{"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":"%e8%a6%8f%e5%88%b6%e6%a5%ad%e5%8b%99%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e3%82%a8%e3%83%bc%e3%82%b8%e3%82%a7%e3%83%b3%e3%83%88%e5%9e%8bai%ef%bc%9a%e3%82%b0%e3%83%ad%e3%83%bc%e3%83%90%e3%83%ab%e3%81%aa","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/agentic-ai-in-regulatory-affairs-rewiring-the-global-regulatory-compliance-function\/","title":{"rendered":"\u898f\u5236\u696d\u52d9\u306b\u304a\u3051\u308b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\uff1a\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u898f\u5236\u696d\u52d9\u306e\u518d\u69cb\u7bc9\u2026"},"content":{"rendered":"<p>\u3053\u306e\u8a18\u4e8b\u306f\u5143\u3005 <strong>DIA Global\u767a\u884c\u306e\u300cGlobal Forum\u300d\u8a8c\u30012026\u5e745\u6708\u53f7\u3002.<\/strong><\/p>\n<p>\u5143\u306e\u8a18\u4e8b\u306f\u3053\u3061\u3089\u304b\u3089\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002 <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=\"\u30ea\u30f3\u30af\uff1aDIA\u30b0\u30ed\u30fc\u30d0\u30eb\u30d5\u30a9\u30fc\u30e9\u30e0 \u2013 2026\u5e745\u6708\u53f7\">DIA \u30b0\u30ed\u30fc\u30d0\u30eb \u30d5\u30a9\u30fc\u30e9\u30e0 \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\/ja\/2026%e5%b9%b4%e3%81%ae%e8%a6%8f%e5%88%b6%e7%8a%b6%e6%b3%81%e3%81%a8%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9%e5%a0%b1%e5%91%8a%e6%9b%b8\/\">\u6bce\u9031\u3001\u307b\u307c\u534a\u6570\u304c<\/a> 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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\u76e4\u3068\u306a\u308b\u5c64\uff1a\u898f\u5236\u696d\u52d9\u306e\u8fd1\u4ee3\u5316\u306b\u304a\u3051\u308bGenAI\u306e\u5f79\u5272<\/h3>\n\t<div id=\"gap-770134794\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-770134794 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u898f\u5236\u306e\u8907\u96d1\u5316\u304c\u6307\u6570\u95a2\u6570\u7684\u306b\u5897\u5927\u3057\u3066\u3044\u308b\u73fe\u72b6\u3067\u306f\u3001\u5f93\u6765\u306e\u30c7\u30b8\u30bf\u30eb\u30c4\u30fc\u30eb\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3042\u308a\u3001\u898f\u5236\u95a2\u9023\u696d\u52d9\uff08RA\uff09\u6a5f\u80fd\u306e\u6839\u672c\u7684\u306a\u518d\u69cb\u7bc9\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u308b\u3002.<\/p>\n<p>\u306b\u3088\u308b\u3068\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\u30c7\u30ed\u30a4\u30c8\u8abf\u67fb<\/a>, \u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u5206\u91ce\u306e\u7d4c\u55b6\u5e79\u90e8\u306e\u5927\u591a\u6570\u306f\u3001\u898f\u5236\u306e\u8907\u96d1\u3055\u3092\u4e0a\u4f4d3\u3064\u306e\u696d\u52d9\u30ea\u30b9\u30af\u306e1\u3064\u3068\u3057\u3066\u6319\u3052\u3066\u3044\u308b\u3002\u898f\u5236\u95a2\u9023\u30c1\u30fc\u30e0\u5168\u4f53\u3067\u3001\u696d\u52d9\u91cf\u306f\u4f9d\u7136\u3068\u3057\u3066\u81a8\u5927\u3067\u3042\u308a\u3001\u30d7\u30ed\u30bb\u30b9\u306f\u4f9d\u7136\u3068\u3057\u3066\u624b\u4f5c\u696d\u306b\u5927\u304d\u304f\u4f9d\u5b58\u3057\u3066\u3044\u308b\u3002.\u00a0<a href=\"https:\/\/regask.com\/ja\/2026%e5%b9%b4%e3%81%ae%e8%a6%8f%e5%88%b6%e7%8a%b6%e6%b3%81%e3%81%a8%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9%e5%a0%b1%e5%91%8a%e6%9b%b8\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u904e\u53bb2\u5e74\u9593\u306e\u8abf\u67fb<\/a>\u00a0\u5c02\u9580\u5bb6\u306e\u7d04451,180\u4e07\u4eba\u304c\u3001\u898f\u5236\u5909\u66f4\u306e\u76e3\u8996\u3060\u3051\u3067\u6bce\u90312\uff5e3\u65e5\u3092\u8cbb\u3084\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u660e\u3089\u304b\u306b\u306a\u3063\u305f\u3002\u3053\u308c\u306f\u3001\u8981\u6c42\u4e8b\u9805\u306e\u5909\u5316\u3001\u591a\u8a00\u8a9e\u5bfe\u5fdc\u3001\u305d\u3057\u3066\u7d76\u3048\u9593\u306a\u3044\u8907\u96d1\u3055\u306b\u3088\u3063\u3066\u3001\u3055\u3089\u306b\u6642\u9593\u306e\u304b\u304b\u308b\u4f5c\u696d\u3068\u306a\u3063\u3066\u3044\u308b\u3002\u305d\u306e\u7d50\u679c\u3001\u30ea\u30bd\u30fc\u30b9\u306e\u903c\u8feb\u3001\u610f\u601d\u6c7a\u5b9a\u306e\u9045\u5ef6\u3001\u305d\u3057\u3066\u5e02\u5834\u6a5f\u4f1a\u306e\u9038\u5931\u306b\u3064\u306a\u304c\u3063\u3066\u3044\u308b\u3002.<\/p>\n<p>\u898f\u5236\u306e\u8907\u96d1\u3055\u304c\u91cd\u5927\u306a\u8ee2\u63db\u70b9\u306b\u9054\u3057\u3001\u00a0<a href=\"https:\/\/artificialintelligenceact.eu\/\" target=\"_blank\" rel=\"noreferrer noopener\">EU \u4eba\u5de5\u77e5\u80fd (AI) \u6cd5<\/a>\u00a0\u898f\u5236\u5f53\u5c40\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u4e16\u754c\u7684\u306b\u62e1\u5927\u3059\u308b\u4e2d\u3001RA\u30c1\u30fc\u30e0\u306f\u660e\u78ba\u306a\u9078\u629e\u3092\u8feb\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u624b\u52d5\u306b\u3088\u308b\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u7d99\u7d9a\u3059\u308b\u304b\u3001AI\u3092\u6d3b\u7528\u3057\u305f\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u63a1\u7528\u3059\u308b\u304b\u3067\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u72b6\u6cc1\u4e0b\u3067\u3001,\u00a0<a href=\"https:\/\/www.ibm.com\/think\/topics\/generative-ai\" target=\"_blank\" rel=\"noreferrer noopener\">\u751f\u6210AI\uff08GenAI\uff09<\/a>, \u5927\u898f\u6a21\u306a\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u304b\u3089\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u751f\u6210\u3001\u8981\u7d04\u3001\u307e\u305f\u306f\u518d\u69cb\u6210\u3067\u304d\u308b\u9ad8\u5ea6\u306a\u6a5f\u68b0\u5b66\u7fd2\u30e2\u30c7\u30eb\u306f\u3001\u4eca\u3084\u4e0d\u53ef\u6b20\u306a\u6a5f\u80fd\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u60c5\u5831\u53ce\u96c6\u304c\u81ea\u52d5\u5316\u3055\u308c\u3001\u65b0\u305f\u306a\u30c8\u30ec\u30f3\u30c9\u304c\u660e\u3089\u304b\u306b\u306a\u3063\u3066\u30ea\u30b9\u30af\u3092\u672a\u7136\u306b\u9632\u304e\u3001\u6587\u66f8\u30ec\u30d3\u30e5\u30fc\u304c\u52b9\u7387\u5316\u3055\u308c\u307e\u3059\u3002.