd5\u89c4\u53ca\u6307\u5bfc\u539f\u5219\u5bf9\u4e34\u5e8a\u671f\u95f4\u53d8\u66f4\u7684\u8981\u6c42\u65b9\u5f0f\uff08\u89c1\u56fe2\uff09\uff0c\u53d1\u73b0<\/span>\u4e24\u8005\u5728\u7533\u62a5\u5f62\u5f0f\u4e0a\u5b58\u5728\u663e\u8457\u5dee\u5f02\uff0c\u4f46\u76d1\u7ba1\u7406\u5ff5\u5374\u5b58<\/span>\u5728\u5171\u6027\uff0c\u5177\u4f53\u4e3a\u4ee5\u4e0b\u65b9\u9762\uff1a<\/span><\/p>\n

\"\u6d45\u6790\u56fd\u5185\u5916\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u7684\u76d1\u7ba1\u53ca\u6280\u672f\u8bc4\u4ef7\u8003\u8651\"<\/p>\n

\u56fe2 \u6b27\u7f8e\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u53d8\u66f4\u7533\u62a5\u8fc7\u7a0b\u5bf9\u6bd4\u793a\u610f\u56fe<\/span><\/strong><\/span>
<\/p>\n

\u2460\u4e34\u5e8a\u671f\u95f4\u53d8\u66f4\u5747\u9700\u6309\u89c4<\/span>\u5b9a\u6e20\u9053\u63d0\u4ea4\u7ed9EMA \u6216FDA\u3002EMA \u91c7\u7528\u5b9e\u8d28\u6027\u53d8\u66f4<\/span>\u901a\u544a\u5236\uff0cFDA \u91c7\u7528CMC \u4fe1\u606f\u4fee\u8ba2\u63d0\u4ea4\u5236\u6216\u5e74\u5ea6\u62a5\u544a<\/span>\u5907\u6848\u5236\u3002\u56e0\u6b64\uff0c\u4e34\u5e8a\u671f\u95f4\u7684\u4efb\u4f55\u53d8\u66f4\u5747\u80fd\u591f\u5f97\u5230\u6b27<\/span>\u7f8e\u76d1\u7ba1\u673a\u6784\u7684\u5173\u6ce8\uff0c\u5e76\u83b7\u5f97\u53ca\u65f6\u7684\u5904\u7406\u3002\u540c\u65f6\u5728\u6d41<\/span>\u7a0b\u4e0a\u76f8\u5bf9\u7b80\u5316\uff0c\u6ca1\u6709\u6279\u4ef6\u9881\u53d1\u7b49\u884c\u653f\u8bbe\u9879\uff0c\u7533\u8bf7\u4eba\u4ec5<\/span>\u9700\u7ea61 \u4e2a\u6708\u5de6\u53f3\u7684\u65f6\u95f4\u5373\u53ef\u5bf9\u4e34\u5e8a\u671f\u95f4\u7684\u53d8\u66f4\u5b9e\u65bd<\/span>\u76f8\u5e94\u4e3e\u63aa\uff0c\u6709\u5229\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6301\u7eed\u5f00\u5c55\u3002\u5bf9\u4e8e\u5b89\u5168<\/span>\u98ce\u9669\u8f83\u5c0f\u7684\u53d8\u66f4\uff0c\u76d1\u7ba1\u673a\u6784\u4e0d\u4f1a\u4ee5\u5373\u65f6\u548c\u9ad8\u9891\u7684\u65b9<\/span>\u5f0f\u8981\u6c42\u7533\u8bf7\u4eba\u63d0\u4f9b\u8d44\u6599\u3002\u6b64\u9879\u4e3e\u63aa\u4e0d\u4ec5\u80fd\u591f\u51cf\u8f7b\u7533<\/span>\u8bf7\u4eba\u7684\u8d1f\u62c5\uff0c\u540c\u65f6\u8fd8\u80fd\u591f\u5e2e\u52a9\u76d1\u7ba1\u673a\u6784\u8282\u7701\u4eba\u529b\u7269<\/span>\u529b\uff0c\u6709\u9488\u5bf9\u6027\u7684\u805a\u7126\u98ce\u9669\u8f83\u5927\u7684\u53d8\u66f4\u3002<\/span><\/p>\n

