{"id":51290,"date":"2021-08-05T10:13:22","date_gmt":"2021-08-05T14:13:22","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022\/"},"modified":"2021-08-11T09:51:22","modified_gmt":"2021-08-11T13:51:22","slug":"fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022\/","title":{"rendered":"\u5ba3\u5e032022 \u8d22\u5e74\u65b0\u7684\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u7528\u6237\u8d39\u7528"},"content":{"rendered":"

\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40(FDA)\u5df2\u6839\u636e\u300a\u4eff\u5236\u836f\u7528\u6237\u8d39\u7528\u4fee\u6b63\u6848(GDUFA)\u300b\u548c\u300a\u533b\u7597\u5668\u68b0\u7528\u6237\u8d39\u7528\u4fee\u6b63\u6848 (MDUFA)\u300b\u5ba3\u5e03\u4e862022\u8d22\u5e74(FY) \u7684\u8d39\u7528\u3002<\/p>\n

2022\u8d22\u653f\u5e74\u5ea6\u4ece2021\u5e74 10 \u6708 1\u65e5\u5f00\u59cb\uff0c\u5230 2022 \u5e749 \u6708 30\u65e5\u7ed3\u675f \u3002\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u5fc5\u987b\u652f\u4ed8\u8d39\u7528\u4ee5\u4fdd\u6301\u5176FDA\u6ce8\u518c\u7684\u5408\u89c4\u72b6\u6001\u3002<\/p>\n

\u836f\u54c1\u8bbe\u65bd\u8d39<\/strong><\/p>\n

\u6839\u636e GDUFA\uff0cFDA \u8bc4\u4f30\u5e76\u5411\u6d3b\u539f\u6599\u836f (API) \u8bbe\u65bd\u3001\u6210\u54c1\u5242\u578b (FDF) \u8bbe\u65bd\u548c\u5408\u540c\u5236\u9020\u7ec4\u7ec7 (CMO)\u6536\u53d6\u8d39\u7528\u3002\u975e\u7f8e\u56fd\u4f01\u4e1a\u7684\u8bbe\u65bd\u8d39\u7528\u66f4\u9ad8\uff0c\u4ee5\u8865\u507f\u989d\u5916\u7684\u9a8c\u5382\u8d39\u7528\u3002<\/p>\n

2022\u8d22\u5e74\u7684GDUFA\u8bbe\u65bd\u8d39\u4e0a\u6da8\u4e86\uff0c\u4e0e2020\u5e74\u81f32021\u7684\u8d39\u7528\u4e0b\u8c03\u6070\u6070\u76f8\u53cd\u3002\u56fd\u5185\u5916API\u8d39\u7528\u4e0a\u6da8\u7ea62%\u3002\u9488\u5bf9\u7f8e\u56fd\u672c\u571f\u548c\u6d77\u5916\u7684FDF \u548c CMO \u8d39\u7528\u5747\u589e\u52a0\u4e86\u7ea6 5%\u3002\u4e0e\u4e4b\u76f8\u53cd\u7684\u662f\uff0c\u5404\u79cd\u89c4\u6a21\u7684\u4f01\u4e1a\u7684\u9879\u76ee\u8d39\u7528\u51cf\u5c11\u4e86\u7ea6 0.4% \u3002<\/p>\n

