{"id":40775,"date":"2018-08-01T14:13:00","date_gmt":"2018-08-01T18:13:00","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-publishes-fy-2019-medical-device-and-generic-drug-user-fees\/"},"modified":"2020-02-07T19:02:26","modified_gmt":"2020-02-07T19:02:26","slug":"fda-publishes-fy-2019-medical-device-and-generic-drug-user-fees","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2019-medical-device-and-generic-drug-user-fees\/","title":{"rendered":"FDA 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\/>\nGDUFA\u7684\u6536\u8d39\u662f\u9488\u5bf9\u7279\u5b9a\u7c7b\u578b\u7684\u836f\u54c1\u4f01\u4e1a\u3002\u4ece2018\u5e7410\u67081\u65e5\u8d77\uff0c\u4eff\u5236\u836f\u54c1\u4f01\u4e1a\u5c06\u9700\u8981\u5411FDA\u652f\u4ed8\u6240\u6709\u9002\u7528\u7684\u4f01\u4e1a\u8d39\u7528\u3002\u9664\u6b64\u4e4b\u5916\uff0cGDUFA\u8fd8\u8981\u6c42\u65b0\u9012\u4ea4\u4e8c\u7c7b\uff08Type II\uff09\u836f\u7269\u7ba1\u7406\u6863\u6848\uff08DMF\uff09\u548c\u7b80\u7565\u65b0\u836f\u7533\u8bf7\uff08ANDA\uff09\u7684\u4f01\u4e1a\u5411FDA\u652f\u4ed8\u8d39\u7528\u3002\u8be6\u60c5\u8bf7\u53c2\u89c1\u4e0b\u6587\u7684\u8d39\u7528\u8868\u3002<\/p>\n<p><strong>2019\u8d22\u5e74GDUFA\u7684\u91cd\u5927\u53d8\u5316<\/strong><\/p>\n<ul>\n<li><strong><em>ANDA\u9879\u76ee\u8d39\u7528<\/em><\/strong>\u2014\u2014\u57282018\u8d22\u5e74\uff0cFDA\u516c\u5e03\u4e86\u7b80\u7565\u65b0\u836f\u7533\u8bf7\u6301\u6709\u8005\u4f01\u4e1a\u7684\u9879\u76ee\u8d39\u7528\u3002\u8fd9\u4e9b\u4f01\u4e1a\u7f34\u7eb3\u7684\u8d39\u7528\u53d6\u51b3\u4e8e\u5176\u5728\u5f53\u5e7410\u67081\u65e5\u6301\u6709\u7684\u7b80\u7565\u65b0\u836f\u7533\u8bf7\u6279\u51c6\u91cf\u3002\u4e0e\u53bb\u5e74\u76f8\u6bd4\uff0c2019\u5e74\u7b80\u7565\u65b0\u836f\u7533\u8bf7\u9879\u76ee\u7684\u8d39\u7528\u589e\u957f\u4e86\u8fd117%\u3002<\/li>\n<li id=\"gdufafees\"><strong><em>II\u7c7bDMF\u9012\u4ea4\u8d39\u7528<\/em><\/strong>\u2014\u2014\u57282018\u8d22\u5e74\uff0c\u5355\u4e2aII\u7c7bDMF\u9012\u4ea4\u8d39\u7528\u4e3a47,829\u7f8e\u5143\uff0c2019\u8d22\u5e74\u540c\u6bd4\u589e\u957f\u8fd115%\uff0c\u8d39\u7528\u4e3a55,013\u7f8e\u5143\u3002<\/li>\n<\/ul>\n<p>\u60a8\u53ef\u4ee5\u67e5\u770b\u4e0b\u65b92018\u8d22\u5e74\u548c2019\u8d22\u5e74\u7684GDUFA\u8d39\u7528\u5bf9\u6bd4\u56fe\uff1a<\/p>\n<p><strong>\u8d39\u7528\u7c7b\u578b<\/strong><\/p>\n<table class=\"feeTable\" border=\"1\" width=\"100%\">\n<tbody>\n<tr>\n<td class=\"dark-bg\" width=\"313\"><strong>\u8d39\u7528\u7c7b\u578b<\/strong><\/td>\n<td class=\"dark-bg\" colspan=\"2\" width=\"168\"><strong>2018\u8d22\u5e74<\/strong><\/td>\n<td class=\"dark-bg\" colspan=\"2\" width=\"157\"><strong>2019\u8d22\u5e74<\/strong><\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" width=\"313\"><strong>\u573a\u5730\u8d39\u7528<\/strong><\/td>\n<td