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    util\u6587\u4ef6\u5939\u5305\u542b\u6587\u6863\u7c7b\u578b\u5b9a\u4e49\uff08Document Type Definition\uff0cDTD\uff09\u548c\u6837\u5f0f\u8868\uff08Stylesheet\uff09\u7684\u4fe1\u606f\uff0c\u5206\u522b\u7f6e\u4e8edtd\u548cstyle\u6587\u4ef6\u5939\u3002<\/span><\/p>\n<\/li>\n

  • \n

    DTD\u662f\u7528\u6765\u89c4\u8303XML\u7684\u7ed3\u6784\uff0cstylesheet\u662f\u5bf9eCTD\u4fe1\u606f\u89c4\u8303\u7684\u8bf4\u660e\uff0c\u4fbf\u4e8eeCTD\u7684\u4f7f\u7528\u3001\u4fdd\u5b58\u4ee5\u53ca\u5e2e\u52a9\u6280\u672f\u4eba\u5458\u4e86\u89e3eCTD\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n

    \n

    1.2 eCTD\u7684\u4f18\u52bf<\/span><\/p>\n

     <\/span><\/p>\n

    eCTD\u5373\u662f\u7535\u5b50\u5316\u7684CTD\u6ce8\u518c\u7533\u62a5\u65b9\u5f0f\uff0c\u76f8\u5bf9\u4e8e\u4f20\u7edf\u7684\u7eb8\u8d28\u8d44\u6599\u63d0\u4ea4\uff0ceCTD\u65b9\u5f0f\u66f4\u65b9\u4fbf\u3001\u66f4\u73af\u4fdd\u3002eCTD\u4f7f\u7533\u62a5\u8d44\u6599\u7684\u7f16\u5236\u3001\u7533\u62a5\u3001\u53d7\u7406\u5ba1\u8bc4\u3001\u5f52\u6863\u5b58\u50a8\u548c\u4ea7\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\u66f4\u52a0\u4fbf\u6377\uff0c\u5b83\u53ef\u53cd\u590d\u4f7f\u7528\uff0c\u80fd\u6709\u6548\u964d\u4f4e\u7533\u8bf7\u8d44\u6599\u63d0\u4ea4\u548c\u8bc4\u5ba1\u7684\u91cd\u590d\u7387\uff0c\u4e00\u65b9\u9762\u964d\u4f4e\u4e86\u4f01\u4e1a\u7533\u62a5\u6210\u672c\uff0c\u53e6\u4e00\u65b9\u9762\u63d0\u9ad8\u4e86\u76d1\u7ba1\u673a\u6784\u7684\u5ba1\u8bc4\u6548\u7387\uff1a<\/span><\/p>\n

    1\uff09eCTD\u5bf9\u7533\u62a5\u8d44\u6599\u7684\u683c\u5f0f\u548c\u5185\u5bb9\u505a\u51fa\u4e86\u7edf\u4e00\u8981\u6c42\uff0c\u4fdd\u8bc1\u4e86\u8d44\u6599\u683c\u5f0f\u7684\u4e00\u81f4\u6027\uff0c\u5bf9\u4e8e\u7533\u8bf7\u4eba\u6765\u8bf4\uff0c\u4e00\u4e2a\u4ea7\u54c1\u5982\u5728\u591a\u4e2a\u56fd\u5bb6\u8fdb\u884c\u6ce8\u518c\u7533\u62a5\uff0cM2-M5\u7684\u8d44\u6599\u53ef\u4ee5\u5171\u4eab\uff0c\u6709\u5229\u4e8e\u56fd\u9645\u5316\u7533\u62a5\uff0c\u540c\u65f6\u4e5f\u5229\u4e8e\u5404\u4e2a\u56fd\u5bb6\u548c\u5730\u533a\u7684\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u7684\u5ba1\u8bc4\u610f\u89c1\u4ea4\u6d41\uff1b<\/span><\/p>\n

    2\uff091\u4e2aeCTD\u7533\u62a5\u53ef\u4ee5\u6db5\u76d6\u540c\u4e00\u54c1\u79cd\u4e0d\u540c\u5242\u578b\u3001\u4e0d\u540c\u89c4\u683c\u7684\u836f\u54c1\uff0c\u7b80\u5316\u4e86\u7533\u62a5\u8d44\u6599\u7684\u7f16\u5236\u5de5\u4f5c\uff1b<\/span><\/p>\n