\u2461\u5bf9\u65e9\u671f\u4e34<\/span>\u5e8a\u671f\u95f4\u53d8\u66f4\u7684\u5173\u6ce8\u4fa7\u91cd\u4e8e\u5b89\u5168\u6027\u7684\u5f71\u54cd\u3002\u65e9\u671f\u4e34\u5e8a<\/span>\u8bd5\u9a8c\u671f\u95f4\u4ea7\u751f\u7684\u53d8\u66f4\u4ecd\u6709\u7ecf\u540e\u7eed\u4eba\u4f53\u4e34\u5e8a\u8bd5\u9a8c\u8fdb\u4e00\u6b65\u786e\u8bc1\u6709\u6548\u6027\u7684\u673a\u4f1a\uff0c\u56e0\u6b64\uff0c\u76f8\u6bd4\u4e8e\u53d8\u66f4\u524d\u540e\u8d28\u91cf\u7684<\/span>\u53ef\u6bd4\u6027\uff0c\u4ea7\u54c1\u5b89\u5168\u6027\u7684\u4fdd\u8bc1\u66f4\u4e3a\u7a81\u51fa\u3002\u5728\u524d\u671f\u5f00\u53d1<\/span>\u6570\u636e\u80fd\u591f\u57fa\u672c\u652f\u6301\u7684\u57fa\u7840\u4e0a\uff0c\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\u5e94<\/span>\u91cd\u70b9\u5173\u6ce8\u53d8\u66f4\u5bf9\u5b89\u5168\u6027\u53ca\u4f53\u5185\u66b4\u9732\u91cf\u7684\u5f71\u54cd\u3002\u5982\u679c<\/span>\u836f\u5b66\u53ef\u6bd4\u6027\u7814\u7a76\u6570\u636e\u663e\u793a\u51fa\u53d8\u66f4\u53ef\u80fd\u5f15\u8d77\u8d28\u91cf\u3001\u6742\u8d28\u3001\u836f\u6548\u7b49\u4e0d\u826f\u6539\u53d8\uff0c\u9700\u8003\u8651\u5f00\u5c55\u9002\u5f53\u7684\u6865\u63a5\u8bd5\u9a8c\u3002<\/span><\/p>\n

\u2462EMA \u53caFDA \u5747\u63d0\u51fa\u5e94\u7531\u7533\u8bf7\u4eba\u81ea\u884c\u5bf9\u53d8\u66f4\u6027\u8d28\u3001\u98ce\u9669\u8fdb\u884c\u5224\u5b9a\u3002\u7533\u8bf7\u4eba\u4f5c\u4e3a\u836f\u54c1\u4e0a\u5e02\u7684\u4e3b\u4f53\uff0c\u540c<\/span>\u65f6\u4e5f\u662f\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7b2c\u4e00\u8d23\u4efb\u4eba\uff0c\u5176\u6709\u5b8c\u5168\u7684\u6743<\/span>\u529b\u548c\u4e49\u52a1\u5bf9\u53d8\u66f4\u8fdb\u884c\u8bc4\u4ef7\u548c\u4fdd\u969c\uff0c\u5305\u62ec\u5bf9\u53d8\u66f4\u5f00\u5c55<\/span>\u5145\u5206\u7814\u7a76\uff0c\u51c6\u786e\u5224\u65ad\u53d8\u66f4\u98ce\u9669\uff0c\u660e\u786e\u53d8\u66f4\u540e\u836f\u54c1\u5b89\u5168<\/span>\u6709\u6548\uff0c\u51b3\u5b9a\u901a\u77e5\u6216\u62a5\u544a\u76d1\u7ba1\u673a\u6784\u7684\u65f6\u95f4\u3001\u5f62\u5f0f\uff0c\u5e76\u627f<\/span>\u62c5\u76f8\u5e94\u7ed3\u679c\u3002<\/span><\/p>\n

