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\u65e5<strong>\u66f4\u65b0\u65e5\u671f\uff1a<\/strong>2024 \u5e74 2 \u6708 26 \u65e5<strong>\u4f5c\u8005\uff1a<\/strong>\u76c8\u5b87\u6574\u5408\u884c\u92b7<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u524d\u8a00<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u9032\u53e3\u4fdd\u5065\u98df\u54c1\u6642\uff0c\u6700\u4ee4\u696d\u8005\u611f\u5230\u6cae\u55aa\u7684\u60c5\u6cc1\u83ab\u904e\u65bc\u7522\u54c1\u88ab\u6d77\u95dc\u6263\u7559\u3001\u67e5\u9a57\u4e0d\u5408\u683c\uff0c\u751a\u81f3\u88ab\u8981\u6c42\u9000\u904b\u6216\u92b7\u6bc0\u3002\u9019\u4e0d\u50c5\u610f\u5473\u8457\u6642\u9593\u8207\u91d1\u9322\u7684\u6d6a\u8cbb\uff0c\u66f4\u53ef\u80fd\u5c0d\u696d\u52d9\u8a08\u756b\u9020\u6210\u91cd\u5927\u6253\u64ca\u3002\u7136\u800c\uff0c\u5927\u591a\u6578\u7684\u9032\u53e3\u9000\u4ef6\u554f\u984c\u90fd\u662f\u53ef\u4ee5\u9810\u9632\u7684\u3002\u672c\u6587\u5c07\u4ee5\u300c\u98df\u54c1\u9032\u53f0\u7063\u7b56\u7565\u9867\u554f\u300d\u7684\u89d2\u5ea6\uff0c\u70ba\u60a8\u8a73\u7d30\u5206\u6790\u4fdd\u5065\u98df\u54c1\u9032\u53e3\u88ab\u9000\u4ef6\u7684\u5e38\u898b\u539f\u56e0\uff0c\u4e26\u63d0\u4f9b\u76f8\u61c9\u7684\u9810\u9632\u8207\u89e3\u6c7a\u65b9\u6848\uff0c\u52a9\u60a8\u907f\u514d\u9019\u4e9b\u5e38\u898b\u9677\u9631\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u4e00\u3001\u9032\u53e3\u9000\u4ef6\u7684\u5e38\u898b\u539f\u56e0<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. \u6210\u5206\u4e0d\u7b26\u6cd5\u898f<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u9019\u662f\u6700\u5e38\u898b\u7684\u9000\u4ef6\u539f\u56e0\u3002\u4e3b\u8981\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><strong>\u542b\u6709\u53f0\u7063\u672a\u6838\u51c6\u7684\u6210\u5206\uff1a<\/strong>\u00a0\u7522\u54c1\u4e2d\u542b\u6709\u5728\u53f0\u7063\u6cd5\u898f\u4e2d\u672a\u5217\u70ba\u300c\u53ef\u4f9b\u98df\u54c1\u4f7f\u7528\u539f\u6599\u300d\u7684\u6210\u5206\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u98df\u54c1\u6dfb\u52a0\u7269\u8d85\u91cf\uff1a<\/strong>\u00a0\u7522\u54c1\u4e2d\u7684\u98df\u54c1\u6dfb\u52a0\u7269\uff08\u5982\u9632\u8150\u5291\u3001\u751c\u5473\u5291\u7b49\uff09\u7684\u542b\u91cf\u8d85\u904e\u300c\u98df\u54c1\u6dfb\u52a0\u7269\u4f7f\u7528\u7bc4\u570d\u53ca\u9650\u91cf\u66a8\u898f\u683c\u6a19\u6e96\u300d\u7684\u898f\u5b9a\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u4f7f\u7528\u7981\u7528\u6210\u5206\uff1a<\/strong>\u00a0\u7522\u54c1\u542b\u6709\u53f0\u7063\u660e\u78ba\u7981\u7528\u7684\u6210\u5206\uff0c\u5982\u7279\u5b9a\u7684\u4eba\u5de5\u8272\u7d20\u6216\u9632\u8150\u5291\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u4e2d\u85e5\u6750\u6210\u5206\u4e0d\u7b26\uff1a<\/strong>\u00a0\u82e5\u542b\u6709\u4e2d\u85e5\u6750\uff0c\u4f46\u8a72\u4e2d\u85e5\u6750\u672a\u5217\u65bc\u300c\u53ef\u540c\u6642\u63d0\u4f9b\u98df\u54c1\u4f7f\u7528\u4e4b\u4e2d\u85e5\u6750\u300d\u6e05\u55ae\u4e2d\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. \u4e2d\u6587\u6a19\u7c64\u6d89\u53ca\u7642\u6548\u5ba3\u7a31<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u9019\u662f\u7b2c\u4e8c\u5927\u5e38\u898b\u539f\u56e0\u3002\u53f0\u7063\u6cd5\u898f\u56b4\u7981\u98df\u54c1\u6a19\u7c64\u6216\u5ee3\u544a\u4e2d\u51fa\u73fe\u6d89\u53ca\u91ab\u7642\u6548\u80fd\u7684\u5b57\u773c\uff0c\u5e38\u898b\u7684\u9055\u898f\u60c5\u6cc1\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><strong>\u54c1\u540d\u6d89\u53ca\u7642\u6548\uff1a<\/strong>\u00a0\u4f8b\u5982\u300c\u82af\u8840\u901a\u300d\u3001\u300c\u7626\u9ad4\u9320\u300d\u3001\u300c\u8b77\u809d\u5bf6\u300d\u7b49\uff0c\u6697\u793a\u5177\u6709\u7279\u5b9a\u7684\u4fdd\u5065\u6216\u6cbb\u7642\u529f\u6548\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u6587\u6848\u4f7f\u7528\u7981\u7528\u5b57\u773c\uff1a<\/strong>\u00a0\u4f7f\u7528\u300c\u9810\u9632\u300d\u3001\u300c\u6539\u5584\u300d\u3001\u300c\u6e1b\u8f15\u300d\u3001\u300c\u6cbb\u7642\u300d\u3001\u300c\u8a3a\u65b7\u300d\u7b49\u5b57\u773c\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u5716\u7247\u6216\u5716\u6848\u8aa4\u5c0e\uff1a<\/strong>\u00a0\u4f7f\u7528\u53ef\u80fd\u8aa4\u5c0e\u6d88\u8cbb\u8005\u7684\u5716\u7247\u6216\u5716\u6848\uff0c\u4f8b\u5982\u5668\u5b98\u5716\u793a\u6216\u4eba\u9ad4\u90e8\u4f4d\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u82f1\u6587\u539f\u5ee0\u6a19\u7c64\u672a\u4fee\u6b63\uff1a<\/strong>\u00a0\u76f4\u63a5\u4f7f\u7528\u570b\u5916\u539f\u5ee0\u7684\u82f1\u6587\u6a19\u7c64\uff0c\u5176\u4e2d\u53ef\u80fd\u5305\u542b\u7642\u6548\u5ba3\u7a31\uff0c\u672a\u9032\u884c\u4e2d\u6587\u4fee\u6b63\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3. \u4e2d\u6587\u6a19\u7c64\u5176\u4ed6\u4e0d\u5408\u898f\u60c5\u6cc1<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u9664\u4e86\u7642\u6548\u5ba3\u7a31\u5916\uff0c\u4e2d\u6587\u6a19\u7c64\u9084\u53ef\u80fd\u56e0\u4ee5\u4e0b\u539f\u56e0\u88ab\u5224\u5b9a\u70ba\u4e0d\u5408\u898f\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><strong>\u71df\u990a\u6a19\u793a\u4e0d\u5b8c\u6574\u6216\u932f\u8aa4\uff1a<\/strong>\u00a0\u7f3a\u5c11\u516b\u5927\u71df\u990a\u7d20\u7684\u6a19\u793a\uff0c\u6216\u6a19\u793a\u6578\u503c\u8207\u6210\u5206\u5206\u6790\u5831\u544a\u4e0d\u7b26\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u6210\u5206\u6a19\u793a\u9806\u5e8f\u932f\u8aa4\uff1a<\/strong>\u00a0\u6210\u5206\u61c9\u4f9d\u542b\u91cf\u7531\u9ad8\u5230\u4f4e\u6392\u5e8f\uff0c\u82e5\u9806\u5e8f\u