{"id":61910,"date":"2018-10-20T01:00:00","date_gmt":"2018-12-07T03:12:16","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/fa55b89629\/"},"modified":"2018-12-07T11:12:27","modified_gmt":"2018-12-07T03:12:27","slug":"fa55b89629","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/61910\/","title":{"rendered":"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b"},"content":{"rendered":"
\n

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

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

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/span><\/a><\/p>\n

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

\u7f8e\u56fd FDA \u4e8e 10 \u6708 18 \u65e5\u58f0\u79f0\u6b63\u5728\u5411 ICH \u63d0\u51fa\u4e00\u9879\u5efa\u8bae\u66f4\u597d\u5730\u534f\u8c03\u4eff\u5236\u836f\u7684\u79d1\u5b66\u548c\u6280\u672f\u6807\u51c6\u3002\u8be5\u63d0\u8bae\u65e8\u5728\u5141\u8bb8\u4eff\u5236\u53d1\u5546\u5b9e\u65bd\u5355\u4e00\u7684\u5168\u7403\u836f\u7269\u7814\u53d1\u8ba1<\/span>\u5212\u4ee5\u53ca\u63d0\u4ea4\u7533\u8bf7\u7684\u901a\u7528\u8981\u7d20\uff0c\u4ee5\u5728\u591a\u4e2a\u5e02\u573a\u540c\u65f6\u6279\u51c6\uff08<\/span>\u539f\u6587\u89c1<\/span>FDA<\/span>\u7f51\u7ad9https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/FDAVoices\/ucm623665.htm\uff09<\/span><\/p>\n

\u5728\u660e\u786eFDA\u8fdb\u4e00\u6b65\u63aa\u65bd\u4e4b\u524d\uff0c\u6211\u4eec\u6709\u5fc5\u8981\u9996\u5148\u4e86\u89e3ICH\u3002<\/span><\/p>\n

2017\u5e746\u6708\uff0c\u539f\u98df\u836f\u76d1\u603b\u5c40\u52a0\u5165\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff08ICH\uff09,2018\u5e746\u6708\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6210\u529f\u5f53\u9009\u4e3aICH\u7ba1\u7406\u59d4\u5458\u4f1a\u6210\u5458\u3002<\/span>
<\/p>\n

ICH\u5de5\u4f5c\u529e\u516c\u5ba4\u4e8e2017\u5e747\u6708\u6210\u7acb\uff0c\u8bbe\u5728\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u3002\u4e3b\u8981\u8d1f\u8d23\u56fd\u5bb6\u836f\u76d1\u5c40ICH\u76f8\u5173\u5de5\u4f5c\u7684\u7edf\u7b79\u548c\u534f\u8c03\uff0c\u5177\u4f53\u8d1f\u8d23\u7ec4\u7ec7\u53c2\u4e0eICH\u8bae\u9898\u56fd\u9645\u534f\u8c03\u3001\u7ec4\u7ec7ICH\u6307\u5bfc\u539f\u5219\u8f6c\u5316\u5b9e\u65bd\u548c\u57f9\u8bad\u3001\u4e0eICH\u548c\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\u8054\u7edc\u7b49\u3002\u4e3a\u505a\u597dICH\u76f8\u5173\u5de5\u4f5c\uff0c\u4fbf\u4e8e\u4e1a\u754c\u53ca\u65f6\u4e86\u89e3ICH\u5de5\u4f5c\u52a8\u6001\uff0c\u79ef\u6781\u53c2\u4e0eICH\u76f8\u5173\u5de5\u4f5c\uff0c\u836f\u5ba1\u4e2d\u5fc3\u7f51\u7ad9<\/span>\u57282018\u5e748\u67083\u65e5\u5f00\u901a\u4e86ICH\u5de5\u4f5c\u529e\u516c\u5ba4\u4e13\u680f\u3002<\/span><\/p>\n

\u5f00\u901a2\u4e2a\u6708\u4ee5\u6765\uff0c\u4e13\u680f\u4e0d\u65ad\u6709\u5185\u5bb9\u66f4\u65b0\uff0c<\/span>\u57289\u6708\u5e95\u8fd8\u516c\u5f00\u5f81\u6c42\u4e86\u300aICH M4\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u901a\u7528\u6280\u672f\u6587\u6863\u300b\u4e2d\u6587\u7ffb\u8bd1\u7a3f\u610f\u89c1\u3002<\/span>\u5728\u6b64\uff0c\u501f\u52a9CDE\u5b98\u65b9\u5e73\u53f0\u518d\u5168\u9762\u4e86\u89e3\u4e00\u4e0bICH\u3002<\/span><\/p>\n

  \u201cICH\u5de5\u4f5c\u529e\u516c\u5ba4\u4e13\u680f\u201d\u9996\u9875\u4e3b\u8981\u5305\u62ecICH\u5de5\u4f5c\u52a8\u6001\u3001\u6307\u5bfc\u539f\u5219\u5f81\u6c42\u610f\u89c1\u3001\u5b9e\u65bd\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u4ee5\u53ca\u7814\u8ba8\u4e0e\u57f9\u8bad\u52a8\u6001\u7b49\u3002ICH\u5de5\u4f5c\u529e\u516c\u5ba4\u4e13\u680f\u8bbe\u67095\u4e2a\u680f\u76ee\uff0c\u5206\u522b\u4e3a\uff1a<\/span><\/p>\n

 1.\u201c\u4e86\u89e3ICH<\/strong>\u201d\u680f\u76ee\uff1a\u4e3b\u8981\u4ecb\u7ecdICH\u57fa\u672c\u60c5\u51b5\u3001\u6210\u5458\u548c\u89c2\u5bdf\u5458\u3001ICH\u6307\u5bfc\u539f\u5219\u5236\u4fee\u8ba2\u5de5\u4f5c\u7a0b\u5e8f\u7b49\u3002<\/span><\/span><\/p>\n

 2.\u201c\u4e86\u89e3MedDRA<\/strong>\u201d\u680f\u76ee\uff1a\u5305\u62ec\u76d1\u7ba1\u6d3b\u52a8\u533b\u5b66\u8bcd\u5178\uff08MedDRA\uff09\u57fa\u672c\u60c5\u51b5\u3001\u76f8\u5173\u57f9\u8bad\u548c\u652f\u6301\u6027\u6587\u4ef6\u3001\u6807\u51c6MedDRA\u5206\u6790\u67e5\u8be2\u4ecb\u7ecd\u4ee5\u53ca\u8ba2\u9605MedDRA\u7b49\u3002<\/span><\/span><\/p>\n

