{"id":49512,"date":"2026-03-09T13:09:19","date_gmt":"2026-03-09T13:09:19","guid":{"rendered":"https:\/\/indogenmed.org\/resource\/legal-early-access-to-medicines-what-to-do-when-your-medicine-is-not-available-locally\/"},"modified":"2026-07-10T09:42:59","modified_gmt":"2026-07-10T09:42:59","slug":"legal-early-access-medicines-not-available","status":"publish","type":"post","link":"https:\/\/indogenmed.org\/zh-hans\/resource\/legal-early-access-medicines-not-available\/","title":{"rendered":"\u5408\u6cd5\u63d0\u524d\u83b7\u53d6\u836f\u54c1\uff1a\u5f53\u5f53\u5730\u65e0\u6cd5\u83b7\u5f97\u6240\u9700\u836f\u54c1\u65f6\u8be5\u600e\u4e48\u529e"},"content":{"rendered":"<p>\u5f53\u4f60\u53d1\u73b0\u67d0\u79cd\u836f\u7269\u5728\u4f60\u7684\u56fd\u5bb6\u65e0\u6cd5\u83b7\u5f97\u65f6\uff0c\u4f60\u4f1a\u611f\u5230\u8d70\u6295\u65e0\u8def\uff0c\u4eff\u4f5b\u8d70\u5230\u4e86\u5c3d\u5934\u3002<\/p>\n<p>\u5f88\u591a\u60c5\u51b5\u4e0b\u5e76\u975e\u5982\u6b64\u3002<\/p>\n<p>\u5982\u679c\u67d0\u79cd\u7597\u6cd5\u5df2\u5728\u5176\u4ed6\u56fd\u5bb6\u83b7\u5f97\u6279\u51c6\u6216\u4ecd\u5728\u7814\u53d1\u4e2d\uff0c\u60a3\u8005\u6216\u8bb8\u80fd\u591f\u901a\u8fc7\u5408\u6cd5\u6e20\u9053\u5728\u5f53\u5730\u4e0a\u5e02\u4e4b\u524d\u83b7\u5f97\u8be5\u7597\u6cd5\u3002<\/p>\n<p>\u8fd9\u4e9b\u6e20\u9053\u662f\u60a3\u8005\u83b7\u53d6\u5f53\u5730\u5c1a\u672a\u63d0\u4f9b\u7684\u836f\u7269\u7684\u6709\u6548\u9014\u5f84\u3002<\/p>\n<p>\u672c\u6307\u5357\u89e3\u91ca\u4e86\u4ec0\u4e48\u662f\u63d0\u524d\u83b7\u53d6\u836f\u7269\u3001\u6709\u54ea\u4e9b\u6cd5\u5f8b\u9014\u5f84\u53ef\u4f9b\u9009\u62e9\uff0c\u4ee5\u53ca\u60a3\u8005\u5728\u63a2\u7d22\u8de8\u5883\u83b7\u53d6\u836f\u7269\u4e4b\u524d\u5e94\u8be5\u4e86\u89e3\u54ea\u4e9b\u4fe1\u606f\u3002<\/p>\n<h2>\u4ec0\u4e48\u662f\u65e9\u671f\u7528\u836f\uff1f<\/h2>\n<p> 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400\">\u673a\u6784\u5ba1\u67e5\u59d4\u5458\u4f1a\uff08IRB\uff09\u5fc5\u987b\u5ba1\u67e5\u8be5\u7533\u8bf7\u3002<\/li>\n<\/ul>\n<h2>\u540c\u60c5\u7528\u836f\uff08\u6b27\u76df\uff09<\/h2>\n<p>\u5728\u6b27\u76df\uff0c\u540c\u60c5\u7528\u836f\u8ba1\u5212\u4e3a\u60a3\u6709\u6162\u6027\u75c5\u3001\u91cd\u75c5\u6216\u5371\u53ca\u751f\u547d\u7684\u75be\u75c5\u7684\u60a3\u8005\u63d0\u4f9b\u83b7\u5f97\u672a\u7ecf\u6279\u51c6\u836f\u7269\u7684\u9014\u5f84\uff0c\u524d\u63d0\u662f\u6ca1\u6709\u4ee4\u4eba\u6ee1\u610f\u7684\u5df2\u6279\u51c6\u7597\u6cd5\u3002<\/p>\n<p>\u8fd9\u4e9b\u9879\u76ee\u5728\u56fd\u5bb6\u5c42\u9762\u8fdb\u884c\u534f\u8c03\uff0c\u4f46\u7531\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