{"id":10073,"date":"2026-05-07T14:51:15","date_gmt":"2026-05-07T06:51:15","guid":{"rendered":"https:\/\/regask.com\/?p=10073"},"modified":"2026-05-14T13:31:35","modified_gmt":"2026-05-14T05:31:35","slug":"%e7%9b%91%e7%ae%a1%e4%ba%8b%e5%8a%a1%e4%b8%ad%e7%9a%84%e6%99%ba%e8%83%bd%e4%bd%93%e4%ba%ba%e5%b7%a5%e6%99%ba%e8%83%bd%e6%ad%a3%e5%9c%a8%e9%87%8d%e5%a1%91%e5%85%a8%e7%90%83%e7%9b%91%e7%ae%a1%e5%90%88","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/agentic-ai-in-regulatory-affairs-rewiring-the-global-regulatory-compliance-function\/","title":{"rendered":"\u76d1\u7ba1\u4e8b\u52a1\u4e2d\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\uff1a\u91cd\u5851\u5168\u7403\u76d1\u7ba1\u2026\u2026"},"content":{"rendered":"<p>\u672c\u6587\u6700\u521d\u53d1\u8868\u4e8e <strong>DIA Global 2026 \u5e74 5 \u6708\u520a\u7684\u300a\u5168\u7403\u8bba\u575b\u300b\u6742\u5fd7\u3002.<\/strong><\/p>\n<p>\u70b9\u51fb\u6b64\u5904\u9605\u8bfb\u539f\u6587\uff1a <a id=\"menur2t43\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"https:\/\/globalforum.diaglobal.org\/issue\/may-2026\/agentic-ai-in-regulatory-affairs-rewiring-the-global-regulatory-compliance-function\/?utm_source=chatgpt.com\" href=\"https:\/\/globalforum.diaglobal.org\/issue\/may-2026\/agentic-ai-in-regulatory-affairs-rewiring-the-global-regulatory-compliance-function\/?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"\u94fe\u63a5 DIA \u5168\u7403\u8bba\u575b \u2013 2026 \u5e74 5 \u6708\u520a\">DIA \u5168\u7403\u8bba\u575b \u2013 2026 \u5e74 5 \u6708\u53f7<\/a><\/p>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<p id=\"ember757\" class=\"ember-view reader-text-block__paragraph\"><a href=\"https:\/\/regask.com\/zh\/2026%e5%b9%b4%e7%9b%91%e7%ae%a1%e4%ba%8b%e5%8a%a1%e5%92%8c%e5%90%88%e8%a7%84%e7%8a%b6%e5%86%b5%e6%8a%a5%e5%91%8a\/\">\u6bcf\u5468\uff0c\u8fd1\u4e00\u534a<\/a> \u6240\u6709\u76d1\u7ba1\u4e8b\u52a1\u4e13\u4e1a\u4eba\u5458\u5728\u64b0\u5199\u4e00\u4efd\u5f71\u54cd\u8bc4\u4f30\u62a5\u544a\u3001\u66f4\u65b0\u4e00\u4efd\u6587\u4ef6\u6216\u505a\u51fa\u4e00\u4efd\u7533\u62a5\u51b3\u5b9a\u4e4b\u524d\uff0c\u90fd\u8981\u82b1\u8d39\u4e24\u5230\u4e09\u5929\u7684\u65f6\u95f4\u6765\u8ffd\u8e2a\u76d1\u7ba1\u53d8\u5316\u3002\u5982\u679c\u5c06\u8fd9\u79cd\u60c5\u51b5\u6269\u5c55\u5230\u591a\u4e2a\u53f8\u6cd5\u7ba1\u8f96\u533a\uff0c\u800c\u6bcf\u4e2a\u53f8\u6cd5\u7ba1\u8f96\u533a\u90fd\u6709\u5176\u81ea\u8eab\u7684\u8bed\u8a00\u3001\u8282\u594f\u548c\u6267\u6cd5\u7acb\u573a\uff0c\u90a3\u4e48\u4eba\u529b\u6210\u672c\u5c31\u65e0\u6cd5\u8ddf\u4e0a\u590d\u6742\u6027\u7684\u589e\u957f\u901f\u5ea6\u3002.<\/p>\n<p>\u7136\u800c\uff0c\u7b54\u6848\u5e76\u975e\u7b80\u5355\u5730\u5c06\u751f\u6210\u5f0f\u4eba\u5de5\u667a\u80fd\u53e0\u52a0\u5230\u73b0\u6709\u5de5\u4f5c\u6d41\u7a0b\u4e0a\u3002\u751f\u6210\u5f0f\u4eba\u5de5\u667a\u80fd\u53ef\u4ee5\u8fdb\u884c\u603b\u7ed3\u548c\u64b0\u5199\u8349\u7a3f\uff0c\u4f46\u5b83\u65e0\u6cd5\u8fdb\u884c\u7edf\u7b79\u534f\u8c03\u3002\u6cd5\u89c4\u4e8b\u52a1\u56e2\u961f\u771f\u6b63\u9700\u8981\u7684\u662f\u4e00\u4e2a\u80fd\u591f\u81ea\u4e3b\u5730\u5728\u65e2\u5b9a\u8303\u56f4\u5185\u68c0\u6d4b\u53d8\u66f4\u3001\u5206\u6790\u5176\u5f71\u54cd\u3001\u64b0\u5199\u5e94\u5bf9\u65b9\u6848\u3001\u63d0\u4ea4\u5ba1\u6279\u5e76\u8bb0\u5f55\u6bcf\u4e00\u6b65\u64cd\u4f5c\u7684\u7cfb\u7edf\u3002\u8fd9\u4e2a\u7cfb\u7edf\u5c31\u662f\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\uff0c\u65e9\u671f\u91c7\u7528\u8005\u5df2\u7ecf\u8bc1\u660e\u4e86\u5b83\u7684\u6709\u6548\u6027\u3002\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u80fd\u591f\u4f7f\u76d1\u7ba1\u60c5\u62a5\u3001\u7533\u62a5\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb (QMS) \u548c\u836f\u7269\u8b66\u6212 (PV) \u5de5\u4f5c\u6d41\u7a0b\u4f5c\u4e3a\u4e00\u4e2a\u7edf\u4e00\u7684\u3001\u534f\u8c03\u7684\u7cfb\u7edf\u8fd0\u884c\uff0c\u4f7f\u5408\u683c\u7684\u6cd5\u89c4\u4e8b\u52a1\u4eba\u5458\u3001\u8d28\u91cf\u4fdd\u8bc1\u4eba\u5458\u548c\u5408\u683c\u4eba\u5458 (QP) \u5728\u6bcf\u4e2a\u9636\u6bb5\u90fd\u62e5\u6709\u5b8c\u6574\u7684\u51b3\u7b56\u6743\u548c\u8d23\u4efb\u3002.<\/p>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3 id=\"ember756\" class=\"ember-view reader-text-block__heading-3\">\u57fa\u7840\u5c42\uff1a\u57fa\u56e0\u4eba\u5de5\u667a\u80fd\u5728\u76d1\u7ba1\u4e8b\u52a1\u73b0\u4ee3\u5316\u4e2d\u7684\u4f5c\u7528<\/h3>\n\t<div id=\"gap-232039682\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-232039682 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u76d1\u7ba1\u590d\u6742\u6027\u7684\u6307\u6570\u7ea7\u589e\u957f\u9700\u8981\u7684\u4e0d\u4ec5\u4ec5\u662f\u4f20\u7edf\u7684\u6570\u5b57\u5de5\u5177\uff1b\u5b83\u9700\u8981\u5bf9\u76d1\u7ba1\u4e8b\u52a1 (RA) \u804c\u80fd\u8fdb\u884c\u6839\u672c\u6027\u7684\u91cd\u65b0\u8bbe\u8ba1\u3002.<\/p>\n<p>\u6839\u636e\u00a0<a href=\"https:\/\/www.deloitte.com\/us\/en\/insights\/industry\/health-care\/life-sciences-and-health-care-industry-outlooks\/2025-life-sciences-executive-outlook.html\" target=\"_blank\" rel=\"noreferrer noopener\">2025\u5e74\u5fb7\u52e4\u8c03\u67e5<\/a>, \u5927\u591a\u6570\u751f\u547d\u79d1\u5b66\u9886\u57df\u7684\u9ad8\u7ba1\u90fd\u5c06\u76d1\u7ba1\u590d\u6742\u6027\u5217\u4e3a\u4e09\u5927\u8fd0\u8425\u98ce\u9669\u4e4b\u4e00\u3002\u5728\u6cd5\u89c4\u4e8b\u52a1\u56e2\u961f\u4e2d\uff0c\u5de5\u4f5c\u91cf\u4f9d\u7136\u5de8\u5927\uff0c\u6d41\u7a0b\u4e5f\u9ad8\u5ea6\u4f9d\u8d56\u4eba\u5de5\u64cd\u4f5c\u3002.