 3.\u201cICH\u6307\u5bfc\u539f\u5219<\/strong>\u201d\u680f\u76ee\uff1a\u53ef\u6309\u7167\u8d28\u91cf\uff08Q\uff09\u3001\u5b89\u5168\u6027\uff08E\uff09\u3001\u6709\u6548\u6027\uff08S\uff09\u3001\u591a\u5b66\u79d1\uff08M\uff09\u67e5\u8be2ICH\u6307\u5bfc\u539f\u5219\u539f\u6587\u53ca\u4e2d\u6587\u7ffb\u8bd1\u7a3f\u3002<\/span><\/span><\/p>\n

 4.\u201c\u610f\u89c1\u5f81\u96c6\u201d\u680f\u76ee\uff1a\u53ef\u63d0\u4ea4\u4e0eICH\u6307\u5bfc\u539f\u5219\u53ca\u4e0eICH\u5de5\u4f5c\u6709\u5173\u7684\u610f\u89c1\u548c\u5efa\u8bae\u7b49\uff0c\u5bf9\u4e8eICH\u8fdb\u5165\u7b2c3\u9636\u6bb5\u516c\u5f00\u5f81\u6c42\u610f\u89c1\u7684\u6307\u5bfc\u539f\u5219\uff0c\u5c06\u5728ICH\u5de5\u4f5c\u529e\u516c\u5ba4\u4e13\u680f\u9996\u9875\u548c\u201c\u610f\u89c1\u5f81\u96c6\u201d\u680f\u76ee\u53d1\u5e03\u5e7f\u6cdb\u5f81\u6c42\u610f\u89c1\uff0c\u6b22\u8fce\u4e1a\u754c\u79ef\u6781\u5173\u6ce8\u63d0\u51fa\u610f\u89c1\u548c\u5efa\u8bae\u3002<\/span><\/span><\/p>\n

 5.\u201c\u5173\u4e8e\u6211\u4eec\u201d\u680f\u76ee\uff1a\u53ef\u67e5\u8be2ICH\u5de5\u4f5c\u529e\u516c\u5ba4\u5de5\u4f5c\u804c\u8d23\u53ca\u5177\u4f53\u5de5\u4f5c\u3002<\/span>
 \u6b22\u8fce\u5404\u754c\u79ef\u6781\u5173\u6ce8\u201cICH\u5de5\u4f5c\u529e\u516c\u5ba4\u4e13\u680f\u201d\u5e76\u5bf9\u53ca\u76f8\u5173\u5de5\u4f5c\u63d0\u51fa\u610f\u89c1\u548c\u5efa\u8bae\u3002<\/span><\/span><\/p>\n

ICH\u5de5\u4f5c\u529e\u516c\u5ba4\u4e13\u680f\uff1a<\/span><\/strong><\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\uff081\uff09\u4e86\u89e3ICH<\/span><\/strong>
<\/span><\/p>\n

ICH\u7b80\u4ecb<\/strong><\/span><\/h2>\n

\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff08ICH\uff09\u662f\u4e00\u4e2a\u56fd\u9645\u6027\u975e\u76c8\u5229\u7ec4\u7ec7\uff0c\u8be5\u7ec4\u7ec7\u4f9d\u7167\u745e\u58eb\u6cd5\u5f8b\u6210\u7acb\u4e8e2015\u5e7410\u6708\u3002 ICH\u7684\u5b97\u65e8\u662f\u901a\u8fc7\u6280\u672f\u8981\u6c42\u7684\u56fd\u9645\u534f\u8c03\u63d0\u9ad8\u516c\u4f17\u5065\u5eb7\uff0c\u8fd9\u4e9b\u6280\u672f\u6807\u51c6\u6709\u5229\u4e8e\u53ca\u65f6\u4e3a\u60a3\u8005\u63d0\u4f9b\u65b0\u836f\u54c1\u5e76\u4fdd\u8bc1\u60a3\u8005\u53ef\u6301\u7eed\u83b7\u5f97\u5df2\u83b7\u6279\u836f\u54c1\uff0c\u9632\u6b62\u4eba\u4f53\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e0d\u5fc5\u8981\u91cd\u590d\uff0c \u4ee5\u9ad8\u6548\u548c\u5177\u6210\u672c\u6548\u76ca\u7684\u65b9\u5f0f\u7814\u53d1\u3001\u6ce8\u518c\u548c\u751f\u4ea7\u5b89\u5168\u3001\u6709\u6548\u548c\u9ad8\u8d28\u91cf\u7684\u836f\u54c1\uff0c\u53ca\u5728\u4e0d\u6298\u635f\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u524d\u63d0\u4e0b\u5c3d\u91cf\u5c11\u7684\u4f7f\u7528\u52a8\u7269\u8bd5\u9a8c\u3002<\/span><\/p>\n

1.\u76ee\u7684<\/span><\/p>\n

\u901a\u8fc7\u5bf9\u76f8\u5173\u6280\u672f\u8981\u6c42\u8fdb\u884c\u56fd\u9645\u534f\u8c03\uff0c\u52a0\u5feb\u5f15\u8fdb\u521b\u65b0\u836f\uff0c\u786e\u4fdd\u60a3\u8005\u80fd\u591f\u6301\u7eed\u83b7\u5f97\u5df2\u6279\u51c6\u836f\u7269\uff0c \u4ece\u800c\u63a8\u52a8\u516c\u4f17\u5065\u5eb7\uff0c\u540c\u65f6\u907f\u514d\u5728\u4eba\u4f53\u4e0a\u91cd\u590d\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u7ecf\u6d4e\u6709\u6548\u7684\u65b9\u5f0f\u6765\u4fdd\u8bc1\u7814\u53d1\u3001\u6ce8\u518c\u548c\u751f\u4ea7\u7684\u836f\u7269\u5b89\u5168\u3001\u6709\u6548\u4e14\u9ad8\u8d28\u91cf\uff0c\u540c\u65f6\u5728\u4e0d\u5f71\u54cd\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u524d\u63d0\u4e0b\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u52a8\u7269\u8bd5\u9a8c\u3002<\/span><\/p>\n