u6307\u5bfc\u3002<\/p>\n<p>\u6b27\u76df\u5404\u6210\u5458\u56fd\u5728\u6b64\u6846\u67b6\u4e0b\u5b9e\u65bd\u5404\u81ea\u7684\u7a0b\u5e8f\u3002<\/p>\n<h2>\u6307\u5b9a\u60a3\u8005\u5bfc\u5165\u9014\u5f84<\/h2>\n<p>\u8bb8\u591a\u56fd\u5bb6\u5141\u8bb8\u533b\u751f\u901a\u8fc7\u6240\u8c13\u7684\u201c\u6307\u5b9a\u60a3\u8005\u9014\u5f84\u201d\u4e3a\u4e2a\u522b\u60a3\u8005\u7533\u8bf7\u672a\u7ecf\u6279\u51c6\u6216\u672a\u5728\u5f53\u5730\u9500\u552e\u7684\u836f\u7269\u3002<\/p>\n<p>\u867d\u7136\u5404\u56fd\u89c4\u5b9a\u4e0d\u5c3d\u76f8\u540c\uff0c\u4f46\u5171\u540c\u8981\u7d20\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u7531\u6267\u4e1a\u533b\u5e08\u5f00\u5177\u7684\u6709\u6548\u5904\u65b9<\/li>\n<li>\u786e\u8ba4\u5f53\u5730\u65e0\u6cd5\u83b7\u5f97\u8be5\u836f\u7269\u3002<\/li>\n<li>\u6587\u4ef6\u8bc1\u660e\u8be5\u836f\u54c1\u4ec5\u4f9b\u4e2a\u4eba\u4f7f\u7528<\/li>\n<li>\u8fdb\u53e3\u56fd\u8981\u6c42\u7684\u76d1\u7ba1\u8868\u683c<\/li>\n<li>\u9075\u5b88\u6d77\u5173\u548c\u836f\u54c1\u8fdb\u53e3\u6cd5\u5f8b<\/li>\n<\/ul>\n<p>\u8fd9\u4e9b\u7cfb\u7edf\u88ab\u4e16\u754c\u5404\u5730\u7684\u533b\u9662\u548c\u533b\u751f\u4f7f\u7528\uff0c\u5e76\u53d7\u56fd\u5bb6\u536b\u751f\u90e8\u95e8\u76d1\u7ba1\u3002<\/p>\n<h2>\u8ff7\u601d\u4e0e\u4e8b\u5b9e\uff1a\u7406\u89e3\u6cd5\u5f8b\u533b\u5b66\u7684\u91cd\u8981\u6027<\/h2>\n<h3>\u8bef\u533a\uff1a\u8fdb\u53e3\u836f\u54c1\u662f\u9ed1\u5e02\u6d3b\u52a8<\/h3>\n<p>\u4e8b\u5b9e\uff1a\u8bb8\u591a\u56fd\u5bb6\u90fd\u5b58\u5728\u5408\u6cd5\u7684\u63d0\u524d\u7528\u836f\u9014\u5f84\u3002\u53ea\u8981\u901a\u8fc7\u6b63\u89c4\u7684\u76d1\u7ba1\u6e20\u9053\uff0c\u5728\u533b\u751f\u76d1\u7763\u4e0b\uff0c\u5e76\u7b26\u5408\u76f8\u5173\u6587\u4ef6\u8981\u6c42\uff0c\u8fdb\u53e3\u836f\u54c1\u5c31\u662f\u5408\u6cd5\u4e14\u53d7\u76d1\u7ba1\u7684\u3002<\/p>\n<h3>\u8bef\u533a\uff1a\u5fc5\u987b\u7b49\u5f85\u5f53\u5730\u653f\u5e9c\u6279\u51c6<\/h3>\n<p>\u4e8b\u5b9e\uff1a\u5728\u8bb8\u591a\u5730\u533a\uff0c\u5373\u4f7f\u836f\u54c1\u5c1a\u672a\u83b7\u5f97\u5f53\u5730\u6279\u51c6\uff0c\u53ea\u8981\u83b7\u5f97\u8ba4\u53ef\u7684\u76d1\u7ba1\u673a\u6784\uff08\u4f8b\u5982FDA\u6216EMA\uff09\u7684\u6279\u51c6\uff0c\u60a3\u8005\u5373\u53ef\u83b7\u5f97\u8be5\u836f\u54c1\u3002\u5177\u4f53\u8d44\u683c\u53d6\u51b3\u4e8e\u5404\u56fd\u6cd5\u5f8b\u3002<\/p>\n<h3>\u8bef\u533a\uff1a\u4f60\u53ea\u9700\u8981\u4e00\u5f20\u5904\u65b9<\/h3>\n<p><b>\u4e8b\u5b9e\uff1a<\/b>\u5904\u65b9\u901a\u5e38\u53ea\u662f\u8d77\u70b9\u3002\u5176\u4ed6\u6587\u4ef6\u901a\u5e38\u5305\u62ec\uff1a<\/p>\n<ul>\n<li style=\"font-weight: 