932f\u8aa4\u6703\u88ab\u8996\u70ba\u4e0d\u5be6\u6a19\u793a\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u6709\u6548\u65e5\u671f\u6216\u4fdd\u5b58\u671f\u9650\u6a19\u793a\u4e0d\u6e05\uff1a<\/strong>\u00a0\u6a19\u793a\u65b9\u5f0f\u4e0d\u7b26\u5408\u898f\u5b9a\u6216\u96e3\u4ee5\u8fa8\u8b58\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u9032\u53e3\u5546\u8cc7\u8a0a\u4e0d\u5b8c\u6574\uff1a<\/strong>\u00a0\u672a\u6a19\u793a\u9032\u53e3\u5546\u7684\u5b8c\u6574\u540d\u7a31\u3001\u5730\u5740\u3001\u96fb\u8a71\u7b49\u8cc7\u8a0a\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. \u672a\u53d6\u5f97\u5fc5\u8981\u7684\u9032\u53e3\u8a31\u53ef<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u91dd\u5c0d\u7279\u5b9a\u7522\u54c1\u578b\u614b\uff0c\u82e5\u672a\u53d6\u5f97\u5fc5\u8981\u7684\u9032\u53e3\u8a31\u53ef\uff0c\u5c07\u7121\u6cd5\u9806\u5229\u901a\u95dc\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><strong>\u81a0\u56ca\u3001\u9320\u72c0\u98df\u54c1\u672a\u53d6\u5f97\u8f38\u5165\u8a31\u53ef\u51fd\uff1a<\/strong>\u00a0\u9019\u985e\u7522\u54c1\u5fc5\u9808\u5411 FDA \u8fa6\u7406\u67e5\u9a57\u767b\u8a18\uff0c\u53d6\u5f97\u8f38\u5165\u8a31\u53ef\u51fd\u5f8c\u65b9\u53ef\u9032\u53e3\u3002\u82e5\u672a\u53d6\u5f97\u8a31\u53ef\u51fd\uff0c\u6d77\u95dc\u5c07\u6263\u7559\u7522\u54c1\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u6709\u6a5f\u98df\u54c1\u672a\u53d6\u5f97\u6709\u6a5f\u8a8d\u8b49\uff1a<\/strong>\u00a0\u82e5\u6a19\u793a\u300c\u6709\u6a5f\u300d\u6216\u300cBio\u300d\uff0c\u9700\u63d0\u4f9b\u53f0\u7063\u884c\u653f\u9662\u8fb2\u696d\u59d4\u54e1\u6703\u7684\u540c\u610f\u516c\u6587\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">5. \u696d\u8005\u8cc7\u683c\u6216\u767b\u9304\u554f\u984c<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u9032\u53e3\u5546\u7684\u8cc7\u683c\u6216\u767b\u9304\u72c0\u614b\u82e5\u6709\u554f\u984c\uff0c\u4e5f\u6703\u5c0e\u81f4\u9032\u53e3\u88ab\u62d2\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><strong>\u500b\u4eba\u540d\u7fa9\u9032\u53e3\uff1a<\/strong>\u00a0\u500b\u4eba\u7121\u6cd5\u9032\u884c\u5546\u696d\u98df\u54c1\u9032\u53e3\uff0c\u5fc5\u9808\u4ee5\u516c\u53f8\u884c\u865f\u540d\u7fa9\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u98df\u54c1\u696d\u8005\u767b\u9304\u5b57\u865f\u7570\u5e38\uff1a<\/strong>\u00a0\u516c\u53f8\u72c0\u614b\u4e0d\u662f\u300c\u71df\u696d\u4e2d\u300d\uff0c\u6216\u98df\u54c1\u696d\u8005\u767b\u9304\u5b57\u865f\u5df2\u5931\u6548\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u71df\u696d\u9805\u76ee\u4e0d\u7b26\uff1a<\/strong>\u00a0\u516c\u53f8\u71df\u696d\u9805\u76ee\u672a\u6db5\u84cb\u98df\u54c1\u9032\u51fa\u53e3\u76f8\u95dc\u696d\u52d9\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