<\/p>\n<p>\u898f\u5236\u95a2\u9023\u696d\u52d9\u306b\u304a\u3051\u308b\u4e3b\u306a\u5fdc\u7528\u4f8b\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n<ul>\n<li>\u81ea\u52d5\u6587\u66f8\u8981\u7d04\n<ul>\n<li>\u9577\u6587\u306e\u898f\u5236\u306b\u95a2\u3059\u308b\u6700\u65b0\u60c5\u5831\u3084\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u3001\u793e\u5185\u30c1\u30fc\u30e0\u5411\u3051\u306e\u7c21\u6f54\u306a\u60c5\u5831\u30ec\u30dd\u30fc\u30c8\u306b\u5909\u63db\u3059\u308b\u3002.<\/li>\n<li>\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u3001\u7533\u8acb\u66f8\u985e\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30b3\u30f3\u30c6\u30f3\u30c4\u306e\u521d\u671f\u8349\u6848\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u3067\u3001\u898f\u5236\u95a2\u9023\u30c1\u30fc\u30e0\u306e\u53cd\u5fa9\u7684\u306a\u6587\u66f8\u4f5c\u6210\u4f5c\u696d\u3092\u5927\u5e45\u306b\u524a\u6e1b\u3057\u307e\u3059\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u4e88\u6e2c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u76e3\u8996\n<ul>\n<li>\u904e\u53bb\u306e\u30c7\u30fc\u30bf\u3068\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066\u3001\u898f\u5236\u30ea\u30b9\u30af\u3001\u691c\u67fb\u6e96\u5099\u72b6\u6cc1\u3001\u304a\u3088\u3073\u8868\u793a\u5909\u66f4\u3092\u4e88\u6e2c\u3059\u308b\u3002.<\/li>\n<li>\u9ad8\u5ea6\u306a\u5927\u898f\u6a21\u8a00\u8a9e\u30e2\u30c7\u30eb\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u8907\u96d1\u306a\u898f\u5236\u6587\u66f8\u3092\u8fc5\u901f\u306b\u5206\u6790\u30fb\u8981\u7d04\u3057\u3001\u7684\u3092\u7d5e\u3063\u305f\u8cea\u554f\u306b\u56de\u7b54\u3057\u3001\u7ba1\u8f44\u533a\u57df\u9593\u306e\u8981\u4ef6\u3092\u6bd4\u8f03\u3059\u308b\u3053\u3068\u3067\u3001\u6642\u9593\u306e\u304b\u304b\u308b\u624b\u4f5c\u696d\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u3092\u6392\u9664\u3057\u307e\u3059\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306b\u304a\u3051\u308bAI\n<ul>\n<li>\u6587\u66f8\u4f5c\u6210\u304a\u3088\u3073\u7cbe\u7dfb\u5316\u3001\u9038\u8131\u7ba1\u7406\u3001\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u5831\u544a\u3092\u652f\u63f4\u3059\u308b\u3002.<\/li>\n<li>\u793e\u5185\u898f\u5b9a\u3092\u65b0\u898f\u307e\u305f\u306f\u66f4\u65b0\u3055\u308c\u305f\u898f\u5236\u306b\u7167\u3089\u3057\u5408\u308f\u305b\u3066\u8a55\u4fa1\u3057\u3001\u77db\u76fe\u70b9\u3092\u7279\u5b9a\u3057\u3001\u3055\u3089\u306b\u306f\u30ae\u30e3\u30c3\u30d7\u3092\u57cb\u3081\u308b\u305f\u3081\u306e\u662f\u6b63\u63aa\u7f6e\u3092\u63d0\u6848\u3059\u308b\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u30b0\u30ed\u30fc\u30d0\u30eb\u8cbf\u6613\u304a\u3088\u3073\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\n<ul>\n<li>\u8981\u4ef6\u306e\u89e3\u91c8\u306a\u3069\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\u306e\u56fa\u6709\u533b\u7642\u6a5f\u5668\u8b58\u5225\u5b50<\/a>\u00a0\uff08UDI\uff09\u3068\u00a0<a href=\"https:\/\/webgate.ec.europa.eu\/eudamed\/landing-page#\/\" target=\"_blank\" rel=\"noreferrer noopener\">EUDAMED<\/a>, \u305d\u3057\u3066\u3001\u5730\u57df\u9593\u3067\u8868\u793a\u57fa\u6e96\u3092\u7d71\u4e00\u3059\u308b\u3053\u3068\u3002.<\/li>\n<li>\u591a\u8a00\u8a9e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u30b5\u30dd\u30fc\u30c8\uff1a\u8a00\u8a9e\u30e2\u30c7\u30eb\u306f\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u4e8b\u696d\u904b\u55b6\u306b\u4e0d\u53ef\u6b20\u306a\u6cd5\u7684\u30c8\u30fc\u30f3\u3068\u6587\u8108\u3092\u7dad\u6301\u3057\u306a\u304c\u3089\u3001\u898f\u5236\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u3055\u307e\u3056\u307e\u306a\u5e02\u5834\u5411\u3051\u306b\u7ffb\u8a33\u304a\u3088\u3073\u9069\u5fdc\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u30ac\u30d0\u30ca\u30f3\u30b9\u3068\u4eba\u7684\u76e3\u7763\n<ul>\n<li>\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u57cb\u3081\u8fbc\u3093\u3067\u3001\u00a0<a href=\"https:\/\/artificialintelligenceact.eu\/\" target=\"_blank\" rel=\"noreferrer noopener\">EU AI\u6cd5<\/a>\u00a0\u307e\u305f\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u30ac\u30d0\u30ca\u30f3\u30b9\u3068\u8aac\u660e\u8cac\u4efb\u3092\u7fa9\u52d9\u4ed8\u3051\u308b\u305d\u306e\u4ed6\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u67a0\u7d44\u307f\u3082\u542b\u307e\u308c\u308b\u3002.<\/li>\n<\/ul>\n<\/li>\n<li>\u898f\u5236\u7d50\u679c\u3092\u4e88\u6e2c\u3059\u308b\n<ul>\n<li>\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u898f\u5236\u60c5\u5831\u6e90\u3092\u7d99\u7d9a\u7684\u306b\u76e3\u8996\u3057\u3001\u5909\u66f4\u3092\u691c\u77e5\u3057\u3066\u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u30a2\u30e9\u30fc\u30c8\u3092\u767a\u4fe1\u3059\u308b\u3053\u3068\u3067\u3001\u30c1\u30fc\u30e0\u304c\u9032\u5316\u3059\u308b\u8981\u4ef6\u306b\u5e38\u306b\u5148\u3093\u3058\u3066\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002.