\u8bbe\u65bd\u8d39\u7528\u7684\u589e\u52a0\u53ef\u80fd\u6e90\u4e8e\u6700\u540e\u4e00\u5e74\u7684\u8c03\u6574\uff0c\u8fd9\u5141\u8bb8 FDA \u589e\u52a0\u8d39\u7528\u4ee5\u63d0\u4f9b\u6700\u591a 3 \u4e2a\u6708\u7684\u8fd0\u8425\u50a8\u5907\u3002\u50a8\u5907\u91d1\u5c06\u62b5\u6d88\u4e0e 2023 \u8d22\u5e74\u521d\u9884\u8ba1\u4eff\u5236\u836f\u6d3b\u52a8\u76f8\u5173\u7684\u6210\u672c\u3002\u4e3a\u4e86\u786e\u5b9a\u8c03\u6574\uff0cFDA \u5206\u6790\u4e86\u9884\u8ba1\u5f81\u6536\u7684\u8d39\u7528\u548c\u5176\u9700\u8981\u5c65\u884c\u7684\u4e49\u52a1\uff0c\u5e76\u8003\u8651\u5230\u8d39\u7528\u589e\u52a0\u53ef\u80fd\u7ed9\u884c\u4e1a\u5e26\u6765\u7684\u8d22\u52a1\u8d1f\u62c5\u3002\u6700\u7ec8\uff0cFDA \u51b3\u5b9a\u589e\u52a0\u8d39\u7528\u4ee5\u63d0\u4f9b 7 \u5468\u7684\u8fd0\u8425\u50a8\u5907\u3002<\/p>\n

2022 \u8d22\u5e74GDUFA \u8d39\u7528<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u8d39\u7528\u7c7b\u578b<\/strong><\/td>\n\u8d22\u5e74 2021<\/strong><\/td>\n\u8d22\u5e74 2022<\/strong><\/td>\n<\/tr>\n
\u8bbe\u65bd\u8d39<\/strong><\/td>\n\u56fd\u5185\u7684<\/strong><\/td>\n\u5916\u56fd\u7684<\/strong><\/td>\n\u56fd\u5185\u7684<\/strong><\/td>\n\u5916\u56fd\u7684<\/strong><\/td>\n<\/tr>\n
\u539f\u6599\u836f (API)<\/td>\n41,671 \u7f8e\u5143<\/td>\n56,671 \u7f8e\u5143<\/td>\n42,557 \u7f8e\u5143<\/td>\n57,557 \u7f8e\u5143<\/td>\n<\/tr>\n
\u6210\u54c1\u5242\u578b (FDF)<\/td>\n184,022 \u7f8e\u5143<\/td>\n199,022 \u7f8e\u5143<\/td>\n195,012 \u7f8e\u5143<\/td>\n210,012 \u7f8e\u5143<\/td>\n<\/tr>\n
\u5408\u540c\u5236\u9020\u7ec4\u7ec7 (CMO)<\/td>\n61,341 \u7f8e\u5143<\/td>\n76,341 \u7f8e\u5143<\/td>\n65,004 \u7f8e\u5143<\/td>\n80,004 \u7f8e\u5143<\/td>\n<\/tr>\n
GDUFA\u8ba1\u5212\u8d39\u7528 \u2013 \u57fa\u4e8e\u5df2\u6279\u51c6\u7684 ANDA \u6570\u91cf<\/strong><\/td>\n<\/tr>\n
\u5927\u578b\uff0820 \u4e2a\u6216\u66f4\u591aANDA)<\/td>\n1,542,993 \u7f8e\u5143<\/td>\n1,536,856 \u7f8e\u5143<\/td>\n<\/tr>\n
\u4e2d\u7b49\uff086 \u2013 19 \u4e2a ANDA)<\/td>\n617,197 \u7f8e\u5143<\/td>\n614,742 \u7f8e\u5143<\/td>\n<\/tr>\n
\u5c0f\uff085 \u4e2a\u6216\u66f4\u5c11 ANDA)<\/td>\n154,299 \u7f8e\u5143<\/td>\n153,686 \u7f8e\u5143<\/td>\n<\/tr>\n
Application Fees<\/strong><\/td>\n<\/tr>\n
ANDA<\/td>\n196,868 \u7f8e\u5143<\/td>\n225,712 \u7f8e\u5143<\/td>\n<\/tr>\n
II\u578bDMF<\/td>\n69,921 \u7f8e\u5143<\/td>\n74,952 \u7f8e\u5143<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u533b\u7597\u5668\u68b0\u8d39\u7528<\/strong><\/p>\n