\u2463EMA \u53caFDA \u5747\u4e3a\u7533\u8bf7\u4eba\u63d0\u4f9b\u6307\u5bfc<\/span>\u5e2e\u52a9\u7684\u6e20\u9053\u3002\u5982\u7533\u8bf7\u4eba\u53ef\u89c6\u836f\u54c1\u60c5\u51b5\u63d0\u51fa\u8981\u6c42\u53ec\u5f00<\/span>\u2160\u671f\u4e34\u5e8a\u7ed3\u675f\u4f1a\u8bae\uff08EOP1\uff09\u6216\u2161\u671f\u4e34\u5e8a\u7ed3\u675f\u4f1a\u8bae<\/span>\uff08EOP2\uff09\uff3b16 \uff3d\uff0c\u4f7fFDA \u63d0\u524d\u77e5\u6653\u62df\u53d8\u66f4\u60c5\u51b5\uff0c\u5e76\u83b7\u53d6<\/span>FDA \u76f8\u5173\u610f\u89c1\u3002\u8fd9\u79cd\u6c9f\u901a\u4ea4\u6d41\u673a\u5236\u53ef\u8ba9\u7533\u8bf7\u4eba\u548cFDA\u5747\u5728\u521d\u671f\u5bf9\u4ea7\u54c1\u52a0\u6df1\u4e86\u89e3\uff0c\u5e76\u4e3a\u6700\u7ec8\u964d\u4f4e\u4e34\u5e8a<\/span>\u8bd5\u9a8c\u98ce\u9669\u5960\u5b9a\u57fa\u7840\u5171\u8bc6\u3002EMA \u76f8\u5173\u6307\u5bfc\u539f\u5219\u4e5f\u660e<\/span>\u786e\u6307\u51fa\uff0c\u5c3d\u7ba1\u7533\u8bf7\u4eba\u5e94\u8d1f\u8d23\u8bc4\u4f30\u67d0\u9879\u53d8\u66f4\u662f\u5426\u4e3a\u5b9e<\/span>\u8d28\u6027\u53d8\u66f4\uff0c\u4f46\u5982\u679c\u7533\u8bf7\u4eba\u5bf9\u6b64\u5411\u56fd\u5bb6\u4e3b\u7ba1\u673a\u6784\u95ee\u8be2\uff0c<\/span>\u5219\u76f8\u5e94\u673a\u6784\u5e94\u5c3d\u5feb\u4e14\u514d\u8d39\u5411\u5176\u56de\u590d\u5efa\u8bae\uff3b14\uff3d\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
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7<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u4e0e\u4e0a\u5e02\u540e\u836f\u5b66\u53d8\u66f4\u7ba1\u7406<\/strong>\u7684\u5f02\u540c<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u7ba1\u7406\u6d41\u7a0b\u4e0e\u4e0a\u5e02\u540e\u836f\u5b66\u53d8\u66f4\u7ba1\u7406\u5b58\u5728\u7c7b\u4f3c\u7406\u5ff5\uff0c\u4f46\u4e5f\u5b58\u5728\u8f83\u5927\u533a\u522b\u3002\u4e8c\u8005<\/span>\u5747\u91c7\u7528\u57fa\u4e8e\u5b89\u5168\u6027\u98ce\u9669\u8bc4\u4f30\u7684\u7ba1\u7406\u5f62\u5f0f\uff0c\u5e76\u7531\u7533\u8bf7<\/span>\u4eba\u81ea\u884c\u8861\u91cf\u98ce\u9669\u7b49\u7ea7\uff0c\u4f46\u5728\u7ba1\u7406\u65b9\u5f0f\u4e0a\u6709\u6240\u4e0d\u540c\u3002<\/span><\/p>\n

\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u6309\u7167\u5bf9\u4e34\u5e8a\u53d7\u8bd5\u8005\u7684\u5b89\u5168\u6027\u98ce\u9669\u8fdb\u884c\u5206\u7c7b\uff0c\u4e0a\u5e02\u540e\u836f\u5b66\u53d8\u66f4\u6309\u7167\u5bf9\u4ea7\u54c1\u5b89\u5168\u6709<\/span>\u6548\u6027\u7684\u5f71\u54cd\u8fdb\u884c\u5206\u7ea7\u7533\u62a5\uff08\u5982\u7f8e\u56fd\u6309PAS\u3001CBE-30\u3001<\/span>CBE-0 \u7b49\u5206\u7ea7\uff1b\u6b27\u76df\u6309II\u3001IB\u3001IA \u7b49\u5206\u7ea7\uff09\u3002<\/span><\/p>\n

FDA \u548c<\/span>EMA \u5747\u4f1a\u5bf9\u6240\u6709\u9012\u4ea4\u7684\u53d8\u66f4\u8fdb\u884c\u5ba1\u9605\uff0c\u4f46\u4e34\u5e8a\u8bd5\u9a8c<\/span>\u671f\u95f4\u6d89\u53ca\u5b89\u5168\u6027\u53ca\u975e\u5b89\u5168\u6027\u7684\u836f\u5b66\u53d8\u66f4\u5747\u91c7\u7528\u9ed8\u8bb8<\/span>\u5236\u5904\u7406\uff0c\u800c\u5bf9\u4e0a\u5e02\u540e\u91cd\u5927\u53d8\u66f4\u5219\u9002\u5f53\u91c7\u7528\u6279\u51c6\u5236\u8fdb<\/span>\u884c\u76d1\u7ba1\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

8<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n

\u6211\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u53d8\u66f4\u76d1\u7ba1\u6982\u51b5<\/strong><\/p>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n
\n

\u7ba1\u7406\u65b9\u9762\uff0c\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u5728\u7533\u62a5\u8d44\u6599\u8981\u6c42\u4e2d\u63d0\u53ca\u9700\u63d0\u4ea4\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u836f\u5b66\u5b8c\u5584\u7684\u7814\u7a76\u8d44<\/span>\u6599\uff0c\u4f46\u672a\u660e\u786e\u63d0\u4ea4\u7684\u8def\u5f84\u548c\u7a0b\u5e8f\u3002<\/span><\/p>\n

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<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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