{"id":12962,"date":"2023-06-06T09:14:03","date_gmt":"2023-06-06T07:14:03","guid":{"rendered":"https:\/\/www.sciencepharma.com\/services\/medical-writing-preparation-of-registration-dossier\/"},"modified":"2025-02-20T11:22:18","modified_gmt":"2025-02-20T10:22:18","slug":"medical-writing-preparation-of-registration-dossier","status":"publish","type":"pharmacovigilance","link":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/","title":{"rendered":"\u533b\u5b66\u5199\u4f5c – \u6ce8\u518c\u6863\u6848\u51c6\u5907"},"content":{"rendered":"\n

\u533b\u5b66\u5199\u4f5c – \u6ce8\u518c\u6863\u6848\u51c6\u5907<\/h1>\n\n\n\n

\u9ad8\u8d28\u91cf\u7684\u533b\u5b66\u5199\u4f5c\u5728\u836f\u54c1\u6ce8\u518c\u7684\u6210\u529f\u4e2d\u8d77\u7740\u91cd\u8981\u4f5c\u7528\u3002\u5b83\u53ef\u4ee5\u964d\u4f4e\u76d1\u7ba1\u98ce\u9669\uff0c\u4ece\u800c\u5e2e\u52a9\u6ee1\u8db3\u9879\u76ee\u7684\u65f6\u95f4\u8868\u548c\u9884\u7b97\u3002\u56e0\u6b64\uff0c\u5982\u679c\u60a8\u6253\u7b97\u6ce8\u518c\u836f\u54c1\u6216\u5df2\u7ecf\u6536\u5230\u4e86\u4e3b\u7ba1\u90e8\u95e8\u7684\u7f3a\u9677\u4fe1\uff0c\u8bf7\u8ba9\u6211\u4eec\u6765\u5e2e\u52a9\u60a8\u3002<\/p>\n\n\n\n

<\/div>\n\n\n\n

\u4ec0\u4e48\u662f\u533b\u5b66\u5199\u4f5c\uff1f<\/h2>\n\n\n

\u5236\u836f\u884c\u4e1a\u7684\u533b\u5b66\u5199\u4f5c\u662f\u4e00\u4e2a\u5e7f\u6cdb\u7684\u672f\u8bed\uff0c\u6db5\u76d6\u4e86\u591a\u4e2a\u5c42\u6b21\u7684\u5199\u4f5c\u670d\u52a1\uff0c\u65e8\u5728\uff08\u4f46\u4e0d\u9650\u4e8e\uff09\u4e3a\u836f\u54c1\u5ba1\u6279\u51c6\u5907\u63d0\u4ea4\u7ed9\u4e3b\u7ba1\u90e8\u95e8\uff08\u76d1\u7ba1\u673a\u6784\uff09\u7684\u6863\u6848\u3002\u8fd9\u6d89\u53ca\u6ce8\u518c\u6863\u6848\u7684\u6574\u4e2a\u533b\u5b66\u90e8\u5206\u7684\u51c6\u5907\uff0c\u5305\u62ec\u4e0e\u975e\u4e34\u5e8a\u6570\u636e\u76f8\u5173\u7684\u90e8\u5206\uff08\u6a21\u57572.4 \u975e\u4e34\u5e8a\u6982\u8ff0\u3001\u6a21\u57572.6 \u975e\u4e34\u5e8a\u603b\u7ed3\u3001\u6a21\u57574 \u975e\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\uff09\u548c\u4e34\u5e8a\u6570\u636e\uff08\u6a21\u57572.5 \u4e34\u5e8a\u6982\u8ff0\u3001\u6a21\u57572.7 \u4e34\u5e8a\u603b\u7ed3\u3001\u6a21\u57575 \u4e34\u5e8a\u7814\u7a76\u62a5\u544a\uff09\uff0c\u5e76\u6839\u636e\u4e0d\u540c\u7c7b\u578b\u7533\u8bf7\u7684\u5177\u4f53\u8981\u6c42\u800c\u6709\u6240\u4e0d\u540c\uff08\u4f8b\u5982\uff0c\u6a21\u57571.5.1 \u6587\u732e\u7533\u8bf7\u7684\u4fe1\u606f\u30011.5.2 \u901a\u7528\u836f\u7269\u3001\u2018\u6df7\u5408\u578b\u2019\u6216\u751f\u7269\u7c7b\u4f3c\u836f\u7533\u8bf7\u7684\u4fe1\u606f\u30011.5.3\uff08\u6269\u5c55\uff09\u6570\u636e\/\u5e02\u573a\u72ec\u5360\u6743\uff09\u3002\u6b64\u5916\uff0c\u533b\u5b66\u5199\u4f5c\u670d\u52a1\u4e0d\u4ec5\u9650\u4e8e\u6863\u6848\u51c6\u5907\uff0c\u8fd8\u5305\u62ec\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u64b0\u5199\u6587\u4ef6\uff0c\u5982\u4e34\u5e8a\u7814\u7a76\u534f\u8bae\u3001\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\u3001\u53d7\u8bd5\u8005\u77e5\u60c5\u540c\u610f\u4e66\u548c\u7814\u7a76\u8005\u624b\u518c\u3002<\/p>\n\n\n