<\/li>\n<li>\u904e\u53bb\u306e\u627f\u8a8d\u50be\u5411\u3092\u5206\u6790\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001,\u00a0<a href=\"https:\/\/intuitionlabs.ai\/articles\/ai-llms-regulatory-affairs\" target=\"_blank\" rel=\"noreferrer noopener\">AI\u306f\u6f5c\u5728\u7684\u306a\u610f\u601d\u6c7a\u5b9a\u3092\u4e88\u6e2c\u3057\u3001\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u9818\u57df\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/a>, \u3053\u308c\u306b\u3088\u308a\u3001\u7a4d\u6975\u7684\u306a\u8a08\u753b\u7b56\u5b9a\u3068\u8cc7\u6e90\u914d\u5206\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\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>\u3057\u304b\u3057\u3001GenAI\u3060\u3051\u3067\u306f\u6700\u7d42\u76ee\u6a19\u306b\u306f\u306a\u308a\u5f97\u307e\u305b\u3093\u3002GenAI\u306f\u8cb4\u91cd\u306a\u6d1e\u5bdf\u3092\u63d0\u4f9b\u3057\u307e\u3059\u304c\u3001\u73fe\u4ee3\u306e\u898f\u5236\u95a2\u9023\u696d\u52d9\u3092\u7279\u5fb4\u3065\u3051\u308b\u8907\u96d1\u306a\u591a\u6bb5\u968e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u5358\u72ec\u3067\u5b9f\u884c\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u6d1e\u5bdf\u3092\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u62e0\u3057\u305f\u884c\u52d5\u3078\u3068\u4e00\u8cab\u3057\u3066\u8ee2\u63db\u3059\u308b\u306b\u306f\u3001\u7d44\u7e54\u306f\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3078\u3068\u79fb\u884c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3067\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u304c\u4eba\u9593\u306e\u76e3\u8996\u4e0b\u3067\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u8a08\u753b\u3001\u5b9f\u884c\u3001\u9069\u5fdc\u3055\u305b\u307e\u3059\u3002.<\/p>\n<\/div>\n<\/div>\n\t<div id=\"gap-1842086975\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1842086975 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-229110702\">\n\n\t<div id=\"col-498631391\" 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-414028273\" class=\"text\">\n\t\t\n<p>GenAI\u304c\u89e6\u5a92\u3068\u306a\u308b\u5834\u5408\u3001\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u306f\u7d71\u5408\u5236\u5fa1\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u3068\u3057\u3066\u6a5f\u80fd\u3057\u3001\u691c\u51fa\u3001\u5206\u6790\u3001\u4f5c\u6210\u3001\u901a\u77e5\u3001\u76e3\u67fb\u8a3c\u8de1\u3092\u5358\u4e00\u306e\u81ea\u52d5\u5316\u3055\u308c\u305f\u904b\u7528\u30c1\u30a7\u30fc\u30f3\u306b\u30ea\u30f3\u30af\u3055\u305b\u308b\u3002.<\/p>\n\t\t\n<style>\n#text-414028273 {\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-498631391 > .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>\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u306e\u98db\u8e8d\uff1a\u30d7\u30ed\u30a2\u30af\u30c6\u30a3\u30d6\u306a\u6d1e\u5bdf\u304b\u3089\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u3078<\/h3>\n\t<div id=\"gap-1372971354\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1372971354 {\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\">\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI<\/a>\u00a0\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3068\u306f\u3001\u5b9a\u7fa9\u3055\u308c\u305f\u30d1\u30e9\u30e1\u30fc\u30bf\u30fc\u5185\u3067\u52d5\u4f5c\u3057\u3001\u63a5\u7d9a\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u8a8d\u8b58\u3001\u63a8\u8ad6\u3001\u304a\u3088\u3073\u884c\u52d5\u3092\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u308b\u3001\u76ee\u6a19\u6307\u5411\u578b\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u3092\u6307\u3057\u307e\u3059\u3002\u30d7\u30ed\u30f3\u30d7\u30c8\u306b\u5fdc\u7b54\u3059\u308b\u6c4e\u7528AI\u3068\u306f\u7570\u306a\u308a\u3001\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u306f\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u4f53\u7cfb\u7684\u306b\u8abf\u6574\u3057\u3001\u4e8b\u524d\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u76ee\u6a19\u3092\u9054\u6210\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u53d7\u52d5\u7684\u306a\u81ea\u52d5\u5316\u304b\u3089\u80fd\u52d5\u7684\u306a\u5b9f\u884c\u3078\u306e\u6839\u672c\u7684\u306a\u8ee2\u63db\u3092\u610f\u5473\u3057\u307e\u3059\u3002.<\/p>\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_794322190\">\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=\"\u30d5\u30ec\u30fc\u30e061396\" 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_794322190 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"gap-1595702372\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1595702372 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u9032\u5316\u306f\u9060\u3044\u672a\u6765\u306e\u8a71\u3067\u306f\u306a\u304f\u3001\u307e\u3055\u306b\u4eca\u8d77\u3053\u3063\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3092\u5c0e\u5165\u3057\u305f\u7d44\u7e54\u306f\u3001\u65e2\u306b\u898f\u5236\u30ea\u30b9\u30af\u306e\u4f4e\u6e1b\u3001\u76e3\u67fb\u5bfe\u5fdc\u80fd\u529b\u306e\u5411\u4e0a\u3001\u5e02\u5834\u53c2\u5165\u306e\u52a0\u901f\u3092\u5b9f\u73fe\u3057\u3066\u3044\u307e\u3059\u3002\u4ee5\u4e0b\u306e\u5b9f\u4f8b\u30d1\u30a4\u30ed\u30c3\u30c8\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306f\u3001\u305d\u306e\u5177\u4f53\u7684\u306a\u52b9\u679c\u3092\u793a\u3057\u3066\u3044\u307e\u3059\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\">\u898f\u5236\u95a2\u9023\u696d\u52d9\u306b\u304a\u3051\u308b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u30d1\u30a4\u30ed\u30c3\u30c8\uff1a\u7406\u8ad6\u304b\u3089\u5b9f\u8df5\u3078<\/h3>\n\t<div id=\"gap-1959925552\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1959925552 