    3\uff09eCTD\u652f\u6301\u4ea7\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\uff0c\u80fd\u591f\u5c55\u793a\u63d0\u4ea4\u7684\u6587\u6863\u4e0e\u590d\u6742\u7684\u7533\u8bf7\u751f\u547d\u5468\u671f\u7684\u5173\u7cfb\uff0c\u5982\u4ea7\u54c1\u5728\u4e0a\u5e02\u540e\u53d1\u751f\u53d8\u66f4\uff0c\u4ec5\u9700\u63d0\u4ea4eCTD\u4e2d\u53d1\u751f\u53d8\u66f4\u7684\u90e8\u5206\u6587\u4ef6\uff0c\u65e0\u9700\u91cd\u65b0\u63d0\u4ea4\u6574\u4e2a\u6587\u4ef6\uff1b<\/span><\/p>\n

    4\uff09\u91c7\u7528eCTD\u63d0\u4ea4\u7684\u7533\u62a5\u8d44\u6599\uff0c\u7533\u8bf7\u4eba\u9700\u8981\u4e25\u683c\u6309\u7167eCTD\u884c\u4e1a\u6307\u5357\u548c\u6280\u672f\u89c4\u8303\u8fdb\u884c\u7f16\u5236\uff0c\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u5728\u6b63\u5f0f\u63a5\u6536\u7533\u62a5\u8d44\u6599\u524d\uff0c\u4f1a\u901a\u8fc7eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u9a8c\u8bc1\u8d44\u6599\u7684\u89c4\u8303\u6027\u548c\u5b8c\u6574\u6027\uff0c\u786e\u4fdd\u7533\u62a5\u8d44\u6599\u7b26\u5408\u76d1\u7ba1\u8981\u6c42\uff0c\u63d0\u9ad8\u7533\u62a5\u8d44\u6599\u7684\u8d28\u91cf\uff0c\u907f\u514d\u56e0\u7533\u62a5\u8d44\u6599\u7684\u8d28\u91cf\u95ee\u9898\u6d6a\u8d39\u5ba1\u8bc4\u8d44\u6e90\uff1b<\/span><\/p>\n

    5\uff09\u5ba1\u8bc4\u4eba\u5458\u65e0\u9700\u67e5\u770b\u7eb8\u8d28\u7533\u62a5\u8d44\u6599\uff0c\u53ef\u501f\u52a9eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u67e5\u9605\u3001\u8c03\u53d6\u548c\u68c0\u7d22\u76f8\u5173\u8d44\u6599\uff0c\u4e3a\u5ba1\u8bc4\u5de5\u4f5c\u63d0\u4f9b\u591a\u79cd\u4fbf\u5229\u6761\u4ef6\u3002\u4f8b\u5982\uff0c\u901a\u8fc7\u4e66\u7b7e\u548c\u8bbe\u5b9a\u597d\u7684\u8d85\u7ea7\u94fe\u63a5\uff0c\u4f7f\u5f97\u5ba1\u8bc4\u4eba\u5458\u53ef\u4ee5\u7b80\u5355\u5feb\u901f\u5730\u5728\u5e9e\u5927\u7684\u6ce8\u518c\u8d44\u6599\u4e2d\u5b9a\u4f4d\u5230\u76f8\u5e94\u7684\u6570\u636e\u53ca\u8d44\u6599\uff1b\u4e0d\u4ec5\u53ef\u4ee5\u8c03\u9605\u5f53\u524d\u5ba1\u8bc4\u4ea7\u54c1\u7684\u5386\u53f2\u8d44\u6599\uff0c\u5728\u4e0d\u540c\u4ea7\u54c1\u5ba1\u8bc4\u65f6\u4e5f\u53ef\u4ee5\u6a2a\u5411\u6bd4\u8f83\uff0c\u5e76\u53ef\u901a\u8fc7\u6dfb\u52a0\u4e66\u7b7e\u3001\u5907\u6ce8\u7b49\u65b9\u5f0f\u5b9e\u65f6\u8bb0\u5f55\u5ba1\u8bc4\u610f\u89c1\uff0c\u4e5f\u53ef\u901a\u8fc7eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u5bf9\u540c\u4e00\u7533\u62a5\u6750\u6599\u8fdb\u884c\u5206\u5de5\uff0c\u7531\u591a\u4eba\u5ba1\u8bc4\uff1b<\/span><\/p>\n

