{"id":9485,"date":"2026-02-16T16:20:31","date_gmt":"2026-02-16T08:20:31","guid":{"rendered":"https:\/\/regask.com\/?p=9485"},"modified":"2026-02-16T16:20:31","modified_gmt":"2026-02-16T08:20:31","slug":"%e8%8b%b1%e5%9b%bdmhra%e3%80%812012%e5%b9%b4%e6%94%b9%e6%ad%a3cir-520%e3%81%ab%e5%9f%ba%e3%81%a5%e3%81%8f%e5%8c%bb%e8%96%ac%e5%93%81%e5%ae%89%e5%85%a8%e6%80%a7%e7%9b%a3%e8%a6%96%e8%a6%81%e4%bb%b6","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/uk-mhra-issues-guidance-on-pharmacovigilance-requirements-under-amended-cir-520-2012\/","title":{"rendered":"\u82f1\u56fdMHRA\u3001\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u8981\u4ef6\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c\u2026"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e742\u67089\u65e5,<\/strong> \u305d\u306e <strong>\u82f1\u56fd\u533b\u85ac\u54c1\u30fb\u533b\u7642\u88fd\u54c1\u898f\u5236\u5e81\uff08MHRA\uff09<\/strong> \u82f1\u56fd\u306e\u8ca9\u58f2\u627f\u8a8d\u4fdd\u6709\u8005\u5411\u3051\u306b\u3001\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u8981\u4ef6\u304c\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3055\u308c\u308b\u304b\u3092\u6982\u8aac\u3057\u305f\u65b0\u3057\u3044\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u958b\u3057\u307e\u3057\u305f\u3002 <strong>\u59d4\u54e1\u4f1a\u5b9f\u65bd\u898f\u5247\uff08CIR\uff09520\/2012\u3002.<\/strong> \u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u304c\u63a1\u629e\u3057\u305f <strong>\u898f\u5247\uff08EU\uff092025\/1466\u3001,<\/strong> \u3053\u308c\u306fCIR 520\/2012\u3092\u6539\u8a02\u3057\u3001 <strong>2026\u5e742\u670812\u65e5,<\/strong> \u9650\u5b9a\u7684\u306a\u898f\u5b9a\u306f <strong>2025\u5e748\u670812\u65e5\u3002.<\/strong> \u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001\u7279\u306b\u4ee5\u4e0b\u306e\u7d44\u7e54\u306b\u95a2\u4fc2\u3057\u307e\u3059\u3002 <strong>\u82f1\u56fd\u8a8d\u53ef\u533b\u85ac\u54c1<\/strong> \u3055\u307e\u3056\u307e\u306a\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u308f\u305f\u3063\u3066 <strong>\u30a6\u30a3\u30f3\u30b6\u30fc\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3002. <\/strong><\/p>\n<div class=\"row\"  id=\"row-282807759\">\n\n\t<div id=\"col-1074567165\" 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-1164097643\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1164097643 {\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-584776025\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-584776025 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u6b21\u306e\u3088\u3046\u306b\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u3002 <strong>CIR 520\/2012<\/strong> \u6b63\u5f0f\u306b\u6539\u6b63\u3055\u308c\u307e\u3057\u305f <strong>\u898f\u5247\uff08EU\uff092025\/1466\u3001,<\/strong> \u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u8981\u4ef6\u306e\u5909\u66f4\u3092\u5c0e\u5165\u3059\u308b\u3002<strong> \u30a6\u30a3\u30f3\u30b6\u30fc\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3001,<\/strong> \u82f1\u56fd\u3067\u8a8d\u53ef\u3055\u308c\u305f\u533b\u85ac\u54c1\u306f\u73fe\u5728\u3001 <strong>\u30ab\u30c6\u30b4\u30ea\u30fc1<\/strong> \u307e\u305f\u306f <strong>\u30ab\u30c6\u30b4\u30ea\u30fc2\u3001,<\/strong> \u9069\u7528\u3055\u308c\u308b\u6cd5\u7684\u67a0\u7d44\u307f\u3092\u6c7a\u5b9a\u3057\u307e\u3059\u3002.<\/p>\n<p>\u304b\u3089 <strong>2026\u5e742\u670812\u65e5\u3001HMR 2012\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb12A<\/strong> \u305d\u3057\u3066\u4fee\u6b63\u3055\u308c\u305f <strong>CIR 520\/2012<\/strong> \u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u7fa9\u52d9\u306b\u95a2\u3059\u308b\u6cd5\u7684\u6574\u5408\u6027\u306f\u5931\u308f\u308c\u307e\u3059\u3002\u3053\u306e\u76f8\u9055\u306f\u3001\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\u3084\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u69cb\u9020\u306b\u5fdc\u3058\u3066\u7570\u306a\u308b\u8981\u4ef6\u304c\u9069\u7528\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002.