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4ee5\u4e0b\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u306f\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u696d\u754c\u52d5\u5411\u3068AI\u99c6\u52d5\u578b\u898f\u5236\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306b\u95a2\u3059\u308b\u516c\u958b\u3055\u308c\u305f\u77e5\u898b\u306b\u57fa\u3065\u3044\u305f\u4f8b\u793a\u3067\u3059\u3002\u3053\u308c\u3089\u306f\u3001\u4e3b\u8981\u306a\u60c5\u5831\u6e90\u306b\u3088\u3063\u3066\u5831\u544a\u3055\u308c\u305f\u5171\u901a\u306e\u30c6\u30fc\u30de\u3092\u53cd\u6620\u3057\u3066\u3044\u307e\u3059\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\u306b\u304a\u3051\u308b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI<\/a>, \u8b70\u8ad6\u306b\u3064\u3044\u3066\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\">\u66f8\u985e\u81ea\u52d5\u5316<\/a>\u3001 \u305d\u3057\u3066\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\">\u898f\u5236\u696d\u52d9\u306e\u305f\u3081\u306e\u30de\u30eb\u30c1\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3<\/a>. \u3053\u308c\u3089\u306e\u4e8b\u4f8b\u306f\u3001\u696d\u754c\u30ec\u30dd\u30fc\u30c8\u3084\u30aa\u30d4\u30cb\u30aa\u30f3\u8a18\u4e8b\u3067\u7d39\u4ecb\u3055\u308c\u3066\u3044\u308b\u5b9f\u969b\u306e\u5c0e\u5165\u4e8b\u4f8b\u304b\u3089\u5f97\u3089\u308c\u305f\u3001\u51e6\u7406\u6642\u9593\u306e\u77ed\u7e2e\u3001\u7cbe\u5ea6\u306e\u5411\u4e0a\u3001\u30ac\u30d0\u30ca\u30f3\u30b9\u306e\u5f37\u5316\u3068\u3044\u3063\u305f\u30e1\u30ea\u30c3\u30c8\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002\u307e\u305f\u3001\u30bf\u30fc\u30b2\u30c3\u30c8\u3092\u7d5e\u3063\u305f\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u306e\u5c0e\u5165\u304c\u3001\u3044\u304b\u306b\u6e2c\u5b9a\u53ef\u80fd\u306a\u6210\u679c\u3092\u3082\u305f\u3089\u3057\u3066\u3044\u308b\u304b\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n<p><b>\u30d1\u30a4\u30ed\u30c3\u30c8A\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\">\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u30e9\u30d9\u30eb\u8868\u793a\u5909\u66f4\u306e\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3<\/a><\/b><\/p>\n<ul>\n<li>\u30d3\u30b8\u30cd\u30b9\u30b1\u30fc\u30b9\uff1a\u4e2d\u898f\u6a21\u306e\u88fd\u85ac\u4f1a\u793e\u306f\u300125\u306e\u5e02\u5834\u306b\u304a\u3051\u308b\u30e9\u30d9\u30eb\u5909\u66f4\u306e\u5f71\u97ff\u8a55\u4fa1\u306b\u5e73\u574710\u65e5\u9593\u3092\u8981\u3057\u3001\u305d\u306e\u7d50\u679c\u300112%\u306e\u5272\u5408\u3067\u66f4\u65b0\u6f0f\u308c\u304c\u767a\u751f\u3057\u3066\u3044\u305f\u3002.<\/li>\n<li>\u89e3\u6c7a\u7b56\uff1a\u4fdd\u5065\u5f53\u5c40\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u76e3\u8996\u3057\u3001\u8868\u793a\u95a2\u9023\u306e\u66f4\u65b0\u3092\u7279\u5b9a\u3057\u3001\u4f1a\u793e\u306e\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306b\u5bfe\u3059\u308b\u521d\u671f\u5f71\u97ff\u5206\u6790\u3092\u5b9f\u884c\u3057\u3001\u4eba\u9593\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u306e\u305f\u3081\u306e\u5f71\u97ff\u30e1\u30e2\u3092\u4f5c\u6210\u3059\u308b\u305f\u3081\u306b\u3001\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u304c\u5c0e\u5165\u3055\u308c\u307e\u3057\u305f\u3002.<\/li>\n<li>\u5b89\u5168\u5bfe\u7b56\uff1a\u5f79\u5272\u306b\u57fa\u3065\u304f\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u60c5\u5831\u6e90\u306e\u8ffd\u8de1\u3001\u304a\u3088\u3073\u6a5f\u68b0\u7ffb\u8a33\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u30b3\u30f3\u30c6\u30f3\u30c4\u306b\u5bfe\u3059\u308b\u5fc5\u9808\u306e\u4e8c\u8a00\u8a9e\u30ec\u30d3\u30e5\u30fc\u3002.<\/li>\n<li>\u4e3b\u8981\u306a\u898f\u5236\uff0f\u54c1\u8cea\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\uff1a\u3053\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u4e3b\u8981\u306a\u898f\u5236\u304a\u3088\u3073\u54c1\u8cea\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u4ea4\u70b9\u306b\u304a\u3044\u3066\u5b9f\u65bd\u3055\u308c\u307e\u3057\u305f\u3002\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) \u30b9\u30c6\u30c3\u30d74\u6587\u66f8<\/a>\u54c1\u8cea\u30ea\u30b9\u30af\u7ba1\u7406\uff082023\u5e741\u6708\u63a1\u629e\uff09\uff1a\u54c1\u8cea\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308bAI\u7531\u6765\u306e\u30ea\u30b9\u30af\u30b9\u30b3\u30a2\u3068\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u4f7f\u7528\u3092\u898f\u5b9a\u3057\u3001\u5ba2\u89b3\u6027\u3001\u4e3b\u89b3\u6027\u306e\u6700\u5c0f\u5316\u3001\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304f\u610f\u601d\u6c7a\u5b9a\u306b\u95a2\u3059\u308b\u8981\u4ef6\u3092\u542b\u307f\u307e\u3059\u3002\u3053\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u304a\u3051\u308bAI\u5f71\u97ff\u30b9\u30b3\u30a2\u30ea\u30f3\u30b0\u30ed\u30b8\u30c3\u30af\u306f\u30014\u3064\u306e\u4e3b\u8981\u306a\u6539\u5584\u9818\u57df\u306b\u6cbf\u3063\u3066\u8a2d\u8a08\u3055\u308c\u307e\u3057\u305f\u3002.<\/li>\n<li>EU MDR\uff08<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:32017R0745\" target=\"_blank\" rel=\"noreferrer noopener\">\u898f\u5247\uff08EU\uff092017\/745<\/a>\uff09\/ EU IVDR\uff08<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:32017R0746\" target=\"_blank\" rel=\"noreferrer noopener\">\u898f\u5247\uff08EU\uff092017\/746<\/a>\uff09+ MDCG 2025-6\uff1a\u5f71\u97ff\u3092\u53d7\u3051\u308b\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306b\u533b\u7642\u6a5f\u5668\u307e\u305f\u306f\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u3001\u8868\u793a\u5909\u66f4\u3068\u305d\u306e\u5f71\u97ff\u8a55\u4fa1\u306f\u3001\u6280\u8853\u6587\u66f8\u3001\u4f7f\u7528\u8aac\u660e\u66f8\uff08IFU\uff09\u3001\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u76e3\u8996\u306b\u95a2\u3059\u308bMDR\/IVDR\u306e\u7fa9\u52d9\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u30022025\u5e746\u6708\u306eMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001AI\u652f\u63f4\u8868\u793a\u30ec\u30d3\u30e5\u30fc\u30c4\u30fc\u30eb\u306f\u3001MDR\/IVDR\u3068EU AI\u6cd5\u306e\u4e8c\u91cd\u306e\u67a0\u7d44\u307f\u306e\u4e0b\u3067\u900f\u660e\u6027\u3068\u4eba\u9593\u306e\u76e3\u8996\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u304c\u660e\u78ba\u5316\u3055\u308c\u307e\u3057\u305f\u3002.