<\/div>\n\n\n\n

\u533b\u5b66\u5199\u4f5c\u5916\u5305<\/h2>\n\n\n\n
\n
\n

\u4e0d\u5f53\u7684\u836f\u54c1\u6863\u6848\u5185\u5bb9\u548c\/\u6216\u683c\u5f0f\u4f1a\u5bfc\u81f4\u4e3b\u7ba1\u90e8\u95e8\u7684\u6307\u63a7\uff0c\u4ece\u800c\u5bfc\u81f4\u9879\u76ee\u65f6\u95f4\u8868\u548c\u9884\u7b97\u51fa\u73b0\u95ee\u9898\u3002\u5e94\u5bf9\u6b27\u76df\u53ca\u975e\u6b27\u76df\u56fd\u5bb6\u4e3b\u7ba1\u90e8\u95e8\u7684\u8981\u6c42\u662f\u4e00\u9879\u6311\u6218\uff0c\u9700\u8981\u4e30\u5bcc\u7684\u77e5\u8bc6\u3001\u7ecf\u9a8c\u548c\u4e2a\u6027\u5316\u7684\u5904\u7406\u65b9\u5f0f\u3002\u65e0\u8bba\u9700\u8981\u63cf\u8ff0\u7684\u6570\u636e\u8303\u56f4\u5982\u4f55\uff0c\u5236\u836f\u516c\u53f8\uff08\u5e02\u573a\u6388\u6743\u6301\u6709\u8005\uff0cMAHs\uff09\u901a\u5e38\u4f1a\u5c06\u533b\u5b66\u5199\u4f5c\uff08\u5373\u6863\u6848\u51c6\u5907\uff09\u5916\u5305\u7ed9\u4e13\u4e1a\u7684\u5916\u90e8\u516c\u53f8\u3002<\/p>\n<\/div>\n\n\n\n

\n
\"A<\/figure>\n<\/div><\/div>\n<\/div>\n\n\n\n
<\/div>\n\n\n\n

\u836f\u54c1\u6863\u6848 – \u51c6\u5907\u5145\u5206\uff0c\u5bb9\u6613\u83b7\u6279<\/h2>\n\n\n\n