class=\"dark-bg\" width=\"90\"><strong>\u7f8e\u56fd<\/strong><\/td>\n<td class=\"dark-bg\" width=\"78\"><strong>\u975e\u7f8e\u56fd<\/strong><\/td>\n<td class=\"dark-bg\" width=\"78\"><strong>\u7f8e\u56fd<\/strong><\/td>\n<td class=\"dark-bg\" width=\"79\"><strong>\u975e\u7f8e\u56fd<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"313\">\u539f\u6599\u836f\uff08API\uff09<\/td>\n<td width=\"90\">$45,367<\/td>\n<td width=\"78\">$60,367<\/td>\n<td width=\"78\">$44,226<\/td>\n<td width=\"79\">$59,226<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">\u836f\u7269\u5236\u5242\uff08FDF\uff09<\/td>\n<td width=\"90\">$211,087<\/td>\n<td width=\"78\">$226,087<\/td>\n<td width=\"78\">$211,305<\/td>\n<td width=\"79\">$226,305<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">\u5408\u7ea6\u751f\u4ea7\u673a\u6784\uff08CMO\uff09<\/td>\n<td width=\"90\">$70,362<\/td>\n<td width=\"78\">$85,362<\/td>\n<td width=\"78\">$70,435<\/td>\n<td width=\"79\">$85,435<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" colspan=\"5\" width=\"638\"><strong>ANDA\u9879\u76ee\u8d39\u7528-\u53d6\u51b3\u4e8e\u5f53\u5e74\u5ea6\u6301\u6709\u7684\u5df2\u6279\u51c6\u91cf<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"313\">\u5927\u578b\u4f01\u4e1a\uff08\u6301\u670920\u4e2a\u53ca\u4ee5\u4e0aANDAs\uff09<\/td>\n<td colspan=\"2\" width=\"168\">$1,590,792<\/td>\n<td colspan=\"2\" width=\"157\">$1,862,167<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">\u4e2d\u7b49\u4f01\u4e1a\uff08\u6301\u67096-19\u4e2aANDAs\uff09<\/td>\n<td colspan=\"2\" width=\"168\">$636,317<\/td>\n<td colspan=\"2\" width=\"157\">$744,867<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">\u5c0f\u578b\u4f01\u4e1a\uff08\u6301\u67095\u4e2a\u53ca\u4ee5\u4e0bANDAs\uff09<\/td>\n<td colspan=\"2\" width=\"168\">$159,079<\/td>\n<td colspan=\"2\" width=\"157\">$186,217<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" colspan=\"5\" width=\"638\"><strong>\u7533\u8bf7\u8d39\u7528<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"313\">ANDA<\/td>\n<td colspan=\"2\" width=\"168\">$171,823<\/td>\n<td colspan=\"2\" width=\"157\">$178,799<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Type II DMF<\/td>\n<td colspan=\"2\" width=\"168\">$47,829<\/td>\n<td colspan=\"2\" width=\"157\">$55,013<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<p><strong>\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5b98\u65b9\u8d39\u7528<\/strong><br \/>\nMDUFA\u8981\u6c42\u6240\u6709\u5411FDA\u6ce8\u518c\u7684\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5728\u6bcf\u5e74\u6ce8\u518c\u66f4\u65b0\u671f\u95f4\u7f34\u7eb3\u5b98\u65b9\u8d39\u7528\u30022019\u8d22\u5e74\u6240\u6709\u7684\u4f01\u4e1a\u5b98\u65b9\u8d39\u7528\u4e3a4,884\u7f8e\u5143\u3002<a