<\/li>\n<li>FDA\u306e\u30e9\u30d9\u30eb\u8868\u793a\u30ac\u30a4\u30c0\u30f3\u30b9\u3068PCCP\uff1a\u7c73\u56fd\u5e02\u5834\u5411\u3051\u88fd\u54c1\u306e\u5834\u5408\u3001AI\u652f\u63f4\u306b\u3088\u308b\u30e9\u30d9\u30eb\u8868\u793a\u5909\u66f4\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306f\u3001FDA\u306e\u4e8b\u524d\u6c7a\u5b9a\u5909\u66f4\u7ba1\u7406\u8a08\u753b\uff08PCCP\uff09\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u3088\u3063\u3066\u7ba1\u7406\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3067\u306f\u3001AI\u306b\u3088\u308b\u6a5f\u5668\u30e9\u30d9\u30eb\u8868\u793a\u306e\u5909\u66f4\u306f\u3059\u3079\u3066\u6587\u66f8\u5316\u3055\u308c\u3001\u8ffd\u8de1\u53ef\u80fd\u3067\u3042\u308a\u3001\u30e6\u30fc\u30b6\u30fc\u306b\u901a\u77e5\u3055\u308c\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u30d1\u30a4\u30ed\u30c3\u30c8\u7248\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406\u3068\u30e1\u30e2\u4f5c\u6210\u306e\u51fa\u529b\u306f\u3001PCCP\u306e\u958b\u793a\u8981\u4ef6\u3068\u4e92\u63db\u6027\u304c\u3042\u308b\u3088\u3046\u306b\u69cb\u6210\u3055\u308c\u307e\u3057\u305f\u3002\u53c2\u7167\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\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>.<\/li>\n<\/ul>\n<\/li>\n<li>\u7d50\u679c\uff086\u30f6\u6708\u9593\u306e\u8a66\u9a13\u904b\u7528\uff09\uff1a\n<ul>\n<li>\u30e1\u30e2\u304c\u53cd\u6620\u3055\u308c\u308b\u307e\u3067\u306e\u5e73\u5747\u6642\u9593\u304c40%\u77ed\u7e2e\u3055\u308c\u307e\u3057\u305f\uff0810\u65e5\u304b\u30896\u65e5\uff09\u3002.<\/li>\n<li>\u66f4\u65b0\u6f0f\u308c\u306f\u307b\u307c\u30bc\u30ed\u306b\u307e\u3067\u6e1b\u5c11\u3057\u307e\u3057\u305f\uff08&lt;1%\uff09\u3002.<\/li>\n<li>\u4e0b\u6d41\u5de5\u7a0b\u306b\u304a\u3051\u308b\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406\u30a8\u30e9\u30fc\u306f50%\u6e1b\u5c11\u3057\u307e\u3057\u305f\u3002.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><b>\u30d1\u30a4\u30ed\u30c3\u30c8B\uff1a\u00a0<a href=\"https:\/\/intuitionlabs.ai\/articles\/agentic-ai-pharma-regulatory-document-automation\" target=\"_blank\" rel=\"noreferrer noopener\">\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u66f8\u985e\u4f5c\u6210\u306e\u81ea\u52d5\u5316<\/a><\/b><\/p>\n<ul>\n<li>\u30d3\u30b8\u30cd\u30b9\u30b1\u30fc\u30b9\uff1a\u3042\u308b\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u4f1a\u793e\u306f\u3001\u63d0\u51fa\u7528\u306e\u30e2\u30b8\u30e5\u30fc\u30eb1\u30c9\u30b7\u30a8\uff08\u5730\u57df\u5225\u30d5\u30a9\u30fc\u30e0\u3001\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\u306a\u3069\uff09\u306e\u4f5c\u6210\u306b\u5927\u5e45\u306a\u9045\u5ef6\u304c\u751f\u3058\u3001\u518d\u4f5c\u696d\u30b5\u30a4\u30af\u30eb\u306b\u30c1\u30fc\u30e0\u306e\u6642\u9593\u306e30%\u4ee5\u4e0a\u304c\u8cbb\u3084\u3055\u308c\u307e\u3057\u305f\u3002.<\/li>\n<li>\u89e3\u6c7a\u7b56\uff1a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u3092\u8a13\u7df4\u3057\u3001\u793e\u5185\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u306e\u30c7\u30fc\u30bf\u3092\u4f7f\u7528\u3057\u3066\u56fd\u5225\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306b\u81ea\u52d5\u7684\u306b\u5165\u529b\u3057\u3001\u5fc5\u8981\u306aPDF\u6587\u66f8\u3092\u7d44\u307f\u7acb\u3066\u3001\u96fb\u5b50\u63d0\u51fa\uff08RPS\/eCTD\uff09\u7528\u306b\u30d1\u30c3\u30b1\u30fc\u30b8\u5316\u3057\u307e\u3057\u305f\u3002.<\/li>\n<li>\u5b89\u5168\u5bfe\u7b56\uff1a\u53b3\u683c\u306a\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u691c\u8a3c\u3001\u6700\u7d42\u5316\u524d\u306e\u5fc5\u9808\u306e\u4eba\u7684\u627f\u8a8d\u3001\u304a\u3088\u3073\u975e\u6a19\u6e96\u8981\u4ef6\u306e\u305f\u3081\u306e\u4f8b\u5916\u30ad\u30e5\u30fc\u3002\u7d50\u679c\uff089\u30f6\u6708\u9593\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u904b\u7528\uff09\uff1a\n<ul>\n<li>\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u7d44\u307f\u7acb\u3066\u30b5\u30a4\u30af\u30eb\u6642\u9593\u306f35%\uff5e45%\u77ed\u7e2e\u3055\u308c\u307e\u3057\u305f\u3002.<\/li>\n<li>\u4e8b\u52d9\u51e6\u7406\u4e0a\u306e\u30df\u30b9\u306b\u3088\u308b\u624b\u623b\u308a\u4f5c\u696d\u306f\u300130%\u306b\u3088\u3063\u3066\u524a\u6e1b\u3055\u308c\u305f\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>\u898f\u5236\u904b\u7528\u30e2\u30c7\u30eb\u306e\u6b21\u306a\u308b\u9032\u5316\uff1aAI\u306b\u3088\u308b\u7a4d\u6975\u7684\u306a\u5b9f\u884c<\/h3>\n\t<div id=\"gap-444683303\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-444683303 {\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>\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u3068\u306f\u3001\u72ec\u7acb\u3057\u3066\u884c\u52d5\u3057\u3001\u9078\u629e\u3092\u884c\u3044\u3001\u81ea\u5206\u306e\u884c\u52d5\u3092\u5236\u5fa1\u3059\u308b\u80fd\u529b\u3092\u6307\u3057\u307e\u3059\u3002\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI\u306f\u3053\u306e\u6982\u5ff5\u3092\u30c7\u30b8\u30bf\u30eb\u9818\u57df\u306b\u6301\u3061\u8fbc\u307f\u307e\u3059\u3002\u898f\u5236\u79d1\u5b66\u306f\u3001\u3053\u308c\u304c\u5b9f\u969b\u306b\u4f55\u3092\u610f\u5473\u3059\u308b\u306e\u304b\u3092\u5f62\u5f0f\u5316\u3057\u59cb\u3081\u3066\u3044\u307e\u3059\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\u2013EMA\u00a0<i>\u533b\u85ac\u54c1\u958b\u767a\u306b\u304a\u3051\u308b\u512a\u308c\u305fAI\u5b9f\u8df5\u306e\u305f\u3081\u306e\u6307\u91dd<\/i><\/a>\u00a0\uff082026\u5e741\u6708\uff09AI\u30b7\u30b9\u30c6\u30e0\u3092\u5b9a\u7fa9\u3059\u308b\u00a0<a