\u5728SciencePharma\uff0c\u6211\u4eec\u63d0\u4f9b\u5168\u9762\u3001\u53ef\u9760\u3001\u8be6\u7ec6\u7684\u533b\u5b66\u5199\u4f5c\u670d\u52a1\uff0c\u7531\u5177\u6709\u76f8\u5173\u4e13\u4e1a\u6559\u80b2\u80cc\u666f\u548c\u4e30\u5bcc\u7ecf\u9a8c\u7684\u4e13\u5bb6\u8fdb\u884c\u3002\u6211\u4eec\u5728\u51c6\u5907\u836f\u54c1\u6863\u6848\u65f6\uff0c\u5145\u5206\u8003\u8651\u5230\u6700\u65b0\u7684\u5f53\u5730\u8981\u6c42\u4ee5\u53ca\u6b27\u76df\u5185\u90e8\u7684\u6807\u51c6\uff08\u53c2\u89c1\u6b27\u76df\u59d4\u5458\u4f1a\u4e3a\u6ee1\u8db3\u300a\u6b27\u6d32\u6cd5\u89c4\uff08EC\uff09\u7b2c726\/2004\u53f7\u300b\u7b2c6\u6761\u800c\u51c6\u5907\u7684\u300a\u7533\u8bf7\u8005\u901a\u77e5\u300b\uff08NTA\u7b2c2B\u5377\uff09\u548c\u300a\u6307\u4ee42001\/83\/EC\u300b\u9644\u5f55I\uff09\uff0c\u4ee5\u53ca\u6b27\u76df\u4ee5\u5916\u7684\u8981\u6c42\u3002\u540c\u6837\uff0c\u5728\u533b\u5b66\u5199\u4f5c\u670d\u52a1\u65b9\u9762\uff0c\u5982\u51c6\u5907\u4e34\u5e8a\u8bd5\u9a8c\u62a5\u544a\u548c\u65b9\u6848\u65f6\uff0c\u6211\u4eec\u4e5f\u9075\u5faa\u8be5\u9886\u57df\u7684\u73b0\u884c\u6307\u5357\uff0c\u4f8b\u5982CPMP\/ICH\/137\/95\u300a\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\u7ed3\u6784\u548c\u5185\u5bb9\u6307\u5bfc\u8bf4\u660e\u300b\u3002<\/p>\n\n\n\n

<\/div>\n\n\n\n
\n
\n

\u6211\u4eec\u5728\u4e0d\u540c\u5730\u533a\uff08\u4f8b\u5982\u6b27\u6d32\u7ecf\u6d4e\u533a\uff08EEA\uff09\u3001\u6b27\u4e9a\u7ecf\u6d4e\u8054\u76df\uff08EAEU\uff09\u3001\u4e2d\u4e1c\u548c\u5317\u975e\uff08MENA\uff09\u3001\u7f8e\u56fd\u3001\u52a0\u62ff\u5927\u3001\u82f1\u56fd\u4ee5\u53ca\u5176\u4ed6\u7b2c\u4e09\u56fd\uff09\u63d0\u4f9b\u533b\u5b66\u5199\u4f5c\u670d\u52a1\u65b9\u9762\u62e5\u6709\u4e30\u5bcc\u7684\u7ecf\u9a8c\u2014\u2014\u6211\u4eec\u5df2\u7ecf\u4e3a\u836f\u54c1\u51c6\u5907\u4e86\u8d85\u8fc7500\u4efd\u6587\u6863\uff0c\u719f\u6089\u4e0d\u540c\u56fd\u5bb6\u4e3b\u7ba1\u673a\u6784\u7684\u8981\u6c42\u548c\u671f\u671b\u3002<\/p>\n<\/div>\n\n\n\n

\n
\"Close-up<\/figure>\n<\/div><\/div>\n<\/div>\n\n\n

\u57fa\u4e8e\u5ba2\u6237\u63d0\u4f9b\u7684\u6570\u636e\uff08\u5373\u5316\u5b66\u548c\u836f\u7269\u6570\u636e\u3001\u81ea\u8eab\u7814\u7a76\u7ed3\u679c\uff09\u4ee5\u53ca\u5df2\u53d1\u8868\u7684\u6587\u732e\uff0c\u6211\u4eec\u53ef\u4ee5\u51c6\u5907\u5b8c\u6574\u7684\u836f\u54c1\u6587\u6863\uff0c\u91c7\u7528\u9002\u5f53\u7684\u683c\u5f0f\uff0c\u7f16\u5236eCTD\u5e8f\u5217\u5e76\u5c06\u6587\u6863\u63d0\u4ea4\u7ed9\u4e3b\u7ba1\u673a\u6784\u3002\u5728\u533b\u5b66\u5199\u4f5c\u670d\u52a1\u4e2d\uff0c\u6211\u4eec\u53ef\u4ee5\u51c6\u5907\u836f\u54c1\u6587\u6863\u7684\u975e\u4e34\u5e8a\u548c\u4e34\u5e8a\u90e8\u5206\u3002\u6211\u4eec\u4e30\u5bcc\u7684\u7ecf\u9a8c\u6765\u81ea\u591a\u5e74\u4e3a\u5404\u79cd\u4f18\u79c0\u4ea7\u54c1\u63d0\u4f9b\u533b\u5b66\u5199\u4f5c\u670d\u52a1\uff1a<\/p>\n\n\n