\u00a0<a href=\"https:\/\/regask.com\/zh\/2026%e5%b9%b4%e7%9b%91%e7%ae%a1%e4%ba%8b%e5%8a%a1%e5%92%8c%e5%90%88%e8%a7%84%e7%8a%b6%e5%86%b5%e6%8a%a5%e5%91%8a\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u8fc7\u53bb\u4e24\u5e74\u7684\u8c03\u67e5<\/a>\u00a0\u6570\u636e\u663e\u793a\uff0c\u8fd145%\u7684\u4e13\u4e1a\u4eba\u58eb\u6bcf\u5468\u8981\u82b1\u8d39\u4e24\u5230\u4e09\u5929\u7684\u65f6\u95f4\u4e13\u95e8\u7528\u4e8e\u76d1\u6d4b\u76d1\u7ba1\u53d8\u5316\uff0c\u8fd9\u662f\u4e00\u9879\u8017\u65f6\u7684\u5de5\u4f5c\uff0c\u800c\u4e0d\u65ad\u53d8\u5316\u7684\u8981\u6c42\u3001\u591a\u79cd\u8bed\u8a00\u4ee5\u53ca\u6301\u7eed\u7684\u590d\u6742\u6027\u66f4\u4f7f\u5176\u96ea\u4e0a\u52a0\u971c\u3002\u5176\u7ed3\u679c\u662f\u8d44\u6e90\u7d27\u5f20\u3001\u51b3\u7b56\u7f13\u6162\u4ee5\u53ca\u9519\u5931\u5e02\u573a\u826f\u673a\u3002.<\/p>\n<p>\u968f\u7740\u76d1\u7ba1\u590d\u6742\u6027\u8fbe\u5230\u5173\u952e\u8f6c\u6298\u70b9\uff0c\u6267\u6cd5\u529b\u5ea6\u4e5f\u968f\u4e4b\u52a0\u5927\u3002\u00a0<a href=\"https:\/\/artificialintelligenceact.eu\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u6b27\u76df\u4eba\u5de5\u667a\u80fd (AI) \u6cd5\u6848<\/a>\u00a0\u968f\u7740\u5168\u7403\u76d1\u7ba1\u6307\u5bfc\u7684\u65e5\u76ca\u5b8c\u5584\u548c\u4e0d\u65ad\u6269\u5c55\uff0c\u6ce8\u518c\u4e8b\u52a1\u56e2\u961f\u9762\u4e34\u7740\u4e00\u4e2a\u660e\u786e\u7684\u9009\u62e9\uff1a\u7ee7\u7eed\u4eba\u5de5\u76d1\u63a7\uff0c\u8fd8\u662f\u91c7\u7528\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u667a\u80fd\u76d1\u63a7\u3002\u5728\u6b64\u80cc\u666f\u4e0b\uff0c,\u00a0<a href=\"https:\/\/www.ibm.com\/think\/topics\/generative-ai\" target=\"_blank\" rel=\"noreferrer noopener\">\u751f\u6210\u5f0f\u4eba\u5de5\u667a\u80fd\uff08GenAI\uff09<\/a>, \u80fd\u591f\u4ece\u5927\u578b\u6570\u636e\u96c6\u4e2d\u751f\u6210\u3001\u6982\u62ec\u6216\u91cd\u6784\u5185\u5bb9\u7684\u9ad8\u7ea7\u673a\u5668\u5b66\u4e60\u6a21\u578b\u5df2\u6210\u4e3a\u4e00\u9879\u57fa\u7840\u6027\u80fd\u529b\u3002\u5b83\u80fd\u591f\u81ea\u52a8\u6536\u96c6\u60c5\u62a5\u3001\u53d1\u73b0\u65b0\u5174\u8d8b\u52bf\u4ee5\u9884\u5148\u9632\u8303\u98ce\u9669\uff0c\u5e76\u7b80\u5316\u6587\u6863\u5ba1\u67e5\u6d41\u7a0b\u3002.<\/p>\n<p>\u76d1\u7ba1\u4e8b\u52a1\u4e2d\u7684\u4e3b\u8981\u5e94\u7528\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u81ea\u52a8\u6587\u6863\u6458\u8981\n<ul>\n<li>\u5c06\u5197\u957f\u7684\u76d1\u7ba1\u66f4\u65b0\u6216\u6307\u5bfc\u610f\u89c1\u8f6c\u5316\u4e3a\u7b80\u6d01\u660e\u4e86\u7684\u60c5\u62a5\u62a5\u544a\uff0c\u4f9b\u5185\u90e8\u56e2\u961f\u53c2\u8003\u3002.<\/li>\n<li>\u64b0\u5199\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\u3001\u7533\u62a5\u6587\u4ef6\u548c\u57f9\u8bad\u5185\u5bb9\u7684\u521d\u7a3f\uff0c\u5927\u5927\u51cf\u5c11\u76d1\u7ba1\u56e2\u961f\u7684\u91cd\u590d\u6027\u5199\u4f5c\u4efb\u52a1\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u9884\u6d4b\u6027\u5408\u89c4\u6027\u76d1\u6d4b\n<ul>\n<li>\u5229\u7528\u5386\u53f2\u6570\u636e\u548c\u5b9e\u65f6\u6570\u636e\u9884\u6d4b\u76d1\u7ba1\u98ce\u9669\u3001\u68c0\u67e5\u51c6\u5907\u60c5\u51b5\u548c\u6807\u7b7e\u53d8\u66f4\u3002.<\/li>\n<li>\u901a\u8fc7\u5148\u8fdb\u7684\u5927\u578b\u8bed\u8a00\u6a21\u578b\uff0c\u5feb\u901f\u5206\u6790\u548c\u603b\u7ed3\u590d\u6742\u7684\u76d1\u7ba1\u6587\u4ef6\uff0c\u56de\u7b54\u6709\u9488\u5bf9\u6027\u7684\u95ee\u9898\uff0c\u5e76\u6bd4\u8f83\u4e0d\u540c\u53f8\u6cd5\u7ba1\u8f96\u533a\u7684\u8981\u6c42\uff0c\u4ece\u800c\u6d88\u9664\u8017\u65f6\u7684\u4eba\u5de5\u5ba1\u67e5\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u4eba\u5de5\u667a\u80fd\u5728\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\uff08QMS\uff09\u4e2d\u7684\u5e94\u7528\n<ul>\n<li>\u652f\u6301\u6587\u4ef6\u7684\u751f\u6210\u548c\u5b8c\u5584\u3001\u504f\u5dee\u7ba1\u7406\u4ee5\u53ca\u836f\u7269\u8b66\u6212\u62a5\u544a\u3002.<\/li>\n<li>\u6839\u636e\u65b0\u7684\u6216\u66f4\u65b0\u7684\u6cd5\u89c4\u8bc4\u4f30\u5185\u90e8\u653f\u7b56\uff0c\u627e\u51fa\u4e0d\u4e00\u81f4\u4e4b\u5904\uff0c\u751a\u81f3\u63d0\u51fa\u7ea0\u6b63\u63aa\u65bd\u6765\u5f25\u8865\u5dee\u8ddd\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u5168\u7403\u8d38\u6613\u548c\u4f9b\u5e94\u94fe\u5408\u89c4\u6027\n<ul>\n<li>\u89e3\u91ca\u8bf8\u5982\u6b64\u7c7b\u7684\u8981\u6c42\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/device-advice-comprehensive-regulatory-assistance\/unique-device-identification-system-udi-system\" target=\"_blank\" rel=\"noreferrer noopener\">FDA \u7684\u552f\u4e00\u8bbe\u5907\u6807\u8bc6\u7b26<\/a>\u00a0\uff08UDI\uff09\u548c\u00a0<a href=\"https:\/\/webgate.ec.europa.eu\/eudamed\/landing-page#\/\" target=\"_blank\" rel=\"noreferrer noopener\">EUDAMED<\/a>, \u5e76\u7edf\u4e00\u5404\u5730\u533a\u7684\u6807\u7b7e\u6807\u51c6\u3002.