{"id":166,"date":"2026-08-07T21:28:35","date_gmt":"2026-08-07T11:28:35","guid":{"rendered":"https:\/\/ozhailun.com\/?p=166"},"modified":"2026-08-24T16:48:18","modified_gmt":"2026-08-24T06:48:18","slug":"how-chinese-companies-can-conduct-early-clinical-trials-in-australia","status":"publish","type":"post","link":"https:\/\/ozhailun.com\/zh_hk\/how-chinese-companies-can-conduct-early-clinical-trials-in-australia\/","title":{"rendered":"\u4e2d\u56fd\u4f01\u4e1a\u5982\u4f55\u5728\u6fb3\u5927\u5229\u4e9a\u5f00\u5c55\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff1a\u4f18\u52bf\u4e0e\u6cd5\u5f8b\u5b89\u6392\u89e3\u6790"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u672c\u6587\u5206\u4e3a\u4e24\u4e2a\u90e8\u5206\uff1a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7b2c\u4e00\u90e8\u5206\uff1a\u6fb3\u5927\u5229\u4e9a\u4f5c\u4e3a\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff08Phase I\uff09\u76ee\u7684\u5730\u7684\u4f18\u52bf<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7b2c\u4e8c\u90e8\u5206\uff1a\u4e2d\u56fd\u4f01\u4e1a\u51fa\u6d77\u6fb3\u6d32\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6cd5\u5f8b\u5b89\u6392<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/mp.weixin.qq.com\/s\/5s54I8HJVCT4KnEM0ccDpA\" type=\"link\" id=\"https:\/\/mp.weixin.qq.com\/s\/5s54I8HJVCT4KnEM0ccDpA\">\u8be5\u6587\u7ae02026\u5e743\u670820\u65e5\u53d1\u5e03\u4e8e\u201c\u571f\u6fb3\u6d77\u4f26-\u6fb3\u6d32\u7b14\u8bb0\u201d\u5fae\u4fe1\u516c\u5171\u53f7<\/a><\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1000\" height=\"651\" src=\"https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c.png\" alt=\"\" class=\"wp-image-167\" srcset=\"https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c.png 1000w, https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c-300x195.png 300w, https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c-768x500.png 768w, https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c-18x12.png 18w, https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c-400x260.png 400w\" sizes=\"auto, (max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u4e00\u3001\u6fb3\u5927\u5229\u4e9a\u4f5c\u4e3a\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff08Phase I\uff09\u76ee\u7684\u5730\u7684\u4f18\u52bf<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6fb3\u5927\u5229\u4e9a\u51ed\u501f\u9ad8\u6548\u4e14\u6210\u719f\u7684\u76d1\u7ba1\u4f53\u7cfb\uff0c\u5df2\u6210\u4e3a\u5168\u7403\u5f00\u5c55\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u91cd\u8981\u76ee\u7684\u5730\u3002\u5728CTN\u673a\u5236\u4e0b\uff0c\u65e0\u9700IND\u5ba1\u6279\u5373\u53ef\u5feb\u901f\u542f\u52a8\u8bd5\u9a8c\u3002\u5ba1\u6279\u901a\u5e38\u4e3a4\u52306\u5468\uff0c\u5982\u679c\u4ece\u6750\u6599\u5ba1\u6279\u5230\u7b2c\u4e00\u4f8b\u5165\u7ec4\u7b97\uff0c\u5927\u7ea6\u662f2\u52302