{"id":11353,"date":"2026-09-29T11:27:36","date_gmt":"2026-09-29T03:27:36","guid":{"rendered":"https:\/\/regask.com\/?p=11353"},"modified":"2026-09-29T11:27:36","modified_gmt":"2026-09-29T03:27:36","slug":"2026%e5%b9%b49%e6%9c%88%e3%81%ae%e3%83%a9%e3%82%a4%e3%83%95%e3%82%b5%e3%82%a4%e3%82%a8%e3%83%b3%e3%82%b9%e5%88%86%e9%87%8e%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e8%a6%8f%e5%88%b6%e5%bd%93%e5%b1%80","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/life-sciences-in-september-2026-three-signs-regulators-are-moving-together\/","title":{"rendered":"2026\u5e749\u6708\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\uff1a\u898f\u5236\u5f53\u5c40\u304c\u2026"},"content":{"rendered":"<p><span class=\"TextRun SCXW255062761 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW255062761 BCX0\">2026\u5e749\u6708\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\u5168\u4f53\u3067\u4e00\u3064\u306e\u3053\u3068\u304c\u660e\u3089\u304b\u306b\u306a\u3063\u305f\u3002\u305d\u308c\u306f\u3001\u898f\u5236\u5f53\u5c40\u304c\u8db3\u4e26\u307f\u3092\u63c3\u3048\u59cb\u3081\u3066\u3044\u308b\u3068\u3044\u3046\u3053\u3068\u3060\u3002\u5f53\u793e\u306e\u30c8\u30ec\u30f3\u30c9\u30ec\u30fc\u30c0\u30fc\u306f\u3001\u533b\u7642\u6a5f\u5668\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3001\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u306e\u52d5\u5411\u3092\u8ffd\u8de1\u3057\u305f\u304c\u3001\u540c\u3058\u30d1\u30bf\u30fc\u30f3\u304c\u7e70\u308a\u8fd4\u3057\u73fe\u308c\u305f\u3002\u7570\u306a\u308b\u5927\u9678\u306e\u5f53\u5c40\u306f\u3001 <\/span><span class=\"NormalTextRun SCXW255062761 BCX0\">\u6574\u5217<\/span><span class=\"NormalTextRun SCXW255062761 BCX0\"> \u5171\u901a\u306e\u57fa\u6e96\u3001\u4e92\u3044\u306e\u6c7a\u5b9a\u306e\u627f\u8a8d\u3001\u305d\u3057\u3066\u540c\u69d8\u306e\u7d50\u8ad6\u306b\u9054\u3059\u308b\u3053\u3068 <\/span><span class=\"NormalTextRun SCXW255062761 BCX0\">\u304a\u304a\u3088\u305d<\/span><span class=\"NormalTextRun SCXW255062761 BCX0\"> \u540c\u3058\u6642\u671f\u306b\u3002\u4eca\u6708\u306f\u3001\u3053\u306e\u5909\u5316\u306e\u80cc\u666f\u306b\u3042\u308b3\u3064\u306e\u30c8\u30ec\u30f3\u30c9\u3092\u898b\u3066\u3044\u304d\u307e\u3059\u3002\u307e\u305a\u3001\u533b\u7642\u6a5f\u5668\u3068\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u898f\u5236\u304c\u3001\u5171\u901a\u306e\u57fa\u6e96\u306b\u5411\u3051\u3066\u9759\u304b\u306b\u7d71\u5408\u3055\u308c\u3064\u3064\u3042\u308b\u3053\u3068\u3002\u6b21\u306b\u3001FDA\u306e10\u67081\u65e5E2B(R3)\u671f\u9650\u3068\u4e2d\u56fd\u306e\u6539\u8a02GCP\u304c\u3001\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306e\u6025\u901f\u306a\u6a19\u6e96\u5316\u3092\u793a\u5506\u3057\u3066\u3044\u308b\u7406\u7531\u3002\u305d\u3057\u3066\u3001\u898f\u5236\u5f53\u5c40\u3078\u306e\u4f9d\u5b58\u304c\u3001\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u306e\u65b0\u898f\u5e02\u5834\u3078\u306e\u8fc5\u901f\u306a\u53c2\u5165\u7d4c\u8def\u3092\u3069\u306e\u3088\u3046\u306b\u5207\u308a\u958b\u3044\u3066\u3044\u308b\u304b\u3002\u30b0\u30ed\u30fc\u30d0\u30eb\u30c1\u30fc\u30e0\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u53ce\u675f\u306f\u771f\u306e\u6a5f\u4f1a\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u304c\u3001\u305d\u308c\u306f\u5404\u898f\u5236\u5f53\u5c40\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3092\u8ffd\u8de1\u3057\u305f\u5834\u5408\u306b\u9650\u308a\u307e\u3059\u3002.