400\">\u60a3\u8005\u58f0\u660e\u8868<\/li>\n<li style=\"font-weight: 400\">\u76d1\u7ba1\u7533\u8bf7<\/li>\n<li style=\"font-weight: 400\">\u8fdb\u53e3\u6388\u6743\u6587\u4ef6<\/li>\n<li style=\"font-weight: 400\">\u6d77\u5173\u6587\u4ef6<\/li>\n<li style=\"font-weight: 400\">\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u9700\u8981\u533b\u751f\u51fa\u5177\u8bc1\u660e\u4fe1\u3002<\/li>\n<\/ul>\n<p>\u6587\u4ef6\u7f3a\u5931\u53ef\u80fd\u5bfc\u81f4\u5ef6\u8bef\u6216\u62d2\u7edd\u3002<\/p>\n<h2>\u4e3a\u4ec0\u4e48\u65f6\u673a\u5f88\u91cd\u8981<\/h2>\n<p>\u4e00\u79cd\u65b0\u83b7\u6279\u7684\u836f\u7269\u53ef\u80fd\u9700\u8981\u6570\u5e74\u65f6\u95f4\u624d\u80fd\u5728\u6240\u6709\u56fd\u5bb6\u4e0a\u5e02\u9500\u552e\u3002\u76d1\u7ba1\u5ba1\u67e5\u65f6\u95f4\u3001\u4ef7\u683c\u8c08\u5224\u548c\u62a5\u9500\u6d41\u7a0b\u53ef\u80fd\u5b58\u5728\u5f88\u5927\u5dee\u5f02\u3002<\/p>\n<p>\u5c3d\u7ba1\u76d1\u7ba1\u4f53\u7cfb\u52aa\u529b\u786e\u4fdd\u5b89\u5168\u548c\u8d28\u91cf\uff0c\u4f46\u4e25\u91cd\u7684\u75be\u75c5\u53ef\u80fd\u4f1a\u5bfc\u81f4\u60a3\u8005\u7b49\u5f85\u6570\u5e74\u624d\u80fd\u63a5\u53d7\u6cbb\u7597\u3002<\/p>\n<p>\u7136\u800c\uff0c\u4efb\u4f55\u51b3\u5b9a\u63d0\u524d\u83b7\u53d6\u8bbf\u95ee\u6743\u9650\u90fd\u5e94\u8be5\u662f\uff1a<\/p>\n<ul>\n<li style=\"font-weight: 400\">\u6839\u636e\u533b\u7597\u5efa\u8bae<\/li>\n<li style=\"font-weight: 400\">\u8bc4\u4f30\u98ce\u9669\u4e0e\u6536\u76ca<\/li>\n<li style=\"font-weight: 400\">\u4e25\u683c\u6309\u7167\u6cd5\u5f8b\u6846\u67b6\u8fdb\u884c<\/li>\n<\/ul>\n<p>\u7b49\u5f85\u65f6\u95f4\u5e94\u8be5\u7531\u533b\u7597\u90e8\u95e8\u51b3\u5b9a\uff0c\u800c\u4e0d\u4ec5\u4ec5\u662f\u884c\u653f\u7a0b\u5e8f\u7684\u7ed3\u679c\u3002<\/p>\n<h3>\u65f6\u95f4\u7ebf\u793a\u4f8b\uff1a<\/h3>\n<p>\u4e00\u79cd\u5728 2024 \u5e74\u83b7\u5f97 FDA \u6279\u51c6\u7684\u764c\u75c7\u836f\u7269\uff0c\u7531\u4e8e\u9700\u8981\u7ecf\u8fc7\u5f53\u5730\u76d1\u7ba1\u5ba1\u67e5\u3001\u4ef7\u683c\u8c08\u5224\u3001\u62a5\u9500\u51b3\u5b9a\u548c\u4f9b\u5e94\u94fe\u6574\u5408\u7b49\u989d\u5916\u6b65\u9aa4\uff0c\u53ef\u80fd\u4ecd\u9700 2 \u81f3 5 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style=\"font-weight: 400\">\u533b\u5e08\u76d1\u7763<\/li>\n<li style=\"font-weight: 400\">\u7ecf\u6838\u5b9e\u7684\u5236\u9020\u5546\u91c7\u8d2d<\/li>\n<li style=\"font-weight: 400\">\u5fc5\u8981\u65f6\u8fdb\u884c\u6e29\u63a7\u8fd0\u8f93<\/li>\n<li style=\"font-weight: 400\">\u6b63\u786e\u7684\u6d77\u5173\u7533\u62a5<\/li>\n<li style=\"font-weight: 400\">\u76d1\u7ba1\u6587\u4ef6<\/li>\n<li