2.\u4efb\u52a1\u53ca\u76ee\u6807<\/span><\/p>\n

\u2022 \u4e3a\u5728\u836f\u54c1\u6ce8\u518c\u4e0e\u6ce8\u518c\u7ef4\u62a4\u7684\u6280\u672f\u6307\u5bfc\u539f\u5219\u548c\u8981\u6c42\u7684\u89e3\u91ca\u4e0e\u5e94\u7528\u4e2d\u4e3a\u5b9e\u73b0\u66f4\u5927\u7a0b\u5ea6\u7684\u534f\u8c03\u63d0\u51fa\u5efa\u8bae\uff1b<\/span><\/p>\n

\u2022 \u8bba\u575b\u7684\u7ef4\u62a4\uff0c\u5c31\u836f\u54c1\u6280\u672f\u8981\u6c42\u7684\u534f\u8c03\u5728\u76d1\u7ba1\u673a\u6784\u548c\u533b\u836f\u884c\u4e1a\u95f4\u6784\u5efa\u79d1\u5b66\u95ee\u9898\u5bf9\u8bdd\uff1b<\/span><\/p>\n

\u2022 \u51fa\u4e8e\u56fd\u9645\u89c6\u89d2\uff0c\u4e3a\u4fdd\u62a4\u516c\u4f17\u5065\u5eb7\u4f5c\u51fa\u8d21\u732e\uff1b<\/span><\/p>\n

\u2022 \u76d1\u6d4b\u4e0e\u66f4\u65b0\u534f\u8c03\u7684\u6280\u672f\u8981\u6c42\uff0c\u4f7f\u7814\u53d1\u6570\u636e\u66f4\u5927\u7a0b\u5ea6\u7684\u76f8\u4e92\u63a5\u53d7\uff1b<\/span><\/p>\n

\u2022 \u56e0\u6cbb\u7597\u7684\u8fdb\u6b65\u548c\u836f\u54c1\u751f\u4ea7\u65b0\u6280\u672f\u7684\u53d1\u5c55\uff0c\u901a\u8fc7\u5bf9\u9700\u8981\u8bae\u9898\u7684\u534f\u8c03\uff0c\u907f\u514d\u672a\u6765\u8981\u6c42\u7684\u4e0d\u540c\uff1b<\/span><\/p>\n

\u2022 \u4fc3\u8fdb\u91c7\u7eb3\u65b0\u7684\u6216\u6539\u5584\u7684\u6280\u672f\u7814\u7a76\u4e0e\u5f00\u53d1\u65b9\u6cd5\uff0c\u66f4\u65b0\u6216\u66ff\u4ee3\u76ee\u524d\u4f5c\u6cd5\uff1b<\/span><\/p>\n

\u2022 \u901a\u8fc7\u534f\u8c03\u7684\u6307\u5bfc\u539f\u5219\u53ca\u5176\u4f7f\u7528\u65b9\u9762\u4fe1\u606f\u7684\u4f20\u64ad\u3001\u4ea4\u6d41\u53ca\u57f9\u8bad\uff0c\u9f13\u52b1\u901a\u7528\u6807\u51c6\u7684\u5b9e\u65bd\u4e0e\u63a5\u8f68\uff1b<\/span><\/p>\n

\u2022 \u5236\u5b9aICH\u76d1\u7ba1\u6d3b\u52a8\u533b\u5b66\u8bcd\u5178\uff08MedDRA\uff09\u672f\u8bed\u7684\u653f\u7b56\uff0c\u540c\u65f6\u786e\u4fddMedDRA\u4f5c\u4e3a\u65b9\u4fbf\u4eba\u7528\u836f\u54c1\u56fd\u9645\u76d1\u7ba1\u4fe1\u606f\u5206\u4eab\u7684\u6807\u51c6\u5316\u8bcd\u5178\u7684\u79d1\u5b66\u4e0e\u6280\u672f\u7ef4\u62a4\u3001\u5f00\u53d1\u548c\u4f20\u64ad\u3002<\/span><\/p>\n

\u6210\u5458\u548c\u89c2\u5bdf\u5458<\/strong><\/span><\/h2>\n

\uff08\u4e00\uff09ICH\u6210\u5458(MEMBERS)<\/span><\/p>\n

1.\u521b\u59cb\u76d1\u7ba1\u673a\u6784\u6210\u5458(Founding Regulatory Members)<\/span><\/p>\n

\u2022 \u6b27\u76df\u59d4\u5458\u4f1a\uff08EC\uff09<\/span><\/p>\n

\u2022 \u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09<\/span><\/p>\n


<\/p>\n

\u2022 \u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\/\u65e5\u672c\u836f\u54c1\u53ca\u533b\u7597\u5668\u68b0\u7ba1\u7406\u5c40<\/span><\/p>\n

\uff08MHLW\/PMDA\uff09<\/span><\/p>\n


<\/p>\n

2.\u521b\u59cb\u884c\u4e1a\u6210\u5458(Founding Industry Members)<\/span><\/p>\n

\u2022 \u6b27\u6d32\u5236\u836f\u5de5\u4e1a\u534f\u4f1a\u8054\u5408\u4f1a\uff08EFPIA\uff09<\/span><\/p>\n

\u2022 \u65e5\u672c\u5236\u836f\u5de5\u4e1a\u534f\u4f1a\uff08JPMA\uff09<\/span><\/p>\n

\u2022 \u7f8e\u56fd\u836f\u54c1\u7814\u7a76\u4e0e\u5236\u9020\u5546\u534f\u4f1a\uff08PhRMA\uff09<\/span><\/p>\n

3.\u5e38\u4efb\u76d1\u7ba1\u673a\u6784\u6210\u5458(Standing Regulatory Members)<\/span><\/p>\n

\u2022 \u52a0\u62ff\u5927\u536b\u751f\u90e8\uff08Health Canada\uff09<\/span><\/p>\n

\u2022 \u745e\u58eb\u533b\u836f\u7ba1\u7406\u5c40\uff08Swissmedic\uff09<\/span><\/p>\n

4.\u76d1\u7ba1\u673a\u6784\u6210\u5458(Regulatory Members)<\/span><\/p>\n

\u2022 \u5df4\u897f\u536b\u751f\u76d1\u7763\u5c40\uff08ANVISA\uff09<\/span><\/p>\n

\u2022 \u4e2d\u56fd\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff08CFDA\uff09<\/span><\/span><\/p>\n

\u2022 \u65b0\u52a0\u5761\u536b\u751f\u79d1\u5b66\u5c40\uff08HSA\uff09<\/span><\/p>\n

