{"id":68858,"date":"2018-11-13T01:00:00","date_gmt":"2018-12-07T04:28:37","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/948ffcb81c\/"},"modified":"2018-12-07T12:28:39","modified_gmt":"2018-12-07T04:28:39","slug":"948ffcb81c","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/68858\/","title":{"rendered":"NMPA\u548cFDA\u8fd1\u4e09\u5e74\u6765\u6cd5\u89c4\u6587\u4ef6\u53ca\u6307\u5bfc\u539f\u5219\u6574\u7406"},"content":{"rendered":"
\n

\"NMPA\u548cFDA\u8fd1\u4e09\u5e74\u6765\u6cd5\u89c4\u6587\u4ef6\u53ca\u6307\u5bfc\u539f\u5219\u6574\u7406\"<\/p>\n


<\/p>\n

Clindata\u7ecf\u5178\u6587\u7ae0\u63a8\u8350<\/span>\uff1a<\/span>
<\/p>\n

1.CFDA CDE<\/span>\u300a\u6297\u80bf\u7624\u65b0\u836f\u9996\u6b21\u4eba\u4f53\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u4e34\u5e8a\u76f8\u5173\u8d44\u6599\u51c6\u5907\u5efa\u8bae\u300b\u542f<\/span><\/a><\/span>\u793a<\/span><\/a><\/span>\uff1b<\/span><\/p>\n

2.\u836f\u7269\u7814\u53d1\u8d28\u91cf\u3001\u6210\u672c\u548c\u65f6\u95f4\u81f3\u5173\u91cd\u8981<\/span><\/a><\/span>;<\/span><\/p>\n

3.\u91cd\u78c5\u4e2d\u56fdPD-1\u53caPD-L1 I\/II\/III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66<\/span><\/a><\/span>;<\/span><\/p>\n

4.\u91cd\u78c5\u4e2d\u56fd\u80bf\u7624\u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66<\/span><\/a><\/span>\uff1b<\/span><\/p>\n

5.\u91cd\u78c5\u4e2d\u56fdPD-1\u53caPD-L1 I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66<\/span><\/a><\/span>;<\/span><\/p>\n

6.<\/span>2018\u5e74\u4e2d\u56fd\u80bf\u7624\u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66<\/span><\/a><\/span><\/span>;<\/span><\/p>\n

7.CDE <\/span>\u4e2d\u56fd\u9996\u4e2aCAR-T \u83b7\u6279\u4e34\u5e8a\/\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u7533\u8bf7\u4e34\u5e8a\u8bd5\u9a8c\u836f\u5b66\u7814\u7a76\u548c\u7533\u62a5\u8d44\u6599\u7684\u8003\u8651\u8981\u70b9\/\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u7814\u7a76\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5bfc\u539f\u5219<\/span><\/a><\/span>;<\/span><\/p>\n

8.Clindata Day23 FDA\u91cd\u78c5 E6 R2\u826f\u597d\u7684\u4e34\u5e8a\u5b9e\u8df5ICH E6(R1)\u884c\u4e1a\u6307\u5357\u7684\u7efc\u5408\u8865\u5145<\/span><\/a><\/span>;<\/span><\/p>\n

9.CDE\u5ba1\u8bc4\u4e13\u5bb6\u9610\u8ff0\u975e\u52a3\u6548\u3001\u7b49\u6548\u548c\u4f18\u6548\u6027\u68c0\u9a8c\u53ca\u5176\u9002\u7528\u8303\u56f4<\/span><\/span><\/a>\uff1b<\/span><\/p>\n

10.EMEA\u53d1\u5e03\u300a\u4f18\u6548\u6027\u4e0e\u975e\u52a3\u6548\u6027\u4e4b\u95f4\u8f6c\u6362\u7684\u8003\u8651\u8981\u70b9\u300b<\/span><\/a><\/span>\uff1b
<\/span><\/p>\n

11.\u521a\u521aFDA\u53d1\u5e03\u5b55\u5987\u7eb3\u5165\u4e34\u5e8a\u8bd5\u9a8c\u79d1\u5b66\u4e0e\u4f26\u7406\u8003\u8651\u884c\u4e1a\u6307\u5357\uff08\u8349\u6848\uff09<\/span><\/a><\/span>;<\/span><\/p>\n

12.CDE\u53d1\u5e03\u300a\u521b\u65b0\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4e34\u5e8a\u836f\u7406\u5b66\u7814\u7a76\u7684\u4e00\u822c\u8003\u8651\u300b<\/span><\/a><\/span> <\/span>           <\/span><\/span><\/p>\n

13.CDE\u53d1\u5e03\u300a\u5316\u5b66\u836f\u7269\u4e34\u5e8a\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b<\/span><\/a>\uff1b<\/span><\/p>\n

14.CDE\u53d1\u5e03\u300a\u6297\u80bf\u7624\u836f\u7269\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c–\u9776\u5411\u6cbb\u7597\u65f6\u4ee3\u7684\u5e38\u89c4\u8bbe\u8ba1\u548c\u65b0\u7b56\u7565\u4ecb\u7ecd\u300b<\/span><\/a>\uff1b<\/span><\/p>\n

15.CDE\u53d1\u5e03\u300a\u884c\u4e1a\u6307\u5357\u2014\u5065\u5eb7\u6210\u5e74\u5fd7\u613f\u8005\u4e2d\u9996\u6b21\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u836f\u7269\u6700\u5927\u5b89\u5168\u8d77\u59cb\u5242\u91cf\u7684\u4f30\u8ba1\u300b<\/span><\/a>\uff1b<\/span>
<\/p>\n

16.<\/span>CDE\u53d1\u5e03\u300a\u4e34\u5e8a\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u7684\u5e38\u89c1\u8bbe\u8ba1\u7c7b\u578b\u4e0e\u7edf\u8ba1\u5206\u6790 \u300b<\/span>\uff1b<\/span><\/a>
<\/p>\n

17.<\/span>\u836f\u7269\u8b66\u6212\u51f8\u663e\u4f5c\u7528 FDA\u9650\u5236Essure\u7684\u9500\u552e\u548c\u5206\u9500\u4ee5\u4fdd\u62a4\u5973\u6027\u5e76\u8981\u6c42\u60a3\u8005\u63a5\u6536\u98ce\u9669\u4fe1\u606f<\/span><\/a>\uff1b
<\/span><\/p>\n

18.CDE\u53d1\u5e03\u300a\u5316\u5b66\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u76ee\u7684\u548c\u8bbe\u8ba1\u300b<\/span><\/a>\uff1b<\/span><\/p>\n

19.FDA\u91cd\u78c5\u53d1\u5e03\u6307\u5357\u300a\u6d41\u611f\u5927\u6d41\u884c\u671f\u95f4\u5bf9\u533b\u7597\u4ea7\u54c1\u548c\u81b3\u98df\u8865\u5145\u5242\u8fdb\u884c\u4e0a\u5e02\u540e\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u300b\u300aE11(R1)\u9644\u5f55:\u513f\u79d1\u4eba\u7fa4\u4e2d\u836f\u54c1\u7684\u4e34\u5e8a\u8c03\u67e5\u300b\uff1b<\/span><\/a>
<\/p>\n

20.CDE\u53d1\u5e03\u300a\u6297\u80bf\u7624\u836f\u7269\u975e\u4e34\u5e8a\u836f\u6548\u5b66\u7814\u7a76\u7684\u4e00\u822c\u8003\u8651 \u300b<\/span><\/a>\uff1b
<\/span><\/p>\n

21.FDA\u91cd\u78c5\u53d1\u5e03\u300a\u65b0\u4e00\u4ee3\u6d4b\u5e8f\uff08NGS\uff09\u7684\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u65e8\u5728\u5e2e\u52a9\u8bca\u65ad\u53ef\u7591\u7684\u79cd\u7cfb\u75be\u75c5\u8003\u8651\u8bbe\u8ba1\u3001\u5f00\u53d1\u548c\u5206\u6790\u9a8c\u8bc1\u300b\uff1b<\/span><\/a>
<\/p>\n