    \n
  • \u5e26\u6709\u751f\u7269\u7b49\u6548\u6027\uff08BE\uff09\u7814\u7a76\u7684\u4eff\u5236\u836f\u53ca\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u8c41\u514d\u62a5\u544a<\/li>\n\n\n\n
  • \u590d\u6742\u4eff\u5236\u836f<\/li>\n\n\n\n
  • \u56fa\u5b9a\u5242\u91cf\u7ec4\u5408\u836f\u54c1\uff08FDC\uff09<\/li>\n\n\n\n
  • \u8349\u836f\u836f\u54c1<\/li>\n\n\n\n
  • \u7ecf\u8fc7\u826f\u597d\u4f7f\u7528\uff08WEU\uff09\u7684\u836f\u54c1\uff08\u5355\u6210\u5206\u548c\u591a\u6210\u5206\u5747\u53ef\uff09<\/li>\n\n\n\n
  • \u751f\u7269\u836f\u54c1\uff08\u5305\u62ec\u751f\u7269\u7c7b\u4f3c\u836f\uff09<\/li>\n\n\n\n
  • \u539f\u521b\u836f<\/li>\n<\/ul>\n\n\n\n
    <\/div>\n\n\n\n
    \"Close-up<\/figure>\n\n\n\n


    \u4e3a\u4ec0\u4e48\u5c06\u533b\u5b66\u5199\u4f5c\u5916\u5305\u7ed9SciencePharma\u66f4\u597d\uff1f\u60a8\u53ef\u4ee5\u907f\u514d\u54ea\u4e9b\u98ce\u9669\uff1f<\/h2>\n\n\n

    \u5728SciencePharma\uff0c\u533b\u5b66\u5199\u4f5c\u670d\u52a1\u7531\u9ad8\u5b66\u5386\u7684\u9876\u7ea7\u4e13\u5bb6\u63d0\u4f9b\uff0c\u4ed6\u4eec\u6765\u81ea\u836f\u5b66\u548c\u751f\u7269\u79d1\u5b66\u7684\u5404\u79cd\u79d1\u5b66\u80cc\u666f\uff08\u8bb8\u591a\u4eba\u62e5\u6709\u535a\u58eb\u5b66\u4f4d\uff09\uff0c\u5e76\u5728\u5b66\u672f\u9886\u57df\u548c\u5236\u836f\u884c\u4e1a\u79ef\u7d2f\u4e86\u4e30\u5bcc\u7684\u7ecf\u9a8c\u3002\u6211\u4eec\u5e7f\u6cdb\u7684\u5b9e\u8df5\u4f7f\u6211\u4eec\u80fd\u591f\u907f\u514d\u7f3a\u4e4f\u7ecf\u9a8c\u7684\u533b\u5b66\u4f5c\u5bb6\u6240\u9762\u4e34\u7684\u9677\u9631\uff0c\u4f8b\u5982\u4e0d\u6070\u5f53\u7684\u79d1\u5b66\u51fa\u7248\u7269\u548c\/\u6216\u6307\u5357\u7684\u9009\u62e9\u3001\u4e0d\u9002\u5f53\u7684\u81ea\u8eab\u7814\u7a76\u6570\u636e\u8303\u56f4\u6216\u9519\u8bef\u7684\u6570\u636e\u5448\u73b0\u65b9\u5f0f\uff0c\u4ee5\u53ca\u603b\u4f53\u4e0a\u6a21\u5757\u5185\u5bb9\u4e0eCTD\u683c\u5f0f\u7684\u4e0d\u5408\u89c4\u3002\u5728SciencePharma\uff0c\u6211\u4eec\u6df1\u77e5\u6570\u636e\u8d28\u91cf\u7684\u91cd\u8981\u6027\uff0c\u56e0\u6b64\u6211\u4eec\u4ed4\u7ec6\u641c\u7d22\u3001\u6709\u6548\u5206\u6790\u548c\u9009\u62e9\u6570\u636e\uff0c\u5e76\u63d0\u4f9b\u9002\u5f53\u7684\u8ba8\u8bba\u548c\u73b0\u6709\u6570\u636e\u7684\u6c47\u7f16\u3002<\/p>\n