.5\u4e2a\u6708\u3002\u9012\u4ea4\u7684\u6750\u6599\u4e5f\u6bd4\u7f8e\u56fd\u66f4\u7b80\u5355\uff0c\u901a\u5e38\u5305\u542b\u7814\u7a76\u8005\u624b\u518c\u3001\u4e34\u5e8a\u7814\u7a76\u65b9\u6848\u3001\u53d7\u8bd5\u8005\u77e5\u60c5\u540c\u610f\u4e66\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b64\u5916\uff0c\u6fb3\u5927\u5229\u4e9a\u5728\u6210\u672c\u4e0e\u8d44\u6e90\u65b9\u9762\u4ea6\u5177\u5907\u660e\u663e\u4f18\u52bf\u3002\u653f\u5e9c\u63d0\u4f9b\u6700\u9ad8\u53ef\u8fbe\u7ea643.5%\u7684\u7814\u53d1\u7a0e\u6536\u6fc0\u52b1\uff0c\u6709\u6548\u964d\u4f4e\u8bd5\u9a8c\u6210\u672c\uff1b\u540c\u65f6\u4f9d\u6258\u5b8c\u5584\u7684\u533b\u7597\u4f53\u7cfb\u3001\u4f18\u8d28\u7814\u7a76\u673a\u6784\u53ca\u591a\u5143\u5316\u53d7\u8bd5\u8005\u7fa4\u4f53\uff0c\u652f\u6301\u9ad8\u8d28\u91cf\u6570\u636e\u83b7\u53d6\u3002\u6fb3\u6d32\u4e34\u5e8a\u6570\u636e\u88abFDA\u3001EMA\u53caNMPA\u5e7f\u6cdb\u8ba4\u53ef\uff0c\u663e\u8457\u63d0\u5347\u5168\u7403\u6ce8\u518c\u4e0e\u5546\u4e1a\u5316\u7684\u53ef\u884c\u6027\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9274\u4e8e\u672c\u6587\u91cd\u70b9\u5728\u4e8e\u6cd5\u5f8b\u5b89\u6392\uff0c\u76f8\u5173\u4f18\u52bf\u4ec5\u4f5c\u7b80\u8981\u6982\u8ff0\uff0c\u76f8\u4fe1\u672c\u6587\u7684\u8bfb\u8005\u5bf9\u6b64\u90e8\u5206\u7684\u7406\u89e3\u4f1a\u6bd4\u6211\u66f4\u4e3a\u6df1\u523b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u4e8c\u3001\u4e2d\u56fd\u4f01\u4e1a\u51fa\u6d77\u6fb3\u6d32\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6cd5\u5f8b\u5b89\u6392<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u4ece\u4e2d\u56fd\u76d1\u7ba1\u65b9\u4e0e\u6fb3\u6d32\u76d1\u7ba1\u65b9\u4e24\u4e2a\u89d2\u5ea6\uff0c\u5bf9\u76f8\u5173\u6cd5\u5f8b\u5b89\u6392\u4f5c\u7b80\u8981\u8bf4\u660e\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uff08\u4e00\uff09 \u6fb3\u5927\u5229\u4e9aCTN\uff08\u5907\u6848\u5236\uff09\u6a21\u5f0f\u4e0b\u7684\u4e34\u5e8a\u8bd5\u9a8c\u542f\u52a8\u8def\u5f84<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"497\" height=\"742\" src=\"https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u4e34\u5e8a\u8bd5\u9a8c\u542f\u52a8\u8def\u5f84.png\" alt=\"\" class=\"wp-image-168\" srcset=\"https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u4e34\u5e8a\u8bd5\u9a8c\u542f\u52a8\u8def\u5f84.png 497w, https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u4e34\u5e8a\u8bd5\u9a8c\u542f\u52a8\u8def\u5f84-201x300.png 201w, https:\/\/ozhailun.com\/wp-content\/uploads\/2026\/08\/\u4e34\u5e8a\u8bd5\u9a8c\u542f\u52a8\u8def\u5f84-8x12.png 8w\" sizes=\"auto, (max-width: 497px) 100vw, 497px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u53c2\u8003\u6765\u6e90\uff1a<a href=\"https:\/\/www.australianclinicaltrials.gov.au\" type=\"link\" id=\"www.australianclinicaltrials.gov.au\">www.australianclinicaltrials.gov.au<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uff08\u4e8c\uff09 \u4e2d\u56fd\u76d1\u7ba1\u89d2\u5ea6\u7684\u6cd5\u5f8b\u5b89\u6392<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1. \u5883\u5916\u6295\u8d44\u5907\u6848\uff08ODI\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f01\u4e1a\u901a\u5e38\u9700\u901a\u8fc7\u5883\u5916\u6295\u8d44\uff08Outbound Direct Investment\uff0cODI\uff09\u8bbe\u7acb\u6fb3\u6d32\u5b50\u516c\u53f8\u4f5c\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u4e3b\u4f53\u3002\u8be5\u8fc7\u7a0b\u4e00\u822c\u6d89\u53ca\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u53d1\u6539\u59d4\u5883\u5916\u6295\u8d44\u5907\u6848\u6216\u6838\u51c6<\/li>\n\n\n\n<li>\u5546\u52a1\u90e8\u5bf9\u5916\u6295\u8d44\u5907\u6848<\/li>\n\n\n\n<li>\u5916\u6c47\u7ba1\u7406\u5c40\u5916\u6c47\u767b\u8bb0\u53ca\u8d44\u91d1\u51fa\u5883\u5408\u89c4<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">2. \u8d44\u91d1\u51fa\u5883\u4e0e\u4f7f\u7528\u5408\u89c4<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e34\u5e8a\u8bd5\u9a8c\u76f8\u5173\u8d39\u7528\uff08\u5982CRO\u8d39\u7528\u3001\u7814\u7a76\u4e2d\u5fc3\u8d39\u7528\u3001\u53d7\u8bd5\u8005\u8865\u507f\u7b49\uff09\u9700\u901a\u8fc7\u5408\u89c4\u8def\u5f84\u6c47\u51fa\uff0c\u4e3b\u8981\u6d89\u53ca\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8d44\u91d1\u7528\u9014\u7684\u771f\u5b9e\u6027\u5ba1\u6838<\/li>\n\n\n\n<li>\u8de8\u5883\u652f\u4ed8\u5408\u89c4\uff08\u907f\u514d\u88ab\u8ba4\u5b9a\u4e3a\u201c\u8d44\u672c\u9879\u76ee\u8fdd\u89c4\u201d\u6216\u201c\u53d8\u76f8\u5229\u6da6\u8f6c\u79fb\u201d\uff09<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">3. \u7a0e\u52a1\u4e0e\u8f6c\u79fb\u5b9a\u4ef7\u5b89\u6392<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e2d\u56fd\u5883\u5185\u6bcd\u516c\u53f8\u4e0e\u6fb3\u6d32\u5b50\u516c\u53f8\u4e4b\u95f4\u7684\u8d44\u91d1\u5f80\u6765\uff08\u5982\u7814\u53d1\u670d\u52a1\u8d39\u3001\u77e5\u8bc6\u4ea7\u6743\u8bb8\u53ef\u7b49\uff09\uff0c\u9700\u7b26\u5408\u8f6c\u79fb\u5b9a\u4ef7\u539f\u5219\uff08arm\u2019s length principle\uff09\uff0c\u4ee5\u907f\u514d\u4ea7\u751f\u7a0e\u52a1\u98ce\u9669\u6216\u88ab\u8ba4\u5b9a\u4e3a\u5229\u6da6\u8f6c\u79fb\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uff08\u4e09\uff09\u6fb3\u6d32\u76d1\u7ba1\u89d2\u5ea6\u7684\u6cd5\u5f8b\u5b89\u6392<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1. \u6fb3\u6d32\u672c\u5730\u5b50\u516c\u53f8\u8bbe\u7acb<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd1\u5e74\u6765\u76d1\u7ba1\u9010\u6b65\u8d8b\u4e25\uff0c\u4f01\u4e1a\u901a\u5e38\u9700\u5148\u5efa\u7acb\u6fb3\u6d32\u672c\u5730\u5b9e\u4f53\uff08\u5373\u6fb3\u6d32\u5b50\u516c\u53f8\uff09\uff0c\u65b9\u53ef\u4f5c\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u7533\u529e\u65b9\u5e76\u7533\u8bf7\u4eab\u53d7\u6fb3\u6d32\u76f8\u5173\u7814\u53d1\u9000\u7a0e\u653f\u7b56\uff08R&amp;D Tax