{"id":7799,"date":"2024-11-12T19:02:25","date_gmt":"2024-11-12T11:02:25","guid":{"rendered":"https:\/\/regask.com\/?p=7799"},"modified":"2024-11-21T09:20:31","modified_gmt":"2024-11-21T01:20:31","slug":"2025-%e5%b9%b4%e7%94%9f%e5%91%bd%e7%a7%91%e5%ad%a6%e4%ba%94%e5%a4%a7%e8%b6%8b%e5%8a%bf","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/top-5-life-sciences-trends-2025\/","title":{"rendered":"202 \u5e74\u751f\u547d\u79d1\u5b66\u9886\u57df\u4e94\u5927\u53d8\u9769\u8d8b\u52bf\u2026\u2026"},"content":{"rendered":"<p>\u968f\u7740 2025 \u5e74\u7684\u4e34\u8fd1\uff0c\u751f\u547d\u79d1\u5b66\u884c\u4e1a\u9762\u4e34\u7740\u7531\u5feb\u901f\u7684\u6280\u672f\u8fdb\u6b65\u3001\u4e0d\u65ad\u53d8\u5316\u7684\u6cd5\u89c4\u4ee5\u53ca\u65e5\u76ca\u91cd\u89c6\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u7406\u5ff5\u6240\u63a8\u52a8\u7684\u52a8\u6001\u683c\u5c40\u3002\u8fd9\u4e9b\u56e0\u7d20\u8feb\u4f7f\u4f01\u4e1a\u91cd\u65b0\u601d\u8003\u5176\u521b\u65b0\u6218\u7565\uff0c <a href=\"https:\/\/regask.com\/zh\/\">\u9075\u5b88<\/a>\u4ee5\u53ca\u53c2\u4e0e\u5ea6\u3002\u4e0b\u9762\u8ba9\u6211\u4eec\u6765\u4ed4\u7ec6\u770b\u770b\u5f71\u54cd\u751f\u547d\u79d1\u5b66\u672a\u6765\u7684\u4e94\u5927\u6700\u5177\u5f71\u54cd\u529b\u7684\u8d8b\u52bf\u3002<\/p>\n<h2><\/h2>\n<h2><span style=\"font-size: 75%;\"><strong>\u63a8\u52a8\u5168\u7403\u76d1\u7ba1\u534f\u8c03\uff1a\u8fc8\u5411\u7edf\u4e00\u7684\u590d\u6742\u5386\u7a0b<\/strong><\/span><\/h2>\n<p>\u751f\u547d\u79d1\u5b66\u516c\u53f8\u5411\u65b0\u5e02\u573a\u7684\u6269\u5f20\u52a0\u5267\u4e86\u5bf9\u7edf\u4e00\u76d1\u7ba1\u6846\u67b6\u7684\u9700\u6c42\u3002 <strong>\u56fd\u9645\u534f\u8c03\u7406\u4e8b\u4f1a\uff08ICH\uff09<\/strong>\u5c24\u5176\u662f\u901a\u8fc7\u4ee5\u4e0b\u4e3e\u63aa <strong>ICH Q12 \u5173\u4e8e\u751f\u547d\u5468\u671f\u7ba1\u7406<\/strong>\u4ee5\u53ca\u53d1\u5c55\u4e2d\u56fd\u5bb6 <strong>\u975e\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (AMA)<\/strong>\u81f4\u529b\u4e8e\u534f\u8c03\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff0c\u52aa\u529b\u5efa\u7acb\u7edf\u4e00\u6807\u51c6\u3002\u5176\u76ee\u7684\u662f\u7b80\u5316\u5408\u89c4\u6027\u3001\u52a0\u5feb\u4ea7\u54c1\u5ba1\u6279\uff0c\u5e76\u6700\u7ec8\u6539\u5584\u5168\u7403\u533b\u7597\u4fdd\u5065\u670d\u52a1\u3002\u7136\u800c\uff0c\u5b9e\u73b0\u771f\u6b63\u7684\u534f\u8c03\u662f\u4e00\u4e2a\u590d\u6742\u7684\u8fc7\u7a0b\u3002\u4f01\u4e1a\u9762\u4e34\u7740\u5e94\u5bf9\u533a\u57df\u590d\u6742\u6027\u3001\u5bf9\u6307\u5357\u7684\u4e0d\u540c\u89e3\u91ca\u4ee5\u53ca\u76f8\u4e92\u8ba4\u53ef\u534f\u8bae\u7684\u590d\u6742\u6027\u7684\u6311\u6218\u3002\u8981\u6210\u529f\u5e94\u5bf9\u8fd9\u4e00\u4e0d\u65ad\u53d8\u5316\u7684\u5168\u7403\u683c\u5c40\uff0c\u9700\u8981\u6df1\u5165\u4e86\u89e3\u56fd\u9645\u6807\u51c6\u548c\u7ec6\u5fae\u7684\u672c\u5730\u9002\u5e94\u6027\u3002<\/p>\n<h2><\/h2>\n<h2><span