    \u5bf9\u6211\u4eec\u800c\u8a00\uff0c\u5bf9\u4e00\u822c\u548c\u7279\u5b9a\u6d3b\u6027\u7269\u8d28\u6216\u75be\u75c5\u7279\u5b9a\u6307\u5357\u7684\u4e86\u89e3\u662f\u6b63\u786e\u8bc4\u4f30\u548c\u8ba8\u8bba\u53ef\u7528\u6570\u636e\u7684\u57fa\u672c\u95ee\u9898\u3002\u5c3d\u7ba1\u4e0d\u540c\u56fd\u5bb6\u7684\u7533\u8bf7\u6587\u4ef6\u7ed3\u6784\u53ef\u80fd\u76f8\u4f3c\uff0c\u4f46\u5404\u4e2a\u673a\u6784\u5728\u7279\u5b9a\u7269\u8d28\u6216\u7533\u8bf7\u7c7b\u578b\u7684\u6587\u4ef6\u5185\u5bb9\u65b9\u9762\u7684\u671f\u671b\u53ef\u80fd\u6709\u6240\u4e0d\u540c\u3002\u4e86\u89e3\u8fd9\u4e00\u70b9\u540e\uff0c\u6211\u4eec\u80fd\u591f\u4f18\u5316\u6587\u6863\u64b0\u5199\uff0c\u4ee5\u4fc3\u8fdb\u7279\u5b9a\u5e02\u573a\u4e0a\u4ea7\u54c1\u7684\u987a\u5229\u6ce8\u518c\u3002\u6211\u4eec\u5728\u8fd9\u4e00\u9886\u57df\u670d\u52a1\u9ad8\u6548\u7684\u8bc1\u660e\u662f\uff0c\u5173\u4e8e\u836f\u54c1\u6ce8\u518c\u6587\u6863\u7684\u533b\u5b66\u5199\u4f5c\u672c\u8eab\u7684\u6295\u8bc9\u7387\u8f83\u4f4e\u3002\u5982\u679c\u51fa\u73b0\u4efb\u4f55\u6295\u8bc9\uff0c\u6211\u4eec\u4f1a\u8fc5\u901f\u5904\u7406\uff0c\u4ee5\u907f\u514d\u6ce8\u518c\u8fc7\u7a0b\u7684\u5ef6\u8bef\u3002<\/p>\n\n\n

    <\/div>\n\n\n\n

    \u5408\u4f5c\u7684\u597d\u5904<\/h2>\n\n\n
    \n
    \""Close-up<\/figure>\n<\/div>\n\n