    6\uff09\u901a\u8fc7\u5bf9\u7533\u62a5\u8d44\u6599\u8fdb\u884c\u7535\u5b50\u5316\u7533\u62a5\u548c\u7ba1\u7406\uff0c\u6709\u5229\u4e8e\u4f01\u4e1a\u51cf\u5c11\u8d44\u6599\u6253\u5370\u3001\u8fd0\u8f93\u548c\u5b58\u50a8\u6210\u672c\uff0c\u800c\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u4e5f\u51cf\u5c11\u4e86\u7269\u7406\u5b58\u50a8\u7a7a\u95f4\u53ca\u4eba\u529b\u7ba1\u7406\u6210\u672c\u3002<\/span><\/p>\n

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

    \n
    \n
    \n
    \n
    \n
     eCTD\u5728\u56fd\u9645\u8303\u56f4\u7684\u5b9e\u65bd\u60c5\u51b5<\/span><\/section>\n<\/section>\n<\/section>\n
    \n
    <\/section>\n
    <\/section>\n<\/section>\n
    \n
    \n

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

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

    2000\u5e74ICH\u53d1\u5e03\u4e86CTD\u6307\u5357\uff0c\u8981\u6c42\u5728ICH\u6210\u5458\u56fd\u5185\uff0c\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u5fc5\u987b\u4f7f\u7528\u7edf\u4e00\u6807\u51c6\u30022003\u5e74\u53d1\u5e03\u7b2c\u4e00\u7248eCTD\u6307\u5357\uff0c\u63a8\u884c\u7533\u62a5\u8d44\u6599\u7684\u7535\u5b50\u63d0\u4ea4\u53ca\u5ba1\u8bc4\uff0c\u73b0\u5df2\u66f4\u65b0\u81f3V3.2.2\u7248\u672c\u3002\u622a\u81f3\u76ee\u524d\uff0c\u5df2\u5728\u7f8e\u56fd\u3001\u6b27\u76df\u3001\u65e5\u672c\u3001\u52a0\u62ff\u5927\u548c\u6fb3\u5927\u5229\u4e9a\u7b4940\u591a\u4e2a\u56fd\u5bb6\/\u5730\u533a\u5b9e\u65bd\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    \u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08Food and Drug Administration\uff0cFDA\uff09\u4e8e2003\u5e74\u5f00\u59cb\u4f7f\u7528CTD\uff0c2008\u5e74\u5c06eCTD\u4f5c\u4e3a\u552f\u4e00\u7684\u7533\u62a5\u8d44\u6599\u7535\u5b50\u63d0\u4ea4\u65b9\u5f0f\u30022017\u5e745\u67085\u65e5\u8d77\uff0cFDA\u5f3a\u5236\u8981\u6c42\u65b0\u836f\u3001\u4eff\u5236\u836f\u3001\u751f\u7269\u5236\u54c1\u4e0a\u5e02\u7533\u8bf7\u548c\u4e3b\u63a7\u6587\u6863\u5b9e\u65bdeCTD\u7533\u62a5\uff1b2018\u5e745\u67085\u65e5\u8d77\uff0c\u5f3a\u5236\u8981\u6c42\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u5b9e\u65bdeCTD\u7533\u62a5\u3002FDA\u57282014\u5e74\u5e95\u7edf\u8ba1\u7684\u6570\u636e\u663e\u793a\uff0c\u8d85\u8fc780%\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u62a5\u8d44\u6599\u662f\u4ee5eCTD\u63d0\u4ea4\u7684\uff0c\u5728\u4e3b\u63a7\u6587\u6863\u7684\u53ef\u5f15\u7528\u5217\u8868\u4e2d\u8d85\u8fc750%\u7684\u4e3b\u63a7\u6587\u6863\u4ee5eCTD\u7684\u5f62\u5f0f\u5b58\u5728\u3002<\/span><\/p>\n