style=\"font-size: 75%;\"><strong>\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u5408\u89c4\u6027\uff1a\u63d0\u9ad8\u6548\u7387\u548c\u51c6\u786e\u6027\uff0c\u4f46\u9700\u8981\u4e25\u683c\u76d1\u7763<\/strong><\/span><\/h2>\n<p><a href=\"https:\/\/regask.com\/zh\/%e5%88%a9%e7%94%a8%e4%ba%ba%e5%b7%a5%e6%99%ba%e8%83%bd%e5%a2%9e%e5%bc%ba-esg-%e6%83%85%e6%8a%a5\/\">\u4eba\u5de5\u667a\u80fd<\/a> \u6b63\u5728\u5f7b\u5e95\u6539\u53d8\u5408\u89c4\u6d41\u7a0b\uff0c\u5728\u76d1\u7ba1\u76d1\u63a7\u548c\u6570\u636e\u4fdd\u62a4\u65b9\u9762\u63d0\u4f9b\u524d\u6240\u672a\u6709\u7684\u6548\u7387\u3002\u5148\u8fdb\u7684\u4eba\u5de5\u667a\u80fd\u6a21\u578b <strong>\u5782\u76f4\u4eba\u5de5\u667a\u80fd<\/strong> \u548c <strong>\u60c5\u5883\u4eba\u5de5\u667a\u80fd<\/strong>\uff0c\u878d\u5165\u7efc\u5408 <strong>\u76d1\u7ba1\u79d1\u6280\u5e73\u53f0<\/strong>\u4f7f\u516c\u53f8\u80fd\u591f\u76d1\u63a7\u548c\u89e3\u8bfb\u76d1\u7ba1\u53d8\u5316\uff0c\u4e3b\u52a8\u8bc6\u522b\u5408\u89c4\u5dee\u8ddd\uff0c\u5e76\u81ea\u52a8\u6267\u884c\u5fc5\u8981\u7684\u62a5\u544a\u3002\u8fd9\u51cf\u5c11\u4e86\u5bf9\u624b\u52a8\u6d41\u7a0b\u7684\u4f9d\u8d56\uff0c\u964d\u4f4e\u4e86\u5408\u89c4\u6210\u672c\uff0c\u5e76\u589e\u5f3a\u4e86\u5bf9 GDPR \u548c CCPA \u7b49\u590d\u6742\u6cd5\u89c4\u7684\u9075\u5b88\uff0c\u8fd9\u5728\u6570\u636e\u5bc6\u96c6\u578b\u751f\u547d\u79d1\u5b66\u73af\u5883\u4e2d\u5c24\u4e3a\u91cd\u8981\u3002<\/p>\n<p>\u7136\u800c\uff0c\u5c3d\u7ba1\u4eba\u5de5\u667a\u80fd\u5177\u6709\u663e\u8457\u7684\u4f18\u52bf\uff0c\u4f46\u4e5f\u9700\u8981\u8c28\u614e\u7684\u76d1\u7763\u3002\u9a8c\u8bc1\u4eba\u5de5\u667a\u80fd\u7684\u51c6\u786e\u6027\u3001\u89e3\u51b3\u67d0\u4e9b\u6a21\u578b\u7684\u201c\u9ed1\u7bb1\u201d\u6027\u8d28\u4ee5\u53ca\u5efa\u7acb\u660e\u786e\u7684\u95ee\u8d23\u6846\u67b6\u5bf9\u4e8e\u786e\u4fdd\u8d1f\u8d23\u4efb\u7684\u5b9e\u65bd\u81f3\u5173\u91cd\u8981\u3002\u4eba\u7c7b\u76d1\u7763\u5bf9\u4e8e\u89e3\u51b3\u4e0e\u4eba\u5de5\u667a\u80fd\u5408\u89c4\u76f8\u5173\u7684\u9053\u5fb7\u8003\u91cf\u548c\u6f5c\u5728\u504f\u89c1\u4ecd\u7136\u81f3\u5173\u91cd\u8981\u3002<\/p>\n<h2><\/h2>\n<h2><span style=\"font-size: 