Incentive\uff09\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u79c1\u6709\u6709\u9650\u8d23\u4efb\u516c\u53f8\uff08Proprietary Company Limited by Shares\uff0cPty Ltd\uff09\u662f\u6fb3\u5927\u5229\u4e9a\u6700\u5e38\u89c1\u7684\u516c\u53f8\u5f62\u5f0f\u3002\u4e2d\u56fd\u836f\u4f01\u5728\u6fb3\u6d32\u8bbe\u7acb\u7684\u5b50\u516c\u53f8\u901a\u5e38\u4ea6\u91c7\u7528\u8be5\u5f62\u5f0f\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2. \u516c\u53f8\u6cbb\u7406\u5408\u89c4<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6fb3\u6d32\u516c\u53f8\u6cd5\u8981\u6c42\u516c\u53f8\u81f3\u5c11\u8bbe\u6709\u4e00\u540d\u6fb3\u6d32\u672c\u5730\u8463\u4e8b\u3002\u8be5\u8463\u4e8b\u4e0d\u5fc5\u4e3a\u6fb3\u6d32\u516c\u6c11\u6216\u6c38\u4e45\u5c45\u6c11\uff0c\u4e5f\u53ef\u4ee5\u4e3a\u6301\u6709\u6709\u6548\u7b7e\u8bc1\u7684\u5728\u6fb3\u4eba\u58eb\u3002\u5b9e\u8df5\u4e2d\uff0c\u8be5\u89d2\u8272\u53ef\u901a\u8fc7\u4ee5\u4e0b\u65b9\u5f0f\u5b89\u6392\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7531\u6bcd\u516c\u53f8\u901a\u8fc7482\/494\/186\u7b49\u96c7\u4e3b\u62c5\u4fdd\u7b7e\u8bc1\u6d3e\u9a7b\u4eba\u5458\u62c5\u4efb\uff08\u540e\u671f\u4ea6\u53ef\u8f6c\u4e3a\u6c38\u4e45\u5c45\u6c11\uff09<\/li>\n\n\n\n<li>\u6216\u8058\u8bf7\u6fb3\u6d32\u672c\u5730\u5f8b\u5e08\u3001\u4f1a\u8ba1\u5e08\u7b49\u4e13\u4e1a\u4eba\u58eb\u62c5\u4efb<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u9700\u8981\u7279\u522b\u6ce8\u610f\u7684\u662f\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6fb3\u6d32\u5bf9\u8463\u4e8b\u4e49\u52a1\uff08directors\u2019 duties\uff09\u7684\u76d1\u7ba1\u8f83\u4e3a\u4e25\u683c<\/li>\n\n\n\n<li>\u6240\u6709\u8463\u4e8b\uff08\u65e0\u8bba\u662f\u5426\u5728\u6fb3\uff09\u5747\u9700\u7533\u8bf7\u8463\u4e8b\u8bc6\u522b\u53f7\uff08Director ID\uff09<\/li>\n\n\n\n<li>\u5b9e\u52a1\u4e2d\u5efa\u8bae\u4e3a\u672c\u5730\u53ca\u5883\u5916\u8463\u4e8b\u914d\u7f6e\u8463\u4e8b\u53ca\u9ad8\u7ba1\u8d23\u4efb\u4fdd\u9669\uff08D&amp;O Insurance\uff09\uff0c\u4ee5\u964d\u4f4e\u6f5c\u5728\u6cd5\u5f8b\u98ce\u9669<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">3. FIRB\u7533\u62a5<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e00\u822c\u800c\u8a00\uff0c\u5355\u7eaf\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u4e1a\u52a1\u672c\u8eab\u5e76\u4e0d\u89e6\u53d1 Foreign Investment Review Board\uff08FIRB\uff0c\u5916\u56fd\u6295\u8d44\u5ba1\u67e5\u59d4\u5458\u4f1a\uff09 \u7684\u7533\u62a5\u8981\u6c42\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f46\u9700\u6ce8\u610f\uff0c\u5982\u6bcd\u516c\u53f8\u5177\u6709\u8f83\u9ad8\u56fd\u6709\u80cc\u666f\uff08\u4f8b\u5982\u56fd\u8d44\u6301\u80a1\u8fbe\u5230\u6216\u8d85\u8fc720%\uff09\uff0c\u5219\u53ef\u80fd\u88ab\u8ba4\u5b9a\u4e3a\u201c\u5916\u56fd\u653f\u5e9c\u6295\u8d44\u8005\u201d\uff08Foreign Government Investor, 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