\u2022 \u97e9\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8\uff08MFDS\uff09<\/span><\/p>\n

\u2022 \u53f0\u6e7e\u536b\u751f\u798f\u5229\u90e8\u98df\u54c1\u836f\u7269\u7ba1\u7406\u7f72\uff08TFDA\uff09<\/span><\/p>\n

5.\u884c\u4e1a\u6210\u5458(Industry Members)<\/span><\/p>\n

\u2022 \u7f8e\u56fd\u751f\u7269\u6280\u672f\u5de5\u4e1a\u7ec4\u7ec7\uff08BIO\uff09<\/span><\/p>\n

\u2022 \u56fd\u9645\u4eff\u5236\u836f\u548c\u751f\u7269\u7c7b\u4f3c\u836f\u534f\u4f1a\uff08IGBA\uff09<\/span><\/p>\n

\u2022 \u4e16\u754c\u81ea\u6211\u533b\u7597\u4ea7\u4e1a\u534f\u4f1a\uff08WSMI\uff09<\/span><\/p>\n

\uff08\u4e8c\uff09\u89c2\u5bdf\u5458(OBSERVERS)<\/span><\/p>\n

1.\u5e38\u4efb\u89c2\u5bdf\u5458(Standing Observers)<\/span><\/p>\n

\u2022 \u56fd\u9645\u5236\u836f\u4f01\u4e1a\u548c\u534f\u4f1a\u8054\u5408\u4f1a\uff08IFPMA\uff09<\/span><\/p>\n

\u2022 \u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09<\/span><\/p>\n

2.\u7acb\u6cd5\u6216\u884c\u653f\u673a\u6784(Legislative or Administrative Authorities)<\/span><\/p>\n

\u2022 \u5370\u5ea6\u4e2d\u592e\u836f\u54c1\u6807\u51c6\u63a7\u5236\u7ec4\u7ec7\uff08CDSCO\uff09<\/span><\/p>\n

\u2022 \u53e4\u5df4\u56fd\u5bb6\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u63a7\u5236\u4e2d\u5fc3\uff08CECMED\uff09<\/span><\/p>\n

\u2022 \u58a8\u897f\u54e5\u8054\u90a6\u536b\u751f\u98ce\u9669\u4fdd\u62a4\u5c40\uff08COFEPRIS\uff09<\/span><\/p>\n

\u2022 \u54e5\u4f26\u6bd4\u4e9a\u56fd\u5bb6\u836f\u54c1\u548c\u98df\u54c1\u76d1\u7763\u5c40\uff08INVIMA\uff09<\/span><\/p>\n

\u2022 \u6469\u5c14\u591a\u74e6\u836f\u76d1\u5c40\uff08MMDA\uff09<\/span><\/p>\n

\u2022 \u54c8\u8428\u514b\u65af\u5766\u56fd\u5bb6\u4e2d\u5fc3\uff08National Center\uff09<\/span><\/p>\n

\u2022 \u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u836f\u54c1\u7ba1\u7406\u5c40\uff08NPRA\uff09<\/span><\/p>\n

\u2022 \u4fc4\u7f57\u65af\u8054\u90a6\u536b\u751f\u76d1\u7763\u5c40\uff08Roszdravnadzor\uff09<\/span><\/p>\n

\u2022 \u5357\u975e\u5065\u5eb7\u4ea7\u54c1\u7ba1\u7406\u5c40\uff08SAHPRA\uff09<\/span><\/p>\n

\u2022 \u4e9a\u7f8e\u5c3c\u4e9a\u836f\u7269\u548c\u533b\u7597\u6280\u672f\u4e13\u4e1a\u79d1\u5b66\u4e2d\u5fc3<\/span><\/p>\n

\uff08SCDMTE\uff09<\/span><\/p>\n

\u2022 \u6fb3\u5927\u5229\u4e9a\u6cbb\u7597\u4ea7\u54c1\u7ba1\u7406\u5c40\uff08TGA\uff09<\/span><\/p>\n

\u2022 \u571f\u8033\u5176\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u673a\u6784(TITCK)<\/span><\/p>\n

3.\u533a\u57df\u534f\u8c03\u7ec4\u7ec7(Regional Harmonisation Initiatives , RHIs)<\/span><\/p>\n

\u2022 \u4e9a\u592a\u7ecf\u6d4e\u5408\u4f5c\u7ec4\u7ec7\uff08APEC\uff09<\/span><\/p>\n

\u2022 \u4e1c\u5357\u4e9a\u56fd\u5bb6\u8054\u76df\uff08ASEAN\uff09<\/span><\/p>\n

\u2022 \u4e1c\u975e\u5171\u540c\u4f53\uff08EAC\uff09<\/span><\/p>\n

\u2022 \u6d77\u6e7e\u5065\u5eb7\u59d4\u5458\u4f1a\uff08GHC\uff09<\/span><\/p>\n

\u2022 \u5357\u975e\u53d1\u5c55\u534f\u4f1a\uff08SADC\uff09<\/span><\/p>\n

4.\u56fd\u9645\u5236\u836f\u884c\u4e1a\u7ec4\u7ec7(International Pharmaceutical Industry Organisation)<\/span><\/p>\n

\u2022 \u6d3b\u6027\u836f\u7269\u6210\u5206\u534f\u4f1a\uff08APIC\uff09<\/span><\/p>\n

5.\u76f8\u5173\u6216\u53d7ICH\u6307\u5bfc\u539f\u5219\u5f71\u54cd\u7684\u56fd\u9645\u7ec4\u7ec7(International Organisation regulated or affected by ICH Guideline(s))<\/span><\/p>\n

\u2022 \u6bd4\u5c14\u548c\u6885\u7433\u8fbe\u2022\u76d6\u8328\u57fa\u91d1\u4f1a\uff08Bill& Melinda<\/span><\/p>\n

Gates Foundation\uff09<\/span><\/p>\n

\u2022 \u56fd\u9645\u533b\u5b66\u7ec4\u7ec7\u7406\u4e8b\u4f1a\uff08CIOMS\uff09<\/span><\/p>\n

\u2022 \u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40\uff08EDQM\uff09<\/span><\/p>\n

\u2022 \u56fd\u9645\u836f\u7528\u8f85\u6599\u534f\u4f1a\uff08IPEC\uff09<\/span><\/p>\n

