{"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-933561653\">\n\n\t<div id=\"col-1217980948\" 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-1724471389\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1724471389 {\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-1299452187\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1299452187 {\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-1217980948 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2073376847\" 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-1532094541\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1532094541 {\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-2073376847 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1309091671\" 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-235508012\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-235508012 {\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-1309091671 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1449921778\" 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-340236374\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-340236374 {\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-1449921778 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-128104148\" 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-49097478\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-49097478 {\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-128104148 > .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-1403666638\">\n\n\t<div id=\"col-1248201897\" 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-1292907967\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1292907967 {\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-1398654436\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1398654436 {\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-1248201897 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-840872140\" 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-1489109405\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1489109405 {\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-840872140 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1434925971\" 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-784655928\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-784655928 {\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-1434925971 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1486992659\" 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-1075409104\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1075409104 {\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-1486992659 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>2026\u5e742\u67089\u65e5\u3001\u82f1\u56fd\u533b\u85ac\u54c1\u30fb\u533b\u7642\u88fd\u54c1\u898f\u5236\u5e81\uff08MHRA\uff09\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u5b9f\u65bd\u898f\u5247\uff08CIR\uff09520\/2012\u306e\u6539\u6b63\u306b\u4f34\u3044\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\u3001\u82f1\u56fd\u306e\u8ca9\u58f2\u627f\u8a8d\u53d6\u5f97\u8005\u5411\u3051\u306e\u65b0\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u8868\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001CIR 520\/2012\u3092\u6539\u8a02\u3057\u30012026\u5e742\u670812\u65e5\u304b\u3089\u9069\u7528\u3055\u308c\u30012025\u5e748\u670812\u65e5\u304b\u3089\u4e00\u90e8\u898f\u5b9a\u304c\u767a\u52b9\u3059\u308b\u898f\u5247\uff08EU\uff092025\/1466\u306e\u6b27\u5dde\u59d4\u54e1\u4f1a\u306b\u3088\u308b\u63a1\u629e\u3092\u53cd\u6620\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u66f4\u65b0\u306f\u3001\u30a6\u30a3\u30f3\u30b6\u30fc\u30fb\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u4e0b\u3067\u69d8\u3005\u306a\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u308f\u305f\u308b\u82f1\u56fd\u627f\u8a8d\u533b\u85ac\u54c1\u3092\u4fdd\u6709\u3059\u308b\u7d44\u7e54\u306b\u3068\u3063\u3066\u7279\u306b\u91cd\u8981\u3067\u3059\u3002.<\/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 v28.4 (Yoast SEO v28.5) - 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 Authorisation Holders.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/ja\/\u82f1\u56fdmhra\u30012012\u5e74\u6539\u6b63cir-520\u306b\u57fa\u3065\u304f\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u8981\u4ef6\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UK MHRA Issues Guidance on Pharmacovigilance Requirements Under Amended CIR 520\/2012\" \/>\n<meta property=\"og:description\" content=\"Explore the UK MHRA&#039;s new guidance on pharmacovigilance requirements under amended CIR 520\/2012 for UK Marketing Authorisation Holders.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/\u82f1\u56fdmhra\u30012012\u5e74\u6539\u6b63cir-520\u306b\u57fa\u3065\u304f\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u8981\u4ef6\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-16T08:20:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/uk-mhra-issues-guidance-pharmacovigilance-requirements-amended-cir-520-2012.png\" \/>\n\t<meta property=\"og:image:width\" content=\"904\" \/>\n\t<meta property=\"og:image:height\" content=\"622\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" 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