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

    \u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08european medicines agency\uff0cEMA\uff09\u57282004\u5e74\u5f00\u59cb\u8bd5\u884cCTD\uff0c\u4ece2008\u5e747\u6708\u8d77\u4ec5\u63a5\u6536\u7535\u5b50\u7533\u62a5\u8d44\u6599\uff1b2010\u5e74\u8d77\uff0c\u96c6\u4e2d\u5ba1\u8bc4\u7a0b\u5e8f\u7684\u7533\u8bf7\u5f3a\u5236\u8981\u6c42\u4f7f\u7528eCTD\u30022015\u5e743\u670813\u65e5\uff0cEMA\u51fa\u53f0\u4e86\u7535\u5b50\u63d0\u4ea4\u7684\u65f6\u95f4\u8868\uff0c\u63a8\u8fdb\u836f\u54c1\u6ce8\u518c\u7684\u7535\u5b50\u5316\uff0c\u8981\u6c42\u57282015\u5e74\u7b2c\u4e09\u5b63\u5ea6\uff0c\u975e\u96c6\u4e2d\u5ba1\u6279\u7a0b\u5e8f\u7684\u7533\u8bf7\u5fc5\u987b\u4ee5eCTD\u63d0\u4ea4\uff1b\u57282017\u5e74\u7b2c\u4e00\u5b63\u5ea6\uff0c\u4e92\u8ba4\u7a0b\u5e8f\u7684\u7533\u8bf7\u5fc5\u987b\u4ee5eCTD\u63d0\u4ea4\uff1b\u57282018\u5e74\u7b2c\u4e00\u5b63\u5ea6\uff0c\u6240\u6709\u7684\u6ce8\u518c\u7a0b\u5e8f\u90fd\u5fc5\u987b\u4ee5eCTD\u63d0\u4ea4\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    \u65e5\u672c\u539a\u751f\u7701\uff08Ministry of Health,Labour and Welfare\uff09\u4ece2001\u5e74\u5f00\u59cb\u8981\u6c42\u4f7f\u7528CTD\uff0c2004\u5e74\u5f00\u59cb\u4f7f\u7528eCTD\uff0c\u4f46\u63a8\u5e7f\u8f83\u6162\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    \u52a0\u62ff\u5927\u536b\u751f\u90e8\uff08Health Canada\uff09\u57282017\u5e744\u670824\u65e5\u53d1\u5e03\u901a\u77e5\uff0c\u8981\u6c42\u4ece2018\u5e741\u67081\u65e5\u8d77\uff0c\u4eba\u7528\u836f\u54c1\u7533\u8bf7\u7c7b\u578b\u4ee5\u53ca\u6240\u6709\u8ffd\u52a0\u4fe1\u606f\u3001\u540e\u7eed\u7684\u7533\u8bf7\/\u4e8b\u52a1\uff08\u836f\u54c1\u7533\u8bf7\u6587\u4ef6\u6307\u5357\u4e2d\u7b2c1.3\u8282\uff09\u5fc5\u987b\u4ee5eCTD\u5f62\u5f0f\u63d0\u4ea4\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    \u9664\u4e0a\u8ff0\u56fd\u5bb6\u5916\uff0c\u4e0d\u5c11\u56fd\u5bb6\u548c\u5730\u533a\u6b63\u91c7\u53d6\u5168\u9762\u6216\u90e8\u5206\u5b9e\u73b0eCTD\u9012\u4ea4\uff0c\u5982\u745e\u58eb\u3001\u6c99\u7279\u963f\u62c9\u4f2f\u3001\u5357\u975e\u3001\u6fb3\u5927\u5229\u4e9a\u3001\u65b0\u897f\u5170\u548c\u6cf0\u56fd\u7b49\u56fd\u5bb6\u3002<\/span><\/p>\n


    <\/p>\n

    \n
    \n
    \n
    \n
    \n
    \u6211\u56fdeCTD\u5b9e\u65bd\u60c5\u51b5\u53ca\u9762\u4e34\u7684\u6311\u6218<\/span><\/section>\n<\/section>\n<\/section>\n
    \n
    <\/section>\n
    <\/section>\n<\/section>\n
    \n
    \n
    3.1 \u6211\u56fdeCTD\u5b9e\u65bd\u60c5\u51b5<\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n