    \u611f\u8c22MED\u548cCMC\u90e8\u95e8\u62e5\u6709\u591a\u6837\u5316\u79d1\u5b66\u80cc\u666f\u7684\u4eba\u5458\uff08\u836f\u5242\u5e08\u3001\u751f\u7269\u5b66\u5bb6\u3001\u751f\u7269\u6280\u672f\u4e13\u5bb6\u3001\u5316\u5b66\u5bb6\uff09\uff0c\u6211\u4eec\u80fd\u591f\u4e3a\u836f\u54c1\u51c6\u5907\u5b8c\u6574\u7684\u6ce8\u518c\u6863\u6848\u3002\u5728\u6ce8\u518c\u4e8b\u52a1\u90e8\uff0c\u6211\u4eec\u53ef\u4ee5\u534f\u52a9\u5e02\u573a\u6388\u6743\u6301\u6709\u8005\u63d0\u4ea4\u6587\u4ef6\uff0c\u5e76\u5728\u540e\u7eed\u6b65\u9aa4\u4e2d\uff0c\u6211\u4eec\u7684\u836f\u7269\u8b66\u6212\u90e8\u95e8\u53ef\u4ee5\u4e3a\u6ce8\u518c\u7684\u836f\u54c1\u63d0\u4f9b\u836f\u7269\u8b66\u6212\u670d\u52a1\u3002\u5c06\u6240\u6709\u8fd9\u4e9b\u670d\u52a1\u96c6\u4e2d\u5728\u4e00\u4e2a\u5730\u65b9\u4ee5\u4e13\u5bb6\u6c34\u5e73\u5168\u9762\u63d0\u4f9b\uff0c\u4e0d\u662f\u5f88\u65b9\u4fbf\u5417\uff1f<\/p>\n\n\n

      \n
    • \u60a8\u60f3\u6ce8\u518c\u4e00\u79cd\u836f\u54c1\uff0c\u4f46\u4e0d\u77e5\u9053\u54ea\u4e9b\u6587\u4ef6\u662f\u5fc5\u9700\u7684\uff1f<\/li>\n\n\n\n
    • \u60f3\u51c6\u5907\u9ad8\u8d28\u91cf\u7684\u836f\u54c1\u6863\u6848\uff0c\u4f46\u4e0d\u77e5\u9053\u5982\u4f55\u5448\u73b0\u6570\u636e\u4ee5\u6ee1\u8db3\u76d1\u7ba1\u8981\u6c42\uff1f<\/li>\n\n\n\n
    • \u60f3\u51c6\u5907\u4e34\u5e8a\u8bd5\u9a8c\u7684\u65b9\u6848\u6216\u62a5\u544a\uff1f\u7814\u7a76\u8005\u624b\u518c\uff1f\u77e5\u60c5\u540c\u610f\u4e66\uff1f<\/li>\n\n\n\n
    • \u4e0d\u786e\u5b9a\u6863\u6848\u662f\u5426\u51c6\u5907\u59a5\u5f53\uff1f<\/li>\n<\/ul>\n\n\n

      \u5982\u679c\u8fd9\u4e9b\u95ee\u9898\u4e2d\u7684\u4efb\u4f55\u4e00\u4e2a\u51fa\u73b0\u5728\u60a8\u8111\u6d77\u4e2d\uff0c\u60a8\u521a\u521a\u627e\u5230\u4e00\u4e2a\u53ef\u9760\u7684\u5408\u4f5c\u4f19\u4f34\uff0c\u53ef\u4ee5\u4e3a\u60a8\u63d0\u4f9b\u5b8c\u5168\u7b26\u5408\u60a8\u671f\u671b\u7684\u89e3\u51b3\u65b9\u6848\u3002<\/p>\n\n\n

      \u7531\u4e8e\u533b\u5b66\u5199\u4f5c\u901a\u5e38\u4e0e\u5176\u4ed6\u670d\u52a1\u76f8\u5173\uff0c\u8bf7\u544a\u77e5\u6211\u4eec\u60a8\u662f\u5426\u9700\u8981\u4ee5\u4e0b\u65b9\u9762\u7684\u5e2e\u52a9\uff1a<\/p>\n\n\n\n

        \n
      • \u836f\u54c1\u6ce8\u518c\u53ef\u80fd\u6027\u7684\u5206\u6790\uff08\u5305\u62ec\u9009\u62e9\u6700\u4f73\u7533\u8bf7\u7c7b\u578b\uff09\uff0c<\/li>\n\n\n\n
      • \u5173\u4e8e\u5904\u65b9\u836f\u8f6c\u975e\u5904\u65b9\u836f\u7684\u53ef\u80fd\u6027\u7684\u610f\u89c1\uff0c<\/li>\n\n\n\n
      • \u4e0a\u5e02\u540e\u53d8\u66f4\uff08\u4f8b\u5982\uff0c\u589e\u52a0\u9002\u5e94\u75c7\uff0c\u5904\u65b9\u836f\u8f6c\u975e\u5904\u65b9\u836f\uff09\uff0c<\/li>\n\n\n\n
      • \u5df2\u51c6\u5907\u6863\u6848\u7684\u5dee\u8ddd\u5206\u6790\u6216\u5ba1\u6838\uff0c<\/li>\n\n\n\n
      • \u4e34\u5e8a\u8bd5\u9a8c\u7684\u89c4\u5212\u548c\u5b9e\u65bd\uff0c<\/li>\n\n\n\n
      • \u513f\u79d1\u7814\u7a76\u8ba1\u5212\uff08PIPs\uff09\u3002<\/li>\n<\/ul>\n\n\n\n