<\/li>\n<li>\u652f\u6301\u591a\u8bed\u8a00\u5408\u89c4\uff1a\u8bed\u8a00\u6a21\u578b\u53ef\u4ee5\u7ffb\u8bd1\u548c\u8c03\u6574\u76d1\u7ba1\u5185\u5bb9\u4ee5\u9002\u5e94\u4e0d\u540c\u7684\u5e02\u573a\uff0c\u540c\u65f6\u4fdd\u7559\u5bf9\u5168\u7403\u8fd0\u8425\u81f3\u5173\u91cd\u8981\u7684\u6cd5\u5f8b\u8bed\u6c14\u548c\u80cc\u666f\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u6cbb\u7406\u4e0e\u4eba\u4e3a\u76d1\u7763\n<ul>\n<li>\u5d4c\u5165\u63a7\u4ef6\u4ee5\u4e0e\u2026\u2026\u5bf9\u9f50\u00a0<a href=\"https:\/\/artificialintelligenceact.eu\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u6b27\u76df\u4eba\u5de5\u667a\u80fd\u6cd5\u6848<\/a>\u00a0\u4ee5\u53ca\u5176\u4ed6\u8981\u6c42\u57fa\u4e8e\u98ce\u9669\u7684\u6cbb\u7406\u548c\u53ef\u89e3\u91ca\u6027\u7684\u5168\u7403\u6846\u67b6\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u9884\u6d4b\u76d1\u7ba1\u7ed3\u679c\n<ul>\n<li>\u6301\u7eed\u76d1\u63a7\u5168\u7403\u76d1\u7ba1\u4fe1\u606f\u6765\u6e90\uff0c\u4ee5\u53d1\u73b0\u53d8\u5316\u5e76\u53ca\u65f6\u53d1\u51fa\u8b66\u62a5\uff0c\u786e\u4fdd\u56e2\u961f\u59cb\u7ec8\u8d70\u5728\u4e0d\u65ad\u53d8\u5316\u7684\u8981\u6c42\u7684\u524d\u6cbf\u3002.<\/li>\n<li>\u901a\u8fc7\u5206\u6790\u5386\u53f2\u5ba1\u6279\u8d8b\u52bf\uff0c,\u00a0<a href=\"https:\/\/intuitionlabs.ai\/articles\/ai-llms-regulatory-affairs\" target=\"_blank\" rel=\"noreferrer noopener\">\u4eba\u5de5\u667a\u80fd\u53ef\u4ee5\u9884\u6d4b\u6f5c\u5728\u51b3\u7b56\u5e76\u7a81\u51fa\u663e\u793a\u9ad8\u98ce\u9669\u9886\u57df<\/a>, \u4ece\u800c\u80fd\u591f\u8fdb\u884c\u79ef\u6781\u4e3b\u52a8\u7684\u89c4\u5212\u548c\u8d44\u6e90\u5206\u914d\u3002.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<div class=\"et_pb_module et_pb_text et_pb_text_4  et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<p>\u7136\u800c\uff0c\u4ec5\u9760\u57fa\u56e0\u4eba\u5de5\u667a\u80fd\uff08GenAI\uff09\u5e76\u975e\u6700\u7ec8\u76ee\u6807\u3002\u867d\u7136\u5b83\u80fd\u63d0\u4f9b\u5b9d\u8d35\u7684\u6d1e\u5bdf\uff0c\u4f46\u5374\u65e0\u6cd5\u72ec\u7acb\u6267\u884c\u73b0\u4ee3\u98ce\u9669\u8bc4\u4f30\uff08RA\uff09\u4e2d\u590d\u6742\u7684\u591a\u6b65\u9aa4\u5de5\u4f5c\u6d41\u7a0b\u3002\u4e3a\u4e86\u6301\u7eed\u5730\u5c06\u6d1e\u5bdf\u8f6c\u5316\u4e3a\u5408\u89c4\u884c\u52a8\uff0c\u7ec4\u7ec7\u5fc5\u987b\u8fc8\u5411\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\uff08Agentic AI\uff09\uff0c\u5373\u5728\u4eba\u5de5\u76d1\u7763\u4e0b\uff0c\u7531\u8f6f\u4ef6\u667a\u80fd\u4f53\u89c4\u5212\u3001\u6267\u884c\u548c\u8c03\u6574\u5de5\u4f5c\u6d41\u7a0b\u3002.<\/p>\n<\/div>\n<\/div>\n\t<div id=\"gap-2538485\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2538485 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-1070730697\">\n\n\t<div id=\"col-780660935\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner box-shadow-2\" style=\"background-color:rgb(233, 236, 245);\" >\n\t\t\t\n\t\t\t\n\t<div id=\"text-1672191805\" class=\"text\">\n\t\t\n<p>\u5982\u679c GenAI \u662f\u50ac\u5316\u5242\uff0c\u90a3\u4e48\u667a\u80fd\u4f53 AI \u5219\u4f5c\u4e3a\u96c6\u6210\u63a7\u5236\u67b6\u6784\u53d1\u6325\u4f5c\u7528\uff0c\u5c06\u68c0\u6d4b\u3001\u5206\u6790\u3001\u8d77\u8349\u3001\u901a\u77e5\u548c\u5ba1\u8ba1\u8ddf\u8e2a\u8fde\u63a5\u6210\u4e00\u4e2a\u5355\u4e00\u7684\u81ea\u52a8\u5316\u64cd\u4f5c\u94fe\u3002.<\/p>\n\t\t\n<style>\n#text-1672191805 {\n  text-align: center;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-780660935 > .col-inner {\n  padding: 20px 20px 10px 20px;\n  border-radius: 13px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u667a\u80fd\u4f53\u98de\u8dc3\uff1a\u4ece\u4e3b\u52a8\u6d1e\u5bdf\u5230\u5de5\u4f5c\u6d41\u7f16\u6392<\/h3>\n\t<div id=\"gap-806565938\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-806565938 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p id=\"ember769\" class=\"ember-view reader-text-block__paragraph\"><a href=\"https:\/\/www.ibm.com\/think\/topics\/agentic-ai\" target=\"_blank\" rel=\"noreferrer noopener\">\u4ee3\u7406\u4eba\u5de5\u667a\u80fd<\/a>\u00a0\u6307\u7684\u662f\u5728\u65e2\u5b9a\u53c2\u6570\u8303\u56f4\u5185\u8fd0\u884c\u7684\u76ee\u6807\u9a71\u52a8\u578b\u8f6f\u4ef6\u4ee3\u7406\uff0c\u5b83\u4eec\u80fd\u591f\u611f\u77e5\u3001\u63a8\u7406\u5e76\u8de8\u4e92\u8054\u7cfb\u7edf\u91c7\u53d6\u884c\u52a8\u3002\u4e0e\u54cd\u5e94\u63d0\u793a\u7684\u901a\u7528\u4eba\u5de5\u667a\u80fd\uff08GenAI\uff09\u4e0d\u540c\uff0c\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\uff08agentic AI\uff09\u80fd\u591f\u7cfb\u7edf\u5730\u534f\u8c03\u5de5\u4f5c\u6d41\u7a0b\u4ee5\u5b9e\u73b0\u9884\u5b9a\u4e49\u76ee\u6807\u3002\u8fd9\u6807\u5fd7\u7740\u81ea\u52a8\u5316\u65b9\u5f0f\u4ece\u88ab\u52a8\u5f0f\u5411\u4e3b\u52a8\u5f0f\u6267\u884c\u7684\u6839\u672c\u6027\u8f6c\u53d8\u3002.