\u2022 \u56fd\u9645\u836f\u54c1\u8ba4\u8bc1\u5408\u4f5c\u7ec4\u7ec7(PIC\/S)<\/span><\/p>\n

\u2022 \u7f8e\u56fd\u836f\u5178\u59d4\u5458\u4f1a(USP)<\/span><\/p>\n

ICH\u6307\u5bfc\u539f\u5219\u5236\u4fee\u8ba2\u5de5\u4f5c\u7a0b\u5e8f<\/strong><\/span><\/p>\n

ICH\u6307\u5bfc\u539f\u5219\u5236\u4fee\u8ba2\u8fc7\u7a0b\u4e00\u822c\u5206\u4e3a<\/strong><\/span>5\u4e2a\u9636\u6bb5<\/strong><\/span>\uff1a<\/span><\/span><\/p>\n

\u2022 \u7b2c1\u9636\u6bb5\u6784\u7b51\u5171\u8bc6\uff1a\u65b0\u8bae\u9898\u63d0\u6848\u7ecf\u5927\u4f1a\u6279\u51c6\u6210\u4e3a\u65b0\u8bae\u9898\u540e\uff0c\u6210\u7acb\u4e13\u5bb6\u5de5\u4f5c\u7ec4\u3002\u4e13\u5bb6\u5de5\u4f5c\u7ec4\u4f9d\u636e\u6982\u5ff5\u6587\u4ef6\u548c\u4e1a\u52a1\u8ba1\u5212\u4e0d\u65ad\u8ba8\u8bba\u5f62\u6210\u7b2c1\u9636\u6bb5\u6280\u672f\u6587\u4ef6 \uff08Step 1 Technical Document\uff09\uff0c\u5373\u6307\u5bfc\u539f\u5219\u8349\u6848\u7684\u57fa\u7840\uff1b<\/span><\/p>\n

\u2022 \u7b2c2\u9636\u6bb5\uff1a<\/span><\/p>\n

\u7b2c2a\u9636\u6bb5\u786e\u8ba4\u5171\u8bc6\uff1a\u7b2c1\u9636\u6bb5\u7684\u6280\u672f\u6587\u4ef6\u7ecf\u5927\u4f1a\u6279\u51c6\u540e\uff0c\u5168\u4f53\u6210\u5458\u5927\u4f1a\u6210\u5458\u5c06\u4f1a\u5bf9\u6280\u672f\u6587\u4ef6\u5171\u8bc6\u8fdb\u884c\u786e\u8ba4\uff0c\u5f62\u6210\u7b2c2a\u9636\u6bb5\u7ec8\u7248\u6280\u672f\u6587\u4ef6 \uff08Step 2a Final Technical Document\uff09\uff1b<\/span><\/p>\n

\u7b2c2b\u9636\u6bb5\u91c7\u7eb3\u6307\u5bfc\u539f\u5219\u8349\u6848\uff1a\u6839\u636e\u7b2c2a\u9636\u6bb5\u7ec8\u7248\u6280\u672f\u6587\u4ef6\u5236\u5b9a\u7b2c2b\u9636\u6bb5\u6307\u5bfc\u539f\u5219\u8349\u6848\uff08Step 2b Draft Guideline\uff09\uff0c\u5e76\u7531ICH\u5927\u4f1a\u76d1\u7ba1\u673a\u6784\u6210\u5458\u786e\u8ba4\u7684\u8fc7\u7a0b\u3002<\/span><\/p>\n

\u2022 \u7b2c3\u9636\u6bb5\u76d1\u7ba1\u673a\u6784\u5f81\u6c42\u610f\u89c1\u548c\u8ba8\u8bba\uff1aICH\u5404\u5730\u533a\/\u56fd\u5bb6\u7684\u76d1\u7ba1\u673a\u6784\u5bf9\u6307\u5bfc\u539f\u5219\u8349\u6848\u516c\u5f00\u5f81\u6c42\u610f\u89c1\u3002\u6839\u636e\u53cd\u9988\u7684\u610f\u89c1\uff0c\u4e13\u5bb6\u5de5\u4f5c\u7ec4\u8fdb\u884c\u8ba8\u8bba\uff0c\u4fee\u6539\u6307\u5bfc\u539f\u5219\u8349\u6848\u3002<\/span><\/p>\n

\u2022 \u7b2c4\u9636\u6bb5\u91c7\u7eb3\u6307\u5bfc\u539f\u5219\uff1a\u5927\u4f1a\u76d1\u7ba1\u673a\u6784\u6210\u5458\u5bf9\u6307\u5bfc\u539f\u5219\u8349\u6848\u8fbe\u6210\u6700\u7ec8\u4e00\u81f4\uff0c\u5e76\u901a\u8fc7\u3002<\/span><\/p>\n

\u2022 \u7b2c5\u9636\u6bb5\u5b9e\u65bd\u6307\u5bfc\u539f\u5219\uff1aICH\u5404\u5730\u533a\/\u56fd\u5bb6\u76d1\u7ba1\u673a\u6784\u901a\u8fc7\u5404\u81ea\u884c\u653f\u7a0b\u5e8f\u5b9e\u65bd\u6307\u5bfc\u539f\u5219\u3002<\/span><\/p>\n

\uff082\uff09\u4e86\u89e3<\/span>MedDRA<\/strong><\/span><\/span><\/p>\n

\u76d1\u7ba1\u6d3b\u52a8\u533b\u5b66\u8bcd\u5178\uff08MedDRA\uff09<\/span><\/h3>\n

Medical Dictionary for Regulatory Activities (MedDRA\uff0c\u4e2d\u6587\u540d\uff1a\u76d1\u7ba1\u6d3b\u52a8\u533b\u5b66\u8bcd\u5178)\u662f\u5728ICH\u7684\u4e3b\u529e\u4e0b\u7f16\u5236\u7684\u533b\u5b66\u6807\u51c6\u672f\u8bed\u96c6\uff0c\u7528\u4e8e\u6574\u4e2a\u76d1\u7ba1\u8fc7\u7a0b\uff08\u4e0a\u5e02\u524d\u81f3\u4e0a\u5e02\u540e\uff09\u5305\u62ec\u6570\u636e\u7684\u5f55\u5165\u3001\u68c0\u7d22\u3001\u8bc4\u4ef7\u548c\u5448\u73b0\uff0c\u5176\u7528\u6237\u5305\u62ec\u76d1\u7ba1\u673a\u6784\u548c\u5de5\u4e1a\u754c\u3002MedDRA\u53ef\u7528\u4e8e\u4fe1\u53f7\u68c0\u6d4b\u548c\u4e34\u5e8a\u75c7\u72b6\u76d1\u6d4b\uff0c\u5176\u75c7\u72b6\u5305\u62ec\u591a\u7cfb\u7edf\u6216\u5668\u5b98\uff0c\u4f7f\u7528\u5176\u591a\u8f74\u5c42\u6b21\u7ed3\u6784\u6216\u901a\u8fc7\u6807\u51c6MedDRA\u5206\u6790\u67e5\u8be2\uff08SMQ\uff09\u7684\u7279\u6b8a\u529f\u80fd\u3002<\/span><\/p>\n