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

        \u533b\u5b66\u5199\u4f5c – \u6ce8\u518c\u6863\u6848\u51c6\u5907 \u9ad8\u8d28\u91cf\u7684\u533b\u5b66\u5199\u4f5c\u5728\u836f\u54c1\u6ce8\u518c\u7684\u6210\u529f\u4e2d\u8d77\u7740\u91cd\u8981\u4f5c\u7528\u3002\u5b83\u53ef\u4ee5\u964d\u4f4e\u76d1\u7ba1\u98ce\u9669\uff0c\u4ece […]<\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"inline_featured_image":false},"taxonomy":[279,277],"class_list":["post-12962","pharmacovigilance","type-pharmacovigilance","status-publish","hentry","taxonomy-279","taxonomy-277"],"acf":[],"yoast_head":"\n\u533b\u5b66\u5199\u4f5c - \u6ce8\u518c\u6863\u6848\u51c6\u5907 - SciencePharma<\/title>\n<meta name=\"description\" content=\"At SciencePharma, medical writing services are provided by highly educated top class experts of various scientific background\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u533b\u5b66\u5199\u4f5c - \u6ce8\u518c\u6863\u6848\u51c6\u5907 - SciencePharma\" \/>\n<meta property=\"og:description\" content=\"At SciencePharma, medical writing services are provided by highly educated top class experts of various scientific background\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/\" \/>\n<meta property=\"og:site_name\" content=\"SciencePharma\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-20T10:22:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/07\/obraz-5-5.png\" \/>\n\t<meta property=\"og:image:width\" content=\"588\" \/>\n\t<meta property=\"og:image:height\" content=\"283\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@science_pharma\" \/>\n<meta name=\"twitter:label1\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/\",\"url\":\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/\",\"name\":\"\u533b\u5b66\u5199\u4f5c - \u6ce8\u518c\u6863\u6848\u51c6\u5907 - SciencePharma\",\"isPartOf\":{\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/07\/obraz-5-5.png\",\"datePublished\":\"2023-06-06T07:14:03+00:00\",\"dateModified\":\"2025-02-20T10:22:18+00:00\",\"description\":\"At SciencePharma, medical writing services are provided by highly educated top class experts of various scientific background\",\"breadcrumb\":{\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#breadcrumb\"},\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#primaryimage\",\"url\":\"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/07\/obraz-5-5.png\",\"contentUrl\":\"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/07\/obraz-5-5.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.sciencepharma.com\/zh-hans\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Services\",\"item\":\"https:\/\/www.sciencepharma.com\/zh-hans\/services\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"\u533b\u5b66\u5199\u4f5c – \u6ce8\u518c\u6863\u6848\u51c6\u5907\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/#website\",\"url\":\"https:\/\/www.sciencepharma.com\/zh-hans\/\",\"name\":\"SciencePharma\",\"description\":\" - More Than Consulting\",\"publisher\":{\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.sciencepharma.com\/zh-hans\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/#organization\",\"name\":\"SciencePharma\",\"url\":\"https:\/\/www.sciencepharma.com\/zh-hans\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/04\/Science-Pharma_poziom.svg\",\"contentUrl\":\"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/04\/Science-Pharma_poziom.svg\",\"width\":244,\"height\":40,\"caption\":\"SciencePharma\"},\"image\":{\"@id\":\"https:\/\/www.sciencepharma.com\/zh-hans\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/x.com\/science_pharma\",\"https:\/\/www.linkedin.com\/company\/sciencepharma\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"\u533b\u5b66\u5199\u4f5c - \u6ce8\u518c\u6863\u6848\u51c6\u5907 - SciencePharma","description":"At SciencePharma, medical writing services are provided by highly educated top class experts of various scientific background","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/","og_locale":"zh_CN","og_type":"article","og_title":"\u533b\u5b66\u5199\u4f5c - \u6ce8\u518c\u6863\u6848\u51c6\u5907 - SciencePharma","og_description":"At SciencePharma, medical writing services are provided by highly educated top class experts of various scientific background","og_url":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/","og_site_name":"SciencePharma","article_modified_time":"2025-02-20T10:22:18+00:00","og_image":[{"width":588,"height":283,"url":"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/07\/obraz-5-5.