<\/p>\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1396453828\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1020\" height=\"458\" src=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/05\/Frame-61396.png\" class=\"attachment-large size-large\" alt=\"\u7b2c 61396 \u5e27\" srcset=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/05\/Frame-61396.png 1544w, https:\/\/regask.com\/wp-content\/uploads\/2026\/05\/Frame-61396-330x148.png 330w, https:\/\/regask.com\/wp-content\/uploads\/2026\/05\/Frame-61396-18x8.png 18w\" sizes=\"auto, (max-width: 1020px) 100vw, 1020px\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_1396453828 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"gap-1200919699\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1200919699 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8fd9\u79cd\u6f14\u53d8\u5e76\u975e\u9065\u8fdc\u7684\u672a\u6765\uff0c\u800c\u662f\u6b63\u5728\u53d1\u751f\u3002\u91c7\u7528\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u7684\u7ec4\u7ec7\u5df2\u7ecf\u5f00\u59cb\u964d\u4f4e\u76d1\u7ba1\u98ce\u9669\u3001\u63d0\u9ad8\u5ba1\u8ba1\u51c6\u5907\u5ea6\u5e76\u52a0\u5feb\u5e02\u573a\u51c6\u5165\u3002\u4ee5\u4e0b\u771f\u5b9e\u6848\u4f8b\u8bd5\u70b9\u5c55\u793a\u4e86\u5176\u5207\u5b9e\u7684\u5f71\u54cd\u3002.<\/p>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3 id=\"ember174\" class=\"ember-view reader-text-block__heading-3\">\u76d1\u7ba1\u4e8b\u52a1\u4e2d\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u8bd5\u70b9\u9879\u76ee\uff1a\u4ece\u7406\u8bba\u5230\u5b9e\u8df5<\/h3>\n\t<div id=\"gap-1021963984\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1021963984 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4ee5\u4e0b\u8bd5\u70b9\u6848\u4f8b\u7814\u7a76\u662f\u57fa\u4e8e\u5df2\u8bb0\u5f55\u7684\u884c\u4e1a\u8d8b\u52bf\u548c\u5df2\u53d1\u5e03\u7684\u5173\u4e8e\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u76d1\u7ba1\u5de5\u4f5c\u6d41\u7a0b\u7684\u89c1\u89e3\u800c\u63d0\u4f9b\u7684\u793a\u4f8b\u6027\u793a\u4f8b\u3002\u5b83\u4eec\u53cd\u6620\u4e86\u9886\u5148\u6765\u6e90\u62a5\u544a\u7684\u5e38\u89c1\u4e3b\u9898\u3002\u00a0<a href=\"https:\/\/www.mckinsey.com\/industries\/life-sciences\/our-insights\/reimagining-life-science-enterprises-with-agentic-ai\" target=\"_blank\" rel=\"noreferrer noopener\">\u751f\u547d\u79d1\u5b66\u9886\u57df\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd<\/a>, \u5173\u4e8e\u2026\u2026\u7684\u8ba8\u8bba\u00a0<a href=\"https:\/\/www.indegene.com\/what-we-think\/blogs\/applying-generative-ai-like-chatgpt-in-regulatory-affairs-from-hype-to-practical-applications\" target=\"_blank\" rel=\"noreferrer noopener\">\u6863\u6848\u81ea\u52a8\u5316<\/a>\uff0c \u548c\u00a0<a href=\"https:\/\/www.businesswire.com\/news\/home\/20250709456799\/en\/RegASK-Launches-First-Agentic-AI-Architecture-for-Regulatory-Affairs\" target=\"_blank\" rel=\"noreferrer noopener\">\u7528\u4e8e\u76d1\u7ba1\u4e8b\u52a1\u7684\u591a\u667a\u80fd\u4f53\u67b6\u6784<\/a>. \u8fd9\u4e9b\u6848\u4f8b\u7efc\u5408\u4e86\u884c\u4e1a\u62a5\u544a\u548c\u601d\u60f3\u9886\u8896\u6587\u7ae0\u4e2d\u63cf\u8ff0\u7684\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\uff0c\u603b\u7ed3\u4e86\u8bf8\u5982\u7f29\u77ed\u5468\u8f6c\u65f6\u95f4\u3001\u63d0\u9ad8\u51c6\u786e\u6027\u548c\u589e\u5f3a\u6cbb\u7406\u7b49\u89c2\u5bdf\u5230\u7684\u76ca\u5904\u3002\u5b83\u4eec\u8fd8\u5c55\u793a\u4e86\u6709\u9488\u5bf9\u6027\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u90e8\u7f72\u5982\u4f55\u5e26\u6765\u53ef\u8861\u91cf\u7684\u6210\u679c\u3002.<\/p>\n<p><b>\u98de\u884c\u5458A\uff1a\u00a0<a href=\"https:\/\/www.mckinsey.com\/industries\/life-sciences\/our-insights\/rewiring-pharmas-regulatory-submissions-with-ai-and-zero-based-design\" target=\"_blank\" rel=\"noreferrer noopener\">\u5168\u7403\u6807\u7b7e\u53d8\u66f4\u534f\u8c03<\/a><\/b><\/p>\n<ul>\n<li>\u5546\u4e1a\u6848\u4f8b\uff1a\u4e00\u5bb6\u4e2d\u578b\u5236\u836f\u516c\u53f8\u5728 25 \u4e2a\u5e02\u573a\u4e2d\uff0c\u6807\u7b7e\u53d8\u66f4\u7684\u5f71\u54cd\u8bc4\u4f30\u5e73\u5747\u5468\u8f6c\u65f6\u95f4\u4e3a 10 \u5929\uff0c\u5bfc\u81f4 12% \u7684\u66f4\u65b0\u7387\u88ab\u9519\u8fc7\u3002.<\/li>\n<li>\u89e3\u51b3\u65b9\u6848\uff1a\u90e8\u7f72\u4e86\u667a\u80fd AI \u5de5\u4f5c\u6d41\u7a0b\u6765\u76d1\u63a7\u536b\u751f\u76d1\u7ba1\u673a\u6784\u7f51\u7ad9\uff0c\u8bc6\u522b\u4e0e\u6807\u7b7e\u76f8\u5173\u7684\u66f4\u65b0\uff0c\u5bf9\u516c\u53f8\u7684\u4ea7\u54c1\u7ec4\u5408\u8fdb\u884c\u521d\u6b65\u5f71\u54cd\u5206\u6790\uff0c\u5e76\u8d77\u8349\u5f71\u54cd\u5907\u5fd8\u5f55\u4f9b\u4eba\u5de5\u5ba1\u6838\u3002.<\/li>\n<li>\u9632\u62a4\u63aa\u65bd\uff1a\u57fa\u4e8e\u89d2\u8272\u7684\u8bbf\u95ee\u63a7\u5236\u3001\u6765\u6e90\u6eaf\u6e90\u8ddf\u8e2a\uff0c\u4ee5\u53ca\u5bf9\u6240\u6709\u673a\u5668\u7ffb\u8bd1\u5185\u5bb9\u8fdb\u884c\u5f3a\u5236\u6027\u53cc\u8bed\u5ba1\u6838\u3002.<\/li>\n<li>\u4e3b\u8981\u76d1\u7ba1\/\u8d28\u91cf\u6846\u67b6\uff1a\u8be5\u8bd5\u70b9\u9879\u76ee\u6d89\u53ca\u591a\u4e2a\u4e3b\u8981\u76d1\u7ba1\u548c\u8d28\u91cf\u6846\u67b6\uff1a\n<ul>\n<li><a href=\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_Q9(R1)_Guideline_Step4_2022_1219.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">ICH Q9(R1) \u7b2c 4 \u6b65\u6587\u4ef6<\/a>\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\uff082023\u5e741\u6708\u901a\u8fc7\uff09\uff1a\u89c4\u8303\u5728\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u6d41\u7a0b\u4e2d\u4f7f\u7528\u4eba\u5de5\u667a\u80fd\u751f\u6210\u7684\u98ce\u9669\u8bc4\u5206\u548c\u63a7\u5236\u63aa\u65bd\uff0c\u5305\u62ec\u5bf9\u5ba2\u89c2\u6027\u3001\u6700\u5927\u9650\u5ea6\u51cf\u5c11\u4e3b\u89c2\u6027\u548c\u57fa\u4e8e\u98ce\u9669\u7684\u51b3\u7b56\u7684\u8981\u6c42\u3002\u672c\u8bd5\u70b9\u9879\u76ee\u4e2d\u7684\u4eba\u5de5\u667a\u80fd\u5f71\u54cd\u8bc4\u5206\u903b\u8f91\u662f\u6839\u636e\u5176\u56db\u4e2a\u5173\u952e\u6539\u8fdb\u9886\u57df\u8bbe\u8ba1\u7684\u3002.