MedDRA\u7ea6\u542b80000\u4e2a\u672f\u8bed\uff0c\u6bcf\u4e2a\u672f\u8bed\u5747\u6709\u4e00\u4e2a\u552f\u4e00\u76848\u4f4d\u963f\u62c9\u4f2f\u6570\u5b57\u4ee3\u7801\uff0c\u5171\u5305\u542b\u4e94\u4e2a\u5c42\u6b21\uff1a\u4f4e\u4f4d\u8bed\uff08LLT\uff09\u3001\u4f18\u9009\u672f\u8bed\uff08PT\uff09\u3001\u9ad8\u4f4d\u8bed\uff08HLT\uff09\u3001\u9ad8\u4f4d\u7ec4\u8bed\uff08HLGT\uff09\u53ca\u7cfb\u7edf\u5668\u5b98\u5206\u7c7b\uff08SOC\uff09\u3002<\/span><\/p>\n

MedDRA\u7684\u5b97\u65e8\u662f\uff081\uff09\u63d0\u4f9b\u5168\u7403\u4f7f\u7528\u7684\u56fd\u9645\u6807\u51c6\uff1b\uff082\uff09\u4e3a\u7528\u6237\u63d0\u4f9b\u4e00\u4e2a\u5185\u5bb9\u4e30\u5bcc\uff0c\u8be6\u7ec6\u7684\u533b\u5b66\u6807\u51c6\u672f\u8bed\uff1b\uff083\uff09\u5229\u7528\u5176\u7eb5\u5411\u7ed3\u6784\u548c\u6807\u51c6MedDRA\u5206\u6790\u67e5\u8be2\uff08SMQ\uff09\u5e2e\u52a9\u7528\u6237\u53d1\u6398\uff0c\u5206\u6790\u4fe1\u53f7\uff1b\uff084\uff09\u4fc3\u8fdb\u4eba\u7528\u533b\u7597\u4ea7\u54c1\u56fd\u9645\u76d1\u7ba1\u4fe1\u606f\u7684\u5171\u4eab\u548c\u4fe1\u606f\u6c9f\u901a\u3002<\/span><\/p>\n

MedDRA\u6bcf\u534a\u5e74\u66f4\u65b0\u4e00\u6b21\u3002\u622a\u6b622018\u5e743\u6708\uff0c\u6765\u81ea120\u4e2a\u56fd\u5bb6\u7684\u7ea65200\u4e2a\u7ec4\u7ec7\u8ba2\u9605\u4e86MedDRA\u3002<\/span><\/p>\n

MedDRA\u662f\u4e00\u79cd\u591a\u8bed\u8a00\u672f\u8bed\uff0c\u76ee\u524d\u670911 \u79cd\u8bed\u8a00\u7248\u672c (\u5305\u62ec\u4e2d\u6587\u7248) \uff0c\u5141\u8bb8\u5927\u591a\u6570\u7528\u6237\u4f7f\u7528\u5176\u6bcd\u8bed\u8fdb\u884c\u64cd\u4f5c\u3002\u4ee5\u4e0b\u56fe\u8868\u663e\u793a\u6bcf\u79cd\u8bed\u8a00\u9996\u6b21\u9881\u53d1\u7684\u7248\u672c\uff1a<\/span>
<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/span><\/p>\n

\u5728\u5f00\u53d1\u548c\u6301\u7eed\u7ef4\u62a4MedDRA\u65f6\uff0cICH\u81f4\u529b\u4e8e\u63d0\u4f9b\u7edf\u4e00\u7684\u6807\u51c6\u5316\u56fd\u9645\u533b\u5b66\u672f\u8bed\uff0c\u7528\u4e8e\u4e0e\u4eba\u7528\u533b\u7597\u4ea7\u54c1\u76f8\u5173 \u7684\u76d1\u7ba1\u6c9f\u901a\u548c\u6570\u636e\u8bc4\u4f30\u3002\u56e0\u6b64\uff0cMedDRA\u65e8\u5728\u7528\u4e8e\u5f00\u53d1\u5468\u671f\u5404\u4e2a\u9636\u6bb5\uff08\u5982\u4ece\u4e34\u5e8a\u8bd5\u9a8c\u5230\u4e0a\u5e02\u540e\u76d1\u7ba1\uff09\u836f\u54c1\u7684\u6ce8\u518c\u3001 \u8bb0\u5f55\u53ca\u5b89\u5168\u76d1\u63a7\u3002\u6b64\u5916\uff0cMedDRA\u662fICH\u7684\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u6863\uff08eCTD\uff09\u548cE2B \u4e2a\u4f8b\u5b89\u5168\u62a5\u544a\u7535\u5b50\u62a5\u544a\u8868\u4e0d\u53ef\u7f3a\u5c11\u7684\u4e00\u90e8\u5206\u3002<\/span>
<\/p>\n

1.\tMedDRA\u6307\u5bfc\u59d4\u5458\u4f1a\u6846\u67b6\u7ed3\u6784<\/span>
<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

2.\tMedDRA\u57f9\u8bad<\/span><\/p>\n

\u4e3a\u4fc3\u8fdbMedDRA\u7684\u5b9e\u65bd\u548c\u6b63\u786e\u4f7f\u7528\uff0cICH MedDRA\u7ba1\u7406\u59d4\u5458\u4f1a\u548cMSSO\u4e3a\u6240\u6709MedDRA\u7528\u6237\u63d0\u4f9b\u4e86\u8bb8\u591a\u4e0d\u540c\u7684\u57f9\u8bad\u673a\u4f1a\u3002<\/span><\/p>\n