<\/p>\n<p>\u4e0d\u5fc5\u8981\u306a\u898f\u5236\u8ca0\u62c5\u3092\u8efd\u6e1b\u3059\u308b\u305f\u3081\u306b\u3001MHRA\u306f <strong>\u5b9f\u7528\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30a2\u30d7\u30ed\u30fc\u30c1<\/strong>. \u8ca9\u58f2\u627f\u8a8d\u4fdd\u6709\u8005 <strong>\u6df7\u5408\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/strong> \u30ab\u30c6\u30b4\u30ea\u30fc1\u3068\u30ab\u30c6\u30b4\u30ea\u30fc2\u306e\u88fd\u54c1\u306e\u4e21\u65b9\u3092\u542b\u3080\u5834\u5408\u306f\u3001\u6539\u6b63\u3055\u308c\u305f <strong>CIR 520\/2012<\/strong> \u82f1\u56fd\u3067\u8a8d\u53ef\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u88fd\u54c1\u306b\u304a\u3044\u3066\u3002\u5bfe\u7167\u7684\u306b\u3001 <strong>\u30ab\u30c6\u30b4\u30ea\u30fc1\u306e\u88fd\u54c1<\/strong> <strong>\u306e\u307f<\/strong> \u5f15\u304d\u7d9a\u304d\u7d9a\u304f\u53ef\u80fd\u6027\u304c\u3042\u308b <strong>HMR\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb12A\u3001,<\/strong> \u5f7c\u3089\u304c\u4fdd\u6301\u3057\u306a\u3044\u9650\u308a <strong>\u540c\u7b49\u306e\u6b27\u5dde\u9023\u5408\u8a8d\u53ef<\/strong>, \u3053\u306e\u5834\u5408\u3001\u8ffd\u52a0\u306e\u8003\u616e\u4e8b\u9805\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002.<\/p>\n<p>MHRA\u306f\u307e\u305f\u3001\u4eca\u5f8c\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306b\u3064\u3044\u3066\u3082\u8a00\u53ca\u3057\u3066\u3044\u308b\u3002 <strong>HMR 2012 \u30b9\u30b1\u30b8\u30e5\u30fc\u30eb 12A<\/strong> \u3088\u308a\u9069\u5207\u306b\u53cd\u6620\u3055\u308c\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u3002 <strong>CIR 520\/2012\u3001,<\/strong> \u305f\u3060\u3057\u3001\u73fe\u6bb5\u968e\u3067\u306f\u5909\u66f4\u306f\u78ba\u8a8d\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1074567165 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1377450984\" 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>\u767a\u52b9\u65e5<\/h2>\n\t<div id=\"gap-2095599468\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2095599468 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6539\u6b63\u3055\u308c\u305f <strong>\u59d4\u54e1\u4f1a\u5b9f\u65bd\u898f\u5247\uff08CIR\uff09520\/2012\u3001,<\/strong> \u6539\u8a02\u7248 <strong>\u898f\u5247 (EU) 2025\/1466 \u306f\u30012026 \u5e74 2 \u6708 12 \u65e5\u304b\u3089\u9069\u7528\u3055\u308c\u307e\u3059\u3002.<\/strong> \u3057\u304b\u3057\u3001, <strong>\u7b2c1\u6761(7)\u53ca\u3073\u7b2c1\u6761(9)<\/strong> \u6539\u6b63\u898f\u5247\u306e <strong>2025\u5e748\u670812\u65e5\u306b\u65e9\u671f\u767a\u52b9\u3057\u307e\u3057\u305f\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1377450984 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-254450564\" 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-1798425868\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1798425868 {\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>\u82f1\u56fd\u3068EU\u306e\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306b\u95a2\u3059\u308b\u6cd5\u7684\u67a0\u7d44\u307f\u306e\u4e0d\u4e00\u81f4,<\/strong> \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8a08\u753b\u306b\u5b9f\u969b\u7684\u306a\u5f71\u97ff\u3092\u3082\u305f\u3089\u3059\u3002MHRA\u306e\u5b9f\u969b\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001 <strong>\u898f\u5236\u306e\u660e\u78ba\u3055\u3001\u696d\u52d9\u306e\u52b9\u7387\u6027\u3001,<\/strong> \u305d\u3057\u3066 <strong>\u30c7\u30b8\u30bf\u30eb\u30a2\u30e9\u30a4\u30e1\u30f3\u30c8\u3001,<\/strong> \u307e\u305f\u3001\u7d44\u7e54\u306f\u8981\u4ef6\u306e\u8aa4\u9069\u7528\u3092\u907f\u3051\u308b\u305f\u3081\u3001\u30d7\u30ed\u30bb\u30b9\u3092\u614e\u91cd\u306b\u7ba1\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u5909\u66f4\u306b\u3088\u308a\u3001\u7279\u306b\u8907\u96d1\u306a\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3084\u8907\u6570\u306e\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3092\u6301\u3064\u7d44\u7e54\u3067\u306f\u3001\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u30b7\u30b9\u30c6\u30e0\u3001\u30ac\u30d0\u30ca\u30f3\u30b9\u69cb\u9020\u3001\u304a\u3088\u3073\u5185\u90e8\u624b\u9806\u306e\u91cd\u70b9\u7684\u306a\u66f4\u65b0\u304c\u5fc5\u8981\u306b\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-254450564 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-818214095\" 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>\u8ab0\u306b\u95a2\u4fc2\u304c\u3042\u308b\u304b<\/h2>\n\t<div id=\"gap-38339139\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-38339139 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001 <strong>\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u3001\u85ac\u4e8b\u898f\u5236\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001,<\/strong> \u305d\u3057\u3066\u79c1<strong>T\u307e\u305f\u306f\u30c7\u30b8\u30bf\u30eb\u30ac\u30d0\u30ca\u30f3\u30b9\u30c1\u30fc\u30e0<\/strong> \u82f1\u56fd\u3067\u8a8d\u53ef\u3055\u308c\u305f\u533b\u85ac\u54c1\u304a\u3088\u3073\u7ba1\u8f44\u533a\u57df\u3092\u8d8a\u3048\u305f\u898f\u5236\u7fa9\u52d9\u306e\u7ba1\u7406\u306b\u643a\u308f\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-818214095 