{"id":9628,"date":"2026-03-11T15:24:15","date_gmt":"2026-03-11T07:24:15","guid":{"rendered":"https:\/\/regask.com\/?p=9628"},"modified":"2026-03-11T15:24:15","modified_gmt":"2026-03-11T07:24:15","slug":"%e8%8b%b1%e5%9b%bd%e8%8d%af%e5%93%81%e5%92%8c%e4%bf%9d%e5%81%a5%e4%ba%a7%e5%93%81%e7%9b%91%e7%ae%a1%e7%bd%b2%e5%8f%91%e5%b8%83%e5%85%b3%e4%ba%8e%e5%a4%aa%e7%a9%ba%e5%88%b6%e9%80%a0%e8%8d%af%e5%93%81","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/uk-mhra-issues-guidance-on-regulatory-approval-for-space-manufactured-pharmaceuticals\/","title":{"rendered":"\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72\u53d1\u5e03\u5173\u4e8e\u7a7a\u95f4\u4f4d\u963b\u76d1\u7ba1\u5ba1\u6279\u7684\u6307\u5357\u2026\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">\u5728\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e743\u67085\u65e5<\/span><\/b><span data-contrast=\"auto\">, \u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u5c40 (MHRA) \u4e0e\u82f1\u56fd\u822a\u5929\u5c40\u3001\u76d1\u7ba1\u521b\u65b0\u529e\u516c\u5ba4 (RIO) \u548c\u6c11\u822a\u5c40 (CAA) \u5171\u540c\u5ba3\u5e03\u4e86\u65b0\u7684\u2026\u2026\u00a0<\/span><b><span data-contrast=\"auto\">\u592a\u7a7a\u5236\u9020\u836f\u54c1\u76d1\u7ba1\u6307\u5357<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u8be5\u5021\u8bae\u6982\u8ff0\u4e86\u73b0\u6709\u65b9\u6cd5\u00a0<\/span><b><span data-contrast=\"auto\">\u82f1\u56fd\u836f\u54c1\u548c\u822a\u5929\u76d1\u7ba1\u6846\u67b6<\/span><\/b><span data-contrast=\"auto\">\u00a0\u53ef\u80fd\u9002\u7528\u4e8e\u5728\u4ee5\u4e0b\u5730\u533a\u751f\u4ea7\u7684\u836f\u54c1\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u5fae\u91cd\u529b\u73af\u5883<\/span><\/b><span data-contrast=\"auto\">, \u7279\u522b\u662f\u751f\u7269\u5236\u5242\u548c\u5176\u4ed6\u590d\u6742\u7597\u6cd5\u3002\u8be5\u6307\u5357\u65e8\u5728\u652f\u6301\u4f01\u4e1a\u5f00\u53d1\u592a\u7a7a\u5236\u836f\u751f\u4ea7\u6280\u672f\uff0c\u540c\u65f6\u660e\u786e\u82f1\u56fd\u76d1\u7ba1\u673a\u6784\u5bf9\u836f\u54c1\u5ba1\u6279\u548c\u5e02\u573a\u51c6\u5165\u7684\u9884\u671f\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-989242997\">\n\n\t<div id=\"col-368654375\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1941642829\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1941642829 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-232370043\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-232370043 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u65b0\u63a8\u51fa\u7684\u6307\u5357\u89e3\u91ca\u4e86\u5982\u4f55\u00a0<\/span><b><span data-contrast=\"auto\">\u73b0\u884c\u7684\u82f1\u56fd\u836f\u54c1\u6cd5\u89c4\u9002\u7528\u4e8e\u5229\u7528\u5fae\u91cd\u529b\u5e73\u53f0\u5728\u8f68\u9053\u4e0a\u5236\u9020\u7684\u836f\u54c1\u3002<\/span><\/b><span data-contrast=\"auto\">. \u8be5\u6846\u67b6\u5e2e\u52a9\u4f01\u4e1a\u4e86\u89e3\u4ea7\u54c1\u5f00\u53d1\u3001\u5236\u9020\u6807\u51c6\u548c\u6700\u7ec8\u5e02\u573a\u51c6\u5165\u65b9\u9762\u7684\u76d1\u7ba1\u8981\u6c42\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u6b64\u5916\uff0c\u76d1\u7ba1\u673a\u6784\u5c06\u5f15\u5165\u00a0<\/span><b><span data-contrast=\"auto\">\u91cd\u8fd4\u76d1\u7ba1\u6c99\u76d2<\/span><\/b><span