href=\"https:\/\/oecd.ai\/en\/wonk\/definition\" target=\"_blank\" rel=\"noreferrer noopener\">OECD<\/a>\u00a0\u300c\u5c55\u958b\u5f8c\u306b\u9069\u5fdc\u6027\u3092\u793a\u3059\u53ef\u80fd\u6027\u306e\u3042\u308b\u3001\u3055\u307e\u3056\u307e\u306a\u30ec\u30d9\u30eb\u306e\u81ea\u5f8b\u6027\u3067\u52d5\u4f5c\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u305f\u6a5f\u68b0\u30d9\u30fc\u30b9\u306e\u30b7\u30b9\u30c6\u30e0\u300d\u3068\u3044\u3046\u5b9a\u7fa9\u306f\u3001\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u3092\u76f4\u63a5\u5305\u542b\u3059\u308b\u3002\u00a0<a href=\"https:\/\/artificialintelligenceact.eu\/article\/3\/\" target=\"_blank\" rel=\"noreferrer noopener\">EU AI\u6cd5<\/a>\u00a0\u3055\u3089\u306b\u3001\u81ea\u5f8b\u578bAI\u30b7\u30b9\u30c6\u30e0\u3092\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u306b\u5fdc\u3058\u3066\u5206\u985e\u3057\u3001\u900f\u660e\u6027\u3001\u4eba\u9593\u306e\u76e3\u8996\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30ac\u30d0\u30ca\u30f3\u30b9\u306b\u95a2\u3057\u3066\u76f8\u5fdc\u306e\u7fa9\u52d9\u3092\u8ab2\u3059\u3053\u3068\u3067\u3001\u3053\u308c\u3092\u3088\u308a\u5177\u4f53\u7684\u306b\u904b\u7528\u3059\u308b\u3002.\u00a0<a href=\"https:\/\/www.iso.org\/standard\/42001\" target=\"_blank\" rel=\"noreferrer noopener\">ISO\/IEC 42001:2023<\/a>, \u521d\u306e\u56fd\u969bAI\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u6a19\u6e96\u3067\u3042\u308b \u306f\u3001AI\u30ea\u30b9\u30af\u8a55\u4fa1\u3001\u5f71\u97ff\u8a55\u4fa1\u3001\u7d99\u7d9a\u7684\u6539\u5584\u3092\u7db2\u7f85\u3059\u308b\u7d44\u7e54\u30ac\u30d0\u30ca\u30f3\u30b9\u306e\u67a0\u7d44\u307f\u3092\u63d0\u4f9b\u3057\u3001\u305d\u306e\u4e2d\u3067\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u306e\u5c55\u958b\u3092\u69cb\u9020\u5316\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u76ee\u6a19\u6307\u5411\u306e\u6a5f\u80fd\u306f\u3001\u7d44\u7e54\u306b\u4ee3\u308f\u3063\u3066\u884c\u52d5\u3059\u308b\u6a29\u9650\u3092\u4e0e\u3048\u3089\u308c\u3066\u3044\u307e\u3059\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\">\u5b9a\u7fa9\u6e08\u307f\u3067\u4eba\u9593\u304c\u627f\u8a8d\u3057\u305f\u30d1\u30e9\u30e1\u30fc\u30bf\u306b\u57fa\u3065\u3044\u3066\u30a2\u30af\u30b7\u30e7\u30f3\u3092\u5b9f\u884c\u3059\u308b<\/a>.<\/p>\n<p>\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u306f\u3001\u53d7\u52d5\u7684\u306a\u81ea\u52d5\u5316\u3092\u8d85\u3048\u3001\u5b9a\u7fa9\u3055\u308c\u7d71\u5236\u3055\u308c\u305f\u5883\u754c\u5185\u3067\u30bf\u30b9\u30af\u306e\u8a08\u753b\u3001\u5b9f\u884c\u3001\u9069\u5fdc\u3092\u884c\u3044\u307e\u3059\u3002\u4ee5\u4e0b\u306b\u3001\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u304c\u4e0a\u8a18\u306e\u6a5f\u80fd\u3092\u5411\u4e0a\u3055\u305b\u308b\u3044\u304f\u3064\u304b\u306e\u65b9\u6cd5\u3092\u793a\u3057\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u52d5\u7684\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3: \u30af\u30a8\u30ea\u306b\u7b54\u3048\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u306f\u30bf\u30b9\u30af\u3092\u9023\u9396\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u65b0\u3057\u3044\u898f\u5236\u306e\u691c\u51fa \u2192 \u30ae\u30e3\u30c3\u30d7\u5206\u6790\u306e\u5b9f\u884c \u2192 \u66f4\u65b0\u3055\u308c\u305fSOP\u306e\u8349\u6848\u4f5c\u6210 \u2192 \u95a2\u4fc2\u8005\u3078\u306e\u901a\u77e5\u3002\u898f\u5236\u5bfe\u8c61\u306e\u51fa\u529b(SOP\u3001\u63d0\u51fa\u6587\u66f8\u3001\u30e9\u30d9\u30eb)\u306b\u89e6\u308c\u308b\u9023\u9396\u578b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306f\u3001GxP\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u691c\u8a3c\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059(\u53c2\u7167:\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\u30ac\u30a4\u30c9<\/a>) \u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u304c\u4f5c\u6210\u307e\u305f\u306f\u5909\u66f4\u3057\u305fSOP\u307e\u305f\u306f\u63d0\u51fa\u6587\u66f8\u306f\u3001\u898f\u5236\u5bfe\u8c61\u306e\u96fb\u5b50\u8a18\u9332\u3092\u69cb\u6210\u3057\u3001\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\">FDA 21 CFR Part 11 (\u7c73\u56fd)<\/a>\u00a0\u305d\u3057\u3066\u00a0<a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en\" target=\"_blank\" rel=\"noreferrer noopener\">EU GMP\u9644\u5c5e\u66f811<\/a>\u00a0\uff08EU\uff09\u306e\u8981\u4ef6\u3002.<\/li>\n<li>\u7d99\u7d9a\u7684\u306a\u76e3\u8996\u3068\u7a4d\u6975\u7684\u306a\u5bfe\u5fdc: \u898f\u5236\u30dd\u30fc\u30bf\u30eb\u3092\u7d99\u7d9a\u7684\u306b\u30b9\u30ad\u30e3\u30f3\u3057\u3001\u30a2\u30e9\u30fc\u30c8\u3092\u30c8\u30ea\u30ac\u30fc\u3057\u3001\u624b\u52d5\u306e\u6307\u793a\u3092\u5f85\u305f\u305a\u306b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u66f4\u65b0\u3092\u958b\u59cb\u3059\u308b\u3053\u3068\u3082\u3067\u304d\u307e\u3059\u3002\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6c7a\u5b9a\u306b\u53cd\u6620\u3055\u308c\u308b\u81ea\u5f8b\u7684\u306a\u898f\u5236\u76e3\u8996\u306f\u3001\u307e\u3055\u306b\u305d\u306e\u7bc4\u56f2\u5185\u306b\u3042\u308a\u307e\u3059\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\u54c1\u8cea\u30ea\u30b9\u30af\u7ba1\u7406\u3002.