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

    \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff08China Food and Drug Administration\uff0cCFDA\uff09\u57282010\u5e749\u6708\u53d1\u5e03\u901a\u77e5\uff0c\u6309\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef62\u4e2d\u5316\u5b66\u836f\u54c1\u6ce8\u518c\u5206\u7c7b3\u30014\u30015\u548c6\u7684\u751f\u4ea7\u6ce8\u518c\u7533\u8bf7\u7684\u836f\u5b66\u90e8\u5206\u7533\u62a5\u8d44\u6599\uff0c\u53ef\u53c2\u7167CFDA\u5728ICH\u901a\u7528\u6280\u672f\u6587\u6863\u57fa\u7840\u4e0a\u5236\u5b9a\u7684\u300a\u5316\u5b66\u836f\u54c1CTD\u683c\u5f0f\u7533\u62a5\u8d44\u6599\u64b0\u5199\u8981\u6c42\u300b\u683c\u5f0f\u6574\u7406\u63d0\u4ea4\uff0c\u540c\u65f6\u63d0\u4ea4\u7535\u5b50\u7248\u30022011\u5e746\u6708\uff0cCFDA\u5370\u53d1\u300a\u5316\u5b66\u836f\u836f\u5b66\u8d44\u6599CTD\u683c\u5f0f\u7535\u5b50\u6587\u6863\u6807\u51c6\uff08\u8bd5\u884c\uff09\u300b\u548c\u300a\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u7684\u4f53\u4f8b\u4e0e\u6574\u7406\u89c4\u8303\u300b\uff0c\u8981\u6c42\u5404\u7701\u3001\u81ea\u6cbb\u533a\u3001\u76f4\u8f96\u5e02\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff09\u4ee5\u53ca\u603b\u540e\u52e4\u90e8\u536b\u751f\u90e8\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u9075\u7167\u6267\u884c\u30022017\u5e743\u6708\uff0cCFDA\u63d0\u51fa2017\u5e74\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u5de5\u4f5c\u5c06\u7ee7\u7eed\u6309\u7167\u56fd\u52a1\u9662\u300a\u5173\u4e8e\u6539\u9769\u836f\u54c1\u533b\u7597\u5668\u68b0\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u7684\u610f\u89c1\u300b\u7684\u8981\u6c42\uff0c\u7ee7\u7eed\u4ee5\u63d0\u9ad8\u836f\u54c1\u8d28\u91cf\u4e3a\u6838\u5fc3\uff0c\u4ee5\u63d0\u9ad8\u5ba1\u8bc4\u6548\u7387\u548c\u6c34\u5e73\u4e3a\u91cd\u70b9\uff0c\u4ee5\u9f13\u52b1\u521b\u65b0\u4e3a\u5bfc\u5411\u5927\u529b\u63a8\u8fdb\u836f\u54c1\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u5de5\u4f5c\uff0c\u91cd\u70b9\u505a\u597d\u6539\u9769\u53d7\u7406\u6a21\u5f0f\uff0c\u52a0\u5feb\u63a8\u8fdbeCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u5efa\u8bbe\uff0c\u9010\u6b65\u5b9e\u73b0\u5316\u5b66\u4eff\u5236\u836f\u7684\u7f51\u4e0a\u96c6\u4e2d\u7533\u62a5\u7b49\u51e0\u9879\u5de5\u4f5c\u3002\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u6b63\u52a0\u5feb\u63a8\u8fdbeCTD\u4f53\u7cfb\u5efa\u8bbe\uff0c\u76ee\u524d\u5df2\u5b8c\u6210\u56fd\u9645eCTD\u6307\u5bfc\u539f\u5219\u53ca\u6280\u672f\u89c4\u8303\u7814\u7a76\u548ceCTD\u7cfb\u7edf\u5efa\u8bbe\u60c5\u51b5\u8c03\u7814\uff0c\u5236\u5b9a\u4e86\u6211\u56fdCTD\u683c\u5f0f\u5185\u5bb9\u8981\u6c42\u53ca\u6307\u5bfc\u539f\u5219\uff0c\u73b0\u5df2\u5c06\u300a\u836f\u54c1\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\u7ed3\u6784\u300b\u548c\u300a\u5316\u5b66\u4eff\u5236\u836f\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\u7533\u62a5\u6307\u5bfc\u539f\u5219\u300b\u518d\u6b21\u516c\u5f00\u5f81\u6c42\u610f\u89c1\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    3.2 \u6211\u56fdeCTD\u5b9e\u65bd\u6311\u6218<\/span><\/p>\n