22.FDA\u53d1\u5e03\u300a\u884c\u4e1a\u6307\u5357\uff1a\u66b4\u9732\u91cf-\u6548\u5e94\u5173\u7cfb–\u7814\u7a76\u8bbe\u8ba1\u3001\u6570\u636e\u5206\u6790\u548c\u6ce8\u518c\u7533\u8bf7\u300b\uff1b<\/span><\/a>
<\/p>\n

23.FDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300a\u8d85\u58f0\u6ce2\u6cbb\u7597\u5668\u68b0\u63d0\u4ea4\u7684\u653f\u7b56\u6f84\u6e05\u548c\u4e0a\u5e02\u524d\u901a\u77e5[510\uff08k\uff09]\u884c\u4e1a\u6307\u5357\u300b<\/span><\/a>\uff1b
<\/span><\/p>\n

24.\u5982\u4f55\u964d\u4f4e\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u5f00\u53d1\u6210\u672c\u7b2c\u4e00\u671f\u300a\u964d\u4f4e\u4e34\u5e8a\u8bd5\u9a8c\u76d1\u67e5\uff08Monitoring\uff09\u6210\u672c\u300b<\/span><\/a>\uff1b<\/span><\/p>\n

25.FDA\u91cd\u78c5\u53d1\u5e03\u300a\u5177\u4f53\u65b9\u6848\u8bc4\u4f30\u6307\u5bfc\u539f\u5219Special Protocol Assessment Guidance\u300b<\/span><\/a>\uff1b
<\/span><\/p>\n

26.\u603b\u7406\uff1a\u8fdb\u53e3\u6297\u764c\u836f\u964d\u5230\u96f6\u5173\u7a0e\u4e0d\u662f\u76ee\u7684<\/span><\/a>\uff1b
<\/span><\/p>\n

27.Clindata\u53d1\u5e03\u300a2013-2018\u5e74\u4e2d\u56fd\u80bf\u7624\u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66\u300b\u7b2c\u4e8c\u7248\uff1b<\/span><\/a>
<\/p>\n

28.CDE\u53d1\u5e03\u300a\u5f53\u524d\u5bf9CAR-T\u7c7b\u4ea7\u54c1\u975e\u4e34\u5e8a\u7814\u7a76\u4e0e\u8bc4\u4ef7\u7684\u4e00\u4e9b\u8003\u8651\u300b\uff1b<\/span><\/a><\/p>\n

29.CDE\u53d1\u5e03\u300a\u975e\u6ce8\u518c\u7c7b\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u836f\u54c1\u6ce8\u518c\u5ba1\u8bc4\u7684\u51e0\u70b9\u601d\u8003\u300b<\/span>;
<\/span><\/p>\n

30.PD-1\/PD-L1\u4e2d\u56fd\u9996\u5bb6\u4e0a\u5e02\u4f01\u4e1a\u662f\u8c01\uff1f\u548c\u300a2013\u5e74\u20142018\u5e74\u4e2d\u56fdPD-1\u53caPD-L1 \u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66\u7b2c\u4e8c\u7248\u300b<\/span><\/a>;
<\/span><\/p>\n

31.PD-1\u4e94\u4e2a\u65b0\u836fCDE\u4f18\u5148\u5ba1\u8bc4\uff0c3\u4e2a\u67085\u6b3e\u4ea7\u54c1\u624e\u5806\u7533\u8bf7\u4e0a\u5e02\u542f\u793a\u300a\u4e2d\u56fd\u81ea\u4e3b\u7814\u53d1\u6297\u4f53\u65b0\u836f\u65b0\u65f6\u4ee3\u5373\u5c06\u5230\u6765\u300b<\/span>\uff1b<\/span><\/a><\/p>\n

32.2018\u5e744\u670824\u65e5FDA\u66f4\u65b0\u53d1\u5e03\u300a\u4ee5\u7535\u5b50\u683c\u5f0f\u63d0\u4f9b\u76d1\u7ba1\u63d0\u4ea4 – \u4eba\u7528\u836f\u54c1\u548c\u76f8\u5173\u63d0\u4ea4\u4f7f\u7528eCTD\u884c\u4e1a\u89c4\u8303\u6307\u5357\u300b\uff1b<\/span><\/a>
<\/p>\n

33.CDE\u53d1\u5e03\u300a\u5c0f\u5206\u5b50\u9776\u5411\u6297\u80bf\u7624\u836f\u7269\u4e34\u5e8a\u7814\u7a76\u7b56\u7565\u63a2\u8ba8\u53ca\u6848\u4f8b\u5206\u6790\u300b\uff1b<\/span><\/a>
<\/p>\n

34.CFDA\u53d1\u5e03\u300a\u5f81\u6c42\u610f\u89c1 | \u56fd\u5bb6\u836f\u76d1\u5c40\u5c31\u836f\u54c1\u8bd5\u9a8c\u6570\u636e\u4fdd\u62a4\u5b9e\u65bd\u529e\u6cd5\u5f81\u6c42\u610f\u89c1\u300b\uff1b<\/span><\/a>
<\/p>\n

35.CDE\u4eca\u65e5\u53d1\u5e03\u300a\u5173\u4e8e\u6ce8\u518c\u5206\u7c7b4\u30015.2\u7c7b\u5316\u5b66\u4eff\u5236\u836f\uff08\u53e3\u670d\u56fa\u4f53\u5236\u5242\uff09\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6279\u6b21\u6837\u54c1\u6279\u91cf\u7684\u4e00\u822c\u8981\u6c42\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\uff1b<\/span><\/a>
<\/p>\n

36.CDE\u53d1\u5e03\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u7684\u6807\u51c6\u548c\u7a0b\u5e8f\u300b\u539f\u6587\u4ee5\u53ca\u89e3\u8bfb\uff1b<\/span><\/a><\/p>\n

37.2018\u5e745\u67081\u65e5CDE\u6267\u884c\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u6807\u51c6\u548c\u7a0b\u5e8f\u4e0a\u62a5\u6d41\u7a0b\u56fe\uff1b<\/span><\/a>
<\/p>\n

38.\u5fc3\u6001\u51b3\u5b9a\u59ff\u6001\uff0c\u59ff\u6001\u51b3\u5b9a\u72b6\u6001\uff0c\u72b6\u6001\u51b3\u5b9a\u4eba\u751f\uff1b<\/span><\/a><\/p>\n

39.CDE\u53d1\u5e03\u300aFDA\u5173\u4e8e\u6297\u80bf\u7624\u836f\u7269\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u548c\u8bf4\u660e\u4e66\u5efa\u8bae\u7684\u6307\u5bfc\u539f\u5219\uff08\u8349\u6848\uff09 \u300b\uff1b<\/span><\/a><\/p>\n

40.CDE\u53d1\u5e03\u300a\u6025\u6027\u7f3a\u8840\u6027\u8111\u5352\u4e2d\u6cbb\u7597\u836f\u7269 \u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff1b<\/span><\/a><\/p>\n

41.CDE\u53d1\u5e03\u300a\u6025\u6027\u5fc3\u529b\u8870\u7aed\u6cbb\u7597\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff1b<\/span><\/a><\/p>\n

42.CDE\u53d1\u5e03\u300a\u513f\u79d1\u4eba\u7fa4\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff1b<\/span><\/a><\/p>\n

43.CDE\u53d1\u5e03\u300a\u6297\u80ba\u7ed3\u6838\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff1b<\/a><\/span><\/p>\n