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1100624629\" 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-693565973\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-693565973 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7d44\u7e54\u306f\u3001 <strong>\u82f1\u56fd\u306e\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/strong> \u88fd\u54c1\u304c\u8a72\u5f53\u3059\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b <strong>\u30ab\u30c6\u30b4\u30ea\u30fc1\u307e\u305f\u306f\u30ab\u30c6\u30b4\u30ea\u30fc2<\/strong> \u305d\u3057\u3066\u3001 <strong>EU\u540c\u7b49\u306e\u30e9\u30a4\u30bb\u30f3\u30b9<\/strong>. \u5185\u90e8\u306e\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u624b\u9806\u3001\u610f\u601d\u6c7a\u5b9a\u306e\u67a0\u7d44\u307f\u3001\u30ac\u30d0\u30ca\u30f3\u30b9\u30e2\u30c7\u30eb\u306f\u3001\u660e\u78ba\u306b\u3055\u308c\u305f\u671f\u5f85\u306b\u7167\u3089\u3057\u3066\u30c1\u30a7\u30c3\u30af\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308a\u3001\u90e8\u9580\u9593\u306e\u8abf\u6574\u304c\u4e8b\u524d\u306b\u884c\u308f\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002 <strong>2026\u5e742\u670812\u65e5<\/strong> \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b\u6709\u52b9\u65e5\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002.<\/p>\n<p>\u898f\u5236\u306e\u76f8\u9055\u306b\u3088\u308a\u904b\u7528\u306e\u8907\u96d1\u3055\u304c\u5897\u3059\u306b\u3064\u308c\u3066\u3001\u5909\u66f4\u3092\u76e3\u8996\u3057\u3001\u305d\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u69cb\u9020\u5316\u3055\u308c\u305f\u65b9\u6cd5\u3092\u6301\u3064\u3053\u3068\u304c\u307e\u3059\u307e\u3059\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002. <strong><a href=\"http:\/\/regask.com\/ja\/\">RegASK<\/a> \u306f\u3001\u4e3b\u8981\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI\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<\/strong> \u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u3092\u542b\u3080\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u3001\u5909\u5316\u3059\u308b\u898f\u5236\u74b0\u5883\u306b\u7a4d\u6975\u7684\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002\u9ad8\u5ea6\u306a <strong>\u5c02\u9580\u5bb6\u304c\u53c2\u52a0\u3059\u308b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI, <a href=\"http:\/\/regask.com\/ja\/\">RegASK<\/a><\/strong> \u30bf\u30a4\u30e0\u30ea\u30fc\u3067\u4e88\u6e2c\u7684\u304b\u3064\u5b9f\u7528\u7684\u306a\u6d1e\u5bdf\u3092\u63d0\u4f9b\u3057\u3001\u30c1\u30fc\u30e0\u304c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u3001160 \u304b\u56fd\u4ee5\u4e0a\u3067\u76e3\u8996\u3092\u7dad\u6301\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002.<strong> <a href=\"http:\/\/regask.com\/ja\/\">\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b<\/a><\/strong> \u307e\u305f\u306f <strong><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\/\">\u4eca\u3059\u3050\u30c7\u30e2\u3092\u4e88\u7d04\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/a><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1100624629 > .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-764728125\">\n\n\t<div id=\"col-1152590087\" 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-347582943\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-347582943 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW240545805 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW240545805 BCX0\">\u59d4\u54e1\u4f1a\u5b9f\u65bd\u898f\u5247 520\/2012 \u3068\u306f\u4f55\u3067\u3059\u304b?<\/span><\/span><span class=\"EOP SCXW240545805 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1757775385\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1757775385 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">\u3053\u308c\u306fEU\u306e\u898f\u5236\u3067\u3042\u308a\u3001\u8a73\u7d30\u3092\u898f\u5b9a\u3057\u3066\u3044\u308b\u3002<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u8981\u4ef6<\/span><\/span><\/strong><span class=\"TextRun SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">\u00a0\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u7fa9\u52d9\u3092\u542b\u3080\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW37803039 BCX0\">\u627f\u8a8d<\/span><span class=\"NormalTextRun SCXW37803039 BCX0\">\u00a0\u4fdd\u6709\u8005\u3002.