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_site":"@science_pharma","twitter_misc":{"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4":"1 \u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/","url":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/","name":"\u533b\u5b66\u5199\u4f5c - \u6ce8\u518c\u6863\u6848\u51c6\u5907 - SciencePharma","isPartOf":{"@id":"https:\/\/www.sciencepharma.com\/zh-hans\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#primaryimage"},"image":{"@id":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#primaryimage"},"thumbnailUrl":"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/07\/obraz-5-5.png","datePublished":"2023-06-06T07:14:03+00:00","dateModified":"2025-02-20T10:22:18+00:00","description":"At SciencePharma, medical writing services are provided by highly educated top class experts of various scientific background","breadcrumb":{"@id":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#breadcrumb"},"inLanguage":"zh-Hans","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/"]}]},{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#primaryimage","url":"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/07\/obraz-5-5.png","contentUrl":"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/07\/obraz-5-5.png"},{"@type":"BreadcrumbList","@id":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/medical-writing-preparation-of-registration-dossier\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.sciencepharma.com\/zh-hans\/"},{"@type":"ListItem","position":2,"name":"Services","item":"https:\/\/www.sciencepharma.com\/zh-hans\/services\/"},{"@type":"ListItem","position":3,"name":"\u533b\u5b66\u5199\u4f5c – \u6ce8\u518c\u6863\u6848\u51c6\u5907"}]},{"@type":"WebSite","@id":"https:\/\/www.sciencepharma.com\/zh-hans\/#website","url":"https:\/\/www.sciencepharma.com\/zh-hans\/","name":"SciencePharma","description":" - More Than Consulting","publisher":{"@id":"https:\/\/www.sciencepharma.com\/zh-hans\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.sciencepharma.com\/zh-hans\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-Hans"},{"@type":"Organization","@id":"https:\/\/www.sciencepharma.com\/zh-hans\/#organization","name":"SciencePharma","url":"https:\/\/www.sciencepharma.com\/zh-hans\/","logo":{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/www.sciencepharma.com\/zh-hans\/#\/schema\/logo\/image\/","url":"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/04\/Science-Pharma_poziom.svg","contentUrl":"https:\/\/www.sciencepharma.com\/wp-content\/uploads\/2023\/04\/Science-Pharma_poziom.svg","width":244,"height":40,"caption":"SciencePharma"},"image":{"@id":"https:\/\/www.sciencepharma.com\/zh-hans\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/x.com\/science_pharma","https:\/\/www.linkedin.com\/company\/sciencepharma\/"]}]}},"_links":{"self":[{"href":"https:\/\/www.sciencepharma.com\/zh-hans\/wp-json\/wp\/v2\/pharmacovigilance\/12962","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.sciencepharma.com\/zh-hans\/wp-json\/wp\/v2\/pharmacovigilance"}],"about":[{"href":"https:\/\/www.sciencepharma.com\/zh-hans\/wp-json\/wp\/v2\/types\/pharmacovigilance"}],"wp:attachment":[{"href":"https:\/\/www.sciencepharma.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=12962"}],"wp:term":[{"taxonomy":"taxonomy","embeddable":true,"href":"https:\/\/www.sciencepharma.com\/zh-hans\/wp-json\/wp\/v2\/taxonomy?post=12962"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}