44.CDE\u53d1\u5e03\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e00\u822c\u8003\u8651\u6307\u5bfc\u539f\u5219\u300b\u548cClindata\u89e3\u8bfb\uff1b<\/span><\/a>
<\/p>\n

45.CDE\u53d1\u5e03\u300a\u65b0\u836fI\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u6280\u672f\u6307\u5357\u300b\uff1b<\/span><\/a>
<\/p>\n

46.\u4e2d\u56fd\u533b\u836f\u751f\u7269\u6280\u672f\u534f\u4f1a\u53d1\u5e03\u300a\u5d4c\u5408\u6297\u539f\u53d7\u4f53\u4fee\u9970T\u7ec6\u80de\uff08CAR-T\u7ec6\u80de\uff09\u5236\u5242\u5236\u5907\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff1b<\/span><\/a>
<\/p>\n

47.\u91cd\u6e29CDE\u53d1\u5e03\u300a\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7535\u5b50\u6570\u636e\u91c7\u96c6\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff1b<\/span><\/a>
<\/p>\n

48.CDE\u53d1\u5e03\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7ba1\u7406\u5de5\u4f5c\u6280\u672f\u6307\u5357\u300b\u548cClindata\u91cd\u78c5\u89e3\u8bfb\uff1b<\/span><\/a><\/p>\n

49.CFDA\u53d1\u5e03\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\u53caClindata\u91cd\u78c5\u89e3\u8bfb\uff1b<\/span><\/a><\/p>\n

50.CFDA\u53d1\u5e03\u300a\u6162\u6027\u4e59\u578b\u809d\u708e\u6297\u75c5\u6bd2\u6cbb\u7597\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff1b<\/span><\/a><\/p>\n

51.Clindata\u53d1\u5e03\u300a2013\u5e74\u20142018\u5e74\u4e2d\u56fd\u7c7b\u98ce\u6e7f\u5173\u8282\u708e\u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66\u300b;<\/span><\/a><\/p>\n

52.\u7126\u70b9\u8bbf\u8c08\u300b 20180507 \u65b0\u836f\u5ba1\u6279\u8fdb\u5165\u5feb\u8f66\u9053 \u65b0\u95fb\u539f\u7a3f\u548c\u89c6\u9891;<\/span><\/a>
<\/p>\n

53.CDE\u53d1\u5e03\u300a\u75ab\u82d7\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b;<\/span><\/a><\/p>\n

54.NCI\u53d1\u5e03\u300aCommon Terminology Criteria for Adverse Events (CTCAE)5.0\u300b<\/span>\uff1b<\/span><\/a>
<\/p>\n

55.FDA\u53d1\u5e03\u300aS3A\u6307\u5bfc\uff1a\u5173\u4e8e\u6bd2\u4ee3\u52a8\u529b\u5b66\u6307\u5bfc\u7684\u6ce8\u91ca\uff1a\u6bd2\u6027\u7814\u7a76\u4e2d\u7cfb\u7edf\u66b4\u9732\u7684\u8bc4\u4f30\uff1a\u5173\u6ce8\u5fae\u91c7\u6837\u95ee\u9898<\/span><\/a>
<\/p>\n

56.CDE<\/span>\u53d1\u5e03\u300a\u809d\u529f\u80fd\u635f\u5bb3\u60a3\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219<\/span>—<\/span>\u7814\u7a76\u8bbe\u8ba1\u3001\u6570\u636e\u5206\u6790\u3001\u7ed9\u836f\u5242\u91cf\u8c03\u6574\u548c\u8bf4\u660e\u4e66\u64b0\u5199\u300b\uff1b<\/span><\/span><\/a><\/span><\/p>\n

57.CDE\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300aICH \u534f\u8c03\u6307\u5bfc\u539f\u5219 \u4ea7\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u6280\u672f\u548c\u6cd5\u89c4\u8003\u8651\u300b\uff1b<\/span><\/a>
<\/p>\n

58.CDE\u53d1\u5e03\u300a\u4e2d\u836f\u809d\u635f\u4f24\u4e34\u5e8a\u8bc4\u4ef7\u6307\u5bfc\u539f\u5219\u5f81\u6c42\u610f\u89c1\u7a3f\u300b\uff1b<\/span><\/a><\/p>\n

59.CFDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300a\u51a0\u72b6\u52a8\u8109\u836f\u7269\u6d17\u8131\u652f\u67b6\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u300b\uff1b<\/span><\/a>
<\/p>\n

60.CFDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300a\u51a0\u72b6\u52a8\u8109\u836f\u7269\u6d17\u8131\u652f\u67b6\u4e34\u5e8a\u524d\u7814\u7a76\u6307\u5bfc\u539f\u5219\u300b\uff1b<\/span><\/a><\/p>\n

61.\u603b\u5c40\u5173\u4e8e\u53d1\u5e03\u65b0\u836fI\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u6280\u672f\u6307\u5357\u7684\u901a\u544a\uff082018\u5e74\u7b2c16\u53f7\uff09<\/span>\uff1b<\/span><\/a><\/p>\n

62.\u603b\u5c40\u53d1\u5e03\u300a\u4e2d\u836f\u65b0\u836f\u7528\u4e8e\u7c7b\u98ce\u6e7f\u5173\u8282\u708e\u4e34\u5e8a\u7814\u7a76 \u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff1b <\/span><\/span><\/a>
<\/p>\n

63.\u603b\u5c40\u53d1\u5e03\u300a\u827e\u6ecb\u75c5\u75ab\u82d7\u4e34\u5e8a\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219 \u300b\uff1b<\/span><\/a><\/p>\n

64.EMA\u53d1\u5e03\u300a\u4eba\u4f53\u6297\u764c\u836f\u7269\u8bc4\u4ef7\u6307\u5357\u300b\uff1b<\/span><\/span><\/a><\/p>\n

65.CDE\u53d1\u5e03\u300a\u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u300b\uff1b<\/span><\/a><\/p>\n

66.EMA\u53d1\u5e03\u300a\u75bc\u75db\u6cbb\u7597\u836f\u7269\u7684\u4e34\u5e8a\u7814\u53d1\u6307\u5357\u300b\uff1b<\/span><\/a><\/p>\n

67.EMA\u53d1\u5e03\u300a\u4e34\u5e8a\u8bd5\u9a8c\u4eba\u7fa4\u57fa\u7ebf\u7279\u5f81\u7684\u8bc4\u4f30\u5de5\u5177\u6307\u5357\u300b\uff1b<\/span><\/a><\/p>\n

68.\u521b\u65b0\u836f\u91cd\u5927\u5229\u597d\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u52a0\u5f3a\u836f\u54c1\u5ba1\u8bc4\u5ba1\u6279\u8fc7\u7a0b\u7ba1\u7406;<\/span><\/a><\/p>\n

69.FDA\u53d1\u5e03\u300a\u673a\u6784\u5ba1\u67e5\u59d4\u5458\u4f1a\uff08IRB\uff09\u64b0\u5199\u7a0b\u5e8f\uff1a\u673a\u6784\u548cIRBs\u6307\u5357<\/span><\/a><\/p>\n

70.\u603b\u5c40\u53d1\u5e03\u300a\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7 \u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u6838\u67e5\u6307\u5bfc\u539f\u5219<\/span><\/span><\/a><\/p>\n

71.\u603b\u5c40\u53d1\u5e03\u300a\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u5236\u73b0\u573a\u6838\u67e5\u6307\u5bfc\u539f\u5219\u300b<\/span><\/span><\/a><\/p>\n

72.\u603b\u5c40\u53d1\u5e03\u300a\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u751f\u4ea7\u73b0\u573a\u68c0\u67e5\u6307\u5bfc\u539f\u5219\u300b<\/span><\/span><\/a><\/p>\n

73.\u603b\u5c40\u53d1\u5e03\u300a\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u6709\u56e0\u68c0\u67e5\u6307\u5bfc\u539f\u5219\u300b<\/span><\/span><\/a><\/p>\n