<\/span><\/span><span class=\"EOP Selected SCXW255062761 BCX0\" data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-283020870\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-283020870 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3><strong><span class=\"TextRun MacChromeBold SCXW147708193 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW147708193 BCX0\" data-ccp-parastyle=\"heading 2\">\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u30eb\u30fc\u30eb\u30d6\u30c3\u30af\u306f\u9759\u304b\u306b\u7d71\u5408\u3055\u308c\u3064\u3064\u3042\u308b<\/span><\/span><span class=\"EOP Selected SCXW147708193 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/strong><\/h3>\n\t<div id=\"gap-1607012136\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1607012136 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"gap-917619631\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-917619631 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u8907\u6570\u306e\u5e02\u5834\u3067\u533b\u7642\u6a5f\u5668\u3084\u4f53\u5916\u8a3a\u65ad\u85ac\u306e\u767b\u9332\u3092\u7ba1\u7406\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u304a\u305d\u3089\u304f\u5404\u7ba1\u8f44\u533a\u57df\u3054\u3068\u306b\u7570\u306a\u308b\u5206\u985e\u3001\u7570\u306a\u308b\u88fd\u9020\u8981\u4ef6\u3001\u7570\u306a\u308b\u5e02\u8ca9\u5f8c\u898f\u5247\u3068\u3044\u3063\u305f\u3001\u5bc4\u305b\u96c6\u3081\u306e\u3088\u3046\u306a\u72b6\u6cc1\u306b\u6163\u308c\u3066\u3057\u307e\u3063\u3066\u3044\u308b\u3067\u3057\u3087\u3046\u3002\u3057\u304b\u3057\u3001\u305d\u306e\u5bc4\u305b\u96c6\u3081\u306f\u89e3\u6d88\u3055\u308c\u3064\u3064\u3042\u308a\u307e\u3059\u30022026\u5e749\u6708\u3001\u5f53\u793e\u306e\u30c8\u30ec\u30f3\u30c9\u30ec\u30fc\u30c0\u30fc\u306f\u533b\u7642\u6a5f\u5668\u3068\u4f53\u5916\u8a3a\u65ad\u85ac\u306b\u95a2\u3059\u308b50\u4ef6\u4ee5\u4e0a\u306e\u516c\u5f0f\u52d5\u5411\u3092\u8ffd\u8de1\u3057\u307e\u3057\u305f\uff08\u3053\u308c\u306f\u4eca\u6708\u6700\u3082\u6d3b\u767a\u306a\u30c6\u30fc\u30de\u3067\u3057\u305f\uff09\u3002\u6ce8\u76ee\u3059\u3079\u304d\u306f\u4ef6\u6570\u3067\u306f\u306a\u304f\u3001\u305d\u306e\u65b9\u5411\u6027\u3067\u3059\u3002\u7570\u306a\u308b\u5927\u9678\u306e\u898f\u5236\u5f53\u5c40\u304c\u3001\u5171\u901a\u306e\u57fa\u6e96\u306b\u5411\u3051\u3066\u52d5\u304d\u59cb\u3081\u3066\u3044\u308b\u306e\u3067\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.federalregister.gov\/documents\/2026\/09\/11\/2026-18612\/medical-devices-cardiovascular-devi%E2%80%A6\"><span data-contrast=\"none\">\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09<\/span><\/a><span data-contrast=\"auto\"> \u4e2d\u56fd\u306f\u3001\u6a5f\u68b0\u5b66\u7fd2\u306b\u57fa\u3065\u304f\u5fc3\u8840\u7ba1\u901a\u77e5\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u542b\u3080\u4e00\u9023\u306e\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e\u3092\u6700\u7d42\u6c7a\u5b9a\u3057\u305f\u3002\u3053\u308c\u306f\u3001\u4e2d\u56fd\u304c\u9069\u5fdc\u578bAI\u99c6\u52d5\u88fd\u54c1\u3092\u3044\u304b\u306b\u771f\u5263\u306b\u6349\u3048\u3066\u3044\u308b\u304b\u3092\u793a\u3059\u3082\u306e\u3060\u3002 <\/span><a href=\"https:\/\/english.nmpa.gov.cn\/2025-11\/07\/c_1138710.htm\"><span data-contrast=\"none\">\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff08GMP\uff09<\/span><\/a><span data-contrast=\"auto\"> \u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u306f2026\u5e7411\u67081\u65e5\u306b\u767a\u52b9\u3059\u308b\u3002\u53f0\u6e7e\u306f <\/span><a href=\"https:\/\/www.fda.gov.tw\/tc\/newsContent.aspx?cid=3&amp;id=31726\"><span data-contrast=\"none\">\u533b\u7642\u6a5f\u5668\u30ea\u30b3\u30fc\u30eb\u898f\u5236<\/span><\/a><span data-contrast=\"auto\">\u3001\u305d\u3057\u3066 <\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/medical-devices\"><span data-contrast=\"none\">EMA<\/span><\/a><span data-contrast=\"auto\"> \u753b\u671f\u7684\u306a\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u5c02\u9580\u5bb6\u30d1\u30cd\u30eb\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30d7\u30ed\u30b0\u30e9\u30e0\u304c\u9032\u5c55\u3057\u305f\u3002\u4eba\u5de5\u77e5\u80fd\u306f\u3001\u5e02\u5834\u306b\u51fa\u56de\u3063\u305f\u5f8c\u3082\u5b66\u7fd2\u3092\u7d9a\u3051\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u3069\u306e\u3088\u3046\u306b\u8a8d\u53ef\u3059\u308b\u304b\u306b\u3064\u3044\u3066\u5f53\u5c40\u304c\u5354\u8b70\u3092\u9032\u3081\u308b\u4e2d\u3067\u3001\u305d\u306e\u3059\u3079\u3066\u306b\u6df1\u304f\u95a2\u308f\u3063\u3066\u304f\u308b\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u898f\u5236\u5f53\u5c40\u306e\u30c1\u30fc\u30e0\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u53ce\u675f\u306f\u65b0\u305f\u306a\u53ef\u80fd\u6027\u3092\u5207\u308a\u958b\u304f\u3082\u306e\u3067\u3059\u3002\u304b\u3064\u3066\u306f\u5927\u304d\u304f\u7570\u306a\u3063\u3066\u3044\u305f\u8981\u6c42\u4e8b\u9805\uff08\u6280\u8853\u6587\u66f8\u3001\u81e8\u5e8a\u7684\u8a3c\u62e0\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306a\u3069\uff09\u306f\u3001\u5171\u901a\u306e\u57fa\u6e96\u3078\u3068\u5f90\u3005\u306b\u8fd1\u3065\u3044\u3066\u3044\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u3042\u308b\u53b3\u3057\u3044\u898f\u5236\u5f53\u5c40\u306e\u8981\u6c42\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u884c\u3063\u3066\u304d\u305f\u4f5c\u696d\u304c\u3001\u4ed6\u306e\u898f\u5236\u5f53\u5c40\u306b\u3082\u5f90\u3005\u306b\u9069\u7528\u3055\u308c\u3066\u3044\u304f\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u53ce\u675f\u3068\u8abf\u548c\u306f\u540c\u3058\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5404\u898f\u5236\u5f53\u5c40\u306f\u305d\u308c\u305e\u308c\u72ec\u81ea\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3067\u5bfe\u5fdc\u3092\u9032\u3081\u3066\u304a\u308a\u3001\u4e2d\u56fd\u306e11\u6708\u306eGMP\u671f\u9650\u306f\u3001\u300c\u539f\u5247\u7684\u306b\u6574\u5408\u3057\u3066\u3044\u308b\u300d\u3068\u306f\u4f9d\u7136\u3068\u3057\u3066\u300c\u7279\u5b9a\u306e\u671f\u65e5\u307e\u3067\u306b\u5b9f\u884c\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u300d\u3053\u3068\u3092\u610f\u5473\u3059\u308b\u3068\u3044\u3046\u3053\u3068\u3092\u5177\u4f53\u7684\u306b\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u6069\u6075\u3092\u53d7\u3051\u308b\u306e\u306f\u3001\u5358\u4e00\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u5207\u308a\u66ff\u3048\u3092\u60f3\u5b9a\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u5404\u898f\u5236\u5f53\u5c40\u306e\u52d5\u5411\u3092\u6ce8\u8996\u3059\u308b\u30c1\u30fc\u30e0\u3067\u3057\u3087\u3046\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW77488179 