\u2022\u9762\u5bf9\u9762\u7684\u57f9\u8bad<\/span><\/p>\n

MSSO\u4e3a\u5404\u5730\u76d1\u7ba1\u673a\u6784\u548c\u884c\u4e1a\u7528\u6237\u63d0\u4f9b\u514d\u8d39\u7684\u8bfe\u5802\u57f9\u8bad\uff0c\u4e3b\u9898\u5305\u62ecMedDRA\u7f16\u7801\u3001MedDRA\u5165\u95e8\u53caMedDRA\uff1a\u5b89\u5168\u6027\u6570\u636e\u5206\u6790\u548cSMQ\u3002\u57f9\u8bad\u5305\u62ec\u4e13\u5bb6\u8bb2\u5e08\u548c\u7535\u5b50\u57f9\u8bad\u6750\u6599\u3002\u4e0e\u4f1a\u8005\u81ea\u7406\u5dee\u65c5\u8d39\u3002\u53ef\u53c2\u9605\u57f9\u8bad\u8ba1\u5212\u65b9\u4fbf\u4f53\u9a8c\u8bfe\u7a0b\u5b89\u6392\u3002\u76d1\u7ba1\u673a\u6784\u7528\u6237\u5e94\u8054\u7cfbMSSO\u670d\u52a1\u53f0\u4ee5\u5b89\u6392\u5728\u673a\u6784\u5185\u8fdb\u884c\u57f9\u8bad\u3002<\/span><\/p>\n

\u2022\u7f51\u7edc\u7814\u8ba8\u4f1a<\/span><\/p>\n

MSSO\u63d0\u4f9b\u6709\u5173\u4ecb\u7ecd\u6027\u4e3b\u9898\u7684\u514d\u8d39\u7f51\u7edc\u7814\u8ba8\u4f1a\uff0c\u5982MedDRA\u5165\u95e8\u3001MedDRA\u6982\u8ff0\u53caMedDRA\u7f16\u7801\u57fa\u7840\u77e5\u8bc6\u3002\u66f4\u9ad8\u7ea7\u7684\u7f51\u7edc\u7814\u8ba8\u4f1a\u4e3b\u9898\u5305\u62ec\u9ad8\u7ea7MedDRA\u7f16\u7801\u3001\u4f7f\u7528MedDRA\u8fdb\u884c\u6570\u636e\u5206\u6790\u548c\u67e5\u8be2\u3001\u6807\u51c6MedDRA\u5206\u6790\u67e5\u8be2\uff08SMQ\uff09\u4ee5\u53caMedDRA\u52a8\u6001\u3002\u57f9\u8bad\u5305\u62ec\u4e13\u5bb6\u8bb2\u5e08\u548c\u57f9\u8bad\u6750\u6599\u3002<\/span><\/p>\n

\u2022\u57f9\u8bad\u89c6\u9891\u8bfe\u7a0b<\/span><\/p>\n

MSSO\u63d0\u4f9b\u4e0e\u5404\u79cdMedDRA\u76f8\u5173\u4e3b\u9898\u7684\u591a\u8bed\u8a00\u514d\u8d39\u89c6\u9891\u8bfe\u7a0b\uff0c\u53ef\u4ee5\u76f4\u63a5\u4eceMedDRA\u7f51\u7ad9\u4e0b\u8f7d\u6216\u67e5\u770b\u76f8\u5173\u89c6\u9891\u8bfe\u7a0b\u3002<\/span><\/p>\n

\u2022\u6536\u8d39\u7684\u73b0\u573a\u57f9\u8bad<\/span><\/p>\n

\u5982\u679c\u9700\u8981\u57f9\u8bad\u7684\u5458\u5de5\u591a\u4e8e\u4e00\u6216\u4e24\u540d\uff0c\u60a8\u53ef\u4ee5\u8003\u8651\u73b0\u573a\u57f9\u8bad\u3002MSSO\u57f9\u8bad\u5e08\u6765\u5230\u60a8\u5355\u4f4d\u5e76\u4f7f\u7528\u4e0e\u4e0a\u8ff0\u514d\u8d39\u9762\u5bf9\u9762\u57f9\u8bad\u76f8\u540c\u7684\u57f9\u8bad\u6750\u6599\u8fdb\u884c\u57f9\u8bad\u3002\u82e5\u6709\u9700\u8981\uff0c\u53ef\u8054\u7cfbMSSO\u3002<\/span><\/p>\n

3.\tMedDRA\u652f\u6301\u6027\u6587\u6863<\/span><\/p>\n

\u6bcf\u4e2aMedDRA\u7248\u672c\u53ca\u5176\u7ffb\u8bd1\u7248\u672c\uff08\u76ee\u524d\u5df2\u66f4\u65b0\u81f321.0\u7248\u672c\uff09\u90fd\u914d\u6709\u5fc5\u8981\u7684\u652f\u6301\u6027\u6587\u6863\uff0c\u4f462\u4efdICH\u8003\u8651\u8981\u70b9\uff08Points to Consider, PtC\uff09\u6587\u6863\u76ee\u524d\u53ea\u6709\u82f1\u8bed\u7248\u548c\u65e5\u8bed\u7248\u3002<\/span><\/p>\n

4.\t\u6807\u51c6MedDRA\u5206\u6790\u67e5\u8be2\uff08Standardised MedDRA Queries,SMQ\uff09<\/span><\/p>\n