74.\u6d45\u8c08\u4e2d\u56fd\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7ba1\u7406\u548c\u7edf\u8ba1\u5206\u6790<\/span><\/span><\/a>
<\/p>\n

75.FDA\u53d1\u5e03\u300a\u8bb0\u5f55\u7535\u5b50\u6570\u636e\u6587\u4ef6\u548c\u7edf\u8ba1\u5206\u6790\u7a0b\u5e8f\u5f81\u6c42\u610f\u89c1\u7a3f\u300b<\/span><\/span><\/a><\/p>\n

76.CDE\u53d1\u5e03\u300a\u5173\u4e8e\u5f00\u5c55\u590d\u53d1\/\u96be\u6cbb\u6027CD20+B\u7ec6\u80de\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u4e34\u5e8a\u7814\u7a76\u4eba\u7fa4\u5b9a\u4e49\u7684\u5efa\u8bae \u300b<\/span><\/span><\/a><\/p>\n

77.FDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300aBioanalytical Method Validation Guidance for Industry\u300b<\/span><\/span><\/a><\/p>\n

78.FDA\u91cd\u78c5\u53d1\u5e03Bioanalytical Method Validation Guidance for Industry(\u7eed)<\/span><\/span><\/a><\/p>\n

79.\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5173\u4e8e\u53d1\u5e03\u56fd\u5bb6\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u5e74\u5ea6\u62a5\u544a\uff082017\u5e74\uff09\u7684\u516c\u544a\uff082018\u5e74\u7b2c25\u53f7\uff09<\/span><\/span><\/a><\/p>\n

80.\u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u804c\u8d23<\/span><\/span><\/a><\/p>\n

81.FDA\u53d1\u5e03E9(R1)Statistical Principles for Clinical Trials: Addendum<\/span><\/span><\/a><\/p>\n

82.CDE\u767b\u8bb0\u7684\u4e2d\u56fd\u80bf\u7624\u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66\uff08\u7b2c\u4e09\u671f\uff09<\/span><\/span><\/a><\/p>\n

83.CFDA\u53d1\u5e03\u300a\u6c5f\u897f\u7701\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u5de5\u4f5c\u53d6\u5f97\u91cd\u5927\u7a81\u7834\u300b<\/span><\/span><\/a><\/p>\n

84.\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5173\u4e8e\u53d1\u5e03\u53ef\u8c41\u514d\u6216\u7b80\u5316\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\uff08BE\uff09\u8bd5\u9a8c\u54c1\u79cd\u7684\u901a\u544a (2018\u5e74\u7b2c32\u53f7)<\/span><\/span><\/a><\/p>\n

85.FDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300a\u5728\u6210\u4eba\u80bf\u7624\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7eb3\u5165\u9752\u5c11\u5e74\u53d7\u8bd5\u8005\u7684\u8003\u8651\u8981\u70b9\u300b\u884c\u4e1a\u5f81\u6c42\u610f\u89c1\u7a3f<\/span><\/span><\/a><\/p>\n

86.CDE\u521a\u521a\u53d1\u5e03\u5173\u4e8e\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u6807\u51c6\u548c\u7a0b\u5e8f\u300b\u6709\u5173\u4e8b\u9879\u7684\u901a\u77e5\u4ee5\u53caClindata\u89e3\u8bfb<\/span><\/span><\/a><\/p>\n

87.FDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300aFDA\u4e0eBsUFA(\u751f\u7269\u4eff\u5236\u836f\u7528\u6237\u8d39\u7528\u6cd5\u6848)\u4ea7\u54c1\u7684\u8d5e\u52a9\u5546\u6216\u7533\u8bf7\u4eba\u4e4b\u95f4\u7684\u6b63\u5f0f\u4f1a\u8bae\u300b\u6307\u5357\u5f81\u6c42\u610f\u89c1\u7a3f<\/span><\/span><\/a><\/p>\n

88.\u5168\u6587\uff01\u4e2d\u68c0\u9662\u91cd\u78c5\u53d1\u5e03\uff1aCAR-T\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u8d28\u63a7\u53ca\u975e\u4e34\u5e8a\u7814\u7a76\uff0c\u8fd9\u4e9b\u8981\u70b9\u9700\u8003\u8651<\/span><\/span><\/a>
<\/p>\n

89.CDR&ADR\u5173\u4e8e\u516c\u5f00\u5f81\u6c42\u300a\u836f\u54c1\u6587\u732e\u8bc4\u4ef7\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u610f\u89c1\u7684\u901a\u77e5<\/span><\/span><\/a><\/p>\n

90.\u4e2d\u56fdPD-1\u53caPD-L1 \u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66\u7b2c\u4e09\u7248<\/span><\/span><\/a><\/p>\n

91.FDA\u53d1\u5e03\u300aData Standards Program  Action Plan\u300b<\/span><\/a><\/p>\n

92.FDA\u53d1\u5e03\u300a\u7528\u4e8eeCTD\u6709\u5173\u63d0\u4ea4\u9700\u8981\u63d0\u4f9b\u7684\u6cd5\u89c4\u8981\u6c42\u63d0\u4ea4\u7684\u884c\u4e1a\u6307\u5357\u300b<\/span><\/span><\/a><\/p>\n

93.\u5b9e\u73b0\u4e2d\u7f8e\u53cc\u62a5\u9700\u8981\u5efa\u7acb\u300aStudy Data Standards\u300b\u4f53\u7cfb<\/span><\/span><\/a><\/p>\n

94.FDA\u8981\u6c42\u7684\u300aData Standards in the Drug Lifecycle\u300b<\/a><\/span>
<\/p>\n

95.FDA\u53d1\u5e03\u300aData Standards Program Action Plan\u300b\u89e3\u8bfb<\/span><\/span><\/a><\/p>\n

96.FDA\u4e94\u6708\u6279\u51c64\u4e2a1\u7c7b\u65b0\u836f\u6c47\u603b<\/span><\/a><\/p>\n

97.CDE\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u548c\u300a\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u7684\u901a\u77e5<\/span><\/span><\/a><\/p>\n

98.FDA\u5173\u6ce8\u52a8\u7269\u7528\u836f\u5bf9\u4eba\u5b89\u5168\u6027\u5f71\u54cd\uff0c\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300a\u8bc4\u4f30\u98df\u54c1\u751f\u4ea7\u52a8\u7269\u65b0\u578b\u52a8\u7269\u836f\u54c1\u4eba\u7c7b\u98df\u54c1\u5b89\u5168\u7684\u4e00\u822c\u539f\u5219\u7684\u6307\u5bfc\u539f\u5219\u300b<\/span><\/a><\/p>\n

99.\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u79bb\u7fa4\u503c\u7684\u4e00\u822c\u8003\u8651<\/span><\/a><\/p>\n

100.FDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300aPatient-Focused Drug Development: \u6536\u96c6\u5168\u9762\u548c\u4ee3\u8868\u6027\u7684\u6295\u5165\u300b<\/span><\/span><\/a><\/p>\n

101.FDA\u91cd\u78c5\u53d1\u5e03\u300a\u4eba\u7c7b\u514d\u75ab\u7f3a\u9677 \u75c5\u6bd2-1\u611f\u67d3\uff1a\u5f00\u53d1\u5168\u8eab\u7528\u836f\u9884\u66b4\u9732\u9884\u9632\u884c\u4e1a\u6307\u5357\u8349\u6848\u300b<\/span><\/span><\/a><\/p>\n

102.FDA\u53d1\u5e03\u300aHazard Analysis and Risk-Based Preventive Controls\u300b<\/span><\/a><\/p>\n