FDA \u8981\u6c42\u5bf9\u67d0\u4e9b\u533b\u7597\u5668\u68b0\u7533\u8bf7\u3001III \u7c7b\u5668\u68b0\u7684\u5b9a\u671f\u62a5\u544a\u4ee5\u53ca\u4f01\u4e1a\u7684\u5e74\u5ea6\u6ce8\u518c\u6536\u53d6\u8d39\u7528\u3002\u6700\u8fd1\u4e00\u4e2a\u7eb3\u7a0e\u5e74\u5ea6\u7684\u603b\u9500\u552e\u989d\u4f4e\u4e8e1\u4ebf\u7f8e\u5143\u7684\u4f01\u4e1a\u53ef\u4ee5\u4f5c\u4e3a\u5c0f\u4f01\u4e1a\u83b7\u5f97\u7533\u8bf7\u8d39\u7528\u51cf\u514d\u7684\u8d44\u683c\u3002\u603b\u9500\u552e\u989d\u4f4e\u4e8e 3000 \u4e07\u7f8e\u5143\u7684\u4f01\u4e1a\u53ef\u4ee5\u8c41\u514d\u9996\u6b21\u4e0a\u5e02\u524d\u7533\u8bf7\u6216\u62a5\u544a\u8d39\u7528\u3002\u5982\u679c\u8d35\u53f8\u7b26\u54082021\u8d22\u5e74\u51cf\u514d\u8d39\u7528\u7684\u6761\u4ef6\uff0c\u5219\u5fc5\u987b\u5728\u7eed\u671f\u671f\u95f4\u5411FDA\u91cd\u65b0\u63d0\u4ea4\u4fe1\u606f\u4ee5\u4fdd\u6301\u5408\u683c\u8d44\u8d28\u3002<\/p>\n

\u5c0f\u578b\u4f01\u4e1a\u5728\u4f01\u4e1a\u6ce8\u518c\u8d39\u7528\u65b9\u9762\u4e0d\u4eab\u53d7\u8d39\u7528\u51cf\u514d\u3002\u4f01\u4e1a\u6ce8\u518c\u5bf9\u5404\u79cd\u89c4\u6a21\u7684\u4f01\u4e1a\u90fd\u662f\u4e00\u6837\u7684\uff0c\u5728\u4ed8\u6b3e\u4e4b\u524d FDA\u4f1a\u89c6\u4e3a\u6ce8\u518c\u672a\u5b8c\u6210\u3002\u6b64\u5916\uff0c\u6b64\u8d39\u7528\u9002\u7528\u4e8e\u516c\u53f8\u62e5\u6709\u7684\u5904\u7406\u533b\u7597\u5668\u68b0\u67d0\u4e9b\u529f\u80fd\u7684\u6bcf\u4e2a\u7269\u7406\u4f4d\u7f6e\u3002\u6bcf\u4e2a\u7269\u7406\u4f4d\u7f6e\u90fd\u9700\u8981\u652f\u4ed8\u4f01\u4e1a\u6ce8\u518c\u8d39\u3002\u5bf9\u4e8e2022 \u8d22\u5e74\uff0c\u533b\u7597\u5668\u68b0\u8d39\u7528\u6bd4 2021 \u8d22\u5e74\u589e\u52a0\u7ea6 2.5%\u3002FDA\u8868\u793a\u8fd9\u662f\u8003\u8651\u5230\u4e86\u53bb\u5e74\u7684\u901a\u8d27\u81a8\u80c0\u3002<\/p>\n