style=\"font-weight: 400\">\u6e05\u6670\u7684\u836f\u7269\u8b66\u6212\u8ffd\u8e2a<\/li>\n<\/ul>\n<p>\u8de8\u5883\u83b7\u53d6\u836f\u54c1\u5fc5\u987b\u9075\u5b88\u51fa\u53e3\u56fd\u548c\u8fdb\u53e3\u56fd\u7684\u836f\u54c1\u6cd5\u89c4\u3002<\/p>\n<h2>\u5e73\u8861\u7684\u89c6\u89d2<\/h2>\n<p>\u65e9\u671f\u51c6\u5165\u9014\u5f84\u65e8\u5728\u4e3a\u8eab\u60a3\u91cd\u75c5\u3001\u6cbb\u7597\u9009\u62e9\u6709\u9650\u7684\u60a3\u8005\u63d0\u4f9b\u652f\u6301\u3002\u8fd9\u4e9b\u9014\u5f84\u662f\u7ed3\u6784\u5316\u3001\u89c4\u8303\u5316\u4e14\u53d7\u6cd5\u5f8b\u8ba4\u53ef\u7684\u673a\u5236\u3002<\/p>\n<p>\u7136\u800c\uff1a<\/p>\n<ul>\n<li style=\"font-weight: 400\">\u5e76\u975e\u6240\u6709\u836f\u7269\u90fd\u7b26\u5408\u6761\u4ef6<\/li>\n<li style=\"font-weight: 400\">\u5e76\u975e\u6240\u6709\u56fd\u5bb6\u90fd\u4ee5\u76f8\u540c\u7684\u65b9\u5f0f\u5141\u8bb8\u8fdb\u53e3\u3002<\/li>\n<li style=\"font-weight: 400\">\u5e76\u975e\u6240\u6709\u60a3\u8005\u90fd\u7b26\u5408\u8d44\u683c\u6807\u51c6<\/li>\n<li style=\"font-weight: 400\">\u53ef\u80fd\u9700\u8981\u5236\u9020\u5546\u53c2\u4e0e\u3002<\/li>\n<\/ul>\n<p>\u60a3\u8005\u6709\u6743\u4e86\u89e3\u5404\u79cd\u53ef\u80fd\u6027\u548c\u5c40\u9650\u6027\u3002<\/p>\n<h2>\u6700\u540e\u60f3\u8bf4<\/h2>\n<p>\u201c\u672c\u5730\u4e0d\u53ef\u7528\u201d\u5e76\u4e0d\u603b\u662f\u610f\u5473\u7740\u201c\u4e0d\u5b58\u5728\u201d\u3002\u5b83\u53ef\u80fd\u610f\u5473\u7740\u8be5\u4ea7\u54c1\u5c1a\u672a\u83b7\u5f97\u60a8\u6240\u5728\u56fd\u5bb6\/\u5730\u533a\u7684\u6279\u51c6\u3002<\/p>\n<p>\u8bf8\u5982\u6269\u5927\u7528\u836f\u3001\u540c\u60c5\u7528\u836f\u548c\u6307\u5b9a\u60a3\u8005\u7528\u836f\u7b49\u5408\u6cd5\u7684\u65e9\u671f\u7528\u836f\u9014\u5f84\u65e8\u5728\u5f25\u5408\u8fd9\u4e00\u5dee\u8ddd\u3002\u5728\u533b\u751f\u6307\u5bfc\u4e0b\u6b63\u786e\u4f7f\u7528\u5e76\u5b8c\u5168\u9075\u5b88\u76d1\u7ba1\u8981\u6c42\uff0c\u8fd9\u4e9b\u9014\u5f84\u53ef\u4ee5\u5e26\u6765\u76ca\u5904\u3002<\/p>\n<p>\u5982\u679c\u60a8\u6b63\u5728\u8003\u8651\u8fd9\u6761\u9014\u5f84\uff0c\u8bf7\u5148\u54a8\u8be2\u533b\u751f\u3002\u52a1\u5fc5\u4e86\u89e3\u60a8\u6240\u5728\u56fd\u5bb6\/\u5730\u533a\u7684\u6cd5\u89c4\uff0c\u5e76\u786e\u4fdd\u6bcf\u4e00\u6b65\u90fd\u7b26\u5408\u6b63\u786e\u7684\u6cd5\u5f8b\u7a0b\u5e8f\u3002<\/p>\n<p>\u5065\u5eb7\u51b3\u7b56\u5e94\u5f53\u57fa\u4e8e\u4fe1\u606f\u3001\u7b26\u5408\u89c4\u5b9a\uff0c\u5e76\u7531\u4e13\u4e1a\u4eba\u58eb\u6307\u5bfc\uff0c\u5c24\u5176\u662f\u5728\u6d89\u53ca\u8de8\u5883\u836f\u54c1\u65f6\u3002<\/p>\n<h2>\u53c2\u8003<\/h2>\n<p><a