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

    1\uff09\u4e00\u65e6\u56fd\u5bb6\u51fa\u53f0\u76f8\u5173\u89c4\u5b9a\uff0c\u5c06eCTD\u4f5c\u4e3a\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u7684\u552f\u4e00\u65b9\u5f0f\uff0c\u4e0d\u518d\u9700\u8981\u63d0\u4ea4\u7eb8\u8d28\u7248\u8d44\u6599\u5b58\u6863\uff0c\u7535\u5b50\u7248\u7533\u62a5\u8d44\u6599\u5373\u5177\u5907\u5408\u6cd5\u6027\u3002eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u5e94\u5efa\u8bbe\u914d\u5957\u7684\u5b89\u5168\u4f53\u7cfb\uff0c\u4f8b\u5982\u5bf9\u5404\u7533\u62a5\u4eba\u8fdb\u884c\u552f\u4e00\u7684\u8eab\u4efd\u8ba4\u8bc1\uff0c\u5bf9\u7533\u62a5\u4eba\u5728\u63d0\u4ea4\u548c\u4fee\u6539\u7533\u62a5\u8d44\u6599\u3001\u5ba1\u8bc4\u4eba\u5458\u5728\u5ba1\u8bc4\u8d44\u6599\u65f6\u7684\u6bcf\u4e00\u6b65\u64cd\u4f5c\u7559\u75d5\uff0c\u9632\u7be1\u6539\u3001\u9632\u62b5\u8d56\u7b49\uff0c\u4ee5\u786e\u4fdd\u5404\u7533\u62a5\u4eba\u901a\u8fc7eCTD\u63d0\u4ea4\u7533\u62a5\u8d44\u6599\u7684\u5b89\u5168\u548c\u771f\u5b9e\uff0c\u4e0d\u88ab\u4ed6\u4eba\u4fee\u6539\u548c\u7a83\u53d6\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    2\uff09\u76ee\u524d\u901a\u884c\u7684\u5411eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u63d0\u4ea4\u7533\u62a5\u8d44\u6599\u65b9\u5f0f\u6709\u4e24\u79cd\u2014\u2014\u5728\u7ebf\u63d0\u4ea4\u548c\u5149\u76d8\u63d0\u4ea4\u3002\u5728\u7ebf\u63d0\u4ea4\u65b9\u5f0f\u8981\u6c42eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u5bf9\u6bcf\u4e2a\u7533\u62a5\u4eba\u8fdb\u884c\u5f3a\u884c\u8eab\u4efd\u8ba4\u8bc1\uff0c\u5bf9\u63d0\u4ea4\u6750\u6599\u8fdb\u884c\u5b89\u5168\u9a8c\u8bc1\u3002\u5927\u5bb9\u91cf\u7684\u7535\u5b50\u6587\u6863\u5728\u7ebf\u63d0\u4ea4\uff0c\u5bf9\u4e8e\u6211\u56fd\u76ee\u524d\u7684\u7f51\u7edc\u57fa\u7840\u6761\u4ef6\u800c\u8a00\uff0c\u63d0\u4ea4\u7684\u96be\u5ea6\u8f83\u5927\u3002\u6b64\u5916\uff0c\u7535\u5b50\u7533\u62a5\u8d44\u6599\u6587\u4ef6\u8f83\u5927\uff0c\u5bf9\u7cfb\u7edf\u5b58\u50a8\u8981\u6c42\u9ad8\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    3\uff09\u73b0\u6709eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u4e2d\u4fe1\u606f\u6d41\u7684\u4f20\u9012\u662f\u5355\u5411\u7684\uff0c\u4ece\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u4eba\u4f20\u9012\u5230\u836f\u54c1\u76d1\u7ba1\u673a\u6784\uff0c\u800c\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u4f20\u9012\u7ed9\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u4eba\u7684\u4fe1\u606f\u6d41\uff08\u4f8b\u5982\u5bf9\u6ce8\u518c\u8d44\u6599\u7684\u7591\u95ee\u3001\u6ce8\u518c\u8d44\u6599\u8865\u5145\u7b49\uff09\u9700\u8981\u901a\u8fc7\u5176\u4ed6\u9014\u5f84\uff08\u4f8b\u5982\u7535\u8bdd\u3001\u4f20\u771f\u3001\u7535\u90ae\u7b49\uff09\u6765\u5b8c\u6210\u3002\u4ece\u53d1\u5c55\u8d8b\u52bf\u6765\u770b\uff0c\u4fe1\u606f\u7684\u4f20\u9012\u4e5f\u5e94\u53cc\u5411\u53d1\u5c55\uff0c\u5728\u8fdb\u884ceCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u8bbe\u8ba1\u65f6\u5e94\u6ce8\u91cd\u4fe1\u606f\u6d41\u7684\u53cc\u5411\u4f20\u9012\uff0c\u5373\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u7684\u610f\u89c1\u56de\u590d\u3001\u53d1\u8865\u8981\u6c42\u7b49\u4e5f\u5e94\u8be5\u901a\u8fc7\u7535\u5b50\u901a\u9053\u6765\u5b8c\u6210\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    