{"id":9714,"date":"2026-03-25T16:42:45","date_gmt":"2026-03-25T08:42:45","guid":{"rendered":"https:\/\/regask.com\/?p=9714"},"modified":"2026-03-25T16:43:42","modified_gmt":"2026-03-25T08:43:42","slug":"fda%e3%81%af%e5%b8%82%e8%b2%a9%e5%be%8c%e5%ae%89%e5%85%a8%e6%80%a7%e5%a0%b1%e5%91%8a%e3%81%ae%e5%8a%b9%e7%8e%87%e5%8c%96%e3%81%ae%e3%81%9f%e3%82%81%e3%80%81%e7%b5%b1%e5%90%88%e6%9c%89%e5%ae%b3","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/fda-launches-unified-adverse-event-monitoring-system-aems-to-streamline-postmarket-safety-reporting\/","title":{"rendered":"FDA\u304c\u7d71\u5408\u6709\u5bb3\u4e8b\u8c61\u76e3\u8996\u30b7\u30b9\u30c6\u30e0\uff08A\u2026"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e743\u670811\u65e5<\/strong>\u3001 <strong>\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09<\/strong> \u767a\u58f2\u3057\u305f <strong>\u6709\u5bb3\u4e8b\u8c61\u76e3\u8996\u30b7\u30b9\u30c6\u30e0\uff08AEMS\uff09<\/strong>, \u5f37\u5316\u3059\u308b\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u7d71\u5408\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0 <strong>\u5e02\u8ca9\u5f8c\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u7ba1\u7406<\/strong> FDA\u898f\u5236\u5bfe\u8c61\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u3002\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u8907\u6570\u306e\u30ec\u30ac\u30b7\u30fc\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u7d71\u5408\u3057\u3001 <strong>\u5358\u4e00\u306e\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30ec\u30dd\u30fc\u30c8\u30c0\u30c3\u30b7\u30e5\u30dc\u30fc\u30c9<\/strong>, \u6bb5\u968e\u7684\u306a\u79fb\u884c\u3068\u30b7\u30b9\u30c6\u30e0\u5ec3\u6b62\u304c\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b <strong>2026\u5e745\u6708<\/strong>.<\/p>\n<div class=\"row\"  id=\"row-1315266281\">\n\n\t<div id=\"col-167196073\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-615520911\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-615520911 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u8a73\u7d30<\/h2>\n\t<div id=\"gap-1486912109\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1486912109 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u65b0\u305f\u306b\u5c0e\u5165\u3055\u308c\u305f <strong>AEMS<\/strong> \u8907\u6570\u306e\u5f93\u6765\u306e\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u30b7\u30b9\u30c6\u30e0\u3092\u7f6e\u304d\u63db\u3048\u308b\u3082\u306e\u3067\u3001 <strong>FAERS<\/strong>, <strong>VAERS<\/strong>, <strong>AERS<\/strong>, <strong>\u30e2\u30fc\u30c9<\/strong>, <strong>\u9ad8\u679c\u7cd6\u30b3\u30fc\u30f3\u30b7\u30ed\u30c3\u30d7<\/strong>\u3001 \u305d\u3057\u3066 <strong>CTPAE<\/strong>, \u3059\u3079\u3066\u306e\u5831\u544a\u3092 <strong>\u96c6\u4e2d\u578b\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/strong>. \u3053\u306e\u7d71\u5408\u306b\u3088\u308a <strong>\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u306e\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u516c\u958b<\/strong> \u533b\u85ac\u54c1\u3001\u751f\u7269\u88fd\u5264\u3001\u30ef\u30af\u30c1\u30f3\u3001\u5316\u7ca7\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001\u98df\u54c1\u3001\u6804\u990a\u88dc\u52a9\u98df\u54c1\u3001\u52d5\u7269\u7528\u98fc\u6599\u3001\u30bf\u30d0\u30b3\u88fd\u54c1\u306a\u3069\u3001\u5e45\u5e83\u3044\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u308f\u305f\u308b\u3002.<\/p>\n<p>\u3053\u306e\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u3001 <strong>\u5f37\u5316\u3055\u308c\u305fAPI\u3068\u5206\u6790\u30c4\u30fc\u30eb<\/strong>, \u6539\u5584\u3092\u53ef\u80fd\u306b\u3059\u308b <strong>\u30c7\u30fc\u30bf\u30a2\u30af\u30bb\u30b9\u3068\u7d71\u5408<\/strong> \u898f\u5236\u3001\u54c1\u8cea\u3001\u304a\u3088\u3073\u5b89\u5168\u306b\u95a2\u3059\u308b\u6a5f\u80fd\u306b\u5bfe\u5fdc\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u6a5f\u80fd\u306f\u3001\u3088\u308a\u52b9\u7387\u7684\u306a\u76e3\u8996\u3001\u4fe1\u53f7\u691c\u51fa\u3001\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8ffd\u8de1\u3092\u652f\u63f4\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n<p>\u30ec\u30ac\u30b7\u30fc\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u306e\u5c65\u6b74\u30c7\u30fc\u30bf\u306f <strong>AEMS\u306b\u79fb\u884c\u3057\u307e\u3057\u305f<\/strong>, \u3001 \u3068 <strong>\u6bb5\u968e\u7684\u5ec3\u6b62\u63aa\u7f6e<\/strong> \u79fb\u884c\u304c\u9032\u3080\u306b\u3064\u308c\u3066\u767a\u751f\u3059\u308b\u4ee5\u524d\u306e\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3002 <strong>2026\u5e745\u6708\u672b<\/strong>, AEMS\u306f\u3001 <strong>\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u3068\u53ef\u8996\u5316\u306e\u305f\u3081\u306e\u4e3b\u8981\u30b7\u30b9\u30c6\u30e0<\/strong> FDA\u304c\u898f\u5236\u3059\u308b\u3059\u3079\u3066\u306e\u5206\u91ce\u306b\u308f\u305f\u3063\u3066\u3002.<\/p>\n<p>\u5229\u5bb3\u95a2\u4fc2\u8005\u3001\u4ee5\u4e0b\u3092\u542b\u3080 <strong>\u88fd\u9020\u696d\u8005\u3001\u533b\u7642\u5f93\u4e8b\u8005\u3001\u60a3\u8005\u5b89\u5168\u30c1\u30fc\u30e0<\/strong>, \u79fb\u884c\u671f\u9593\u4e2d\u306f\u3001\u5831\u544a\u30d7\u30ed\u30bb\u30b9\u3092\u65b0\u3057\u3044\u30b7\u30b9\u30c6\u30e0\u8981\u4ef6\u306b\u5408\u308f\u305b\u308b\u3088\u3046\u306b\u8abf\u6574\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-167196073 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1660513629\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u7de0\u3081\u5207\u308a<\/h2>\n\t<div id=\"gap-785304886\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-785304886 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u306e <strong>AEMS\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f2026\u5e743\u670811\u65e5\u306b\u30ed\u30fc\u30f3\u30c1\u3055\u308c\u307e\u3057\u305f\u3002<\/strong>, \u3001 \u3068 <strong>\u6bb5\u968e\u7684\u306a\u79fb\u884c\u3068\u5ec3\u6b62<\/strong> \u30ec\u30ac\u30b7\u30fc\u30b7\u30b9\u30c6\u30e0\u306e\u3046\u3061\u3001 <strong>2026\u5e745\u6708\u672b<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1660513629 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-570725603\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u306a\u305c\u305d\u308c\u304c\u91cd\u8981\u306a\u306e\u304b<\/h2>\n\t<div id=\"gap-1466750361\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1466750361 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067\u306f\u3001 <strong>\u900f\u660e\u6027\u3068\u52b9\u7387\u6027<\/strong> \u5e02\u8ca9\u5f8c\u5b89\u5168\u6027\u76e3\u8996\u306b\u304a\u3044\u3066\u3001 <strong>\u6709\u5bb3\u4e8b\u8c61\u30c7\u30fc\u30bf\u3078\u306e\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30a2\u30af\u30bb\u30b9<\/strong> \u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u3002\u4e2d\u592e\u96c6\u4e2d\u578b\u30b7\u30b9\u30c6\u30e0\u306f\u3001 <strong>\u30c7\u30b8\u30bf\u30eb\u7d71\u5408<\/strong>, \u5f37\u5316\u3059\u308b <strong>\u898f\u5236\u76e3\u7763<\/strong>, \u5408\u7406\u5316 <strong>\u30c7\u30fc\u30bf\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9<\/strong>, \u5b89\u5168\u5831\u544a\u306b\u304a\u3051\u308b\u65ad\u7247\u5316\u3092\u6e1b\u3089\u3057\u3001\u4e00\u8cab\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-570725603 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-164913230\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u5f71\u97ff\u3092\u53d7\u3051\u308b\u4eba\u3005<\/h2>\n\t<div id=\"gap-1808844517\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1808844517 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001 <strong>\u898f\u5236\u95a2\u9023\u696d\u52d9<\/strong>, <strong>\u54c1\u8cea\u4fdd\u8a3c<\/strong>, <strong>\u60a3\u8005\u5b89\u5168<\/strong>\u3001 \u305d\u3057\u3066 <strong>\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u30c1\u30fc\u30e0<\/strong> \u7d44\u7e54\u6a2a\u65ad\u7684\u306a\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0 <strong>FDA\u898f\u5236\u5bfe\u8c61\u88fd\u54c1<\/strong>, \u533b\u85ac\u54c1\u3001\u751f\u7269\u88fd\u5264\u3001\u533b\u7642\u6a5f\u5668\u3001\u98df\u54c1\u3001\u30bf\u30d0\u30b3\u88fd\u54c1\u306a\u3069\u3092\u542b\u3080\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-164913230 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1626146200\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/h2>\n\t<div id=\"gap-121334264\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-121334264 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7d44\u7e54\u306f <strong>\u73fe\u5728\u306e\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u8a55\u4fa1\u3059\u308b<\/strong> \u305d\u3057\u3066\u78ba\u5b9f\u306b <strong>AEMS\u8981\u4ef6\u3068\u306e\u30b7\u30b9\u30c6\u30e0\u4e92\u63db\u6027<\/strong>. \u30af\u30ed\u30b9\u30d5\u30a1\u30f3\u30af\u30b7\u30e7\u30ca\u30eb\u30c1\u30fc\u30e0\u306f\u5354\u529b\u3057\u3066 <strong>\u5185\u90e8\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u66f4\u65b0\u3059\u308b<\/strong>, \u6574\u5217 <strong>\u30c7\u30fc\u30bf\u7d71\u5408\u30d7\u30ed\u30bb\u30b9<\/strong>, \u305d\u3057\u3066\u6e96\u5099\u3059\u308b <strong>\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u306e\u5831\u544a\u3068\u76e3\u8996<\/strong> \u6bb5\u968e\u7684\u306a\u79fb\u884c\u304c\u9032\u3080\u306b\u3064\u308c\u3066\u3002.<\/p>\n<p>\u4e16\u754c\u306e\u898f\u5236\u5f53\u5c40\u304c\u5b89\u5168\u76e3\u8996\u30b7\u30b9\u30c6\u30e0\u306e\u8fd1\u4ee3\u5316\u3092\u9032\u3081\u308b\u4e2d\u3067\u3001\u9032\u5316\u3059\u308b\u5831\u544a\u30a4\u30f3\u30d5\u30e9\u3068\u306e\u6574\u5408\u6027\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u30ea\u30b9\u30af\u7ba1\u7406\u306b\u3068\u3063\u3066\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3002.<\/p>\n<p><a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u306f\u3001\u6d88\u8cbb\u8ca1\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306a\u3069\u3001\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u3092\u7a4d\u6975\u7684\u306b\u4e57\u308a\u8d8a\u3048\u3089\u308c\u308b\u3088\u3046\u652f\u63f4\u3059\u308b\u3001\u696d\u754c\u3092\u30ea\u30fc\u30c9\u3059\u308b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u304a\u3088\u3073\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002\u9ad8\u5ea6\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3068\u5c02\u9580\u5bb6\u306e\u77e5\u898b\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001, <a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u4e88\u6e2c\u7684\u304b\u3064\u5b9f\u7528\u7684\u306a\u6d1e\u5bdf\u3068\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u81ea\u52d5\u5316\u3092\u63d0\u4f9b\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001160 \u304b\u56fd\u4ee5\u4e0a\u3067\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3057\u307e\u3059\u3002. <a href=\"https:\/\/regask.com\/ja\/%e8%a3%bd%e5%93%81\/\">\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b<\/a> \u307e\u305f\u306f <a href=\"https:\/\/regask.com\/ja\/%e3%83%87%e3%83%a2%e3%82%92%e4%ba%88%e7%b4%84%e3%81%99%e3%82%8b\/\">\u30c7\u30e2\u3092\u4e88\u7d04\u3059\u308b<\/a> \u4eca\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1626146200 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1128337557\">\n\n\t<div id=\"col-1826928916\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\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>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h3>\n\t<div id=\"gap-217014762\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-217014762 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>FDA\u6709\u5bb3\u4e8b\u8c61\u76e3\u8996\u30b7\u30b9\u30c6\u30e0\uff08AEMS\uff09\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h4>\n\t<div id=\"gap-138409465\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-138409465 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u305d\u308c\u306f <strong>\u96c6\u4e2d\u578b\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/strong> \u306e\u305f\u3081\u306b <strong>\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u306e\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u304a\u3088\u3073\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<\/strong> FDA\u304c\u898f\u5236\u3059\u308b\u3059\u3079\u3066\u306e\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u304a\u3044\u3066\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1826928916 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1850123325\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>AEMS\u306b\u3088\u3063\u3066\u7f6e\u304d\u63db\u3048\u3089\u308c\u308b\u30b7\u30b9\u30c6\u30e0\u306f\u3069\u308c\u3067\u3059\u304b\uff1f<\/h4>\n\t<div id=\"gap-50670629\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-50670629 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>AEMS\u304c\u7f6e\u304d\u63db\u3048\u308b <strong>FAERS<\/strong>, <strong>VAERS<\/strong>, <strong>AERS<\/strong>, <strong>\u30e2\u30fc\u30c9<\/strong>, <strong>\u9ad8\u679c\u7cd6\u30b3\u30fc\u30f3\u30b7\u30ed\u30c3\u30d7<\/strong>\u3001 \u305d\u3057\u3066 <strong>CTPAE<\/strong>, \u305d\u308c\u3089\u3092\u5358\u4e00\u306e\u30b7\u30b9\u30c6\u30e0\u306b\u7d71\u5408\u3059\u308b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1850123325 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-773056721\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>AEMS\u3078\u306e\u79fb\u884c\u306f\u3044\u3064\u5b8c\u4e86\u3057\u307e\u3059\u304b\uff1f<\/h4>\n\t<div id=\"gap-1426505848\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1426505848 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u306e <strong>\u6bb5\u968e\u7684\u306a\u79fb\u884c\u3068\u5ec3\u6b62<\/strong> \u30ec\u30ac\u30b7\u30fc\u30b7\u30b9\u30c6\u30e0\u306e\u79fb\u884c\u306f\u3001 <strong>2026\u5e745\u6708\u672b<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-773056721 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1945619033\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>RegASK\u306f\u3001AEMS\u3078\u306e\u9069\u5fdc\u3092\u9032\u3081\u308b\u7d44\u7e54\u3092\u3069\u306e\u3088\u3046\u306b\u652f\u63f4\u3067\u304d\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/h4>\n\t<div id=\"gap-459962768\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-459962768 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/ja\/\">RegASK <\/a>\u7d44\u7e54\u3092\u652f\u63f4\u3059\u308b <strong>\u898f\u5236\u30b7\u30b9\u30c6\u30e0\u306e\u5909\u66f4\u3092\u8ffd\u8de1\u3059\u308b<\/strong>, \u6574\u5217 <strong>\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210\u30ef\u30fc\u30af\u30d5\u30ed\u30fc<\/strong>, \u5408\u7406\u5316 <strong>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30d7\u30ed\u30bb\u30b9<\/strong>, \u65b0\u305f\u306a\u5b89\u5168\u76e3\u8996\u8981\u4ef6\u3078\u306e\u5186\u6ed1\u306a\u9069\u5fdc\u3092\u4fdd\u8a3c\u3059\u308b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1945619033 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On March 11, 2026, the U.S. Food and Drug Administration (FDA) launched the Adverse Event Monitoring System (AEMS), a unified platform designed to enhance postmarket safety data management across all FDA-regulated product categories. The system consolidates multiple legacy databases into a single real-time reporting dashboard, with phased migration and system decommissioning scheduled through May 2026.<\/p>","protected":false},"author":32,"featured_media":9715,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33],"tags":[],"class_list":["post-9714","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Launches Unified Adverse Event Monitoring System Overview<\/title>\n<meta name=\"description\" content=\"The FDA launches a unified adverse event monitoring system to enhance postmarket safety reporting for all regulated products.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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