data-contrast=\"auto\">, \u65e8\u5728\u652f\u6301\u4f01\u4e1a\u6d4b\u8bd5\u5c06\u592a\u7a7a\u5236\u9020\u7684\u4ea7\u54c1\u5b89\u5168\u8fd4\u56de\u5730\u7403\u7684\u76d1\u7ba1\u65b9\u6cd5\u3002\u8fd9\u4e2a\u6c99\u76d2\u73af\u5883\u5141\u8bb8\u76d1\u7ba1\u673a\u6784\u548c\u884c\u4e1a\u5229\u76ca\u76f8\u5173\u8005\u8bc4\u4f30\u4e0e\u518d\u5165\u548c\u4ea7\u54c1\u5904\u7406\u76f8\u5173\u7684\u64cd\u4f5c\u3001\u5b89\u5168\u548c\u5408\u89c4\u6027\u65b9\u9762\u7684\u8003\u91cf\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4e3a\u4e86\u8fdb\u4e00\u6b65\u589e\u8fdb\u4e1a\u754c\u4e86\u89e3\uff0c\u5404\u673a\u6784\u5c06\u53d1\u5e03\u00a0<\/span><b><span data-contrast=\"auto\">\u57fa\u4e8e\u539f\u5219\u7684\u6848\u4f8b\u7814\u7a76<\/span><\/b><span data-contrast=\"auto\">\u00a0\u672c\u6587\u65e8\u5728\u5c55\u793a\u592a\u7a7a\u5236\u836f\u751f\u4ea7\u7684\u6f5c\u5728\u76d1\u7ba1\u8def\u5f84\u3002\u8fd9\u4e9b\u6848\u4f8b\u65e8\u5728\u5e2e\u52a9\u5404\u673a\u6784\u8bc4\u4f30\u73b0\u6709\u6cd5\u89c4\u5982\u4f55\u9002\u7528\u4e8e\u5fae\u91cd\u529b\u73af\u5883\u4e0b\u7684\u4e0d\u540c\u751f\u4ea7\u573a\u666f\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u8be5\u5021\u8bae\u8fd8\u5f3a\u8c03\u00a0<\/span><b><span data-contrast=\"auto\">\u5c3d\u65e9\u4e0e\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72\uff08MHRA\uff09\u7684\u79d1\u5b66\u548c\u76d1\u7ba1\u54a8\u8be2\u670d\u52a1\u90e8\u95e8\u63a5\u6d3d<\/span><\/b><span data-contrast=\"auto\">, \u9f13\u52b1\u4f01\u4e1a\u5728\u53d1\u5c55\u89c4\u5212\u9636\u6bb5\u54a8\u8be2\u76d1\u7ba1\u673a\u6784\uff0c\u4ee5\u4fbf\u66f4\u597d\u5730\u4e86\u89e3\u9002\u7528\u7684\u76d1\u7ba1\u8981\u6c42\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u6700\u540e\uff0c\u8be5\u8282\u76ee\u5f3a\u8c03\u4e86\u4ee5\u4e0b\u65b9\u9762\u7684\u91cd\u8981\u6027\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u52a0\u5f3a\u533b\u836f\u548c\u822a\u5929\u6280\u672f\u4f9b\u5e94\u94fe\u5404\u73af\u8282\u7684\u5408\u4f5c<\/span><\/b><span data-contrast=\"auto\">, \u6709\u52a9\u4e8e\u4fc3\u8fdb\u592a\u7a7a\u5236\u9020\u836f\u7269\u7684\u957f\u671f\u5546\u4e1a\u5316\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-368654375 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1373618868\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u4e3a\u4ec0\u4e48\u91cd\u8981<\/h2>\n\t<div id=\"gap-1912154534\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1912154534 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">\u8fd9\u9879\u76d1\u7ba1\u4e3e\u63aa\u89c4\u5b9a\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\"><strong>\u9700\u8981\u66f4\u6e05\u6670\u5730\u9610\u660e\u73b0\u6709\u7684\u82f1\u56fd\u836f\u54c1\u548c\u822a\u5929\u6cd5\u89c4\u5982\u4f55\u9002\u7528\u4e8e\u5728\u5fae\u91cd\u529b\u73af\u5883\u4e0b\u751f\u4ea7\u7684\u836f\u54c1<\/strong><\/span><\/span><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\"><strong>.<\/strong> \u7ecf\u8fc7\u00a0<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u5efa\u7acb<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u00a0\u901a\u8fc7\u6307\u5bfc\u3001\u6848\u4f8b\u7814\u7a76\u548c\u76d1\u7ba1\u6c99\u76d2\uff0c\u8be5\u6846\u67b6\u652f\u6301\u521b\u65b0\uff1b\u00a0<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u4fdd\u6301<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u00a0\u76d1\u7ba1\u76d1\u7763\u3002\u5b83\u8fd8\u4fc3\u8fdb\u4e86\u2026\u2026<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">\u76d1\u7ba1\u534f\u8c03\u3001\u6539\u8fdb\u7684\u53d1\u5c55\u89c4\u5212\u4ee5\u53ca\u4e3a\u65b0\u5174\u7684\u592a\u7a7a\u751f\u547d\u79d1\u5b66\u6280\u672f\u63d0\u4f9b\u9ad8\u6548\u7684\u53d1\u5c55\u8def\u5f84<\/span><\/span><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">.