<\/span><\/span><span class=\"EOP SCXW37803039 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1152590087 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1918530014\" 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>\u898f\u5247 (EU) 2025\/1466 \u3067\u4f55\u304c\u5909\u308f\u308a\u307e\u3057\u305f\u304b?<\/h4>\n\t<div id=\"gap-1006848820\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1006848820 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u898f\u5247\uff08EU\uff092025\/1466<strong> CIR 520\/2012\u3092\u6539\u6b63\u3057\u3001,<\/strong> \u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u8981\u4ef6\u306e\u6539\u8a02\u3068\u9069\u7528 <strong>2026\u5e742\u670812\u65e5,<\/strong> \u9650\u5b9a\u7684\u306a\u898f\u5b9a\u306f<strong> 2025\u5e748\u670812\u65e5\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1918530014 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-719683555\" 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>\u30a6\u30a3\u30f3\u30b6\u30fc\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306f\u82f1\u56fd\u306e\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u7fa9\u52d9\u306b\u3069\u306e\u3088\u3046\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-1231564807\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1231564807 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u30a6\u30a3\u30f3\u30b6\u30fc\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306f\u3001 <strong>\u30ab\u30c6\u30b4\u30ea\u30fc1\u3068\u30ab\u30c6\u30b4\u30ea\u30fc2\u306e\u5206\u985e<\/strong> \u82f1\u56fd\u3067\u8a8d\u53ef\u3055\u308c\u305f\u533b\u85ac\u54c1\u306b\u3064\u3044\u3066\u306f\u3001<strong> \u9069\u7528\u3055\u308c\u308b\u6cd5\u7684\u67a0\u7d44\u307f\u304c\u7570\u306a\u308b <\/strong>\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306e\u305f\u3081\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-719683555 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1219229708\" 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>H<span class=\"NormalTextRun SCXW207083187 BCX0\">\u3069\u3046\u3059\u308c\u3070\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW207083187 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW207083187 BCX0\">\u00a0\u30d8\u30eb\u30d7\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW207083187 BCX0\">\u7d44\u7e54<\/span><span class=\"NormalTextRun SCXW207083187 BCX0\">\u00a0\u3053\u308c\u3089\u306e\u5909\u66f4\u3092\u7ba1\u7406\u3057\u307e\u3059\u304b?<\/span><\/h4>\n\t<div id=\"gap-2131634259\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2131634259 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u30c1\u30fc\u30e0\u306e\u8ffd\u8de1\u3092\u652f\u63f4 <strong>\u898f\u5236\u306e\u66f4\u65b0\u3001,<\/strong> \u8a55\u4fa1 <strong>\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u56fa\u6709\u306e\u5f71\u97ff\u3001,<\/strong> \u304a\u3088\u3073\u8abf\u6574 <strong>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ef\u30fc\u30af\u30d5\u30ed\u30fc,<\/strong> \u82f1\u56fd\u3068 EU \u306e\u7570\u306a\u308b\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u8981\u4ef6\u3092\u3088\u308a\u52b9\u7387\u7684\u306b\u7ba1\u7406\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1219229708 > .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 9 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance for UK Marketing Authorisation Holders outlining how pharmacovigilance requirements will apply following amendments to Commission Implementing Regulation (CIR) 520\/2012. The guidance reflects the European Commission\u2019s adoption of Regulation (EU) 2025\/1466, which revises CIR 520\/2012 and becomes applicable from 12 February 2026, with limited provisions effective from 12 August 2025. The update is particularly relevant for organisations holding UK-authorised medicinal products across different categories under the Windsor Framework.<\/p>","protected":false},"author":43,"featured_media":9486,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,35],"tags":[],"class_list":["post-9485","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Issues Guidance on Pharmacovigilance Overview<\/title>\n<meta name=\"description\" content=\"Explore the UK MHRA&#039;s new guidance on pharmacovigilance requirements under amended CIR 520\/2012 for UK Marketing 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