<\/li>\n<li>\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08EU MDR\uff09<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:32017R0745\" target=\"_blank\" rel=\"noreferrer noopener\">\uff08\u6b27\u76df\uff092017\/745\u53f7\u6761\u4f8b<\/a>) \/ \u6b27\u76df\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6cd5\u89c4 (<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:32017R0746\" target=\"_blank\" rel=\"noreferrer noopener\">\uff08\u6b27\u76df\uff092017\/746\u53f7\u6761\u4f8b<\/a>) + MDCG 2025-6\uff1a\u5982\u679c\u53d7\u5f71\u54cd\u7684\u4ea7\u54c1\u7ec4\u5408\u5305\u542b\u533b\u7597\u5668\u68b0\u6216\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff0c\u5219\u6807\u7b7e\u53d8\u66f4\u53ca\u5176\u5f71\u54cd\u8bc4\u4f30\u987b\u9075\u5b88 MDR\/IVDR \u5bf9\u6280\u672f\u6587\u6863\u3001\u4f7f\u7528\u8bf4\u660e (IFU) \u548c\u4e0a\u5e02\u540e\u76d1\u6d4b\u7684\u8981\u6c42\u30022025 \u5e74 6 \u6708\u53d1\u5e03\u7684 MDCG \u6307\u5357\u660e\u786e\u6307\u51fa\uff0c\u4eba\u5de5\u667a\u80fd\u8f85\u52a9\u6807\u7b7e\u5ba1\u67e5\u5de5\u5177\u5fc5\u987b\u6ee1\u8db3 MDR\/IVDR + \u6b27\u76df\u4eba\u5de5\u667a\u80fd\u6cd5\u6848\u53cc\u91cd\u6846\u67b6\u4e0b\u7684\u900f\u660e\u5ea6\u548c\u4eba\u5de5\u76d1\u7763\u8981\u6c42\u3002.<\/li>\n<li>FDA\u6807\u7b7e\u6307\u5357\u548cPCCP\uff1a\u5bf9\u4e8e\u7f8e\u56fd\u5e02\u573a\u4ea7\u54c1\uff0c\u4eba\u5de5\u667a\u80fd\u8f85\u52a9\u6807\u7b7e\u53d8\u66f4\u5de5\u4f5c\u6d41\u7a0b\u53d7FDA\u9884\u5b9a\u53d8\u66f4\u63a7\u5236\u8ba1\u5212\uff08PCCP\uff09\u6846\u67b6\u7684\u7ea6\u675f\uff0c\u8be5\u6846\u67b6\u8981\u6c42\u4efb\u4f55\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u8bbe\u5907\u6807\u7b7e\u4fee\u6539\u90fd\u5fc5\u987b\u6709\u636e\u53ef\u67e5\u3001\u53ef\u8ffd\u6eaf\uff0c\u5e76\u4f20\u8fbe\u7ed9\u7528\u6237\u3002\u8bd5\u70b9\u9879\u76ee\u7684\u7248\u672c\u63a7\u5236\u548c\u5907\u5fd8\u5f55\u8349\u62df\u8f93\u51fa\u5747\u7b26\u5408PCCP\u62ab\u9732\u8981\u6c42\u3002\u53c2\u8003\u6587\u732e\uff1a\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence\" target=\"_blank\" rel=\"noreferrer noopener\">FDA PCCP \u6307\u5357<\/a>.<\/li>\n<\/ul>\n<\/li>\n<li>\u7ed3\u679c\uff086\u4e2a\u6708\u8bd5\u70b9\uff09\uff1a\n<ul>\n<li>\u5f71\u54cd\u5907\u5fd8\u5f55\u7684\u5e73\u5747\u65f6\u95f4\u51cf\u5c11\u4e86 40%\uff08\u4ece 10 \u5929\u51cf\u5c11\u5230 6 \u5929\uff09\u3002.<\/li>\n<li>\u672a\u66f4\u65b0\u6b21\u6570\u964d\u81f3\u63a5\u8fd1\u96f6\uff08&lt;1%\uff09\u3002.<\/li>\n<li>\u4e0b\u6e38\u6d41\u7a0b\u4e2d\u7684\u7248\u672c\u63a7\u5236\u9519\u8bef\u51cf\u5c11\u4e86 50%\u3002.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><b>\u98de\u884c\u5458B\uff1a\u00a0<a href=\"https:\/\/intuitionlabs.ai\/articles\/agentic-ai-pharma-regulatory-document-automation\" target=\"_blank\" rel=\"noreferrer noopener\">\u81ea\u52a8\u5316\u6a21\u5757 1 \u6587\u4ef6\u7ec4\u88c5<\/a><\/b><\/p>\n<ul>\n<li>\u5546\u4e1a\u6848\u4f8b\uff1a\u4e00\u5bb6\u4eff\u5236\u836f\u516c\u53f8\u5728\u7ec4\u88c5\u63d0\u4ea4\u7684\u6a21\u5757 1 \u6587\u4ef6\uff08\u4f8b\u5982\uff0c\u533a\u57df\u8868\u683c\u3001\u5c01\u9762\u4fe1\uff09\u65f6\u9047\u5230\u4e86\u4e25\u91cd\u7684\u5ef6\u8bef\uff0c\u8fd4\u5de5\u5468\u671f\u6d88\u8017\u4e86\u56e2\u961f\u8d85\u8fc7 30% \u7684\u65f6\u95f4\u3002.<\/li>\n<li>\u89e3\u51b3\u65b9\u6848\uff1a\u8bad\u7ec3\u4e00\u4e2a\u4ee3\u7406\u7a0b\u5e8f\uff0c\u4f7f\u5176\u80fd\u591f\u4f7f\u7528\u5185\u90e8\u7cfb\u7edf\u4e2d\u7684\u6570\u636e\u81ea\u52a8\u586b\u5145\u7279\u5b9a\u56fd\u5bb6\u7684\u6a21\u677f\uff0c\u7ec4\u88c5\u6240\u9700\u7684 PDF \u6587\u6863\uff0c\u5e76\u5c06\u5176\u6253\u5305\u4ee5\u8fdb\u884c\u7535\u5b50\u63d0\u4ea4\uff08RPS\/eCTD\uff09\u3002.<\/li>\n<li>\u9632\u62a4\u63aa\u65bd\uff1a\u4e25\u683c\u7684\u6a21\u677f\u9a8c\u8bc1\u3001\u6700\u7ec8\u5b9a\u7a3f\u524d\u5fc5\u987b\u4eba\u5de5\u7b7e\u5b57\u786e\u8ba4\uff0c\u4ee5\u53ca\u9488\u5bf9\u975e\u6807\u51c6\u9700\u6c42\u7684\u4f8b\u5916\u961f\u5217\u3002\u7ed3\u679c\uff089 \u4e2a\u6708\u8bd5\u70b9\uff09\uff1a\n<ul>\n<li>\u6a21\u5757 1 \u7684\u7ec4\u88c5\u5468\u671f\u65f6\u95f4\u51cf\u5c11\u4e86 35%-45%\u3002.<\/li>\n<li>30% \u51cf\u5c11\u4e86\u56e0\u884c\u653f\u9519\u8bef\u9020\u6210\u7684\u8fd4\u5de5\u3002.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u76d1\u7ba1\u8fd0\u8425\u6a21\u5f0f\u7684\u4e0b\u4e00\u4e2a\u6f14\u8fdb\u9636\u6bb5\uff1a\u501f\u52a9\u4eba\u5de5\u667a\u80fd\u5b9e\u73b0\u4e3b\u52a8\u6267\u884c<\/h3>\n\t<div id=\"gap-1316590652\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1316590652 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"et_pb_section et_pb_section_3 et_section_regular\">\n<div class=\"et_pb_row et_pb_row_4\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_4  et_pb_css_mix_blend_mode_passthrough et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_7  et_pb_text_align_left