{"id":42925,"date":"2023-09-14T13:49:01","date_gmt":"2023-09-14T11:49:01","guid":{"rendered":"https:\/\/kymos.com\/news\/fda-%e6%96%b0%e6%8c%87%e5%8d%97%ef%bc%9andsris-%e6%8e%a8%e8%8d%90%e7%9a%84%e5%8f%af%e6%8e%a5%e5%8f%97%e6%91%84%e5%85%a5%e9%87%8f%e9%99%90%e5%88%b6\/"},"modified":"2023-09-14T13:49:01","modified_gmt":"2023-09-14T11:49:01","slug":"fda-%e6%96%b0%e6%8c%87%e5%8d%97%ef%bc%9andsris-%e6%8e%a8%e8%8d%90%e7%9a%84%e5%8f%af%e6%8e%a5%e5%8f%97%e6%91%84%e5%85%a5%e9%87%8f%e9%99%90%e5%88%b6","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/fda-%e6%96%b0%e6%8c%87%e5%8d%97%ef%bc%9andsris-%e6%8e%a8%e8%8d%90%e7%9a%84%e5%8f%af%e6%8e%a5%e5%8f%97%e6%91%84%e5%85%a5%e9%87%8f%e9%99%90%e5%88%b6\/","title":{"rendered":"FDA \u65b0\u6307\u5357\uff1aNDSRIs \u63a8\u8350\u7684\u53ef\u63a5\u53d7\u6444\u5165\u91cf\u9650\u5236"},"content":{"rendered":"<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u5df2\u91c7\u53d6\u91cd\u5927\u63aa\u65bd\uff0c\u4ee5\u5e94\u5bf9\u4e0e\u4e9a\u785d\u80fa\u7c7b\u836f\u7269\u76f8\u5173\u6742\u8d28 (NDSRIs) \u76f8\u5173\u7684\u81f4\u7a81\u53d8\u548c\u81f4\u764c\u98ce\u9669\u3002\u4eca\u5e74 8 \u6708\uff0cFDA \u63a8\u51fa\u4e86\u4e00\u9879<a href=\"https:\/\/www.fda.gov\/media\/170794\/download\" target=\"_blank\" rel=\"noopener\" data-wpel-link=\"external\">\u6700\u7ec8\u6307\u5357<\/a>\u6846\u67b6\uff0c\u8be5\u6846\u67b6\u4e0d\u4ec5\u80fd\u9884\u6d4b\u98ce\u9669\uff0c\u8fd8\u4e3a\u836f\u54c1\u548c\u539f\u6599\u836f (APIs) \u4e2d\u7684 NDSRIs \u8bbe\u5b9a\u4e86\u63a8\u8350\u7684\u53ef\u63a5\u53d7\u6444\u5165\u91cf (AI) \u9650\u5236\u3002\u8fd9\u4e00\u5173\u952e\u8fdb\u5c55\u4e0e\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u4fdd\u6301\u4e00\u81f4\uff0c\u65e8\u5728\u63d0\u5347\u5236\u836f\u884c\u4e1a\u7684\u5b89\u5168\u6027\u3002  <\/p>\n<p>\u4e9a\u785d\u80fa\uff0c\u7279\u522b\u662f NDSRIs\uff0c\u56e0\u5176\u6f5c\u5728\u7684\u5065\u5eb7\u98ce\u9669\u800c\u65e5\u76ca\u53d7\u5230\u5236\u836f\u884c\u4e1a\u7684\u5173\u6ce8\u3002\u8fd9\u4e9b\u6742\u8d28\u53ef\u80fd\u5728\u542b\u6709\u4ef2\u80fa\u6216\u4e8c\u7532\u57fa\u53d4\u80fa\u7684\u836f\u54c1\u548c\u539f\u6599\u836f\u4e2d\u5f62\u6210\u3002FDA \u7684\u524d\u77bb\u6027\u65b9\u6cd5\u65e8\u5728\u51cf\u8f7b\u4e0e NDSRIs \u76f8\u5173\u7684\u98ce\u9669\uff0c\u5e76\u786e\u4fdd\u836f\u7269\u7684\u5b89\u5168\u6027\u3002  <\/p>\n<h3><strong>FDA \u5173\u4e8e NDSRIs \u7684\u6743\u5a01\u6307\u5357<\/strong><\/h3>\n<p>\u8fd9\u4efd\u6700\u8fd1\u53d1\u5e03\u7684\u884c\u4e1a\u6307\u5357 (GFI) \u9898\u4e3a\u201c\u4e9a\u785d\u80fa\u7c7b\u836f\u7269\u76f8\u5173\u6742\u8d28 (NDSRIs) \u7684\u63a8\u8350\u53ef\u63a5\u53d7\u6444\u5165\u91cf\u9650\u5236\u201d\uff0c\u662f\u4e00\u9879\u5177\u6709\u91cc\u7a0b\u7891\u610f\u4e49\u7684\u8fdb\u5c55\u3002\u8be5\u6307\u5357\u9002\u7528\u4e8e\u5e7f\u6cdb\u7684\u533b\u836f\u4ea7\u54c1\uff0c\u5305\u62ec\u539f\u6599\u836f\u3001\u975e\u5904\u65b9\u836f (OTC) \u548c\u5904\u65b9\u836f\u3002\u5b83\u4e3a\u786e\u5b9a AI \u9650\u5236\u548c\u9884\u6d4b\u81f4\u764c\u6548\u529b\u5206\u7c7b\u63d0\u4f9b\u4e86\u4e00\u5957\u7ed3\u6784\u5316\u65b9\u6cd5\u3002  <\/p>\n<p>\u6b63\u5982\u6211\u4eec\u4e4b\u524d\u4ecb\u7ecd\u7684\uff0c\u8fd9\u79cd\u5904\u7406\u4e9a\u785d\u80fa\u6742\u8d28\u7684\u65b9\u6cd5\u4e0e\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u5b8c\u5168\u4e00\u81f4\uff0c\u786e\u4fdd\u4e86\u5728\u51cf\u8f7b NDSRIs \u76f8\u5173\u98ce\u9669\u65b9\u9762\u7684\u5168\u7403\u4e00\u81f4\u6027\u548c\u534f\u8c03\u6027\uff0c\u4ece\u800c\u5728\u56fd\u9645\u8303\u56f4\u5185\u4e3a\u60a3\u8005\u5b89\u5168\u505a\u51fa\u8d21\u732e\u3002<\/p>\n<h3><strong>\u4e09\u6b65\u7f13\u89e3\u7b56\u7565<\/strong><\/h3>\n<p>\u6307\u5357\u6982\u8ff0\u4e86 FDA \u671f\u671b\u5236\u9020\u5546\u548c\u7533\u8bf7\u4eba\u5728\u8bc4\u4f30 NDSRIs \u65f6\u4f7f\u7528\u7684\u4e09\u6b65\u7f13\u89e3\u7b56\u7565\uff1a<\/p>\n<ul>\n<li>\u5bf9\u539f\u6599\u836f\u548c\u836f\u54c1\u4e2d\u7684\u4e9a\u785d\u80fa\u8fdb\u884c\u98ce\u9669\u8bc4\u4f30\u3002<\/li>\n<li>\u5982\u679c\u8bc6\u522b\u51fa\u98ce\u9669\uff0c\u5219\u8fdb\u884c\u786e\u8ba4\u6027\u6d4b\u8bd5\u3002<\/li>\n<li>\u9488\u5bf9\u5df2\u6279\u51c6\u548c\u5f85\u6279\u7684\u65b0\u836f\u7533\u8bf7 (NDAs) \u4ee5\u53ca\u7b80\u7565\u65b0\u836f\u7533\u8bf7 (ANDAs)\uff0c\u62a5\u544a\u4e3a\u9632\u6b62\u539f\u6599\u836f\u548c\u836f\u54c1\u4e2d\u51fa\u73b0\u8fd9\u4e9b\u6742\u8d28\u800c\u5b9e\u65bd\u7684\u53d8\u66f4\u3002<\/li>\n<\/ul>\n<h3><strong>\u9884\u6d4b\u81f4\u764c\u6548\u529b\u548c AI \u9650\u5236<\/strong><\/h3>\n<p>\u6307\u5357\u5f15\u5165\u4e86\u4e00\u79cd\u4f7f\u7528\u9884\u6d4b\u81f4\u764c\u6548\u529b\u5206\u7c7b\u7684\u65b9\u6cd5\uff0c\u4e3a NDSRIs \u5206\u914d\u63a8\u8350\u7684 AI \u9650\u5236\u3002\u8be5\u65b9\u6cd5\u4e0e ICH M7(R2) \u6307\u5357\u4fdd\u6301\u4e00\u81f4\uff0c\u5f3a\u8c03\u4f7f\u7528\u7ed3\u6784-\u6d3b\u6027\u5173\u7cfb (SAR) \u6982\u5ff5\u3002AI \u9650\u5236\u7684\u8bbe\u5b9a\u65e8\u5728\u4f7f\u7ec8\u751f\u764c\u75c7\u98ce\u9669\u7684\u589e\u52a0\u63a7\u5236\u5728\u5341\u4e07\u5206\u4e4b\u4e00\u5de6\u53f3\u3002\u6307\u5357\u4e2d\u7684\u8868 1 \u5217\u51fa\u4e86\u9884\u6d4b\u7684\u81f4\u764c\u6548\u529b\u7c7b\u522b\u53ca\u76f8\u5173\u7684\u63a8\u8350 AI \u9650\u5236\uff0c\u8303\u56f4\u4ece 26.5 ng\/\u5929\uff08\u76f8\u6bd4\u4e4b\u4e0b EMA \u6307\u5357\u4e3a 18 ng\/\u5929\uff09\u5230 1500 ng\/\u5929\u3002   <\/p>\n<p>FDA \u8fd8\u627f\u8ba4\uff0cNDSRIs \u6709\u9650\u7684\u5316\u5408\u7269\u7279\u5b9a\u6570\u636e\u5e26\u6765\u4e86\u6311\u6218\u3002\u7f3a\u4e4f\u6570\u636e\u5bfc\u81f4\u7533\u8bf7\u4eba\u8fdb\u884c\u4e0d\u5fc5\u8981\u7684\u7814\u7a76\uff0c\u751a\u81f3\u5bfc\u81f4\u836f\u54c1\u9000\u5e02\u3002\u968f\u4e4b\u800c\u6765\u7684\u836f\u54c1\u77ed\u7f3a\u5f71\u54cd\u4e86\u60a3\u8005\u83b7\u5f97\u836f\u7269\u7684\u673a\u4f1a\u3002\u56e0\u6b64\uff0c\u8be5\u6307\u5357\u65e8\u5728\u5e94\u5bf9\u8fd9\u4e9b\u6311\u6218\uff0c\u5e76\u5728\u5b89\u5168\u8bc4\u4f30\u4e0e\u4e0d\u95f4\u65ad\u836f\u7269\u4f9b\u5e94\u4e4b\u95f4\u53d6\u5f97\u5e73\u8861\u3002   <\/p>\n<h3><strong>\u884c\u4e1a\u4e49\u52a1\u4e0e\u65f6\u95f4\u8868<\/strong><\/h3>\n<p>FDA \u7684\u6307\u5357\u89c4\u5b9a\u4e86\u5236\u836f\u5546\u7684\u5177\u4f53\u4e49\u52a1\u3002\u5df2\u6279\u51c6\u4ea7\u54c1\u7684\u5236\u9020\u5546\u88ab\u8981\u6c42\u5728\u6307\u5357\u53d1\u5e03\u540e\u7684\u4e09\u4e2a\u6708\u5185\uff082023 \u5e74 8 \u6708\uff09\u8bc4\u4f30\u4e9a\u785d\u80fa\u98ce\u9669\uff0c\u5e76\u5efa\u8bae\u5728 2023 \u5e74 11 \u6708 1 \u65e5\u524d\u5b8c\u6210\u8fd9\u4e9b\u8bc4\u4f30\u3002 <\/p>\n<p>\u6b64\u5916\uff0c\u5236\u9020\u5546\u548c\u7533\u8bf7\u4eba\u5fc5\u987b\u786e\u4fdd\u5176\u836f\u54c1\u4e2d\u7684\u4efb\u4f55 NDSRIs \u5728 2025 \u5e74 8 \u6708 1 \u65e5\u524d\u7b26\u5408 FDA \u63a8\u8350\u7684 AI \u9650\u5236\u53ca\u76f8\u5e94\u7684\u81f4\u764c\u6548\u529b\u7c7b\u522b\u3002<\/p>\n<h3><strong>\u5b9e\u65f6\u66f4\u65b0\u4e13\u7528\u7f51\u9875<\/strong><\/h3>\n<p>\u9664\u4e86\u5728\u6307\u5357\u4e2d\u5f3a\u52bf\u8d77\u6b65\u5e76\u63d0\u4f9b\u8fd1 250 \u4e2a\u63a8\u8350 AI \u9650\u5236\u5916\uff0cFDA \u8fd8\u63a8\u51fa\u4e86\u4e00\u4e2a\u4e13\u7528\u7f51\u9875\uff0c\u5176\u4e2d\u5305\u542b\u53ef\u80fd\u5728\u4eba\u7c7b\u836f\u7269\u4e2d\u5f62\u6210\u7684 NDSRIs \u53ef\u63a5\u53d7\u6444\u5165\u91cf\u9650\u5236\u7684\u5b9e\u65f6\u4fe1\u606f\u3002\u8be5\u673a\u6784\u6253\u7b97\u5b9a\u671f\u66f4\u65b0\u8fd9\u4e9b\u4fe1\u606f\uff0c\u786e\u4fdd\u5229\u76ca\u76f8\u5173\u8005\u80fd\u591f\u83b7\u53d6\u6700\u65b0\u6570\u636e\u3002 <\/p>\n<h3><strong>\u7ed3\u8bba<\/strong><\/h3>\n<p>FDA \u5173\u4e8e\u4e9a\u785d\u80fa\u6742\u8d28\u7684\u6700\u7ec8\u6307\u5357\u4ee3\u8868\u4e86\u5236\u836f\u884c\u4e1a\u5728\u63d0\u5347\u5b89\u5168\u6027\u548c\u60a3\u8005\u62a4\u7406\u5386\u7a0b\u4e2d\u7684\u4e00\u4e2a\u91cc\u7a0b\u7891\u3002\u901a\u8fc7\u5e94\u5bf9\u4e0e NDSRIs \u76f8\u5173\u7684\u6311\u6218\u5e76\u8bbe\u5b9a AI \u9650\u5236\uff0cFDA \u548c EMA \u6b63\u5728\u91c7\u53d6\u91cd\u5927\u63aa\u65bd\u4fdd\u62a4\u516c\u4f17\u5065\u5eb7\u3002\u5236\u836f\u5546\u73b0\u5728\u80fd\u591f\u4e0e\u76d1\u7ba1\u673a\u6784\u5408\u4f5c\uff0c\u5e94\u5bf9\u8fd9\u4e9b\u53d8\u5316\uff0c\u5e76\u4e3a\u5168\u7403\u60a3\u8005\u63d0\u4f9b\u5b89\u5168\u6709\u6548\u7684\u836f\u54c1\u3002  <\/p>\n<p>\u5982\u679c\u60a8\u9700\u8981\u4e9a\u785d\u80fa\u6742\u8d28\u5206\u6790\u65b9\u9762\u7684\u534f\u52a9\uff0c\u8bf7\u968f\u65f6\u8054\u7cfb\u6211\u4eec\u4ee5\u83b7\u53d6\u4e13\u5bb6\u652f\u6301\uff1a<a href=\"https:\/\/kymos.com\/zh-hans\/%e8%81%94%e7%b3%bb%e6%88%91%e4%bb%ac\/\" data-wpel-link=\"internal\">https:\/\/kymos.com\/contact\/<\/a>\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406  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