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW77488179 BCX0\" data-ccp-parastyle=\"heading 2\">\u4e8c\u3064\u306e\u7de0\u3081\u5207\u308a\u3001\u4e00\u3064\u306e\u65b9\u5411\u6027\uff1a\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306f\u6025\u901f\u306b\u6a19\u6e96\u5316\u3055\u308c\u3064\u3064\u3042\u308b<\/span><\/span><span class=\"EOP Selected SCXW77488179 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/strong><\/h3>\n\t<div id=\"gap-633250324\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-633250324 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">2026\u5e7410\u67081\u65e5\u306f\u3001\u5370\u3092\u3064\u3051\u3066\u304a\u304f\u3079\u304d\u65e5\u3067\u3059\u3002\u305d\u306e\u65e5\u3001 <\/span><a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/development-approval-process-cber\/electronic-submission-postmarket-safety-reports\"><span data-contrast=\"none\">\u7c73\u56fdFDA\u306e<\/span><\/a><span data-contrast=\"auto\"> \u5f37\u5236\u7684\u306b\u5207\u308a\u66ff\u3048 <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/fda-adverse-event-monitoring-system-aems\/fda-adverse-event-monitoring-system-aems-electronic-submissions\"><span data-contrast=\"none\">ICH E2B(R3)<\/span><\/a><span data-contrast=\"auto\"> \u5e02\u8ca9\u5f8c\u5b89\u5168\u5831\u544a\u66f8\u306e\u63d0\u51fa\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u304c\u767a\u52b9\u3057\u3001\u81ea\u4e3b\u7684\u306a\u79fb\u884c\u306f\u7d42\u4e86\u3001\u5f93\u6765\u306e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3082\u5ec3\u6b62\u3055\u308c\u308b\u3002\u3053\u308c\u306f\u3001\u4e2d\u56fd\u304c\u6539\u8a02\u3057\u305f\u3001, <\/span><a href=\"https:\/\/www.ccfdie.org\/en\/gzdt\/webinfo\/2026\/06\/1784092178460426.htm\"><span data-contrast=\"none\">ICH\u306b\u6e96\u62e0\u3057\u305f\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u57fa\u6e96\uff08GCP\uff09<\/span><\/a><span data-contrast=\"auto\"> \u3053\u308c\u3089\u306f9\u67081\u65e5\u306b\u767a\u52b9\u3057\u305f\u3002\u3053\u308c\u3089\u3092\u7dcf\u5408\u3059\u308b\u3068\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u3001\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3001\u304a\u3088\u3073\u4ea4\u63db\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u5171\u901a\u57fa\u6e96\u3078\u306e\u4e16\u754c\u7684\u306a\u7740\u5b9f\u306a\u6d41\u308c\u3092\u793a\u3057\u3066\u3044\u308b\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3057\u304b\u3057\u3001\u6280\u8853\u7684\u306a\u8abf\u548c\u306f\u3001\u4eca\u6708\u306e\u30c8\u30ec\u30f3\u30c9\u30ec\u30fc\u30c0\u30fc\u304c\u6349\u3048\u305f\u30b9\u30c8\u30fc\u30ea\u30fc\u306e\u534a\u5206\u306b\u904e\u304e\u307e\u305b\u3093\u3002\u3082\u3046\u534a\u5206\u306f\u3001\u30b5\u30cf\u30e9\u4ee5\u5357\u30a2\u30d5\u30ea\u30ab\u3001\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab\u3001\u4e2d\u6771\u3067\u7570\u4f8b\u306e\u30ea\u30b3\u30fc\u30eb\u3068\u5b89\u5168\