">6. \u5831\u95dc\u6587\u4ef6\u7f3a\u6f0f\u6216\u4e0d\u7b26<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5831\u95dc\u6587\u4ef6\u7684\u5b8c\u6574\u6027\u8207\u6b63\u78ba\u6027\u76f4\u63a5\u5f71\u97ff\u901a\u95dc\u6548\u7387\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><strong>\u6587\u4ef6\u7f3a\u6f0f\uff1a<\/strong>\u00a0\u7f3a\u5c11\u6210\u5206\u5206\u6790\u5831\u544a\u3001\u88fd\u9020\u5ee0\u8b49\u660e\u3001\u4e2d\u6587\u6a19\u7c64\u6a23\u672c\u7b49\u5fc5\u8981\u6587\u4ef6\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u6587\u4ef6\u8cc7\u8a0a\u4e0d\u7b26\uff1a<\/strong>\u00a0\u5546\u696d\u767c\u7968\u3001\u88dd\u7bb1\u55ae\u3001\u6210\u5206\u5206\u6790\u5831\u544a\u7b49\u6587\u4ef6\u4e0a\u7684\u7522\u54c1\u540d\u7a31\u3001\u6210\u5206\u3001\u6de8\u91cd\u7b49\u8cc7\u8a0a\u4e0d\u4e00\u81f4\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u7ffb\u8b6f\u4e0d\u7b26\u898f\u5b9a\uff1a<\/strong>\u00a0\u82f1\u6587\u6587\u4ef6\u7684\u4e2d\u6587\u7ffb\u8b6f\u4e0d\u6e96\u78ba\u6216\u4e0d\u7b26\u5408 FDA \u8981\u6c42\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">7. \u6aa2\u9a57\u7d50\u679c\u4e0d\u5408\u683c<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u6d77\u95dc\u53ef\u80fd\u5c0d\u9032\u53e3\u98df\u54c1\u9032\u884c\u62bd\u6a23\u6aa2\u9a57\uff0c\u82e5\u6aa2\u9a57\u7d50\u679c\u4e0d\u5408\u683c\uff0c\u7522\u54c1\u5c07\u88ab\u6263\u7559\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"\"><strong>\u91cd\u91d1\u5c6c\u8d85\u6a19\uff1a<\/strong>\u00a0\u4f8b\u5982\u925b\u3001\u9398\u3001\u7837\u7b49\u91cd\u91d1\u5c6c\u542b\u91cf\u8d85\u904e\u6cd5\u898f\u9650\u5236\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u5fae\u751f\u7269\u8d85\u6a19\uff1a<\/strong>\u00a0\u5927\u8178\u687f\u83cc\u3001\u674e\u65af\u7279\u83cc\u7b49\u5fae\u751f\u7269\u542b\u91cf\u8d85\u904e\u6a19\u6e96\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u8fb2\u85e5\u6b98\u7559\u8d85\u6a19\uff1a<\/strong>\u00a0\u7522\u54c1\u4e2d\u7684\u8fb2\u85e5\u6b98\u7559\u8d85\u904e\u5141\u8a31\u7bc4\u570d\u3002<\/li>\n\n\n\n<li class=\"\"><strong>\u6210\u5206\u542b\u91cf\u4e0d\u7b26\u5ba3\u7a31\uff1a<\/strong>\u00a0\u5be6\u969b\u6210\u5206\u542b\u91cf\u8207\u6a19\u7c64\u6216\u6210\u5206\u5206\u6790\u5831\u544a\u4e0d\u7b26\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u4e8c\u3001\u9810\u9632\u9000\u4ef6\u7684\u95dc\u9375\u7b56\u7565<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th class=\"has-text-align-left\" data-align=\"left\"><strong>\u9000\u4ef6\u539f\u56e0<\/strong><\/th><th class=\"has-text-align-left\" data-align=\"left\">\u9810\u9632\u65b9\u6cd5<\/th><th class=\"has-text-align-left\" 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