et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<p>\u81ea\u4e3b\u6027\u6307\u7684\u662f\u72ec\u7acb\u884c\u52a8\u3001\u505a\u51fa\u9009\u62e9\u548c\u63a7\u5236\u81ea\u8eab\u884c\u4e3a\u7684\u80fd\u529b\u3002\u81ea\u4e3b\u4eba\u5de5\u667a\u80fd\u5c06\u8fd9\u4e00\u6982\u5ff5\u5e26\u5165\u4e86\u6570\u5b57\u9886\u57df\u3002\u76d1\u7ba1\u79d1\u5b66\u5df2\u7ecf\u5f00\u59cb\u6b63\u5f0f\u9610\u660e\u5176\u5728\u5b9e\u8df5\u4e2d\u7684\u542b\u4e49\uff1a\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-fda-set-common-principles-ai-medicine-development-0\" target=\"_blank\" rel=\"noreferrer noopener\">FDA\u2013EMA\u00a0<i>\u836f\u7269\u7814\u53d1\u4e2d\u4eba\u5de5\u667a\u80fd\u826f\u597d\u5b9e\u8df5\u7684\u6307\u5bfc\u539f\u5219<\/i><\/a>\u00a0\uff082026\u5e741\u6708\uff09\u4f7f\u7528\u4ee5\u4e0b\u65b9\u5f0f\u5b9a\u4e49\u4eba\u5de5\u667a\u80fd\u7cfb\u7edf\u00a0<a href=\"https:\/\/oecd.ai\/en\/wonk\/definition\" target=\"_blank\" rel=\"noreferrer noopener\">\u7ecf\u5408\u7ec4\u7ec7<\/a>\u00a0\u5c06\u5176\u5b9a\u4e49\u4e3a\u201c\u65e8\u5728\u4ee5\u4e0d\u540c\u7a0b\u5ea6\u7684\u81ea\u4e3b\u6027\u8fd0\u884c\uff0c\u5e76\u5728\u90e8\u7f72\u540e\u53ef\u80fd\u8868\u73b0\u51fa\u9002\u5e94\u6027\u7684\u57fa\u4e8e\u673a\u5668\u7684\u7cfb\u7edf\u201d\uff0c\u8fd9\u4e00\u5b9a\u4e49\u76f4\u63a5\u6db5\u76d6\u4e86\u667a\u80fd\u4f53\u67b6\u6784\u3002\u00a0<a href=\"https:\/\/artificialintelligenceact.eu\/article\/3\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u6b27\u76df\u4eba\u5de5\u667a\u80fd\u6cd5\u6848<\/a>\u00a0\u8fdb\u4e00\u6b65\u5c06\u8fd9\u4e00\u7406\u5ff5\u4ed8\u8bf8\u5b9e\u8df5\uff0c\u6839\u636e\u98ce\u9669\u7b49\u7ea7\u5bf9\u81ea\u4e3b\u4eba\u5de5\u667a\u80fd\u7cfb\u7edf\u8fdb\u884c\u5206\u7c7b\uff0c\u5bf9\u900f\u660e\u5ea6\u3001\u4eba\u5de5\u76d1\u7763\u548c\u751f\u547d\u5468\u671f\u6cbb\u7406\u65bd\u52a0\u76f8\u5e94\u7684\u4e49\u52a1\u3002.\u00a0<a href=\"https:\/\/www.iso.org\/standard\/42001\" target=\"_blank\" rel=\"noreferrer noopener\">ISO\/IEC 42001:2023<\/a>, \u4f5c\u4e3a\u9996\u4e2a\u56fd\u9645\u4eba\u5de5\u667a\u80fd\u7ba1\u7406\u7cfb\u7edf\u6807\u51c6\uff0c\u5b83\u63d0\u4f9b\u4e86\u7ec4\u7ec7\u6cbb\u7406\u6846\u67b6\uff0c\u6db5\u76d6\u4eba\u5de5\u667a\u80fd\u98ce\u9669\u8bc4\u4f30\u3001\u5f71\u54cd\u8bc4\u4f30\u548c\u6301\u7eed\u6539\u8fdb\uff0c\u667a\u80fd\u4f53\u90e8\u7f72\u5e94\u5728\u6b64\u6846\u67b6\u5185\u8fdb\u884c\u3002\u5176\u76ee\u6807\u9a71\u52a8\u80fd\u529b\u88ab\u8d4b\u4e88\u4e86\u4ee3\u8868\u7ec4\u7ec7\u884c\u4e8b\u7684\u6743\u529b\u3002,\u00a0<a href=\"https:\/\/www.mckinsey.com\/industries\/life-sciences\/our-insights\/reimagining-life-science-enterprises-with-agentic-ai#\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u4f7f\u7528\u5df2\u5b9a\u4e49\u4e14\u7ecf\u4eba\u5de5\u6279\u51c6\u7684\u53c2\u6570\u6267\u884c\u64cd\u4f5c<\/a>.<\/p>\n<p>\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u8d85\u8d8a\u4e86\u88ab\u52a8\u81ea\u52a8\u5316\uff1b\u5b83\u5728\u9884\u5148\u8bbe\u5b9a\u7684\u3001\u53d7\u63a7\u7684\u8fb9\u754c\u5185\u8fd0\u884c\uff0c\u80fd\u591f\u89c4\u5212\u3001\u6267\u884c\u548c\u8c03\u6574\u4efb\u52a1\u3002\u4ee5\u4e0b\u662f\u5b83\u63d0\u5347\u4e0a\u8ff0\u80fd\u529b\u7684\u4e00\u4e9b\u65b9\u5f0f\uff1a<\/p>\n<ul>\n<li>\u52a8\u6001\u5de5\u4f5c\u6d41\u7f16\u6392\uff1a\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4e0d\u4ec5\u53ef\u4ee5\u56de\u7b54\u67e5\u8be2\uff0c\u8fd8\u53ef\u4ee5\u5c06\u4efb\u52a1\u4e32\u8054\u8d77\u6765\uff1a\u68c0\u6d4b\u65b0\u6cd5\u89c4 \u2192 \u8fd0\u884c\u5dee\u8ddd\u5206\u6790 \u2192 \u8d77\u8349\u66f4\u65b0\u540e\u7684\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b (SOP) \u2192 \u901a\u77e5\u5229\u76ca\u76f8\u5173\u8005\u3002\u6d89\u53ca\u53d7\u76d1\u7ba1\u8f93\u51fa\uff08SOP\u3001\u63d0\u4ea4\u6587\u4ef6\u3001\u6807\u7b7e\uff09\u7684\u4e32\u8054\u667a\u80fd\u4f53\u5de5\u4f5c\u6d41\u9700\u63a5\u53d7 GxP \u8ba1\u7b97\u673a\u7cfb\u7edf\u9a8c\u8bc1\uff08\u53c2\u8003\u6587\u732e\uff1a\u00a0<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-5-guide-2nd-edition\" target=\"_blank\" rel=\"noreferrer noopener\">GAMP 5<\/a>\u00a0|\u00a0<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-guide-artificial-intelligence\" target=\"_blank\" rel=\"noreferrer noopener\">GAMP AI \u6307\u5357<\/a>\uff09\u3002\u4efb\u4f55\u7531\u4ee3\u7406\u4eba\u751f\u6210\u6216\u4fee\u6539\u7684\u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f\u6216\u63d0\u4ea4\u6587\u4ef6\u5747\u6784\u6210\u53d7\u76d1\u7ba1\u7684\u7535\u5b50\u8bb0\u5f55\uff0c\u4ece\u800c\u89e6\u53d1\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/part-11-electronic-records-electronic-signatures-scope-and-application\" target=\"_blank\" rel=\"noreferrer noopener\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) 21 CFR \u7b2c 11 \u90e8\u5206<\/a>\u00a0\u548c\u00a0<a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en\" target=\"_blank\" rel=\"noreferrer noopener\">\u6b27\u76dfGMP\u9644\u4ef611<\/a>\u00a0\uff08\u6b27\u76df\uff09\u8981\u6c42\u3002.<\/li>\n<li>\u6301\u7eed\u76d1\u63a7\u548c\u4e3b\u52a8\u884c\u52a8\uff1a\u5b83\u53ef\u4ee5\u6301\u7eed\u626b\u63cf\u76d1\u7ba1\u95e8\u6237\u7f51\u7ad9\uff0c\u89e6\u53d1\u8b66\u62a5\uff0c\u751a\u81f3\u65e0\u9700\u4eba\u5de5\u63d0\u793a\u5373\u53ef\u542f\u52a8\u5408\u89c4\u66f4\u65b0\u3002\u81ea\u4e3b\u76d1\u7ba1\u76d1\u63a7\u4e3a\u5408\u89c4\u51b3\u7b56\u63d0\u4f9b\u4fe1\u606f\uff0c\u8fd9\u6b63\u662f\u5176\u529f\u80fd\u7684\u6838\u5fc3\u6240\u5728\u3002\u00a0<a href=\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_Q9(R1)_Guideline_Step4_2022_1219.