103.ICH\u91cd\u78c5\u53d1\u5e03\u300aS9\u6297\u764c\u836f\u7269\u975e\u4e34\u5e8a\u8bc4\u4f30\u95ee\u9898\u548c\u89e3\u7b54\u884c\u4e1a\u6307\u5357\u300b<\/span><\/span><\/a><\/p>\n

104.\u6210\u529f\u81ea\u6211\u7ba1\u7406\u768429\u4e2a\u5de5\u5177\uff08\u91cd\u78c5\u5e72\u8d27\uff01\uff09<\/span><\/span><\/a><\/p>\n

105.\u81f4\u8001\u677f\uff1a\u505a\u5230\u8fd9\u4e5d\u70b9\uff0c\u518d\u81ea\u4fe1\u5730\u8bf4\u201c\u4e0b\u5c5e\u548c\u6211\u4e00\u6761\u5fc3\u201d<\/span><\/span><\/a><\/p>\n

106.\u65b0\u95fb\u8054\u64ad\u91cd\u78c5\u76f4\u64ad | \u56fd\u5185\u9996\u4e2aPD-1\u6291\u5236\u5242\u83b7\u6279\u4e0a\u5e02\uff0c\u4f18\u5148\u5ba1\u8bc4\u7684\u65f6\u95f4\u80fd\u591f\u7f29\u77ed\u5230\u56db\u5230\u516d\u4e2a\u6708\u6279\u51c6\u4e0a\u5e02<\/span><\/span><\/p>\n

107.FDA\u53d1\u5e03\u300a\u786e\u5b9a\u4e0a\u5e02\u524d\u540e\u671f\u548c\u6279\u51c6\u540e\u4e34\u5e8a\u7814\u7a76\u4e2d\u5b89\u5168\u6027\u6570\u636e\u7684\u6536\u96c6\u8303\u56f4\u300b<\/span><\/span><\/a><\/p>\n

108.FDA\u53d1\u5e03Safety Considerations ProductDesignMinimizeMedicationErrors<\/span><\/span><\/a><\/p>\n

109.Mitigation Strategies Protect FoodAgainstIntentionalAdulteration<\/span><\/span><\/p>\n

110.CDE\u53d1\u5e03\u300a\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7 \u767e \u95ee \u767e \u7b54\u300b<\/span><\/a><\/p>\n

111.\u4e2d\u68c0\u9662\u53d1\u5e03\u300a\u6297\u4f53\u5076\u8054\u836f\u7269\u8d28\u91cf\u63a7\u5236\u548c\u4e34\u5e8a\u524d\u8bc4\u4ef7\u4e13\u5bb6\u5171\u8bc6\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b<\/span><\/a><\/p>\n

112.FDA\u53d1\u5e03\u300aMajor Depressive  Disorder: Developing  Drugs Treatment\u300b<\/span><\/a><\/p>\n

113.CDE\u53d1\u5e03\u300a\u5173\u4e8e\u53d1\u5e03\u300a\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u8981\u6c42\uff08\u8bd5\u884c\uff09\u300b\u7684\u901a\u77e5\u300b<\/span><\/span><\/a><\/p>\n

114.CDE\u53d1\u5e03\u300a\u5173\u4e8e\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u7f51\u7ad9\u5f00\u901a\u63d0\u4ea4\u201c\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u201d\u9879\u76ee\u7684\u901a\u77e5\u300b<\/span><\/span><\/a><\/p>\n

115.FDA\u53d1\u5e03\u300aClinical TrialEndpointsApprovalNon-Small Lung Cancer\u300b<\/span><\/a><\/p>\n

116FDA\u53d1\u5e03\u300aSafety Reporting Requirements for INDs and BA\/BE Studies\u300b<\/span><\/span><\/a><\/p>\n

117.CDE\u53d1\u5e03\u300a\u6297\u80bf\u7624\u836f\u7269\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c–\u9776\u5411\u6cbb\u7597\u65f6\u4ee3\u7684\u5e38\u89c4\u8bbe\u8ba1\u548c\u65b0\u7b56\u7565\u4ecb\u7ecd\u300b<\/span><\/span><\/a><\/p>\n

118.\u3010\u80bf\u7624\u65b0\u53d1\u91cd\u78c5\u63a8\u8350\u3011\u65b0\u836f\u4e34\u5e8a\u4ef7\u503c\u8bc4\u4f30\u4e0e\u4f18\u5148\u5ba1\u8bc4 CDE \u6768\u5fd7\u654f\u5728\u4e2d\u56fd\u521b\u65b0\u836f\u9ad8\u5cf0\u8bba\u575b\u89c2\u70b9<\/span><\/span><\/a><\/p>\n

119.FDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300a\u80bf\u7624\u6cbb\u7597\u653e\u5c04\u6027\u836f\u7269:\u975e\u4e34\u5e8a\u7814\u7a76\u548c\u6807\u7b7e\u63a8\u8350\u884c\u4e1a\u6307\u5357\u300b<\/span><\/span><\/a><\/p>\n

120.\u7f8e\u56fd\u6297\u80bf\u7624\u836f\u7269III\u671f\u4e34\u5e8a\u8bbe\u8ba1\u548c\u8bc4\u4ef7\u4ecb\u7ecd<\/span><\/span><\/a><\/p>\n

121.2018\u5e744\u670824\u65e5FDA\u66f4\u65b0\u53d1\u5e03\u300a\u4ee5\u7535\u5b50\u683c\u5f0f\u63d0\u4f9b\u76d1\u7ba1\u63d0\u4ea4 – \u4eba\u7528\u836f\u54c1\u548c\u76f8\u5173\u63d0\u4ea4\u4f7f\u7528eCTD\u884c\u4e1a\u89c4\u8303\u6307\u5357\u300b<\/span><\/span><\/a><\/p>\n

122.\u3010\u91cd\u78c5\u65b0\u836f\u5927\u76d8\u70b9\u3011FDA2018\u5e74\u4e0a\u534a\u5e74\u6279\u51c6\u65b0\u836f\u6c47\u603b<\/span><\/strong><\/span><\/a><\/p>\n

123.\u56fd\u836f\u5c40CNDA\u6b63\u5f0f\u53d1\u5e03\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b2015\u5e74\u7248\u7b2c\u4e00\u589e\u8865\u672c<\/span><\/strong><\/span><\/a><\/p>\n

124.FDA Study Data Validator Rules Introduction<\/strong><\/strong><\/span><\/a><\/p>\n

125.FDA\u53d1\u5e03\u300aTechnical Rejection Criteria for Study Data\u300b<\/strong><\/a><\/p>\n

126.\u6ca1\u6709\u836f\u795e\uff0c\u53ea\u6709\u8d23\u4efb\u2014\u2014\u6211\u4eec\u662f\u533b\u53d1\u7684\u4e00\u53ea\u5e55\u540e\u63a8\u624b<\/span><\/strong><\/span><\/a><\/p>\n

127.\u4ea4\u5f85\u4f60\u7684\u4e8b\u529e\u5b8c\u4e86\uff0c\u5c31\u4e0d\u80fd\u56de\u4e2a\u8bdd\u4e48\uff1f<\/span><\/strong><\/span><\/a><\/p>\n

128.\u4f60\u603b\u95ee\u6211\u600e\u4e48\u505a\uff0c\u516c\u53f8\u8bf7\u4f60\u6765\u5e72\u561b\uff1f\uff01(\u53e5\u53e5\u9707\u64bc)<\/span><\/strong><\/span><\/a><\/p>\n

129.\u4f18\u79c0\u5458\u5de5\uff0c\u4ece\u4e0d\u62b1\u6028\uff08\u591a\u8bfb\u51e0\u904d\uff09<\/span><\/strong><\/span><\/a><\/p>\n

130.\u56fd\u5bb6\u836f\u76d1\u5c40\u300a\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836fGMP\u6307\u5357\u300b\u53d1\u5e03\u4ee5\u53caClindata\u5c31\u91cd\u70b9\u5185\u5bb9\u7684\u6807\u6ce8<\/span><\/strong><\/span><\/a><\/p>\n