4\uff09CFDA\u57282016\u5e748\u6708\u53d1\u5e03\u516c\u544a\uff0c\u8981\u6c42\u5c06\u76f4\u63a5\u63a5\u89e6\u836f\u54c1\u7684\u5305\u88c5\u6750\u6599\u548c\u5bb9\u5668\u3001\u836f\u7528\u8f85\u6599\u7531\u5355\u72ec\u5ba1\u6279\u6539\u4e3a\u5728\u5ba1\u6279\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u65f6\u4e00\u5e76\u5ba1\u8bc4\u5ba1\u6279\u3002\u4ece\u7cfb\u7edf\u8bbe\u8ba1\u5f00\u53d1\u89d2\u5ea6\u770b\uff0c\u5982\u4f55\u5c06eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u4e2d\u539f\u8f85\u6599\u76f8\u5173\u6570\u636e\u4e0e\u836f\u54c1\u6ce8\u518c\u6570\u636e\u4fe1\u606f\u8fdb\u884c\u5173\u8054\uff0c\u662f\u4e00\u4e2a\u96be\u70b9\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    5\uff09\u4e2d\u836f\u5236\u5242\u4f5c\u4e3a\u6211\u56fd\u7684\u7279\u8272\uff0c\u5728\u56fd\u5185\u5236\u5242\u5e02\u573a\u5360\u6709\u5f88\u5927\u6bd4\u91cd\uff0c\u76ee\u524d\u6211\u56fd\u4ece\u5316\u836f\u4eff\u5236\u836f\u5f00\u59cb\u8bd5\u884ceCTD\uff0c\u4eca\u540e\u52bf\u5fc5\u5c06\u63a8\u5e7f\u5230\u4e2d\u836f\u5236\u5242\u7684\u6ce8\u518c\u7533\u62a5\u3002\u4e3a\u4e86\u80fd\u66f4\u597d\u5730\u628a\u4e2d\u836f\u5236\u5242\u63a8\u5e7f\u5230\u56fd\u5916\uff0c\u9002\u5e94\u5168\u7403\u901a\u884c\u7684eCTD\u7533\u62a5\u65b9\u5f0f\uff0c\u5bf9\u5236\u836f\u4f01\u4e1a\u6765\u8bf4\uff0c\u5e94\u8be5\u4e25\u683c\u6309\u7167CTD\u5bf9\u7533\u62a5\u8d44\u6599\u5185\u5bb9\u7684\u8981\u6c42\uff0c\u63d0\u9ad8\u7533\u62a5\u6750\u6599\u7684\u8d28\u91cf\uff1b\u800c\u76d1\u7ba1\u90e8\u95e8\uff0c\u9700\u8981\u5c3d\u65e9\u5bf9\u4e2d\u836f\u5236\u5242\u6ce8\u518ceCTD\u7533\u62a5\u505a\u597d\u653f\u7b56\u7814\u7a76\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    6\uff09\u4ee5eCTD\u5f62\u5f0f\u63d0\u4ea4\u7684\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u8981\u6c42\u8f83\u9ad8\uff0c\u5236\u4f5c\u96be\u5ea6\u5927\uff0c\u6211\u56fd\u521a\u5f00\u59cb\u8bd5\u884c\uff0c\u719f\u6089\u6b64\u9879\u5de5\u4f5c\u7684\u4e13\u4e1a\u4eba\u5458\u6570\u91cf\u8f83\u5c11\uff0c\u5982\u4f55\u5236\u4f5c\u51fa\u80fd\u591f\u987a\u5229\u901a\u8fc7eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u9a8c\u8bc1\u7684\u7533\u62a5\u8d44\u6599\u9700\u8981\u5927\u91cf\u57f9\u8bad\u53ca\u5b9e\u8df5\u3002\u53e6\u4e00\u65b9\u9762\uff0c\u5bf9\u4e8e\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u7684\u5ba1\u8bc4\u4eba\u5458\u6765\u8bf4\uff0c\u719f\u7ec3\u5229\u7528eCTD\u4fe1\u606f\u5316\u7cfb\u7edf\u6765\u8fdb\u884c\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u7684\u5ba1\u8bc4\u4e5f\u79bb\u4e0d\u5f00\u5927\u91cf\u7684\u57f9\u8bad\u548c\u5b9e\u8df5\u3002<\/span><\/p>\n