href=\"https:\/\/www.federalregister.gov\/documents\/2018\/07\/30\/2018-16178\/medical-device-user-fee-rates-for-fiscal-year-2019#h-20\">\u6839\u636eMDUFA\u7684\u6cd5\u89c4\u89c4\u5b9a<\/a>\uff0c\u5bf9\u4e8e\u6ca1\u6709\u7f34\u7eb3\u8be5\u5b98\u65b9\u8d39\u7528\u7684\u4f01\u4e1a\uff0cFDA\u5c06\u4e0d\u4f1a\u627f\u8ba4\u5176\u6ce8\u518c\u7684\u5408\u6cd5\u6027\u3002<\/p>\n<p>\u6b64\u5916\uff0cMDUFA\u8fd8\u89c4\u5b9a\u9012\u4ea4\u67d0\u4e9b\u7279\u5b9a\u7684\u533b\u7597\u5668\u68b0\u7533\u8bf7\uff0c\u4ea6\u9700\u5411FDA\u7f34\u7eb3\u8d39\u7528\u3002\u5c0f\u578b\u4f01\u4e1a\uff0c\u5373MDUFA\u5b9a\u4e49\u4e3a\u6700\u8fd1\u4e00\u4e2a\u7a0e\u6536\u5e74\u5ea6\u7684\u8d38\u6613\u603b\u989d\u6216\u6536\u6b3e\u989d\u4e0d\u8d85\u8fc7\u4e00\u4ebf\u7f8e\u5143\u7684\u4f01\u4e1a\uff0c\u53ef\u4ee5\u6309\u7167\u5c0f\u4f01\u4e1a\u6536\u8d39\u6807\u51c6\u7f34\u7eb3\u8d39\u7528\u3002\u6240\u6709\u7684\u533b\u7597\u5668\u68b0\u7533\u8bf7\u8d39\u8f83\u53bb\u5e74\u540c\u6bd4\u4e0a\u6da83-4%\u3002<\/p>\n<p>\u60a8\u53ef\u4ee5\u67e5\u770b\u4e0b\u65b92018\u8d22\u5e74\u548c2019\u8d22\u5e74\u7684MDUFA\u8d39\u7528\u5bf9\u6bd4\u56fe\uff1a<\/p>\n<p><strong>2019\u8d22\u5e74MDUFA\u5b98\u65b9\u8d39\u7528<\/strong><\/p>\n<table class=\"feeTable\" border=\"1\" width=\"100%\">\n<tbody>\n<tr>\n<td class=\"dark-bg\" width=\"229\"><strong>\u8d39\u7528\u7c7b\u578b<\/strong><\/td>\n<td class=\"dark-bg\" colspan=\"2\" width=\"196\"><strong>2018\u8d22\u5e74<\/strong><\/td>\n<td class=\"dark-bg\" colspan=\"2\" width=\"213\"><strong>2019\u8d22\u5e74<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">\u4f01\u4e1a\u5e74\u8d39<\/td>\n<td colspan=\"2\" width=\"196\">$4,624<\/td>\n<td colspan=\"2\" width=\"213\">$4,884<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" width=\"229\"><strong>\u7533\u8bf7\u8d39\u7528<\/strong><\/td>\n<td class=\"dark-bg\" width=\"90\"><strong>\u6807\u51c6\u8d39\u7528<\/strong><\/td>\n<td class=\"dark-bg\" width=\"106\"><strong>\u5c0f\u578b\u4f01\u4e1a\u6536\u8d39<\/strong><\/td>\n<td class=\"dark-bg\" width=\"106\"><strong>\u6807\u51c6\u6536\u8d39<\/strong><\/td>\n<td class=\"dark-bg\" width=\"106\"><strong>\u5c0f\u4f01\u4e1a\u6536\u8d39<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">510(K)\u7533\u8bf7<\/td>\n<td width=\"90\">$10,566<\/td>\n<td width=\"106\">$2,642<\/td>\n<td width=\"106\">$10,953<\/td>\n<td width=\"106\">$2,738<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">513(g)\u7533\u8bf7<\/td>\n<td width=\"90\">$4,195<\/td>\n<td width=\"106\">$2,098<\/td>\n<td width=\"106\">$4,349<\/td>\n<td width=\"106\">$2,175<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">De Novo\u7533\u8bf7<\/td>\n<td