131.\u4e0d\u61c2\u6c47\u62a5\uff0c\u5de5\u4f5c\u80fd\u529b\u518d\u5f3a\u4e5f\u6ca1\u7528<\/span><\/strong><\/span><\/strong><\/span><\/a><\/p>\n

132.\u8fc7\u5ea6\u7ba1\u7406\uff0c\u5378\u78e8\u6740\u9a74\uff08\u4f20\u75af\u4e86\uff09\uff01<\/span><\/strong><\/span><\/strong><\/span><\/a><\/p>\n

133.FDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300aCMC Information for Human Gene Therapy INDs\u300b<\/span><\/span><\/strong><\/span><\/strong><\/a><\/p>\n

134.\u5458\u5de5\u51ed\u4ec0\u4e48\u5fe0\u8bda\uff1f\uff08\u8bb2\u7684\u900f\u5f7b\uff01\uff09<\/span><\/strong><\/span><\/a><\/p>\n

135.FDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300aHuman Gene Therapy for Rare Diseases\u300b\u884c\u4e1a\u6307\u5357<\/span><\/span><\/strong><\/span><\/strong><\/a><\/p>\n

136.\u4e00\u4e2a\u4f18\u79c0\u5458\u5de5\u7684\u79bb\u804c\u6210\u672c\u5f88\u6050\u6016\uff0c\u6211\u4eec\u5fc5\u987b\u7559\u4f4f\u4ed6\uff08\u5979\uff09\uff01<\/span><\/strong><\/span><\/a><\/p>\n

137.\u5feb\u770b\uff01\uff01\uff01\u4e2d\u56fd\u653f\u5e9c\u7f51\u521a\u521a\u53d1\u5e03\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303 \uff08\u4fee\u8ba2\u8349\u6848\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b<\/span><\/strong><\/span><\/a><\/p>\n

138.\u79bb\u5f00\u516c\u53f8\uff0c\u4f60\u662f\u4ec0\u4e48\uff1f\u5f88\u591a\u5458\u5de5\u770b\u5b8c\u90fd\u8e0f\u5b9e\u7684\u5de5\u4f5c\u4e86\uff01<\/span><\/strong><\/span><\/a><\/p>\n

139.\u901f\u89c8 | \u7b2c30\u6279\u62df\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u516c\u793a<\/span><\/span><\/a><\/p>\n

140.CDE\u6587\u7ae0||ICH E17 \u591a\u5730\u533a\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u7684\u4e34\u5e8a\u89c6\u89d2\u89e3\u8bfb<\/span><\/span><\/a><\/p>\n

141.<\/span>\u4e00\u9f99\u6559\u6388\uff1a\u80ba\u764c\u5e38\u7528\u9776\u5411\u836f\u53ca\u7528\u836f\u987a\u5e8f<\/span><\/a><\/p>\n

142.CDE\u767b\u8bb0\u7684\u4e2d\u56fd\u80bf\u7624\u4e34\u5e8a\u8bd5\u9a8c\u7ea2\u5b9d\u4e66\uff08\u7b2c\u56db\u671f\uff09<\/span><\/strong><\/span><\/a><\/p>\n

143.\u4e00\u4e2aCRA\u7684\u6c42\u52a9<\/span><\/span><\/strong><\/p>\n

144.\u5173\u4e8e\u5370\u53d1\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u5b89\u5168\u8bc4\u4ef7\u2022\u5e7f\u4e1c\u5171\u8bc6\u300b\uff082018\uff09\u7684\u901a\u77e5\uff08\u6b63\u5f0f\u7a3f\uff09<\/span><\/span><\/strong><\/p>\n

145.FDA\u521a\u521a\u53d1\u5e03\u300aE17\u591a\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u8ba1\u5212\u548c\u8bbe\u8ba1\u4e00\u822c\u539f\u5219\u884c\u4e1a\u6307\u5357\u300b<\/span><\/span><\/strong><\/span><\/a><\/p>\n

146.FDA\u521a\u521a\u53d1\u5e03\u300aLabeling for Biosimilar Products Guidance for Industry\u300b<\/span><\/span><\/strong><\/span><\/strong><\/a><\/p>\n

147.FDA\u53d1\u5e03Use Electronic Health Record Data in Clinical Investigation<\/span><\/span><\/a><\/p>\n

148.\u957f\u751f\u751f\u7269\u9ad8\u67d0\u82b3\u7b4915\u4eba\u88ab\u5211\u62d8\uff01\u8fd9\u4e9b\u624b\u6bb5\u53ef\u67e5\u75ab\u82d7\u662f\u5426\u5b89\u5168<\/span><\/strong><\/span><\/a><\/p>\n

149.\u3010\u56fd\u5bb6\u836f\u76d1\u5c40\u6743\u5a01\u53d1\u5e03\u3011\u4e2d\u56fd\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u5907\u6848\u5236\u6b63\u5f0f\u5230\u6765\uff01<\/strong><\/a><\/p>\n

150.\u9a6c\u660e\u54f2\uff1a\u62e5\u6709\u6267\u884c\u529b\u624d\u80fd\u8ba9\u4f60\u5f3a\u5927<\/span><\/strong><\/span><\/strong><\/a><\/p>\n

151.\u4f60\u5582\u5458\u5de5\u5403\u8349\uff0c\u5374\u6307\u671b\u4ed6\u4eec\u6709\u72fc\u6027\uff1f<\/span><\/strong><\/span><\/strong><\/a><\/p>\n

152.\u8bf7\u505a\u597d5\u5e74\u5185\u968f\u65f6\u5931\u4e1a\u7684\u51c6\u5907<\/span><\/strong><\/span><\/a><\/p>\n

153.\u3010\u56fd\u5bb6\u836f\u76d1\u5c40\u6743\u5a01\u53d1\u5e03\u3011\u4e2d\u56fd\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u5907\u6848\u5236\u6b63\u5f0f\u5230\u6765\uff01<\/span><\/span><\/strong><\/a><\/p>\n

154.\u3010\u6d41\u7a0b\u56fe\u3011\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u8c03\u6574\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u5ba1\u8bc4\u5ba1\u6279\u7a0b\u5e8f\u6d41\u7a0b\u56fe(2018\u5e74\u7b2c50\u53f7)<\/span><\/strong><\/span><\/strong><\/a><\/p>\n

155.CDE\u53d1\u5e03\u300a\u5e38\u89c1\u4e00\u822c\u6027\u6280\u672f\u95ee\u9898\u89e3\u7b54\u300b\u5171\u8ba176\u6761<\/strong><\/span><\/a><\/p>\n

156.Risk-Based Monitoring\uff1a\u73b0\u4ee3\u5316\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5b9e\u65bd\u4e0e\u76d1\u7ba1<\/span><\/strong><\/span><\/strong><\/a><\/p>\n

157.CDE\u53d1\u5e03\u300a\u5f00\u901a\u201cICH\u5de5\u4f5c\u529e\u516c\u5ba4\u4e13\u680f\u901a\u77e5\u300b<\/strong><\/span><\/a><\/p>\n

158.CDE\u53d1\u5e03\u300a\u6297\u80bf\u7624\u65b0\u836f\u9996\u6b21\u4eba\u4f53\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u4e34\u5e8a\u76f8\u5173\u8d44\u6599\u51c6\u5907\u5efa\u8bae\u300b\u542f\u793a \u5171\u8ba19\u4e2a\u6307\u5bfc\u539f\u5219 \u719f\u7ec3\u638c\u63e1 \u80bf\u7624\u4e34\u5e8a\u8bd5\u9a8c\u4e00\u7f51\u6253\u5c3d<\/span><\/span><\/strong><\/span><\/strong><\/a><\/p>\n