75%;\"><strong>\u771f\u5b9e\u4e16\u754c\u6570\u636e\u4e0e\u8bc1\u636e\uff1a\u4e2a\u6027\u5316\u533b\u7597\u4e0e\u4ef7\u503c\u8bba\u8bc1\u7684\u57fa\u77f3<\/strong><\/span><\/h2>\n<p>\u771f\u5b9e\u4e16\u754c\u6570\u636e (RWD) \u548c\u771f\u5b9e\u4e16\u754c\u8bc1\u636e (RWE) \u7684\u4f7f\u7528\u6b63\u5728\u6539\u53d8\u836f\u7269\u5f00\u53d1\u548c\u76d1\u7ba1\u51b3\u7b56\u3002\u5728\u8bc1\u660e\u4ef7\u503c\u7684\u9700\u6c42\u548c\u5411\u4e2a\u6027\u5316\u533b\u7597\u8f6c\u53d8\u7684\u63a8\u52a8\u4e0b\uff0cRWD\/RWE \u63d0\u4f9b\u4e86\u5bf9\u7597\u6cd5\u5728\u771f\u5b9e\u73af\u5883\u4e2d\u7684\u8868\u73b0\u7684\u6d1e\u5bdf\uff0c\u8d85\u8d8a\u4e86\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d7\u63a7\u73af\u5883\u3002\u8fd9\u4e3a\u4f18\u5316\u6cbb\u7597\u3001\u52a0\u5feb\u76d1\u7ba1\u5ba1\u6279\u548c\u652f\u6301\u4e0a\u5e02\u540e\u76d1\u7763\u63d0\u4f9b\u4e86\u5b9d\u8d35\u7684\u4fe1\u606f\u3002\u76d1\u7ba1\u673a\u6784\uff0c\u5982 <strong>FDA<\/strong> \u548c <strong>\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09<\/strong> \u8d8a\u6765\u8d8a\u8ba4\u8bc6\u5230RWE\u5728\u5b9e\u9645\u4f7f\u7528\u4e2d\u8bc1\u660e\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u6f5c\u529b\u3002<\/p>\n<p>\u4e3a\u4e86\u6709\u6548\u5229\u7528 RWD\/RWE\uff0c\u516c\u53f8\u9700\u8981\u5f3a\u5927\u7684\u6570\u636e\u805a\u5408\u548c\u5206\u6790\u7cfb\u7edf\uff0c\u786e\u4fdd\u9075\u5b88 GDPR \u548c HIPAA \u7b49\u6570\u636e\u9690\u79c1\u6cd5\u89c4\u3002 <strong>RegTech \u89e3\u51b3\u65b9\u6848<\/strong> \u53ef\u4ee5\u5728\u7b80\u5316\u8fd9\u4e9b\u6d41\u7a0b\u548c\u786e\u4fdd\u6570\u636e\u5b8c\u6574\u6027\u65b9\u9762\u53d1\u6325\u5173\u952e\u4f5c\u7528\u3002<\/p>\n<h2><\/h2>\n<h2><span style=\"font-size: 75%;\"><strong>\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u533b\u7597\u6a21\u5f0f\u7684\u5174\u8d77\uff1a\u8d4b\u4e88\u60a3\u8005\u6743\u529b\u3001\u9075\u5faa SaMD \u6cd5\u89c4<\/strong><\/span><\/h2>\n<p>\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u62a4\u7406\u6a21\u5f0f\u6b63\u5728\u91cd\u65b0\u5b9a\u4e49\u533b\u7597\u4fdd\u5065\u3002\u501f\u52a9\u6570\u5b57\u533b\u7597\u5de5\u5177\u548c <strong>\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u5206\u6790<\/strong>\u60a3\u8005\u6b63\u5728\u6210\u4e3a\u62a4\u7406\u7684\u79ef\u6781\u53c2\u4e0e\u8005\uff0c\u4ece\u800c\u63d0\u9ad8\u4f9d\u4ece\u6027\u548c\u6539\u5584\u7ed3\u679c\u3002\u8fd9\u79cd\u8f6c\u53d8\u9700\u8981\u4e25\u683c\u9075\u5b88 <strong>\u8f6f\u4ef6\u5373\u533b\u7597\u8bbe\u5907 (SaMD)<\/strong> \u6cd5\u89c4\uff0c\u5305\u62ec\u9075\u5b88 FDA \u5173\u4e8e\u201c\u8f6f\u4ef6\u4f5c\u4e3a\u533b\u7597\u5668\u68b0 (SaMD)\uff1a\u4e34\u5e8a\u8bc4\u4f30\u201d\u7684\u6307\u5bfc\u3002\u5728\u4e2a\u6027\u5316\u4e0e\u76d1\u7ba1\u4e25\u683c\u6027\u4e4b\u95f4\u53d6\u5f97\u5e73\u8861\u5bf9\u4e8e\u6210\u529f\u5b9e\u65bd\u81f3\u5173\u91cd\u8981\u3002\u901a\u8fc7\u9075\u5b88 SaMD \u6307\u5357\u5e76\u4f18\u5148\u8003\u8651\u6570\u636e\u5b89\u5168\uff0c\u516c\u53f8\u53ef\u4ee5\u6709\u6548\u5730\u90e8\u7f72\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u65b9\u6cd5\uff0c\u63d0\u9ad8\u60a3\u8005\u6ee1\u610f\u5ea6\u5e76\u6ee1\u8db3\u4e0d\u65ad\u53d8\u5316\u7684\u76d1\u7ba1\u671f\u671b\u3002<\/p>\n<h2><\/h2>\n<h2><span style=\"font-size: 75%;\"><strong>\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u7814\u53d1\u521b\u65b0\uff1a\u52a0\u901f\u53d1\u73b0\uff0c\u89e3\u51b3\u4f26\u7406\u95ee\u9898<\/strong><\/span><\/h2>\n<p>\u4eba\u5de5\u667a\u80fd\u6b63\u5728\u5f7b\u5e95\u6539\u53d8\u7814\u7a76\u548c\u5f00\u53d1\uff0c\u52a0\u901f\u836f\u7269\u53d1\u73b0\u3001\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u4e2a\u6027\u5316\u6cbb\u7597\u8ba1\u5212\u7b49\u8fdb\u7a0b\u3002 <a href=\"https:\/\/regask.com\/zh\/%e4%ba%ba%e5%b7%a5%e6%99%ba%e8%83%bd%e9%a9%b1%e5%8a%a8%e7%9a%84%e7%9b%91%e7%ae%a1%e6%83%85%e6%8a%a5%e5%af%b9%e7%94%9f%e5%91%bd%e7%a7%91%e5%ad%a6%e7%9a%84%e5%bd%b1%e5%93%8d\/\">\u751f\u6210\u5f0f AI \u6a21\u578b<\/a> \u5206\u6790\u5927\u91cf\u6570\u636e\u96c6\u4ee5\u786e\u5b9a\u6f5c\u5728\u7684\u6cbb\u7597\u65b9\u6cd5\uff0c\u9884\u6d4b\u60a3\u8005\u7684\u53cd\u5e94\uff0c\u5e76\u6839\u636e\u7279\u5b9a\u7684\u57fa\u56e0\u7279\u5f81\u5b9a\u5236\u6cbb\u7597\u65b9\u6848\uff0c\u7a81\u7834\u7cbe\u51c6\u533b\u7597\u7684\u754c\u9650\u3002<\/p>\n<p>\u7136\u800c\uff0c\u8fd9\u79cd\u5feb\u901f\u53d1\u5c55\u9700\u8981\u5f3a\u6709\u529b\u7684\u76d1\u7ba1\u76d1\u7763\u3002\u786e\u4fdd\u6570\u636e\u51c6\u786e\u6027\u3001\u89e3\u51b3\u9053\u5fb7\u95ee\u9898\u548c\u4fdd\u6301\u900f\u660e\u5ea6\u81f3\u5173\u91cd\u8981\u3002\u516c\u53f8\u5fc5\u987b\u5efa\u7acb\u660e\u786e\u7684\u6846\u67b6\uff0c\u4ee5\u51cf\u8f7b\u6f5c\u5728\u7684\u504f\u89c1\u5e76\u786e\u4fdd\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7814\u53d1\u7684\u516c\u5e73\u6027\u3002\u901a\u8fc7\u79ef\u6781\u6ee1\u8db3\u8fd9\u4e9b\u76d1\u7ba1\u671f\u671b\uff0c\u7ec4\u7ec7\u53ef\u4ee5\u5f15\u9886\u884c\u4e1a\u521b\u9020\u521b\u65b0\u7597\u6cd5\u5e76\u5728\u7cbe\u51c6\u533b\u7597\u65b9\u9762\u6811\u7acb\u65b0\u6807\u51c6\u3002<\/p>\n<h2><\/h2>\n<h2><span 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