href=\"https:\/\/www.fda.gov\/news-events\/public-health-focus\/expanded-access\" target=\"_blank\" rel=\"noopener nofollow\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40<\/a>\u3002\u6269\u5927\u4f7f\u7528\u8303\u56f4\u3002<\/p>\n<p> <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compassionate-use\" target=\"_blank\" rel=\"noopener nofollow\">\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u3002<\/a>\u540c\u60c5\u7528\u836f\u3002<\/p>\n<p> <a href=\"https:\/\/www.gov.uk\/guidance\/supply-unlicensed-medicinal-products-specials\" target=\"_blank\" rel=\"noopener nofollow\">\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065<\/a>\u4ea7\u54c1\u76d1\u7ba1\u673a\u6784\u3002\u4f9b\u5e94\u672a\u7ecf\u8bb8\u53ef\u7684\u836f\u54c1\uff08\u7279\u6b8a\u836f\u54c1\uff09\u3002<\/p>\n<p> <a href=\"https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/substandard-and-falsified-medical-products\" target=\"_blank\" rel=\"noopener nofollow\">\u4e16\u754c\u536b\u751f\u7ec4\u7ec7<\/a>\u3002\u4e0d\u5408\u683c\u548c\u5047\u5192\u7684\u533b\u7597\u4ea7\u54c1\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u5f53\u4f60\u53d1\u73b0\u67d0\u79cd\u836f\u7269\u5728\u4f60\u7684\u56fd\u5bb6\u65e0\u6cd5\u83b7\u5f97\u65f6\uff0c\u4f60\u4f1a\u611f\u5230\u8d70\u6295\u65e0\u8def\uff0c\u4eff\u4f5b\u8d70\u5230\u4e86\u5c3d\u5934\u3002 \u5f88\u591a\u60c5\u51b5\u4e0b\u5e76\u975e\u5982\u6b64\u3002 \u5982\u679c\u67d0\u79cd\u7597\u6cd5\u5df2 [&hellip;]<\/p>\n","protected":false},"author":120,"featured_media":49503,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6137],"tags":[],"class_list":["post-49512","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicine-import-guidelines"],"_links":{"self":[{"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/posts\/49512","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/users\/120"}],"replies":[{"embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/comments?post=49512"}],"version-history":[{"count":1,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/posts\/49512\/revisions"}],"predecessor-version":[{"id":125360,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/posts\/49512\/revisions\/125360"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/media\/49503"}],"wp:attachment":[{"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/media?parent=49512"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/categories?post=49512"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/indogenmed.org\/zh-hans\/wp-json\/wp\/v2\/tags?post=49512"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}