159.CDE\u53d1\u5e03\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u505a\u597d\u4e00\u822c\u6027\u6280\u672f\u95ee\u9898\u6c9f\u901a\u7684\u901a\u77e5\u300b<\/span><\/a><\/p>\n

160.\u5168\u7403\u6297\u80bf\u7624\u836f\u7269\u5341\u5927\u8d8b\u52bf<\/strong><\/a><\/p>\n

161.\u3010CDE\u91cd\u78c5\u53d1\u5e03\u3011\u56fd\u5916\u4e0a\u5e02\u6025\u9700\u836f\u54c1\u53ef\u4ee5\u76f4\u63a5\u5728CDE\u7533\u8bf7\u4e0a\u5e02\uff0c\u514d\u505a\u4e34\u5e8a\u300a\u5173\u4e8e\u5f81\u6c42\u5883\u5916\u5df2\u4e0a\u5e02\u4e34\u5e8a\u6025\u9700\u65b0\u836f\u540d\u5355\u610f\u89c1\u7684\u901a\u77e5\u300b<\/span><\/span><\/strong><\/a><\/p>\n

162.\u3010FDA\u7533\u62a5\u80bf\u7624\u836f\u7269\u548c\u751f\u7269\u5236\u54c1\u6ce8\u610f\u4e86 \u521a\u521a\u53d1\u5e03\u4e34\u5e8a\u8bd5\u9a8c\u7814\u53d1\u6307\u5bfc\u539f\u5219\u3011I\u671f\u6269\u5c55:\u9996\u6b21\u4eba\u4f53\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u52a0\u901f\u80bf\u7624\u836f\u7269\u548c\u751f\u7269\u5236\u54c1\u5f00\u53d1\u6307\u5357<\/span><\/span><\/strong><\/a><\/p>\n

163.\u91cd\u78c5\u3011\u6bd5\u4e95\u6cc9\u5f15\u548e\u8f9e\u804c\uff012015-2018\u4e0a\u4efb\u4e09\u5e74\u6539\u9769\u6709\u76ee\u5171\u7779 \u4e0b\u4e00\u6b65\u6539\u9769\u8d70\u5411\u4f55\u65b9\uff1f<\/span><\/strong><\/span><\/p>\n

164.<\/span>CDE\u53d1\u5e03\u300a\u6297\u80bf\u7624\u836f\u7269III\u671f\u4e34\u5e8a\u8bbe\u8ba1\u548c\u8bc4\u4ef7\u4ecb\u7ecd\u300b<\/strong><\/span><\/a><\/p>\n

165.CDE\u53d1\u5e03\u300a\u6297\u80bf\u7624\u836f\u7269\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c–\u9776\u5411\u6cbb\u7597\u65f6\u4ee3\u7684\u5e38\u89c4\u8bbe\u8ba1\u548c\u65b0\u7b56\u7565\u4ecb\u7ecd\u300b<\/strong><\/span><\/a><\/p>\n

166.CDE\u53d1\u5e03\u300aICH E17\u591a\u5730\u533a\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\u7684\u4e34\u5e8a\u89c6\u89d2\u89e3\u8bfb\u300b\u9f13\u52b1\u65b0\u53d1\u653e\u773c\u56fd\u9645\u89c6\u91ce \u65b9\u80fd\u53d6\u80dc\u5168\u7403<\/span><\/a><\/p>\n

167.\u56fe\u89e3 | \u5b9e\u4f53\u80bf\u7624\u4e34\u5e8a\u7597\u6548\u8bc4\u4ef7\u6307\u6807\uff08RECIST 1.1\u8bc4\u5206\uff09<\/span><\/a><\/p>\n

168.FDA\u91cd\u78c5\u53d1\u5e03\u300a\u8840\u6db2\u7cfb\u7edf\u6076\u6027\u8840\u6db2\u75be\u75c5\u548c\u80bf\u7624\u75be\u75c5\uff1a\u836f\u54c1\u5f00\u53d1\u5728\u968f\u673a\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4f7f\u7528\u5b89\u6170\u5242\u548c\u76f2\u6cd5\u7684\u884c\u4e1a\u6307\u5357\u300b\u65b9\u6848\u660e\u786e\u5b89\u6170\u5242\u548c\u76f2\u6cd5\u98ce\u9669<\/span><\/a><\/p>\n

169.\u56fd\u5bb6\u536b\u5065\u59d4\u53d1\u6587\uff0c\u7ed9\u533b\u751f\u6da8\u5de5\u8d44\u3001\u653e\u5047\u3001\u6253\u51fb\u533b\u95f9\u2026\u2026\u4e00\u5927\u6ce2\u798f\u5229\u6765\u4e86\uff01<\/span><\/a><\/p>\n

170.CFDA\u91cd\u78c5\u53d1\u5e03\u6025\uff01\uff01\u300a\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u8868\u65b0\u7248\u62a5\u76d8\u7a0b\u5e8f2018\u5e749\u67081\u542f\u7528\uff082018\u5e748\u670829\u65e5\u66f4\u65b0\uff09\u300b<\/span><\/a><\/p>\n

171.NMPA\u5df2\u6d3e\u51fa\u7763\u67e5\u7ec4\u5bf9\u91cd\u5e86\u5e02\u98df\u836f\u76d1\u5c40\u8c03\u67e5\u91cd\u5e86\u533b\u5de5\u9662\u5de5\u4f5c\u8fdb\u884c\u7763\u67e5 \u67d0\u836f\u5382\u88ab\u5458\u5de5\u4e3e\u62a5\uff0c\u9a97\u53d6GMP\u8bc1\u4e66\uff0c\u6bd4\u957f\u6625\u957f\u751f\u751f\u7269\u6709\u8fc7\u4e4b\u65e0\u4e0d\u53ca<\/span><\/a><\/p>\n

172.\u518d\u89c1CFDA\uff01\u56fd\u5bb6\u836f\u76d1\u5c40\u82f1\u6587\u7b80\u79f0\u6539\u4e3aNMPA \u4eceSDA\u5230NMPA\u5145\u5206\u53cd\u5e94\u4e86\u836f\u76d1\u65f6\u4ee3\u7684\u53d8\u8fc1 \u7b80\u79f0\u7684\u53d8\u66f4\u4f53\u73b0\u4e86\u836f\u76d1\u6539\u9769\u7684\u51b3\u5fc3<\/span><\/a><\/p>\n

173.\u836f\u54c1\u53ef\u4ee5\u6eaf\u6e90\u4e86\uff01\uff01\uff01\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u529e\u516c\u5ba4\u516c\u5f00\u5f81\u6c42\u300a\u5173\u4e8e\u836f\u54c1\u4fe1\u606f\u5316\u8ffd\u6eaf\u4f53\u7cfb\u5efa\u8bbe\u7684\u6307\u5bfc\u610f\u89c1\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u610f\u89c1<\/span><\/a><\/p>\n

174.\u521a\u521a\uff0c\u75ab\u82d7\u98ce\u66b4\u514d\u804c\u7b2c\u4e09\u6ce2\uff1a\u56fd\u5bb6\u836f\u76d1\u5c40\u53c8\u6709\u591a\u540d\u5b98\u5458\u88ab\u514d\u804c\uff0c\u4e2d\u68c0\u9662\u4e5f\u672a\u80fd\u5e78\u514d \u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u5bf9\u95ee\u9898\u75ab\u82d7\u6848\u4ef6\u76f8\u5173\u5de5\u4f5c\u4eba\u5458\u95ee\u8d23<\/span><\/a><\/p>\n

175.CDE\u53d1\u5e03\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u6838\u67e5\u5de5\u4f5c\u53ca\u5e38\u89c1\u95ee\u9898\u5206\u6790\u300b<\/span><\/strong><\/span><\/a><\/p>\n

