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       \u7eb3\u5165\u5883\u5916\u5df2\u4e0a\u5e02\u4e34\u5e8a\u6025\u9700\u65b0\u836f\u540d\u5355\u7684\u836f\u54c1\uff0c<\/span><\/span>\u5c1a\u672a\u8fdb\u884c\u7533\u62a5\u7684\u6216\u6b63\u5728\u6211\u56fd\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\uff0c\u7ecf\u7533\u8bf7\u4eba\u7814\u7a76\u8ba4\u4e3a\u4e0d\u5b58\u5728\u4eba\u79cd\u5dee\u5f02\u7684\uff0c\u5747\u53ef\u63d0\u4ea4\u6216\u8865\u4ea4\u5883\u5916\u53d6\u5f97\u7684\u5168\u90e8\u7814\u7a76\u8d44\u6599\u548c\u4e0d\u5b58\u5728\u4eba\u79cd\u5dee\u5f02\u7684\u652f\u6301\u6027\u6750\u6599\uff0c\u76f4\u63a5\u63d0\u51fa\u4e0a\u5e02\u7533\u8bf7<\/span>\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5c06\u6309\u7167\u4f18\u5148\u5ba1\u8bc4\u5ba1\u6279\u7a0b\u5e8f\uff0c\u52a0\u5feb\u5ba1\u8bc4\u5ba1\u6279\u3002\u5373\u65e5\u8d77\uff0c\u4e0a\u8ff048\u4e2a\u836f\u54c1\u7533\u8bf7\u4eba\u5373\u53ef\u6309\u300a\u836f\u7269\u7814\u53d1\u4e0e\u6280\u672f\u5ba1\u8bc4\u6c9f\u901a\u4ea4\u6d41\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u8bd5\u884c\uff09\u7684\u8981\u6c42\uff0c\u5411\u6211\u4e2d\u5fc3\u63d0\u51fa\u2160\u7c7b\u4f1a\u8bae\u7533\u8bf7\uff0c\u5bf9\u7533\u62a5\u76f8\u5173\u95ee\u9898\u8fdb\u884c\u6c9f\u901a\u3002<\/span>
       \u73b0\u5c06\u5883\u5916\u5df2\u4e0a\u5e02\u4e34\u5e8a\u6025\u9700\u65b0\u836f\u540d\u5355\uff08\u89c1\u9644\u4ef61\uff09\u548c\u7533\u62a5\u8d44\u6599\u8981\u6c42\uff08\u89c1\u9644\u4ef62\uff09\u5411\u793e\u4f1a\u5404\u754c\u5f81\u6c42\u610f\u89c1\u3002\u5982\u6709\u610f\u89c1\uff0c\u8bf7\u4e8e2018\u5e748\u670818\u65e5\u524d\u56de\u9988\u610f\u89c1\u3002\u8054\u7cfb\u4eba\uff1a\u674e\u9038\u4e91\uff0c\u90ae\u7bb1\uff1a<\/span>liyy@cde.org.cn\u3002          <\/span>
 \u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3<\/span><\/span>
 2018\u5e748\u67088\u65e5 <\/span>
\u9644\u4ef61<\/span>
\u5883\u5916\u5df2\u4e0a\u5e02\u4e34\u5e8a\u6025\u9700\u65b0\u836f\u540d\u5355
<\/strong><\/p>\n


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<\/strong>\u7533\u62a5\u8d44\u6599\u8981\u6c42<\/strong> <\/span>
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       <\/span>1.\u8bc1\u660e\u6027\u6587\u4ef6
<\/strong>       \u63d0\u4f9b\u7f8e\u56fd\u3001\u6b27\u76df\u548c\u65e5\u672c\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u6279\u51c6\u4e0a\u5e02\u7684\u8bc1\u660e\u6027\u6587\u4ef6\uff1b\u63d0\u4f9b\u8be5\u836f\u54c1\u5df2\u5728\u65e5\u672c\u3001\u9999\u6e2f\u3001\u6fb3\u95e8\u3001\u53f0\u6e7e\u7b49\u5730\u533a\u4e4b\u4e00\u4e0a\u5e02\u7684\u8bc1\u660e\u6587\u4ef6\uff0c\u4ee5\u53ca\u8fd1\u4e94\u5e74\u5185\u51fa\u53e3\u81f3\u8be5\u5730\u533a\u7684\u836f\u54c1\u6570\u91cf\u53ca\u76f8\u5173\u8bc1\u660e\u6587\u4ef6\u3002<\/span>
       <\/span>2.\u4eba\u7528\u836f\u54c1\u901a\u7528\u6280\u672f\u6587\u6863\uff08CTD\uff09\u8981\u6c42
<\/strong>       \u7533\u8bf7\u4eba\u5e94\u4e25\u683c\u6309\u7167ICH CTD\u683c\u5f0f\u8981\u6c42\u9012\u4ea4\u7533\u62a5\u8d44\u6599\u3002\u7533\u62a5\u8d44\u6599\u5e94\u4e0e\u62a5\u9001\u81f3\u53d1\u8fbe\u56fd\u5bb6\u76d1\u7ba1\u673a\u6784\u7684\u5185\u5bb9\u57fa\u672c\u76f8\u540c\uff0c\u540c\u65f6\u5e94\u63d0\u4ea4\u4e0a\u5e02\u540e\u79ef\u7d2f\u7684\u7814\u7a76\u6570\u636e\u3002\u5176\u4e2d\uff0cCTD\u6587\u4ef6\u4e2dM1\u6a21\u5757\u3001M2\u6a21\u5757\u4ee5\u53caM3\uff0dM5\u6a21\u5757\u5173\u952e\u7814\u7a76\u62a5\u544a\u7684\u6458\u8981\u90e8\u5206\uff0c\u5e94\u4e3a\u4e2d\u6587\u7248\uff0c\u5e76\u9644\u539f\u6587\u5907\u67e5\u9605\u3002\u63d0\u4f9b\u7684\u836f\u54c1\u8bf4\u660e\u4e66\uff0c\u5185\u5bb9\u4e0e\u539f\u4e0a\u5e02\u56fd\u5ba1\u6838\u53d1\u5e03\u8bf4\u660e\u4e66\u5185\u5bb9\u76f8\u540c\uff0c\u683c\u5f0f\u91c7\u7528\u539f\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u836f\u54c1\u8bf4\u660e\u4e66\u548c\u6807\u7b7e\u7ba1\u7406\u89c4\u5b9a\u300b\uff08\u5c40\u4ee4\u7b2c24\u53f7\uff09\u8981\u6c42\u3002<\/span>
       <\/span>3.\u79cd\u65cf\u654f\u611f\u6027\u5206\u6790\u62a5\u544a
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       <\/span>4.\u4e0a\u5e02\u540e\u7814\u7a76\u548c\u4e0a\u5e02\u540e\u98ce\u9669\u63a7\u5236\u8ba1\u5212
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       <\/span>5.\u7533\u62a5\u8d44\u6599\u4e00\u81f4\u6027\u58f0\u660e
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