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

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

    4. \u7ed3\u8bed<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

    eCTD\u4f5c\u4e3a\u4e00\u79cd\u5148\u8fdb\u7684\u3001\u683c\u5f0f\u5316\u7684\u836f\u54c1\u6ce8\u518c\u4e8b\u52a1\u7533\u8bf7\u6807\u51c6\uff0c\u53ef\u4ee5\u6781\u5927\u5730\u51cf\u5c11\u7533\u8bf7\u8005\u4e0e\u5ba1\u8bc4\u8005\u7684\u5de5\u4f5c\u91cf\uff0c\u5e76\u663e\u8457\u63d0\u9ad8\u533b\u836f\u4f01\u4e1a\u548c\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u4e4b\u95f4\u7684\u6570\u636e\u4ea4\u6362\u6548\u7387\uff0c\u52a0\u5feb\u836f\u54c1\u6ce8\u518c\u5ba1\u6279\u901f\u5ea6\uff0c\u5df2\u7ecf\u88ab\u8d8a\u6765\u8d8a\u591a\u56fd\u5bb6\u7684\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u6240\u63a5\u53d7\uff0c\u8fd9\u7ed9\u836f\u54c1\u6ce8\u518c\uff0c\u5c24\u5176\u662f\u65b0\u836f\u5f00\u53d1\u5de5\u4f5c\u5e26\u6765\u4e86\u5de8\u5927\u7684\u4fc3\u8fdb\u548c\u53d8\u9769\u3002\u6211\u56fd\u5982\u4f55\u987a\u5229\u5b9e\u65bdeCTD\uff0c\u5bf9\u4e8e\u533b\u836f\u884c\u4e1a\u548c\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u6765\u8bf4\u65e2\u662f\u673a\u9047\u4e5f\u662f\u6311\u6218\u3002<\/span><\/p>\n

    \n
    \n
    \n
    \n
    <\/figure>\n
    \n
    \n

    \u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e66\u4e2d\u516c2017\u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8d44\u683c\u8003\u8bd5\u8f85\u5bfc\u7528\u4e66\u836f\u4e8b\u7ba1\u7406\u4e0e\u6cd5\u89c4\u8003\u524d\u63d0\u5206\u5bc6\u62bc\u5377<\/h2>\n

    \u4f5c\u8005\uff1a\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7814\u7a76\u4e2d\u5fc3<\/p>\n<\/p><\/div>\n

    \n
    <\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

    <\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n


    <\/section>\n

    \n
    \n
    \n
    \n
    <\/figure>\n
    \n
    \n

    \u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e66\u4e2d\u516c2017\u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8d44\u683c\u8003\u8bd5\u8f85\u5bfc\u7528\u4e66\u836f\u5b66\u4e13\u4e1a\u77e5\u8bc6\u4e8c\u8003\u524d\u63d0\u5206\u5bc6\u62bc\u5377<\/h2>\n

    \u4f5c\u8005\uff1a\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7814\u7a76\u4e2d\u5fc3<\/p>\n<\/p><\/div>\n

    \n
    <\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

    <\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n

    \n
    \n
    \n
    \n
    <\/figure>\n
    \n
    \n

    \u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e66\u4e2d\u516c2017\u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8d44\u683c\u8003\u8bd5\u8f85\u5bfc\u7528\u4e66\u836f\u5b66\u4e13\u4e1a\u77e5\u8bc6\u4e00\u8003\u524d\u63d0\u5206\u5bc6\u62bc\u5377<\/h2>\n

    \u4f5c\u8005\uff1a\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7814\u7a76\u4e2d\u5fc3<\/p>\n<\/p><\/div>\n

    \n
    <\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

    <\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

    \n

    \u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u5236\u836f\u5de5\u7a0b\u8bba\u575b <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    \u4e2d\u56fd\u4eff\u5236\u836f\u84dd\u76ae\u4e66 \u4f5c\u8005\uff1a\u4e2d\u56fd\u533b\u5b66\u79d1\u5b66\u9662\u836f\u7269\u7814\u7a76\u6240\u3001\u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u4fe1\u606f\u4e2d\u5fc3\u3001\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u6240\u7f16 \u5f53\u5f53 \u5e7f\u544a […]<\/p>\n","protected":false},"author":1,"featured_media":12791,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12790"}],"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=12790"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12790\/revisions"}],"predecessor-version":[{"id":12796,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12790\/revisions\/12796"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/12791"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=12790"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=12790"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=12790"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}