<\/span><\/span><span class=\"EOP SCXW10975365 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1373618868 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-3837648\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u8fd9\u9002\u7528\u4e8e\u54ea\u4e9b\u4eba\u7fa4<\/h2>\n\t<div id=\"gap-691996828\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-691996828 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u8be5\u6307\u5357\u5c24\u5176\u9002\u7528\u4e8e\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u5236\u836f\u4f01\u4e1a\u3001\u751f\u7269\u6280\u672f\u516c\u53f8\u548c\u5fae\u91cd\u529b\u5e73\u53f0\u63d0\u4f9b\u5546<\/span><\/span><\/strong><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0\u63a2\u7d22\u53d1\u5c55\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u751f\u7269\u5236\u5242\u3001\u5148\u8fdb\u7597\u6cd5\u548c\u5176\u4ed6\u590d\u6742\u836f\u7269<\/span><\/span><\/strong><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0\u90a3\u53ef\u80fd\u00a0<\/span><span class=\"NormalTextRun SCXW248171813 BCX0\">\u76ca\u5904<\/span><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0\u6765\u81ea\u5fae\u91cd\u529b\u5236\u9020\u73af\u5883\u3002.<\/span><\/span><span class=\"EOP SCXW248171813 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-3837648 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-130009624\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u4e0b\u4e00\u6b65<\/h2>\n\t<div id=\"gap-705807652\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-705807652 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u53c2\u4e0e\u5176\u4e2d\u7684\u7ec4\u7ec7\u00a0<\/span><b><span data-contrast=\"auto\">\u5229\u7528\u592a\u7a7a\u8fdb\u884c\u5236\u836f\u751f\u4ea7<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5e94\u5ba1\u67e5\u5df2\u6982\u8ff0\u7684\u76d1\u7ba1\u65b9\u6cd5\uff0c\u5e76\u8bc4\u4f30\u5f53\u524d\u6216\u8ba1\u5212\u4e2d\u7684\u4e3e\u63aa\u662f\u5426\u4e0e\u65b0\u6846\u67b6\u76f8\u7b26\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u9f13\u52b1\u5f00\u53d1\u6b64\u7c7b\u6280\u672f\u7684\u516c\u53f8\u00a0<\/span><b><span data-contrast=\"auto\">\u5c3d\u65e9\u4e0e\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72 (MHRA) \u7684\u79d1\u5b66\u548c\u76d1\u7ba1\u54a8\u8be2\u670d\u52a1\u90e8\u95e8\u63a5\u6d3d\u3002<\/span><\/b><span data-contrast=\"auto\">\u00a0\u4ee5\u4fbf\u66f4\u597d\u5730\u4e86\u89e3\u9002\u7528\u7684\u76d1\u7ba1\u9014\u5f84\u3001\u5f00\u53d1\u8003\u8651\u56e0\u7d20\u548c\u5408\u89c4\u8981\u6c42\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u968f\u7740\u76d1\u7ba1\u6846\u67b6\u4e0d\u65ad\u53d1\u5c55\u4ee5\u652f\u6301\u592a\u7a7a\u5236\u9020\u7b49\u65b0\u5174\u6280\u672f\uff0c\u76d1\u7ba1\u56e2\u961f\u5fc5\u987b\u65f6\u523b\u5173\u6ce8\u65b0\u7684\u6307\u5bfc\u65b9\u9488\u548c\u8de8\u90e8\u95e8\u653f\u7b56\u53d1\u5c55\u3002.\u00a0<a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a>\u00a0\u662f\u9886\u5148\u7684\u00a0<\/span><b><span data-contrast=\"auto\">agentic AI \u76d1\u7ba1\u667a\u80fd\u548c\u5de5\u4f5c\u6d41\u7a0b\u7f16\u6392\u5e73\u53f0<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5b83\u8d4b\u80fd\u5168\u7403\u4f01\u4e1a\uff0c\u4f7f\u5176\u80fd\u591f\u79ef\u6781\u5e94\u5bf9\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\u5728\u5185\u7684\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u590d\u6742\u76d1\u7ba1\u73af\u5883\u3002\u901a\u8fc7\u7ed3\u5408\u5148\u8fdb\u7684\u6280\u672f\uff0c\u00a0<\/span><b><span 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