u8b66\u544a\u304c\u76f8\u6b21\u3044\u3060\u3053\u3068\u3092\u80cc\u666f\u306b\u3001\u5b89\u5168\u6027\u30b7\u30b0\u30ca\u30eb\u305d\u306e\u3082\u306e\u306b\u95a2\u3059\u308b\u79d1\u5b66\u7684\u53ce\u675f\uff08\u5f53\u5c40\u304c\u307b\u307c\u540c\u6642\u306b\u540c\u3058\u8868\u793a\u3068\u30ea\u30b9\u30af\u306b\u95a2\u3059\u308b\u7d50\u8ad6\u306b\u9054\u3059\u308b\u30b1\u30fc\u30b9\u304c\u5897\u3048\u3066\u3044\u308b\uff09\u3067\u3059\u3002\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u6d3b\u52d5\u306f\u3001\u5f53\u793e\u304c\u76e3\u8996\u3057\u3066\u3044\u308b9\u3064\u306e\u5730\u57df\u3059\u3079\u3066\u306b\u53ca\u3073\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u5206\u91ce\u306e\u30c6\u30fc\u30de\u3068\u3057\u3066\u306f\u6700\u3082\u5e83\u3044\u5730\u7406\u7684\u7bc4\u56f2\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u5b89\u5168\u7ba1\u7406\u6a5f\u80fd\u3092\u62c5\u3046\u3059\u3079\u3066\u306e\u4eba\u306b\u3068\u3063\u3066\u30012\u3064\u306e\u5b9f\u7528\u7684\u306a\u6559\u8a13\u304c\u3042\u308a\u307e\u3059\u3002\u77ed\u671f\u7684\u306a\u6559\u8a13\u306f\u904b\u7528\u9762\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u30b7\u30b9\u30c6\u30e0\u304c\u9069\u5207\u306b\u6a5f\u80fd\u3057\u3066\u3044\u306a\u3044\u5834\u5408\u3001 <\/span><a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/development-approval-process-cber\/electronic-submission-postmarket-safety-reports\"><span data-contrast=\"none\">E2B(R3)<\/span><\/a><span data-contrast=\"auto\">\u6e96\u5099\u306f\u4e07\u7aef\u3067\u3059\u3002FDA\u306e\u671f\u9650\u306f\u3082\u3046\u3059\u3050\u3067\u3059\u3002\u3088\u308a\u9577\u671f\u7684\u306a\u8996\u70b9\u3067\u898b\u308b\u3068\u3001\u6226\u7565\u7684\u306a\u554f\u984c\u304c\u3042\u308a\u307e\u3059\u3002\u5f53\u5c40\u306e\u898f\u5236\u304c\u7d71\u4e00\u3055\u308c\u308b\u306b\u3064\u308c\u3001\u3042\u308b\u5e02\u5834\u3067\u767a\u751f\u3057\u305f\u5b89\u5168\u30b7\u30b0\u30ca\u30eb\u306f\u3001\u4ed6\u306e\u5e02\u5834\u306b\u304a\u3051\u308b\u898f\u5236\u63aa\u7f6e\u306e\u5f37\u529b\u306a\u4e88\u6e2c\u56e0\u5b50\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u5404\u56fd\u306e\u8b66\u544a\u3092\u500b\u5225\u306e\u4e8b\u8c61\u3068\u3057\u3066\u6271\u3046\u3068\u3001\u3053\u308c\u3089\u306e\u6c7a\u5b9a\u304c\u3069\u308c\u307b\u3069\u5bc6\u63a5\u306b\u95a2\u9023\u3057\u3066\u3044\u308b\u304b\u3092\u904e\u5c0f\u8a55\u4fa1\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u7af6\u4e89\u512a\u4f4d\u6027\u3092\u5f97\u308b\u306b\u306f\u3001\u6700\u521d\u306e\u30b7\u30b0\u30ca\u30eb\u3092\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306e\u4ed6\u306e\u5e02\u5834\u3078\u306e\u65e9\u671f\u8b66\u544a\u3068\u3057\u3066\u6349\u3048\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW193139655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW193139655 BCX0\" data-ccp-parastyle=\"heading 2\">\u30ea\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u3001\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u304c\u65b0\u305f\u306a\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u65b9\u6cd5\u3092\u5909\u9769\u3057\u3066\u3044\u308b\u3002<\/span><\/span><span class=\"EOP Selected SCXW193139655 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/strong><\/h3>\n\t<div