{"id":1571,"date":"2015-09-03T20:58:26","date_gmt":"2015-09-03T20:58:26","guid":{"rendered":"http:\/\/www.wi.rwth-aachen.de\/SmartMedCN\/?p=1571"},"modified":"2015-09-03T20:58:26","modified_gmt":"2015-09-03T20:58:26","slug":"latest-issue-of-cfda-new-procedures-rule-for-drug-registration","status":"publish","type":"post","link":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/2015\/09\/03\/latest-issue-of-cfda-new-procedures-rule-for-drug-registration\/","title":{"rendered":"Latest issue of CFDA: new procedures rule for drug registration"},"content":{"rendered":"<p style=\"text-align: justify\"><strong>Recently, China Food and Drug Administration (CFDA) published an announcement to regulate the acceptance work of drug registration further more. The purport is clear: to clean the backlog and regulate the acceptance. Nevertheless, one term needs to be paid attention to \u2013 the deadline of the acceptance of the drug registration should be strictly obeyed; the name and the responsibility of the handling personnel should be given clear indication of; the problems of \u201cscrambling for numbers\u201d and duplicate claim should be corrected in time. (Source: Chinamsr) <\/strong><\/p>\n<h3 style=\"text-align: justify\">CFDA\u6700\u65b0\u53d1\u5e03\uff1a\u836f\u54c1\u6ce8\u518c\u6d41\u7a0b\u65b0\u89c4\u5219<\/h3>\n<p style=\"text-align: justify\">\u6765\u6e90\uff1a<a href=\"http:\/\/www.chinamsr.com\/2015\/0814\/86518.shtml\" target=\"_blank\">\u4e2d\u56fd\u533b\u836f\u8054\u76df<\/a> 2015-08-14<\/p>\n<p style=\"text-align: justify\">\u6838\u5fc3\u63d0\u793a\uff1a\u8fd1\u65e5\uff0c\u56fd\u5bb6\u98df\u836f\u603b\u5c40\u4e3a\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\uff0c\u5370\u53d1\u4e86\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u7684\u901a\u77e5\u300b\u3002\u4e3b\u65e8\u975e\u5e38\u660e\u786e\uff1a\u6e05\u7406\u79ef\u538b\uff0c\u89c4\u8303\u53d7\u7406\u3002\u4e0d\u8fc7\uff0c\u9700\u8981\u6ce8\u610f\u7684\u5176\u4e2d\u6700\u91cd\u8981\u7684\u4e00\u6761\uff1a\u201c\u901a\u77e5\u8981\u6c42\u5404\u7701\u5c40\u4e25\u5b88\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u7684\u65f6\u95f4\u9650\u5236\u3001\u6ce8\u660e\u7ecf\u529e\u4eba\u5458\u7684\u59d3\u540d\u53ca\u8d23\u4efb\u3001\u53ca\u65f6\u7ea0\u6b63\u62a2\u53f7\u548c\u91cd\u590d\u7533\u62a5\u7b49\u95ee\u9898\u3002\u201d<\/p>\n<p style=\"text-align: justify\">[hide for= &#8220;!logged&#8221;]<\/p>\n<p style=\"text-align: justify\">\u8fd1\u65e5\uff0c\u56fd\u5bb6\u98df\u836f\u603b\u5c40\u4e3a\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\uff0c\u5370\u53d1\u4e86\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u7684\u901a\u77e5\u300b\u3002<\/p>\n<p style=\"text-align: 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justify\">\u98df\u54c1\u836f\u54c1\u76d1\u7ba1\u603b\u5c40<\/p>\n<p style=\"text-align: justify\">\u9644\u4ef6\uff1a<\/p>\n<p style=\"text-align: justify\"><strong>\u836f\u54c1\u6ce8\u518c\u5f62\u5f0f\u5ba1\u67e5\u8865\u5145\u8981\u6c42<\/strong><\/p>\n<p style=\"text-align: justify\"><strong>\u4e00\u3001\u5173\u4e8e\u65b0\u836f\u6ce8\u518c\u7533\u8bf7<\/strong><\/p>\n<p style=\"text-align: justify\">\uff08\u4e00\uff09\u65b0\u836f\u53ca\u6309\u7167\u65b0\u836f\u7a0b\u5e8f\u7533\u8bf7\u7684\u56fd\u4ea7\u836f\u54c1\u548c\u8fdb\u53e3\u836f\u54c1\uff0c\u5e94\u6309\u7a0b\u5e8f\u9996\u5148\u63d0\u4ea4\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff0c\u83b7\u5f97\u6279\u51c6\u540e\u518d\u6b21\u63d0\u4ea4\u7533\u62a5\u751f\u4ea7\/\u8fdb\u53e3\u6ce8\u518c\u7533\u8bf7\u3002<\/p>\n<p style=\"text-align: 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justify\">\u7533\u62a5\u5316\u5b66\u836f\u54c1\u7b2c1.6\u30013.4\u7c7b\u589e\u52a0\u65b0\u9002\u5e94\u75c7\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u5e94\u7531\u5df2\u6301\u6709\u8be5\u54c1\u79cd\u836f\u54c1\u6279\u51c6\u6587\u53f7\u3001\u8fdb\u53e3\u836f\u54c1\u6ce8\u518c\u8bc1\u3001\u533b\u836f\u4ea7\u54c1\u6ce8\u518c\u8bc1\u7684\u7533\u8bf7\u4eba\u63d0\u51fa\uff1b\u4e0d\u6301\u6709\u4e0a\u8ff0\u836f\u54c1\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u7684\u7533\u8bf7\u4eba\u7533\u62a5\u6b64\u7c7b\u589e\u52a0\u65b0\u9002\u5e94\u75c7\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u5e94\u5728\u63d0\u51fa\u8be5\u54c1\u79cd\u7684\u4eff\u5236\u836f\u6ce8\u518c\u7533\u8bf7\u7684\u540c\u65f6\u6216\u4e4b\u540e\u63d0\u51fa\u3002\u535a\u534e-CPhI\u5236\u836f\u5728\u7ebf\u535a\u534e-CPhI\u5236\u836f\u5728\u7ebf<\/p>\n<p style=\"text-align: justify\">\uff08\u4e09\uff09\u65b0\u836f\u8fdb\u5165\u76d1\u6d4b\u671f\u4e4b\u65e5\u8d77\u4e0d\u518d\u53d7\u7406\u5176\u4ed6\u7533\u8bf7\u4eba\u7684\u76f8\u540c\u54c1\u79cd\/\u6539\u5242\u578b\u4f46\u4e0d\u6539\u53d8\u7ed9\u836f\u9014\u5f84\u54c1\u79cd\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff1b\u5df2\u6279\u51c6\u4e34\u5e8a\u7684\uff0c\u53ef\u53d7\u7406\u7533\u62a5\u751f\u4ea7\/\u8fdb\u53e3\u6ce8\u518c\u7533\u8bf7\u3002<\/p>\n<p style=\"text-align: justify\">\uff08\u56db\uff09\u56fd\u4ea7\u5316\u5b66\u65b0\u836f\u53ca\u6309\u7167\u65b0\u836f\u7a0b\u5e8f\u7533\u8bf7\u7684\u8fdb\u53e3\u5316\u5b66\u836f\u54c1\u5728\u63d0\u4ea4\u751f\u4ea7\/\u8fdb\u53e3\u6ce8\u518c\u7533\u8bf7\u65f6\uff0c\u5e94\u63d0\u4f9b\u836f\u54c1\u901a\u7528\u540d\u79f0\u7684\u547d\u540d\u8bc1\u660e\u6587\u4ef6\u3002<\/p>\n<p style=\"text-align: justify\"><strong>\u4e8c\u3001\u5173\u4e8e\u4eff\u5236\u836f\u6ce8\u518c\u7533\u8bf7<\/strong><\/p>\n<p style=\"text-align: justify\">\uff08\u4e94\uff09\u6309\u7167\u5316\u5b66\u836f\u54c16\u7c7b\u7533\u62a5\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u9996\u6b21\u7533\u62a5\u6309\u7167\u7533\u62a5\u751f\u4ea7\u6ce8\u518c\u7a0b\u5e8f\u7533\u8bf7\uff0c\u7ecf\u5ba1\u8bc4\u53ef\u4ee5\u51cf\u514d\u4e34\u5e8a\u7684\uff0c\u53ef\u76f4\u63a5\u6279\u51c6\u4e0a\u5e02\uff1b\u4e0d\u80fd\u51cf\u514d\u4e34\u5e8a\u7684\uff0c\u6279\u51c6\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n<p style=\"text-align: justify\">\uff08\u516d\uff09\u7533\u62a5\u7684\u836f\u54c1\u4e0e\u5df2\u4e0a\u5e02\u836f\u54c1\u6d3b\u6027\u6210\u4efd\u3001\u5242\u578b\u3001\u9002\u5e94\u75c7\u76f8\u540c\u4f46\u89c4\u683c\u3001\u7528\u6cd5\u7528\u91cf\u4e0d\u540c\u7684\uff0c\u6309\u7167\u4eff\u5236\u836f\u7a0b\u5e8f\u53d7\u7406\u3002<\/p>\n<p style=\"text-align: justify\"><strong>\u4e09\u3001\u5173\u4e8e\u8fdb\u53e3\u836f\u6ce8\u518c\u7533\u8bf7<\/strong><\/p>\n<p style=\"text-align: justify\">\uff08\u4e03\uff09\u63d0\u51fa\u8fdb\u53e3\u4e2d\u836f\u6216\u5929\u7136\u836f\u7269\u518d\u6ce8\u518c\u7533\u8bf7\u65f6\uff0c\u82e5\u5c1a\u672a\u786e\u5b9a\u6216\u5f62\u6210\u8be6\u7ec6\u7684\u89c4\u6a21\u5316\u751f\u4ea7\u5de5\u827a\u6587\u4ef6\u4f5c\u4e3a\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u9644\u4ef6\u7684\uff0c\u7531\u603b\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u8fdb\u884c\u6280\u672f\u5ba1\u8bc4\uff0c\u539f\u5219\u4e0a\u4e0d\u6309\u6838\u6863\u7a0b\u5e8f\u7533\u8bf7\u3002<\/p>\n<p style=\"text-align: justify\"><strong>\u56db\u3001\u5173\u4e8e\u8865\u5145\u7533\u8bf7<\/strong><\/p>\n<p style=\"text-align: justify\">\uff08\u516b\uff09\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef64\u4e2d\u836f\u54c1\u8865\u5145\u7533\u8bf7\u6ce8\u518c\u4e8b\u9879\u7b2c20\u9879\u6d89\u53ca\u836f\u54c1\u5b9e\u9645\u751f\u4ea7\u5730\u5740\u53d8\u66f4\u7684\uff0c\u7533\u8bf7\u4eba\u5e94\u6309\u7167\u300a\u836f\u54c1\u6280\u672f\u8f6c\u8ba9\u6ce8\u518c\u7ba1\u7406\u89c4\u5b9a\u300b\uff08\u56fd\u98df\u836f\u76d1\u6ce8\u30142009\u3015518\u53f7\uff09\u9644\u4ef6\u201c\u7b2c\u4e8c\u90e8\u5206\u751f\u4ea7\u6280\u672f\u8f6c\u8ba9\u201d\u4e2d\u201c5.\u836f\u5b66\u7814\u7a76\u8d44\u6599\u201d\u7684\u6280\u672f\u8981\u6c42\u8865\u5145\u63d0\u4f9b\u76f8\u5e94\u7814\u7a76\u8d44\u6599\u3002<\/p>\n<p style=\"text-align: justify\">\uff08\u4e5d\uff09\u6838\u51cf\u836f\u54c1\u529f\u80fd\u4e3b\u6cbb\u3001\u9002\u5e94\u75c7\u7684\uff0c\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef64\u4e2d\u836f\u54c1\u8865\u5145\u7533\u8bf7\u6ce8\u518c\u4e8b\u9879\u7b2c3\u9879\u7684\u7a0b\u5e8f\u548c\u8981\u6c42\u529e\u7406\u3002<\/p>\n<p style=\"text-align: justify\">\uff08\u5341\uff09\u7533\u8bf7\u4eba\u6839\u636e\u836f\u54c1\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u8981\u6c42\u5b8c\u6210\u4e0a\u5e02\u540e\u76f8\u5173\u6280\u672f\u7814\u7a76\u7684\uff0c\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef64\u836f\u54c1\u8865\u5145\u7533\u8bf7\u6ce8\u518c\u4e8b\u9879\u7b2c18\u9879\u529e\u7406\u3002<\/p>\n<p style=\"text-align: justify\">\uff08\u5341\u4e00\uff09\u773c\u7528\u5236\u5242\u7533\u8bf7\u53d8\u66f4\u6700\u5c0f\u5236\u5242\u5355\u4f4d\u88c5\u91cf\u7684\u8865\u5145\u7533\u8bf7\uff0c\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef64\u836f\u54c1\u8865\u5145\u7533\u8bf7\u6ce8\u518c\u4e8b\u9879\u7b2c5\u9879\u7684\u7a0b\u5e8f\u548c\u8981\u6c42\u529e\u7406\u3002<\/p>\n<p style=\"text-align: justify\">\uff08\u5341\u4e8c\uff09\u7533\u8bf7\u64a4\u9500\u5546\u54c1\u540d\u79f0\u7684\u8865\u5145\u7533\u8bf7\uff0c\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef64\u836f\u54c1\u8865\u5145\u7533\u8bf7\u6ce8\u518c\u4e8b\u9879\u7b2c36\u9879\u529e\u7406\uff0c\u5e76\u5e94\u7b26\u5408\u300a\u5173\u4e8e\u529e\u7406\u64a4\u9500\u5546\u54c1\u540d\u8865\u5145\u7533\u8bf7\u6709\u5173\u4e8b\u9879\u7684\u901a\u77e5\u300b\uff08\u98df\u836f\u76d1\u529e\u6ce8\u30142012\u3015130\u53f7\uff09\u76f8\u5173\u8981\u6c42\u3002<\/p>\n<p style=\"text-align: justify\">\uff08\u5341\u4e09\uff09\u836f\u54c1\u6279\u51c6\u8bc1\u660e\u6587\u4ef6\u5df2\u5931\u6548\u7684\uff0c\u76f8\u5173\u54c1\u79cd\u7684\u8865\u5145\u7533\u8bf7\u4e0d\u4e88\u53d7\u7406\u3002<\/p>\n<p style=\"text-align: justify\">\uff08\u5341\u56db\uff09\u540c\u4e00\u54c1\u79cd\u4e0d\u540c\u5236\u5242\u89c4\u683c\u7684\u8865\u5145\u7533\u8bf7\uff0c\u5e94\u6309\u7167\u4e0d\u540c\u5236\u5242\u89c4\u683c\u9010\u4e00\u53d7\u7406\u3002<\/p>\n<p style=\"text-align: justify\"><strong>\u4e94\u3001\u5173\u4e8e\u539f\u6599\u836f\u4e0e\u5236\u5242\u5173\u8054\u7533\u62a5<\/strong><\/p>\n<p style=\"text-align: justify\">\uff08\u5341\u4e94\uff09\u6309\u7167\u56fd\u4ea7\u5316\u5b66\u836f\u54c11-5\u7c7b\u63d0\u51fa\u7684\u65b0\u836f\u5236\u5242\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff081.6\u30013.4\u7c7b\u9664\u5916\uff09\u53ca\u4eff\u5236\u836f\u5236\u5242\u6ce8\u518c\u7533\u8bf7\uff0c\u53d7\u7406\u65f6\u5e94\u5ba1\u6838\u5176\u6240\u7528\u539f\u6599\u836f\u6765\u6e90\uff0c\u6240\u7528\u539f\u6599\u836f\u672a\u83b7\u51c6\u4e0a\u5e02\u7684\uff0c\u5e94\u63d0\u4f9b\u539f\u6599\u836f\u6ce8\u518c\u7533\u8bf7\u7684\u53d7\u7406\u901a\u77e5\u4e66\u590d\u5370\u4ef6\uff0c\u5e76\u5173\u8054\u76f8\u5173\u539f\u6599\u836f\u7684\u53d7\u7406\u53f7\uff0c\u76f8\u5173\u539f\u6599\u836f\u4e0e\u5236\u5242\u5408\u5e76\u5ba1\u8bc4\u3002\u539f\u6599\u836f\u7533\u62a5\u65f6\uff0c\u5e94\u63d0\u4f9b\u5df2\u5173\u8054\u7684\u5236\u5242\u5382\u5bb6\u76f8\u5173\u4fe1\u606f\u3002<\/p>\n<p style=\"text-align: justify\">\u4ec5\u63d0\u51fa\u56fd\u4ea7\u65b0\u836f\u539f\u6599\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08\u5305\u62ec\u6309\u7167\u65b0\u836f\u7a0b\u5e8f\u7533\u8bf7\u7684\u8fdb\u53e3\u539f\u6599\u836f\uff09\uff0c\u540e\u7eed\u672a\u63d0\u51fa\u76f8\u5e94\u5236\u5242\u4e34\u5e8a\/\u7533\u62a5\u751f\u4ea7\u6ce8\u518c\u7533\u8bf7\u7684\uff0c\u4e0d\u4e88\u6279\u51c6\u3002\u5355\u72ec\u63d0\u51fa\u5df2\u83b7\u51c6\u8fdb\u53e3\u5236\u5242\u6240\u7528\u539f\u6599\u836f\u7684\u6ce8\u518c\u7533\u8bf7\u9664\u5916\u3002<\/p>\n<p style=\"text-align: justify\">\uff08\u5341\u516d\uff09\u539f\u6599\u836f\u548c\u5236\u5242\u5206\u522b\u6309\u5316\u5b66\u836f\u54c13\u7c7b\u548c5\u7c7b\u7533\u62a5\u7684\uff0c\u539f\u6599\u836f\u53ca\u5236\u5242\u9996\u6b21\u7533\u62a5\u5747\u5e94\u6309\u65b0\u836f\u4e34\u5e8a\u6ce8\u518c\u7a0b\u5e8f\u7533\u8bf7\u3002<\/p>\n<p style=\"text-align: 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The purport is clear: to clean the backlog and regulate [&hellip;]<\/p>\n","protected":false},"author":1001,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"c2c_always_allow_admin_comments":false,"footnotes":""},"categories":[5],"tags":[14,17,28],"class_list":["post-1571","post","type-post","status-publish","format-standard","hentry","category-pharmaceutical-company-news","tag-drug-supply-chain","tag-government-supervision","tag-standards"],"_links":{"self":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/1571","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/users\/1001"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/comments?post=1571"}],"version-history":[{"count":0,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/1571\/revisions"}],"wp:attachment":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/media?parent=1571"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/categories?post=1571"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/tags?post=1571"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}