176.\u3010NMPA\u91cd\u78c5\u53d1\u5e03\u3011\u4e0d\u826f\u53cd\u5e94\u62a5\u544a\u6ce8\u610f\u4e86\uff01\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u529e\u516c\u5ba4\u516c\u5f00\u5f81\u6c42\u5173\u4e8e\u4e2a\u4f8b\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u6536\u96c6\u548c\u62a5\u544a\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u610f\u89c1<\/span><\/span><\/strong><\/span><\/a><\/p>\n

177.[CDE\u91cd\u78c5\u53d1\u5e03]ICH\u65f6\u4ee3\u771f\u7684\u5230\u6765\u4e86\uff01\uff01\u5173\u4e8e\u516c\u5f00\u5f81\u6c42\u300aICH E2F\uff1a\u836f\u7269\u7814\u53d1\u671f\u95f4\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a\u6307\u5bfc\u539f\u5219\u300b\u4e2d\u6587\u7ffb\u8bd1\u7a3f\u610f\u89c1\u7684\u901a\u77e5<\/span><\/strong><\/span><\/a><\/p>\n

178.\u3010CDE\u91cd\u78c5\u53d1\u5e03\u3011ICH\u65f6\u4ee3\u771f\u7684\u5230\u6765\u4e86\uff01\uff01\uff01\u300a\u5173\u4e8e\u516c\u5f00\u5f81\u6c426\u4e2aICH\u6307\u5bfc\u539f\u5219\u4e2d\u6587\u7ffb\u8bd1\u7a3f\u610f\u89c1\u7684\u901a\u77e5\u300b<\/span><\/strong><\/span><\/a><\/p>\n

179.ICH\u52a0\u901f\u5230\u6765\uff01\uff01\uff01\u5173\u4e8e\u516c\u5f00\u5f81\u6c42\u300aICH M4\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u901a\u7528\u6280\u672f\u6587\u6863\u300b\u4e2d\u6587\u7ffb\u8bd1\u7a3f\u610f\u89c1\u7684\u901a\u77e5<\/span><\/span><\/strong><\/a><\/p>\n

180.FDA\u521a\u521a\u91cd\u78c5\u53d1\u5e03\u300aClinicalTrials.gov\u6570\u636e\u5e93\u6c11\u4e8b\u7f5a\u6b3e\u300b\u672a\u5728ClinicalTrials.gov\u6ce8\u518c\u7814\u7a76\u4f1a\u88ab\u7f5a\u6b3e<\/span><\/span><\/strong><\/a><\/p>\n

181.\u3010FDA\u521a\u521a\u9996\u6b21\u91cd\u78c5\u53d1\u5e03\u3011\u300aMaster Protocols:\u52a0\u901f\u80bf\u7624\u836f\u7269\u548c\u751f\u7269\u5236\u54c1\u5f00\u53d1\u9ad8\u6548\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u7b56\u7565\u884c\u4e1a\u6307\u5357\u300b<\/span><\/span><\/strong><\/a><\/p>\n

182.\u91cd\u78c5 \u65e0\u9700\u4e34\u5e8a\u8bd5\u9a8c\u5c31\u53ef\u4ee5\u4e0a\u5e02 \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 \u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a\u5173\u4e8e\u4e34\u5e8a\u6025\u9700\u5883\u5916\u65b0\u836f\u5ba1\u8bc4\u5ba1\u6279\u76f8\u5173\u4e8b\u5b9c\u7684\u516c\u544a<\/span><\/span><\/strong><\/span><\/strong><\/a><\/p>\n

183.\u91cd\u78c5 \u786e\u5b9a\u4e86\uff01\uff01\uff01\u65e0\u9700\u4e34\u5e8a\u8bd5\u9a8c\u76f4\u63a5\u53ef\u4ee5\u4e0a\u5e02 CDE\u53d1\u5e03\u300a\u53d1\u5e03\u7b2c\u4e00\u6279\u4e34\u5e8a\u6025\u9700\u5883\u5916\u65b0\u836f\u540d\u5355\u7684\u901a\u77e5\u300b8\u4e2a\u5df2\u7ecf\u76f4\u63a5\u4e0a\u5e02 40\u4e2a\u5728\u5ba1<\/span><\/span><\/strong><\/span><\/strong><\/a><\/p>\n

184.\u5b9a\u7a3f\u4e86!!!\u56fd\u5bb6\u5c40\u521a\u521a\u5b9a\u4e86\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219<\/span><\/span><\/strong><\/span><\/strong><\/a><\/p>\n

185.\u3010\u4f26\u7406\u524d\u7f6e\u65f6\u4ee3\u771f\u7684\u6765\u4e86\uff01\uff01\uff01\u3011\u8fd9\u6b21\uff0c\u534e\u897f\u533b\u9662\u53c8\u8d70\u5728\u4e86\u65f6\u4ee3\u524d\u5217<\/span><\/a><\/span><\/strong><\/p>\n

186.\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5173\u4e8e\u53d1\u5e03\u836f\u7269\u7814\u53d1\u4e0e\u6280\u672f\u5ba1\u8bc4\u6c9f\u901a\u4ea4\u6d41\u7ba1\u7406\u529e\u6cd5\u7684\u516c\u544a\uff082018\u5e74\u7b2c74\u53f7\uff09<\/span><\/a><\/span><\/p>\n

187.\u3010FDA\u521a\u521a\u518d\u6b21\u91cd\u78c5\u53d1\u5e03\u3011\u300a\u836f\u7269\u548c\u751f\u7269\u5236\u54c1Adaptive Designs for Clinical Trials\u884c\u4e1a\u6307\u5357\u300b<\/span><\/a><\/span><\/strong><\/p>\n


<\/strong>
<\/p>\n

\u4ee5\u4e0b\u662f2016\u5e74\u548c2017\u5e74NMPA\u5185\u5bb9\uff1a<\/strong>
<\/p>\n

2017\u5e7410\u67088\u65e5\uff0c\u4e2d\u5171\u4e2d\u592e\u529e\u516c\u5385\u3001\u56fd\u52a1\u9662\u529e\u516c\u5385\u5370\u53d1\u4e86\u300a\u5173\u4e8e\u6df1\u5316\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u9f13\u52b1\u836f\u54c1\u533b\u7597\u5668\u68b0\u521b\u65b0\u7684\u610f\u89c1\u300b\uff0c\u5e76\u53d1\u51fa\u901a\u77e5\u3002\u8fd9\u662f\u7ee72015\u5e748\u6708\u300a\u56fd\u52a1\u9662\u5173\u4e8e\u6539\u9769\u836f\u54c1\u533b\u7597\u5668\u68b0\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u7684\u610f\u89c1\u300b\u4e4b\u540e\uff0c\u53c8\u4e00\u4e2a\u6df1\u5316\u836f\u54c1\u533b\u7597\u5668\u68b0\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u7684\u7eb2\u9886\u6027\u6587\u4ef6\uff0c\u5bf9\u6211\u56fd\u533b\u836f\u4ea7\u4e1a\u521b\u65b0\u53d1\u5c55\u5177\u6709\u91cc\u7a0b\u7891\u610f\u4e49\u3002\u672c\u6587\u4ee5\u300a\u521b\u65b0\u610f\u89c1\u300b\u4e3a\u7ebf\u7d22\uff0c\u5bf9CFDA\u53caCDE\u81ea2015\u5e747\u670822\u65e5\u4ee5\u6765\u53d1\u5e03\u7684\u91cd\u8981\u6587\u4ef6\u8fdb\u884c\u68b3\u7406\uff0c\u7ed9\u5404\u4f4d\u540c\u4ec1\u7814\u7a76\u76f8\u5173\u653f\u7b56\u63d0\u4f9b\u4e00\u4efd\u53c2\u8003\u3002
<\/p>\n

1. \u6539\u9769\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406<\/h2>\n