id=\"gap-1171684654\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1171684654 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u6570\u5341\u5e74\u306b\u308f\u305f\u308a\u3001\u751f\u7269\u88fd\u5264\u3084\u30ef\u30af\u30c1\u30f3\u3092\u65b0\u305f\u306a\u56fd\u306b\u5c0e\u5165\u3059\u308b\u3068\u3044\u3046\u3053\u3068\u306f\u3001\u4ed6\u56fd\u3067\u3059\u3067\u306b\u5b9f\u65bd\u3055\u308c\u305f\u624b\u7d9a\u304d\u3092\u307b\u307c\u305d\u306e\u307e\u307e\u7e70\u308a\u8fd4\u3059\u3001\u5305\u62ec\u7684\u306a\u898f\u5236\u5be9\u67fb\u3092\u518d\u5ea6\u53d7\u3051\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u3066\u3044\u305f\u3002\u3057\u304b\u3057\u3001\u305d\u306e\u30e2\u30c7\u30eb\u306f\u5909\u308f\u308a\u3064\u3064\u3042\u308a\u30012026\u5e749\u6708\u306f\u305d\u306e\u5178\u578b\u7684\u306a\u4f8b\u3068\u306a\u3063\u305f\u3002. <\/span><a href=\"https:\/\/sidof.segob.gob.mx\/notas\/docFuente\/5797710\"><span data-contrast=\"none\">\u30e1\u30ad\u30b7\u30b3\u306eCOFEPRIS<\/span><\/a><span data-contrast=\"auto\"> \u30d6\u30e9\u30b8\u30eb\u306eANVISA\uff08\u56fd\u5bb6\u885b\u751f\u76e3\u7763\u5e81\uff09\u306e\u627f\u8a8d\u3092\u6b63\u5f0f\u306b\u8a8d\u3081\u308b\u7c21\u7565\u5316\u3055\u308c\u305f\u8ca9\u58f2\u627f\u8a8d\u7d4c\u8def\u3092\u5275\u8a2d\u3057\u305f\u3002\u3053\u308c\u306f\u3001\u4fe1\u983c\u3067\u304d\u308b\u53c2\u7167\u6c7a\u5b9a\u304c\u5b8c\u5168\u306a\u72ec\u7acb\u8a55\u4fa1\u306e\u4ee3\u308f\u308a\u3068\u306a\u308b\u3001\u898f\u5236\u4e0a\u306e\u4f9d\u5b58\u306e\u5177\u4f53\u7684\u306a\u4f8b\u3067\u3042\u308b\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u308c\u306f\u5b64\u7acb\u3057\u305f\u51fa\u6765\u4e8b\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3067\u3057\u305f\u3002\u4eca\u6708\u3001\u5f53\u793e\u306e\u30c8\u30ec\u30f3\u30c9\u30ec\u30fc\u30c0\u30fc\u306f\u3001\u751f\u7269\u88fd\u5264\u3001\u30ef\u30af\u30c1\u30f3\u3001\u5148\u9032\u6cbb\u7642\u6cd5\u306b\u95a2\u3059\u308b\u7d0420\u4ef6\u306e\u52d5\u5411\u3092\u8ffd\u8de1\u3057\u307e\u3057\u305f\u304c\u3001\u305d\u306e\u591a\u304f\u306f\u65b0\u8208\u5e02\u5834\u306b\u7126\u70b9\u3092\u5f53\u3066\u305f\u3082\u306e\u3067\u3057\u305f\u3002. <\/span><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2026\/anvisa-atualiza-vacina-da-covid-e-lista-de-medicamentos-de-baixo-risco\"><span data-contrast=\"none\">\u30a2\u30f3\u30d3\u30b5<\/span><\/a><span data-contrast=\"auto\"> \u72ec\u81ea\u306eCOVID-19\u30ef\u30af\u30c1\u30f3\u3068\u4f4e\u30ea\u30b9\u30af\u533b\u85ac\u54c1\u30ea\u30b9\u30c8\u3092\u66f4\u65b0\u3002\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u306f\u7d71\u5408\u6cd5\u6848\u3092\u53ef\u6c7a\u3002 <\/span><a href=\"https:\/\/www.hsa.gov.sg\/announcements\"><span data-contrast=\"none\">\u5065\u5eb7\u898f\u5236\u6a5f\u80fd<\/span><\/a><span data-contrast=\"auto\"> HSA\u306e\u4e0b\u3067\u306e\u76e3\u7763\u306e\u5408\u7406\u5316\u3001\u305d\u3057\u3066 <\/span><a href=\"https:\/\/www.federalregister.gov\/documents\/2026\/06\/24\/2026-12622\/demonstrating-substantial-evidence-%E2%80%A6\"><span data-contrast=\"none\">FDA<\/span><\/a><span