<\/li>\n<li>\u30b3\u30f3\u30c6\u30ad\u30b9\u30c8\u8a8d\u8b58\u578b\u30c9\u30e9\u30d5\u30c8\u4f5c\u6210\uff1a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u306f\u3001\u8907\u6570\u306e\u5185\u90e8\u30b7\u30b9\u30c6\u30e0\uff08\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306a\u3069\uff09\u304b\u3089\u30c7\u30fc\u30bf\u3092\u53d6\u5f97\u3057\u3001\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3055\u308c\u305f\u63d0\u51fa\u7528\u30c9\u30e9\u30d5\u30c8\u3092\u751f\u6210\u3067\u304d\u307e\u3059\u3002\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u304c\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u30a2\u30af\u30bb\u30b9\u3057\u3066\u63d0\u51fa\u7528\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u751f\u6210\u3059\u308b\u5834\u5408\u3001\u8907\u6570\u306e\u91cd\u8907\u3059\u308b\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u4e0b\u3067\u540c\u6642\u306b\u52d5\u4f5c\u3057\u307e\u3059\u3002\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>, \u96fb\u5b50\u63d0\u51fa\u3092\u76ee\u7684\u3068\u3059\u308b\u3042\u3089\u3086\u308b\u30b3\u30f3\u30c6\u30f3\u30c4\u306e\u69cb\u9020\u3001\u30e1\u30bf\u30c7\u30fc\u30bf\u3001\u304a\u3088\u3073\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u8981\u4ef6\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u3002\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\u306eAI\u306b\u95a2\u3059\u308b\u8003\u5bdf\u8ad6\u6587<\/a>\u00a0\u88fd\u54c1\u60c5\u5831\u3084\u63d0\u51fa\u6587\u66f8\u306e\u4f5c\u6210\u306b\u4f7f\u7528\u3055\u308c\u308b\u751f\u6210\u8a00\u8a9e\u30e2\u30c7\u30eb\u306f\u3001\u53b3\u5bc6\u306a\u4eba\u9593\u306e\u76e3\u8996\u4e0b\u3067\u4f7f\u7528\u3055\u308c\u3001\u898f\u5236\u5f53\u5c40\u3078\u306e\u63d0\u51fa\u524d\u306b\u4e8b\u5b9f\u3068\u69cb\u6587\u306e\u6b63\u78ba\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u54c1\u8cea\u30ec\u30d3\u30e5\u30fc\u30e1\u30ab\u30cb\u30ba\u30e0\u304c\u8a2d\u3051\u3089\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3053\u3068\u304c\u660e\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u81e8\u5e8a\u30c7\u30fc\u30bf\u3084\u60a3\u8005\u30ec\u30d9\u30eb\u306e\u30c7\u30fc\u30bf\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b\u5834\u5408\u3001,\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32016R0679\" target=\"_blank\" rel=\"noreferrer noopener\">GDPR<\/a>\u00a0\uff08\u898f\u5247\uff08EU\uff092016\/679\uff09\u304a\u3088\u3073\u540c\u7b49\u306e\u30c7\u30fc\u30bf\u4fdd\u8b77\u5236\u5ea6\u306f\u3001\u30c7\u30fc\u30bf\u6700\u5c0f\u5316\u3001\u76ee\u7684\u5236\u9650\u3001\u304a\u3088\u3073\u30a2\u30af\u30bb\u30b9\u7ba1\u7406\u306e\u7fa9\u52d9\u3092\u8ab2\u3057\u3066\u3044\u307e\u3059\u3002.<\/li>\n<li>\u591a\u8a00\u8a9e\u5bfe\u5fdc\u3068\u5e02\u5834\u56fa\u6709\u306e\u9069\u5fdc\uff1a\u7570\u306a\u308b\u7ba1\u8f44\u533a\u57df\u5411\u3051\u306b\u6587\u66f8\u3092\u81ea\u52d5\u7684\u306b\u30ed\u30fc\u30ab\u30e9\u30a4\u30ba\u3057\u3001\u5730\u57df\u30c1\u30fc\u30e0\u3068\u306e\u30ec\u30d3\u30e5\u30fc\u3092\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3067\u304d\u307e\u3059\u3002.\u00a0<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-5-guide-2nd-edition\" target=\"_blank\" rel=\"noreferrer noopener\">GAMP 5<\/a>\u00a0\u691c\u8a3c\u8981\u4ef6\u306f\u3001GxP\u6e96\u62e0\u306e\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u3068\u3057\u3066\u3001\u30ed\u30fc\u30ab\u30e9\u30a4\u30ba\u5264\u81ea\u4f53\u306b\u3082\u9069\u7528\u3055\u308c\u307e\u3059\u3002.<\/li>\n<li>\u4e88\u6e2c\u7684\u304a\u3088\u3073\u51e6\u65b9\u7684\u6d1e\u5bdf: \u4e88\u6e2c\u3092\u8d85\u3048\u3066\u3001\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578b AI \u306f\u30ea\u30b9\u30af \u30b9\u30b3\u30a2\u30ea\u30f3\u30b0\u306b\u57fa\u3065\u3044\u3066\u6b21\u306e\u30b9\u30c6\u30c3\u30d7 (\u7279\u5b9a\u306e\u7533\u8acb\u306e\u512a\u5148\u9806\u4f4d\u4ed8\u3051\u3001\u30ea\u30bd\u30fc\u30b9\u306e\u5272\u308a\u5f53\u3066\u306a\u3069) \u3092\u63a8\u5968\u3067\u304d\u307e\u3059\u3002AI \u304c\u751f\u6210\u3057\u305f\u30ea\u30b9\u30af \u30b9\u30b3\u30a2\u3068\u63a8\u5968\u4e8b\u9805\u304c\u3001\u63d0\u51fa\u306e\u512a\u5148\u9806\u4f4d\u4ed8\u3051\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306b\u5bfe\u3059\u308b\u30ea\u30bd\u30fc\u30b9\u306e\u5272\u308a\u5f53\u3066\u3001\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306e\u30a8\u30b9\u30ab\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u30b7\u30b0\u30ca\u30eb\u306a\u3069\u3001\u898f\u5236\u4e0a\u306e\u6c7a\u5b9a\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u5834\u5408\u3001,\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\u306f\u4e3b\u8981\u306a\u54c1\u8cea\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3067\u3059\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\u3068EMA\u306b\u3088\u308bAI\uff08\u4eba\u5de5\u6388\u7cbe\uff09\u306b\u95a2\u3059\u308b\u512a\u826f\u5b9f\u65bd\u57fa\u6e96\u306e\u5171\u540c\u539f\u5247<\/a>\u00a0\u533b\u85ac\u54c1\u958b\u767a\u306b\u304a\u3044\u3066\u306f\u3001\u539f\u52472\uff08\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\uff09\u3068\u539f\u52478\uff08\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\uff09\u3092\u901a\u3058\u3066\u3053\u308c\u3092\u5f37\u5316\u3057\u3066\u304a\u308a\u3001\u691c\u8a3c\u3001\u76e3\u8996\u3001\u304a\u3088\u3073\u5b89\u5168\u5bfe\u7b56\u306e\u30ec\u30d9\u30eb\u306f\u3001AI\u306e\u4f7f\u7528\u72b6\u6cc1\u3068\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u306b\u5408\u81f4\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u8ff0\u3079\u3066\u3044\u308b\u3002.<\/li>\n<\/ul>\n<p>\u3053\u308c\u306f\u5358\u306a\u308b\u81ea\u52d5\u5316\u3067\u306f\u306a\u304f\u3001\u52b9\u7387\u6027\u3068\u6226\u7565\u7684\u4fa1\u5024\u3078\u306e\u6839\u672c\u7684\u306a\u8ee2\u63db\u3067\u3042\u308b\u3002.