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">ICH Q9(R1)<\/a>\u00a0\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u3002.<\/li>\n<li>\u60c5\u5883\u611f\u77e5\u8349\u7a3f\u751f\u6210\uff1a\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u53ef\u4ee5\u4ece\u591a\u4e2a\u5185\u90e8\u7cfb\u7edf\uff08\u4f8b\u5982\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u5e93\u3001\u8d28\u91cf\u7cfb\u7edf\uff09\u63d0\u53d6\u6570\u636e\uff0c\u751f\u6210\u5b9a\u5236\u5316\u7684\u7533\u62a5\u8349\u7a3f\u3002\u5f53\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u8bbf\u95ee\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u5e93\u4ee5\u751f\u6210\u7533\u62a5\u5185\u5bb9\u65f6\uff0c\u5b83\u4f1a\u540c\u65f6\u5728\u591a\u4e2a\u91cd\u53e0\u7684\u6846\u67b6\u4e0b\u8fd0\u884c\uff1a\u00a0<a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines\" target=\"_blank\" rel=\"noreferrer noopener\">ICH M8<\/a>\/<a href=\"https:\/\/globalforum.diaglobal.org\/issue\/may-2025\/ectd-v4-0-a-look-at-2025-and-beyond\/\">eCTD v4.0<\/a>, \uff0c\u7528\u4e8e\u89c4\u8303\u4efb\u4f55\u62df\u4ee5\u7535\u5b50\u65b9\u5f0f\u63d0\u4ea4\u7684\u5185\u5bb9\u7684\u7ed3\u6784\u3001\u5143\u6570\u636e\u548c\u53ef\u8ffd\u6eaf\u6027\u8981\u6c42\uff1b\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">EMA\u5173\u4e8e\u4eba\u5de5\u667a\u80fd\u7684\u53cd\u601d\u6587\u4ef6<\/a>\u00a0\u660e\u786e\u89c4\u5b9a\uff0c\u7528\u4e8e\u64b0\u5199\u4ea7\u54c1\u4fe1\u606f\u6216\u7533\u62a5\u6587\u4ef6\u7684\u751f\u6210\u5f0f\u8bed\u8a00\u6a21\u578b\u5fc5\u987b\u5728\u4e25\u683c\u7684\u4eba\u5de5\u76d1\u7763\u4e0b\u4f7f\u7528\uff0c\u8d28\u91cf\u5ba1\u67e5\u673a\u5236\u5fc5\u987b\u786e\u4fdd\u5728\u63d0\u4ea4\u76d1\u7ba1\u90e8\u95e8\u4e4b\u524d\uff0c\u5176\u5185\u5bb9\u5728\u4e8b\u5b9e\u548c\u8bed\u6cd5\u4e0a\u90fd\u662f\u6b63\u786e\u7684\uff1b\u5982\u679c\u6d89\u53ca\u4e34\u5e8a\u6216\u60a3\u8005\u7ea7\u522b\u7684\u6570\u636e\uff0c,\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32016R0679\" target=\"_blank\" rel=\"noreferrer noopener\">GDPR<\/a>\u00a0\uff08\u6b27\u76df\u7b2c 2016\/679 \u53f7\u6761\u4f8b\uff09\u548c\u540c\u7b49\u7684\u6570\u636e\u4fdd\u62a4\u5236\u5ea6\u89c4\u5b9a\u4e86\u6570\u636e\u6700\u5c0f\u5316\u3001\u76ee\u7684\u9650\u5236\u548c\u8bbf\u95ee\u6cbb\u7406\u4e49\u52a1\u3002.<\/li>\n<li>\u591a\u8bed\u8a00\u548c\u5e02\u573a\u7279\u5b9a\u9002\u5e94\u6027\uff1a\u5b83\u53ef\u4ee5\u81ea\u52a8\u5c06\u6587\u6863\u672c\u5730\u5316\u4ee5\u9002\u5e94\u4e0d\u540c\u7684\u53f8\u6cd5\u7ba1\u8f96\u533a\uff0c\u5e76\u5b89\u6392\u4e0e\u533a\u57df\u56e2\u961f\u8fdb\u884c\u5ba1\u67e5\u3002.\u00a0<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-5-guide-2nd-edition\" target=\"_blank\" rel=\"noreferrer noopener\">GAMP 5<\/a>\u00a0\u9a8c\u8bc1\u8981\u6c42\u9002\u7528\u4e8e\u5b9a\u4f4d\u4ee3\u7406\u672c\u8eab\uff0c\u56e0\u4e3a\u5b83\u662f\u4e00\u4e2a GxP \u8ba1\u7b97\u673a\u7cfb\u7edf\u3002.<\/li>\n<li>\u9884\u6d4b\u6027\u548c\u6307\u5bfc\u6027\u6d1e\u5bdf\uff1a\u9664\u4e86\u9884\u6d4b\u4e4b\u5916\uff0c\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u8fd8\u53ef\u4ee5\u6839\u636e\u98ce\u9669\u8bc4\u5206\u63a8\u8350\u540e\u7eed\u6b65\u9aa4\uff08\u4f8b\u5982\uff0c\u4f18\u5148\u5904\u7406\u67d0\u4e9b\u7533\u62a5\u6587\u4ef6\u3001\u5206\u914d\u8d44\u6e90\uff09\u3002\u4eba\u5de5\u667a\u80fd\u751f\u6210\u7684\u98ce\u9669\u8bc4\u5206\u548c\u5efa\u8bae\u4f1a\u5f71\u54cd\u76d1\u7ba1\u51b3\u7b56\uff0c\u5305\u62ec\u7533\u62a5\u6587\u4ef6\u7684\u4f18\u5148\u7ea7\u6392\u5e8f\u3001\u6839\u636e\u5408\u89c4\u65f6\u95f4\u8868\u5206\u914d\u8d44\u6e90\uff0c\u6216\u5728\u836f\u7269\u8b66\u6212\u4e2d\u53d1\u51fa\u4fe1\u53f7\u5347\u7ea7\u3002,\u00a0<a href=\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_Q9(R1)_Guideline_Step4_2022_1219.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">ICH Q9(R1)<\/a>\u00a0\u662f\u4e3b\u8981\u7684\u8d28\u91cf\u6846\u67b6\u3002\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-fda-set-common-principles-ai-medicine-development-0\" target=\"_blank\" rel=\"noreferrer noopener\">FDA-EMA\u4eba\u5de5\u667a\u80fd\u826f\u597d\u5b9e\u8df5\u8054\u5408\u539f\u5219<\/a>\u00a0\u5728\u836f\u7269\u5f00\u53d1\u4e2d\uff0c\u901a\u8fc7\u539f\u5219 2\uff08\u57fa\u4e8e\u98ce\u9669\u7684\u65b9\u6cd5\uff09\u548c\u539f\u5219 8\uff08\u751f\u547d\u5468\u671f\u7ba1\u7406\uff09\u5f3a\u5316\u4e86\u8fd9\u4e00\u70b9\uff0c\u6307\u51fa\u9a8c\u8bc1\u3001\u76d1\u7763\u548c\u4fdd\u969c\u7684\u6c34\u5e73\u5fc5\u987b\u4e0e\u4eba\u5de5\u667a\u80fd\u7684\u4f7f\u7528\u73af\u5883\u548c\u76f8\u5173\u98ce\u9669\u76f8\u5339\u914d\u3002.<\/li>\n<\/ul>\n<p>\u8fd9\u4e0d\u4ec5\u4ec5\u662f\u81ea\u52a8\u5316\uff1b\u8fd9\u662f\u5411\u6548\u7387\u548c\u6218\u7565\u4ef7\u503c\u7684\u6839\u672c\u6027\u8f6c\u53d8\u3002.