data-contrast=\"auto\"> \u533b\u85ac\u54c1\u304a\u3088\u3073\u751f\u7269\u88fd\u5264\u306e\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u5341\u5206\u306a\u8a3c\u62e0\u3092\u793a\u3059\u305f\u3081\u306e\u3001\u3088\u308a\u9ad8\u5ea6\u3067\u6539\u8a02\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3002\u5171\u901a\u70b9\u306f\u30a2\u30af\u30bb\u30b9\u3067\u3042\u308a\u3001\u5f53\u5c40\u306f\u6bce\u56de\u5be9\u67fb\u3092\u3084\u308a\u76f4\u3059\u306e\u3067\u306f\u306a\u304f\u3001\u3088\u308a\u8fc5\u901f\u3067\u52b9\u7387\u7684\u306a\u627f\u8a8d\u7d4c\u8def\u3092\u69cb\u7bc9\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4f01\u696d\u306b\u3068\u3063\u3066\u306e\u30c1\u30e3\u30f3\u30b9\u306f\u78ba\u304b\u306b\u5b58\u5728\u3059\u308b\u304c\u3001\u6761\u4ef6\u4ed8\u304d\u3067\u3042\u308b\u3002\u8a8d\u77e5\u3055\u308c\u305f\u53c2\u7167\u5e02\u5834\u306b\u304a\u3051\u308b\u5f37\u529b\u306a\u7533\u8acb\u66f8\u985e\u306f\u3001\u4eca\u3084\u4ed6\u56fd\u3067\u3082\u901a\u7528\u3059\u308b\u8cc7\u7523\u3068\u306a\u308a\u3001\u30ea\u30e9\u30a4\u30a2\u30f3\u30b9\u5236\u5ea6\u3092\u63a1\u7528\u3059\u308b\u7ba1\u8f44\u533a\u57df\u306b\u304a\u3051\u308b\u627f\u8a8d\u307e\u3067\u306e\u6642\u9593\u3092\u5927\u5e45\u306b\u77ed\u7e2e\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002\u305f\u3060\u3057\u3001\u30ea\u30e9\u30a4\u30a2\u30f3\u30b9\u5236\u5ea6\u3054\u3068\u306b\u3001\u8a8d\u5b9a\u6a5f\u95a2\u3001\u5bfe\u8c61\u3068\u306a\u308b\u88fd\u54c1\u30bf\u30a4\u30d7\u3001\u304a\u3088\u3073\u6587\u66f8\u5316\u898f\u5247\u304c\u7570\u306a\u308b\u3068\u3044\u3046\u70b9\u304c\u91cd\u8981\u3068\u306a\u308b\u3002\u3069\u306e\u627f\u8a8d\u304c\u3069\u306e\u5730\u57df\u3067\u8a8d\u3081\u3089\u308c\u308b\u304b\u3092\u6b63\u78ba\u306b\u628a\u63e1\u3059\u308b\u3053\u3068\u306f\u3001\u898f\u5236\u4e0a\u306e\u5f8c\u56de\u3057\u306e\u5bfe\u5fdc\u3067\u306f\u306a\u304f\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u5c55\u958b\u6226\u7565\u306e\u4e2d\u6838\u3092\u6210\u3059\u8981\u7d20\u306b\u306a\u308a\u3064\u3064\u3042\u308b\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>September 2026 made one thing clear across life sciences: regulators are starting to move in step. Our Trends Radar tracked activity across devices, drug safety and biologics, and the same pattern kept showing up. Authorities on different continents are aligning shared standards, recognizing each other&#8217;s decisions, and reaching similar conclusions at roughly the same time. This month we look at three trends behind that shift. First, how medical device and IVD rules are quietly merging toward a common baseline. Second, why the FDA&#8217;s 1 October E2B(R3) deadline and China&#8217;s revised GCP point to pharmacovigilance standardizing fast. Third, how regulatory reliance is opening faster routes for biologics into new markets. For&#8230;<\/p>","protected":false},"author":46,"featured_media":9717,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-11353","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 v28.4 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Life Sciences in September 2026: Key Regulatory Changes<\/title>\n<meta name=\"description\" content=\"Explore signs of harmonization in Life Sciences in September 2026 as regulators align standards across continents.\" \/>\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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