\u6807\u51c6MedDRA\u5206\u6790\u67e5\u8be2\uff08SMQ\uff09\u662f\u4e3a\u65b9\u4fbfMedDRA \u7f16\u7801\u6570\u636e\u68c0\u7d22\u800c\u5f00\u53d1\u7684\u4e00\u6b3e\u5de5\u5177\uff0c\u7528\u4e8e\u836f\u7269\u8b66\u6212\u548c\u4e34\u5e8a\u7814\u53d1\u8fc7\u7a0b\u6570\u636e\u5206\u6790\u7684\u7b2c\u4e00\u6b65\u3002 SMQ\u542b\u6709\u4e0e\u5176\u8bfe\u9898\u76f8\u5173\u7684MedDRA\u672f\u8bed\uff0c\u672f\u8bed\u7684\u9009\u62e9\u662f\u7ecf\u5927\u91cf\u5ba1\u6838\u3001\u6d4b\u8bd5\u3001\u5206\u6790\u53ca\u4e13\u5bb6\u8ba8\u8bba\u800c\u51b3\u5b9a\u7684\u3002SMQ \u662fMedDRA \u7684\u72ec\u7279\u529f\u80fd\uff0c\u662f\u652f\u6301\u5b89\u5168\u5206\u6790\u548c\u62a5\u544a\u7684\u5f3a\u5927\u5de5\u5177\u3002 SMQ \u6db5\u76d6\u7684\u4e3b\u9898\u65e8\u5728\u89e3\u51b3\u76d1\u7ba1\u65b9\u548c\u884c\u4e1a\u7528\u6237\u6240\u9700\u7684\u91cd\u8981\u836f\u7269\u8b66\u6212\u95ee\u9898\u3002SMQ \u7684\u5f00\u53d1\u65b9\u5305\u62ecSMQ CIOMS \u5de5\u4f5c\u7ec4\uff0c\u8be5\u5de5\u4f5c\u7ec4\u5177\u6709\u836f\u7269\u8b66\u6212\u65b9\u9762\u7684\u4e13\u4e1a\u77e5\u8bc6\u5e76\u63d0\u4f9bSMQ \u9a8c\u8bc1\u3002\u968f\u7740\u6bcf\u6b21MedDRA \u7684\u53d1\u5e03\uff0cMSSO \u5bf9SMQ \u8fdb\u884c\u7ef4\u62a4\u3002<\/span><\/p>\n

\u76ee\u524d\u521b\u5efa\u7684SMQ\u903e100\u4e2a\uff0c\u53ef\u6309\u9700\u53ef\u521b\u5efa\u5176\u4ed6SMQ\u3002\u4ee5\u4e0b\u662f\u7528\u6237\u53ef\u4f7f\u7528\u7684SMQ\u793a\u4f8b\u3002<\/span><\/p>\n

\u2022\u901f\u53d1\u8fc7\u654f\u53cd\u5e94<\/span><\/p>\n

\u2022\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u8840\u7ba1\u75be\u75c5<\/span><\/p>\n

\u2022\u60ca\u53a5<\/span><\/p>\n

\u2022\u6291\u90c1\u53ca\u548c\u81ea\u6740\/\u81ea\u4f24<\/span><\/p>\n

\u2022\u836f\u7269\u6ee5\u7528\u3001\u4f9d\u8d56\u548c\u6212\u9664<\/span><\/p>\n

\u2022\u9ad8\u8840\u7cd6\u75c7\/\u65b0\u53d1\u7cd6\u5c3f\u75c5<\/span><\/p>\n

\u2022\u8d85\u654f\u6027<\/span><\/p>\n

\u2022\u7f3a\u8840\u6027\u5fc3\u810f\u75c5<\/span><\/p>\n

\u2022\u7f3a\u4e4f\u7597\u6548\/\u6548\u679c<\/span><\/p>\n

\u2022\u7528\u836f\u9519\u8bef<\/span><\/p>\n

\u2022\u4e25\u91cd\u76ae\u80a4\u4e0d\u826f\u53cd\u5e94<\/span><\/p>\n

5.\t\u8ba2\u9605MedDRA<\/span>
<\/p>\n

MedDRA\u7ba1\u7406\u59d4\u5458\u4f1a\u6bcf\u5e74\u5ba1\u6279\u8ba2\u9605\u8d39\u7528\u5e76\u5c06\u6536\u8d39\u6240\u5f97\u7528\u4e8eMedDRA MSSO\u5305\u62ecMedDRA\u5f00\u53d1\u6d3b\u52a8\u7684\u7ecf\u8d39\u3002\u5bf9\u4e8e\u5546\u4e1a\u6027\uff08\u76c8\u5229\u6027\uff09\u673a\u6784\uff0cMedDRA\u8ba2\u9605\u8d39\u7528\u7ea7\u522b\u662f\u6bcd\u516c\u53f8\u5e74\u6536\u5165\u6765\u5b9a\u7684\u3002\u8ba2\u9605\u516c\u53f8\u7684\u5e74\u6536\u5165\u6458\u81ea\u516c\u53f8\u5e74\u7ec8\u62a5\u544a\u3002<\/span><\/p>\n

6.\tMedDRA\u81ea\u52a9\u670d\u52a1\u5de5\u5177<\/span>
<\/p>\n

MedDRA\u81ea\u52a9\u670d\u52a1\u5de5\u5177\u4e3a\u5e38\u89c1\u95ee\u9898\u63d0\u4f9b24\/7\u670d\u52a1\uff0c\u5e76\u5177\u6709\u4ee5\u4e0b\u529f\u80fd\uff1a<\/span><\/p>\n

\u2022\u67e5\u672c\u673a\u6784MedDRA ID<\/span><\/p>\n

\u2022\u67e5\u672c\u673a\u6784MedDRA\u5bc6\u7801\u548cCRID<\/span><\/p>\n

\u2022\u67e5MedDRA\u89e3\u538b\u7f29\u5bc6\u7801<\/span><\/p>\n

\u2022\u67e5\u8be2\u4e1a\u52a1\u5408\u4f5c\u4f19\u4f34\u7684MedDRA\u8ba2\u9605\u72b6\u6001<\/span><\/p>\n

\u2022\u67e5\u672c\u673a\u6784\u7684MedDRA\u4e3b\u8981\u8054\u7cfb\u4eba<\/span><\/p>\n

\uff083\uff09<\/span>ICH\u6307\u5bfc\u539f\u5219<\/strong><\/span>
<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

\"\u72fc\u8981\u6765\u4e86\uff1fICH\u4e86\u89e3\u4e0b\"<\/p>\n

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


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

\u5185\u5bb9\u6765\u6e90\uff1aCDE\u3001FDA\uff0c\u7f16\u8f91\u6574\u7406<\/span><\/em><\/p>\n


<\/p>\n

\n


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

\u7f8e\u56fd FDA \u4e8e 10 \u6708 18 \u65e5\u58f0\u79f0\u6b63\u5728\u5411 ICH \u63d0\u51fa\u4e00\u9879\u5efa\u8bae\u66f4\u597d\u5730\u534f\u8c03\u4eff\u5236\u836f\u7684\u79d1\u5b66\u548c\u6280\u672f\u6807\u51c6\u3002\u8be5\u63d0\u8bae\u65e8 […]<\/p>\n","protected":false},"author":1,"featured_media":61911,"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\/61910"}],"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=61910"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/61910\/revisions"}],"predecessor-version":[{"id":61935,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/61910\/revisions\/61935"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/61911"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=61910"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=61910"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=61910"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}