<\/p>\n<p>\u4e0a\u8ff0\u6548\u7387\u548c\u6218\u7565\u6536\u76ca\u662f\u5728\u4e0d\u53ef\u534f\u5546\u7684\u8303\u56f4\u5185\u5b9e\u73b0\u7684\uff0c\u7ec4\u7ec7\u5fc5\u987b\u4ece\u4e00\u5f00\u59cb\u5c31\u5c06\u8fd9\u4e9b\u8303\u56f4\u7eb3\u5165\u5230\u6bcf\u4e2a\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u90e8\u7f72\u7684\u8bbe\u8ba1\u4e2d\uff1a<\/p>\n<ul>\n<li>\u4eba\u5de5\u667a\u80fd\u4ee3\u7406\u7528\u4e8e\u652f\u6301\u76d1\u7ba1\u548c\u79d1\u5b66\u5de5\u4f5c\uff0c\u800c\u4e0d\u662f\u53d6\u4ee3\u6b63\u5f0f\u7684\u5224\u65ad\u6216\u95ee\u8d23\u3002.<\/li>\n<li>\u6240\u6709\u4eba\u5de5\u667a\u80fd\u751f\u6210\u7684\u8f93\u51fa\uff0c\u5305\u62ec\u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f\u3001\u6807\u7b7e\u548c\u63d0\u4ea4\u6587\u4ef6\uff0c\u5728\u4e0e\u536b\u751f\u90e8\u95e8\u5171\u4eab\u4e4b\u524d\uff0c\u90fd\u5fc5\u987b\u7ecf\u8fc7\u4e66\u9762\u7684\u4eba\u5de5\u5ba1\u67e5\u548c\u6279\u51c6\u3002.<\/li>\n<li>\u4efb\u4f55\u7531\u667a\u80fd\u4eba\u5de5\u667a\u80fd\u4ea7\u751f\u7684\u9884\u6d4b\u5206\u6790\uff0c\u4f8b\u5982\u5bf9\u6279\u51c6\u53ef\u80fd\u6027\u6216\u9884\u671f\u536b\u751f\u5f53\u5c40\u884c\u52a8\u7684\u8bc4\u4f30\uff0c\u4ec5\u7528\u4e8e\u51b3\u7b56\u652f\u6301\uff0c\u5e76\u4e0d\u88ab\u89c6\u4e3a\u6700\u7ec8\u9884\u6d4b\u6216\u76d1\u7ba1\u673a\u6784\u8ba4\u53ef\u7684\u9884\u6d4b\u3002.<\/li>\n<\/ul>\n<p>\u76d1\u7ba1\u4e8b\u52a1\u8d1f\u8d23\u4eba\u65e0\u9700\u7b49\u5f85\u4f01\u4e1a\u8303\u56f4\u5185\u7684\u8f6c\u578b\u3002\u4ed6\u4eec\u53ef\u4ee5\u5148\u4ece\u8bc6\u522b\u4e00\u4e2a\u9ad8\u5bb9\u91cf\u3001\u91cd\u590d\u6027\u7684\u5de5\u4f5c\u6d41\u7a0b\u5165\u624b\uff0c\u4f8b\u5982\u524d\u77bb\u6027\u626b\u63cf\u3001\u6863\u6848\u6574\u7406\u6216\u6807\u7b7e\u53d8\u66f4\u76d1\u63a7\uff0c\u5e76\u5728\u5355\u4e00\u4ea7\u54c1\u7ebf\u6216\u5e02\u573a\u96c6\u7fa4\u4e2d\u8bd5\u70b9\u667a\u80fd\u4f53\u65b9\u6cd5\u3002\u8bbe\u5b9a\u4e00\u4e2a\u4e3a\u671f 90 \u5929\u7684\u8bc4\u4f30\u7a97\u53e3\uff0c\u5e76\u5236\u5b9a\u660e\u786e\u7684\u6307\u6807\uff1a\u884c\u52a8\u54cd\u5e94\u65f6\u95f4\u3001\u66f4\u65b0\u6f0f\u62a5\u7387\u4ee5\u53ca\u91cd\u65b0\u5206\u914d\u7ed9\u6218\u7565\u5de5\u4f5c\u7684\u56e2\u961f\u5de5\u65f6\u3002\u5982\u4eca\uff0c\u5c06\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u878d\u5165\u5176\u76d1\u7ba1\u8fd0\u8425\u6a21\u5f0f\u7684\u7ec4\u7ec7\u4e0d\u4ec5\u80fd\u591f\u8ddf\u4e0a\u590d\u6742\u6027\u7684\u6b65\u4f10\uff0c\u8fd8\u80fd\u5c06\u5176\u8f6c\u5316\u4e3a\u7ade\u4e89\u4f18\u52bf\u3002\u6709\u9488\u5bf9\u6027\u7684\u5b9e\u65bd\u4ec5\u4ec5\u662f\u5f00\u59cb\u3002\u6269\u5c55\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u9700\u8981\u6210\u719f\u5ea6\u8def\u7ebf\u56fe\u3001\u591a\u667a\u80fd\u4f53\u67b6\u6784\u4ee5\u53ca\u4e13\u4e3a\u53d7\u76d1\u7ba1\u73af\u5883\u8bbe\u8ba1\u7684\u6cbb\u7406\u673a\u5236\u3002\uff08\u672c\u7cfb\u5217\u7684\u4e0b\u4e00\u7bc7\u6587\u7ae0\u5c06\u63a2\u8ba8\u5982\u4f55\u6784\u5efa\u8fd9\u4e09\u8005\u3002\uff09<\/p>\n<p>\u672c\u6587\u662f\u5bf9\u2026\u2026\u7684\u6269\u5c55\u00a0<a href=\"https:\/\/globalforum.diaglobal.org\/issue\/august-2025\/\">2025\u5e748\u6708\u00a0<i>\u5168\u7403\u8bba\u575b<\/i><\/a>\u00a0\u5173\u4e8e\u5c06\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4ece\u4e34\u5e8a\u64cd\u4f5c\u6269\u5c55\u5230\u76d1\u7ba1\u4e8b\u52a1\uff08RA\uff09\u804c\u80fd\u7684\u8ba8\u8bba\uff0c\u201c<a href=\"https:\/\/globalforum.diaglobal.org\/issue\/august-2025\/next-steps-in-artificial-intelligence-agentic-ai\/\">\u4eba\u5de5\u667a\u80fd\u7684\u4e0b\u4e00\u6b65\uff1a\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd<\/a>\u201d<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"et_pb_section et_pb_section_4 et_section_regular\">\n<div class=\"et_pb_row et_pb_row_5\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_5  et_pb_css_mix_blend_mode_passthrough et-last-child\">\u00a0<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>This article was originally published in the May 2026 issue of DIA Global\u2019s Global Forum magazine. Read the original publication here: DIA Global Forum \u2013 May 2026 Issue Every week, nearly half of all Regulatory Affairs professionals lose two to three days just tracking regulatory changes before a single impact assessment is written, a single&#8230;<\/p>","protected":false},"author":32,"featured_media":10110,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10073","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Agentic AI in Regulatory Affairs: A New Approach<\/title>\n<meta name=\"description\" content=\"Learn the impact of Agentic AI in Regulatory Affairs and how it can rewire compliance processes for better outcomes.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/zh\/\u76d1\u7ba1\u4e8b\u52a1\u4e2d\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u6b63\u5728\u91cd\u5851\u5168\u7403\u76d1\u7ba1\u5408\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Agentic AI in Regulatory Affairs: Rewiring the Global Regulatory Compliance Function\" \/>\n<meta property=\"og:description\" content=\"Learn the impact of Agentic AI in Regulatory Affairs and how it can rewire compliance processes for better outcomes.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/\u76d1\u7ba1\u4e8b\u52a1\u4e2d\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u6b63\u5728\u91cd\u5851\u5168\u7403\u76d1\u7ba1\u5408\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" 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