2022 \u8d22\u5e74MDUFA \u8d39\u7528<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u8d39\u7528\u7c7b\u578b<\/strong><\/td>\n2021\u5e74<\/strong><\/td>\n2022\u5e74<\/strong><\/td>\n<\/tr>\n
\u5e74\u5ea6\u673a\u6784\u6ce8\u518c<\/td>\n5,546 \u7f8e\u5143<\/td>\n5,672 \u7f8e\u5143<\/td>\n<\/tr>\n
\u7533\u8bf7\u8d39<\/strong><\/td>\n\u6807\u51c6<\/strong><\/td>\n\u5c0f\u578b\u4f01\u4e1a<\/strong><\/td>\n\u6807\u51c6<\/strong><\/td>\n\u5c0f\u578b\u4f01\u4e1a<\/strong><\/td>\n<\/tr>\n
510(k)<\/td>\n12,432 \u7f8e\u5143<\/td>\n3,108 \u7f8e\u5143<\/td>\n12,745\u7f8e\u5143<\/td>\n3,186\u7f8e\u5143<\/td>\n<\/tr>\n
513(g)<\/td>\n4,936 \u7f8e\u5143<\/td>\n2,468 \u7f8e\u5143<\/td>\n5,061\u7f8e\u5143<\/td>\n2,530\u7f8e\u5143<\/td>\n<\/tr>\n
De Novo Classification<\/td>\n109,697 \u7f8e\u5143<\/td>\n27,424 \u7f8e\u5143<\/td>\n112,457\u7f8e\u5143<\/td>\n28,114\u7f8e\u5143<\/td>\n<\/tr>\n
PMA\u3001PDP\u3001PMR\u3001BLA<\/td>\n365,657 \u7f8e\u5143<\/td>\n91,414 \u7f8e\u5143<\/td>\n374,858 \u7f8e\u5143<\/td>\n93,714\u7f8e\u5143<\/td>\n<\/tr>\n
panel-track supplement<\/td>\n274,243 \u7f8e\u5143<\/td>\n68,561 \u7f8e\u5143<\/td>\n281,143\u7f8e\u5143<\/td>\n70,286\u7f8e\u5143<\/td>\n<\/tr>\n
180-day supplement<\/td>\n54,849 \u7f8e\u5143<\/td>\n13,712 \u7f8e\u5143<\/td>\n56,229\u7f8e\u5143<\/td>\n14,057\u7f8e\u5143<\/td>\n<\/tr>\n
real-time supplement<\/td>\n25,596 \u7f8e\u5143<\/td>\n6,399 \u7f8e\u5143<\/td>\n26,240\u7f8e\u5143<\/td>\n6,560\u7f8e\u5143<\/td>\n<\/tr>\n
BLA efficacy supplement<\/td>\n365,657 \u7f8e\u5143<\/td>\n91,414 \u7f8e\u5143<\/td>\n374,858 \u7f8e\u5143<\/td>\n93,714\u7f8e\u5143<\/td>\n<\/tr>\n
PMA\u5e74\u5ea6\u62a5\u544a<\/td>\n12,798 \u7f8e\u5143<\/td>\n3,200 \u7f8e\u5143<\/td>\n13,120\u7f8e\u5143<\/td>\n3,280 \u7f8e\u5143<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Registrar Corp \u662f\u4e00\u5bb6\u534f\u52a9\u4f01\u4e1a\u9075\u5b88 FDA \u6cd5\u89c4\u7684\u79c1\u8425\u516c\u53f8\u3002\u6211\u4eec\u53ef\u4ee5\u5e2e\u52a9\u786e\u5b9a\u8d35\u53f8\u9700\u8981\u652f\u4ed8\u54ea\u4e9b\u8d39\u7528\u5e76\u53ef\u4ee5\u4ee3\u7f34FDA\u8d39\u7528\u3002\u6b32\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u81f4\u7535+ 1-757 – 224 – 0177 \uff0c\u6216\u53d1\u9001\u7535\u5b50\u90ae\u4ef6\u81f3info@registrarcorp.com<\/a>\u4e0e\u6211\u4eec\u8054\u7cfb\uff0c\u6216\u8005\u901a\u8fc7regstaging.wpengine.com\/livechat<\/a>\u4e0e\u6211\u4eec\u5168\u5929\u5019\u5728\u7ebf\u7684\u6cd5\u89c4\u987e\u95ee\u5373\u65f6\u8054\u7cfb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

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