<\/p>\n<p>\u4e0a\u8a18\u3067\u8ff0\u3079\u305f\u52b9\u7387\u6027\u3068\u6226\u7565\u7684\u5229\u76ca\u306f\u3001\u7d44\u7e54\u304c\u3059\u3079\u3066\u306e\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u5c0e\u5165\u306e\u6700\u521d\u304b\u3089\u8a2d\u8a08\u306b\u7d44\u307f\u8fbc\u307e\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3001\u8b72\u308b\u3053\u3068\u306e\u3067\u304d\u306a\u3044\u5236\u7d04\u306e\u7bc4\u56f2\u5185\u3067\u6a5f\u80fd\u3059\u308b\u3002<\/p>\n<ul>\n<li>AI\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u306f\u3001\u898f\u5236\u3084\u79d1\u5b66\u7684\u306a\u696d\u52d9\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u6b63\u5f0f\u306a\u5224\u65ad\u3084\u8aac\u660e\u8cac\u4efb\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/li>\n<li>\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\u3001\u30e9\u30d9\u30eb\u8868\u793a\u3001\u63d0\u51fa\u66f8\u985e\u306a\u3069\u3001AI\u304c\u751f\u6210\u3057\u305f\u3059\u3079\u3066\u306e\u51fa\u529b\u306f\u3001\u4fdd\u5065\u5f53\u5c40\u3068\u5171\u6709\u3055\u308c\u308b\u524d\u306b\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u4eba\u9593\u306e\u30ec\u30d3\u30e5\u30fc\u3068\u627f\u8a8d\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002.<\/li>\n<li>\u627f\u8a8d\u306e\u53ef\u80fd\u6027\u306e\u8a55\u4fa1\u3084\u4fdd\u5065\u5f53\u5c40\u306e\u4e88\u60f3\u3055\u308c\u308b\u63aa\u7f6e\u306a\u3069\u3001\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u306b\u3088\u3063\u3066\u751f\u6210\u3055\u308c\u308b\u4e88\u6e2c\u5206\u6790\u306f\u3001\u610f\u601d\u6c7a\u5b9a\u652f\u63f4\u306e\u307f\u3092\u76ee\u7684\u3068\u3057\u3066\u304a\u308a\u3001\u78ba\u5b9a\u7684\u306a\u4e88\u6e2c\u3084\u898f\u5236\u5f53\u5c40\u304c\u627f\u8a8d\u3057\u305f\u4e88\u6e2c\u3068\u306f\u307f\u306a\u3055\u308c\u307e\u305b\u3093\u3002.<\/li>\n<\/ul>\n<p>\u898f\u5236\u5f53\u5c40\u306e\u30ea\u30fc\u30c0\u30fc\u306f\u3001\u4f01\u696d\u5168\u4f53\u306e\u5909\u9769\u3092\u5f85\u3064\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u307e\u305a\u306f\u3001\u30db\u30e9\u30a4\u30ba\u30f3\u30b9\u30ad\u30e3\u30cb\u30f3\u30b0\u3001\u30c9\u30b7\u30a8\u4f5c\u6210\u3001\u30e9\u30d9\u30eb\u5909\u66f4\u76e3\u8996\u306a\u3069\u3001\u51e6\u7406\u91cf\u304c\u591a\u304f\u53cd\u5fa9\u7684\u306a\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u7279\u5b9a\u3057\u3001\u5358\u4e00\u306e\u88fd\u54c1\u30e9\u30a4\u30f3\u307e\u305f\u306f\u5e02\u5834\u30af\u30e9\u30b9\u30bf\u30fc\u5185\u3067\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578b\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u8a66\u9a13\u7684\u306b\u5c0e\u5165\u3059\u308b\u3053\u3068\u304b\u3089\u59cb\u3081\u307e\u3057\u3087\u3046\u3002\u30a2\u30af\u30b7\u30e7\u30f3\u307e\u3067\u306e\u6642\u9593\u3001\u66f4\u65b0\u6f0f\u308c\u7387\u3001\u6226\u7565\u7684\u306a\u696d\u52d9\u306b\u518d\u914d\u5206\u3055\u308c\u305f\u30c1\u30fc\u30e0\u6642\u9593\u306a\u3069\u3001\u660e\u78ba\u306a\u6307\u6a19\u3092\u7528\u3044\u306690\u65e5\u9593\u306e\u8a55\u4fa1\u671f\u9593\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002\u4eca\u65e5\u3001\u898f\u5236\u904b\u7528\u30e2\u30c7\u30eb\u306b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3092\u7d44\u307f\u8fbc\u3093\u3060\u7d44\u7e54\u306f\u3001\u8907\u96d1\u6027\u306b\u5bfe\u5fdc\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u305d\u308c\u3092\u7af6\u4e89\u512a\u4f4d\u6027\u3078\u3068\u8ee2\u63db\u3067\u304d\u308b\u3067\u3057\u3087\u3046\u3002\u7684\u3092\u7d5e\u3063\u305f\u5b9f\u88c5\u306f\u59cb\u307e\u308a\u306b\u904e\u304e\u307e\u305b\u3093\u3002\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3092\u62e1\u5f35\u3059\u308b\u306b\u306f\u3001\u6210\u719f\u5ea6\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u3001\u30de\u30eb\u30c1\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u3001\u898f\u5236\u74b0\u5883\u5411\u3051\u306b\u8a2d\u8a08\u3055\u308c\u305f\u30ac\u30d0\u30ca\u30f3\u30b9\u304c\u5fc5\u8981\u3067\u3059\u3002\uff08\u3053\u306e\u30b7\u30ea\u30fc\u30ba\u306e\u6b21\u306e\u8a18\u4e8b\u3067\u306f\u3001\u3053\u308c\u30893\u3064\u3059\u3079\u3066\u3092\u69cb\u7bc9\u3059\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002\uff09<\/p>\n<p>\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u00a0<a href=\"https:\/\/globalforum.diaglobal.org\/issue\/august-2025\/\">2025\u5e748\u6708\u00a0<i>\u30b0\u30ed\u30fc\u30d0\u30eb\u30d5\u30a9\u30fc\u30e9\u30e0<\/i><\/a>\u00a0\u81e8\u5e8a\u696d\u52d9\u3092\u8d85\u3048\u3066\u898f\u5236\u95a2\u9023\u696d\u52d9\uff08RA\uff09\u6a5f\u80fd\u3078\u306e\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u306b\u95a2\u3059\u308b\u8b70\u8ad6\u3001\u300c\u201c<a href=\"https:\/\/globalforum.diaglobal.org\/issue\/august-2025\/next-steps-in-artificial-intelligence-agentic-ai\/\">\u4eba\u5de5\u77e5\u80fd\u306e\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\uff1a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI<\/a>\u3002\u300d<\/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 dossier is updated, or a single filing decision is made. Multiply that across multiple jurisdictions, each with its own language, cadence, and enforcement posture, and the math stops working. Headcount cannot scale at the rate complexity does. Yet the answer is not simply layering Generative AI onto existing workflows. GenAI can summarize and draft, but&#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\" 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