width=\"90\">$93,229<\/td>\n<td width=\"106\">$23,307<\/td>\n<td width=\"106\">$96,644<\/td>\n<td width=\"106\">$24,161<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">PMA, PDP, PMR, BLA<\/td>\n<td width=\"90\">$310,764<\/td>\n<td width=\"106\">$77,691<\/td>\n<td width=\"106\">$322,147<\/td>\n<td width=\"106\">$80,537<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">\u5ea7\u8c08\u4f1a\u8865\u5145<\/td>\n<td width=\"90\">$233,073<\/td>\n<td width=\"106\">$58,268<\/td>\n<td width=\"106\">$241,610<\/td>\n<td width=\"106\">$60,403<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">180-\u5929\u8865\u5145<\/td>\n<td width=\"90\">$46,615<\/td>\n<td width=\"106\">$11,654<\/td>\n<td width=\"106\">$48,322<\/td>\n<td width=\"106\">$12,081<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">\u5b9e\u65f6\u8865\u5145<\/td>\n<td width=\"90\">$21,753<\/td>\n<td width=\"106\">$5,438<\/td>\n<td width=\"106\">$22,550<\/td>\n<td width=\"106\">$5,638<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">BLA \u6709\u6548\u6027\u8865\u5145<\/td>\n<td width=\"90\">$310,764<\/td>\n<td width=\"106\">$77,691<\/td>\n<td width=\"106\">$322,147<\/td>\n<td width=\"106\">$80,537<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">\u5e74\u5ea6PMA\u62a5\u544a<\/td>\n<td width=\"90\">$10,877<\/td>\n<td width=\"106\">$2,719<\/td>\n<td width=\"106\">$11,275<\/td>\n<td width=\"106\">$2,819<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5982\u679c\u60a8\u4e0d\u80fd\u786e\u5b9a\u5e94\u8be5\u7f34\u7eb3\u4f55\u79cd\u8d39\u7528\uff1fRegistrar Corp\u7684\u6cd5\u89c4\u4e13\u5bb6\u53ef\u4ee5\u534f\u52a9\u60a8\u786e\u8ba4\u5e76\u7b80\u5316\u60a8\u7684\u4ed8\u6b3e\u6d41\u7a0b\u3002\u5982\u6b32\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u81f4\u7535+1-757-224-0177\uff0c\u6216\u70b9\u51fb<a href=\"https:\/\/regstaging.wpengine.com\/livehelp\">regstaging.wpengine.com\/livehelp<\/a> \u4e0e\u6211\u4eec24\u5c0f\u65f6\u5728\u7ebf\u6cd5\u89c4\u987e\u95ee\u5b9e\u65f6\u8054\u7cfb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u8fd1\u671f\u516c\u5e03\u4e862019\u8d22\u5e74\uff08FY\uff09\u4eff\u5236\u836f\u4f01\u4e1a\u4ed8\u8d39\u6cd5\u6848\uff08GDUFA\uff09\u548c\u533b\u7597\u5668\u68b0\u4ed8\u8d39\u6cd5\u6848\uff08MDUFA\uff09\u7684\u6536\u8d39\u8ba1\u5212\u30022019\u8d22\u5e74\u7684\u8fd9\u4e24\u9879\u8d39\u7528\u5c06\u57282018\u5e7410\u67081\u65e5\u5f00\u59cb\u751f\u6548\u3002\u4e3a\u4fdd\u8bc1\u4f01\u4e1a\u53ca\u65f6\u4e86\u89e3\u8fd9\u4e9b\u6cd5\u89c4\u8981\u6c42\uff0cRegistrar Corp\u5bf9\u5373\u5c06\u5230\u6765\u7684\u8d39\u7528\u53d8\u5316\u8fdb\u884c\u4e86\u5982\u4e0b\u6982\u62ec\u3002 \u836f\u54c1\u4f01\u4e1a\u7684\u6536\u8d39 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