{"id":9356,"date":"2026-01-20T16:10:07","date_gmt":"2026-01-20T08:10:07","guid":{"rendered":"https:\/\/regask.com\/?p=9356"},"modified":"2026-01-29T19:59:22","modified_gmt":"2026-01-29T11:59:22","slug":"%e8%8b%b1%e5%9b%bdmhra%e3%80%81%e5%8c%96%e7%b2%a7%e5%93%81%e3%80%81%e9%a3%9f%e5%93%81%e3%82%b5%e3%83%97%e3%83%aa%e3%83%a1%e3%83%b3%e3%83%88%e3%80%81%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/uk-mhra-updates-guidance-on-determining-borderline-products-and-medicinal-status-for-cosmetics-food-supplement-and-medical-devices\/","title":{"rendered":"\u82f1\u56fdMHRA\u3001\u5883\u754c\u7dda\u88fd\u54c1\u306e\u5224\u5b9a\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u66f4\u65b0"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2025\u5e7410\u670817\u65e5,<\/strong> \u305d\u306e <strong><a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\">\u533b\u85ac\u54c1\u30fb\u533b\u7642\u88fd\u54c1\u898f\u5236\u5e81\uff08MHRA\uff09<\/a><\/strong> \u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u958b <strong>\u5883\u754c\u7dda\u88fd\u54c1\u3001,<\/strong> \u88fd\u54c1\u304c\u898f\u5236\u3055\u308c\u308b\u3079\u304d\u304b\u3069\u3046\u304b\u3092\u3069\u306e\u3088\u3046\u306b\u6c7a\u5b9a\u3059\u308b\u304b\u3092\u660e\u78ba\u306b\u3059\u308b <strong>\u533b\u85ac\u54c1<\/strong> \u307e\u305f\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u4ed6\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u8a72\u5f53\u3059\u308b <strong>\u533b\u7642\u6a5f\u5668\u3001\u5316\u7ca7\u54c1\u3001\u6804\u990a\u88dc\u52a9\u98df\u54c1\u3001\u30cf\u30fc\u30d6\u88fd\u54c1\u3001\u307e\u305f\u306f\u6bba\u751f\u7269\u5264\u3002.<\/strong> \u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001\u88fd\u54c1\u304c\u8907\u6570\u306e\u898f\u5236\u4f53\u5236\u306e\u4ea4\u5dee\u70b9\u306b\u4f4d\u7f6e\u3059\u308b\u3001\u307e\u305f\u306f\u533b\u85ac\u54c1\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u306b\u95a2\u3057\u3066\u82e6\u60c5\u306e\u5bfe\u8c61\u3068\u306a\u3063\u3066\u3044\u308b\u88fd\u9020\u696d\u8005\u3084\u8ca9\u58f2\u696d\u8005\u306b\u3068\u3063\u3066\u7279\u306b\u91cd\u8981\u3067\u3059\u3002.<\/p>\n<div class=\"row\"  id=\"row-381493773\">\n\n\t<div id=\"col-1931988064\" 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-962439865\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-962439865 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u5185\u5bb9<\/h2>\n\t<div id=\"gap-146525040\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-146525040 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6539\u8a02\u3055\u308c\u305fMHRA\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u88fd\u54c1\u306e\u5206\u985e\u306f\u6b21\u306e\u3088\u3046\u306b\u6c7a\u5b9a\u3055\u308c\u308b\u3068\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u3002 <strong>\u30b1\u30fc\u30b9\u30d0\u30a4\u30b1\u30fc\u30b9<\/strong>, \u8a55\u4fa1\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u3044\u304f\u3064\u304b\u306e\u91cd\u8981\u306a\u57fa\u6e96\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u884c\u308f\u308c\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>\u4e3b\u5f35\u3055\u308c\u305f\u5185\u5bb9<\/strong> \u88fd\u54c1\u306e\u76ee\u7684\u3084\u5229\u70b9\u306b\u3064\u3044\u3066<\/li>\n<li><strong>\u6709\u52b9\u6210\u5206\u306e\u7279\u6027\u00a0<\/strong><\/li>\n<li><strong>\u4f7f\u7528\u76ee\u7684\u00a0<\/strong><\/li>\n<li><strong>\u6d88\u8cbb\u8005\u3078\u306e\u5168\u4f53\u7684\u306a\u30d7\u30ec\u30bc\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u00a0<\/strong><\/li>\n<\/ul>\n<p>\u88fd\u54c1\u304c\u305d\u306e\u4e3b\u52b9\u679c\u3092\u3001 <strong>\u85ac\u7406\u5b66\u7684\u3001\u514d\u75ab\u5b66\u7684\u3001\u307e\u305f\u306f\u4ee3\u8b1d\u7684\u4f5c\u7528\u6a5f\u5e8f\u3001,<\/strong> \u3053\u308c\u306f <strong>\u533b\u85ac\u54c1\u3068\u3057\u3066\u306e\u5730\u4f4d<\/strong> \u82f1\u56fd\u306e\u898f\u5236\u306e\u4e0b\u3067\u3002.<\/p>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u4e00\u822c\u7684\u306b <strong>\u5883\u754c\u7dda<\/strong> \u542b\u3080\uff1a<\/p>\n<ul>\n<li><strong>\u5316\u7ca7\u54c1\u00a0<\/strong><\/li>\n<li><strong>\u6804\u990a\u88dc\u52a9\u98df\u54c1\u00a0<\/strong><\/li>\n<li><strong>\u30cf\u30fc\u30d6\u88fd\u54c1\u00a0<\/strong><\/li>\n<li><strong>\u6bba\u751f\u7269\u5264\u00a0<\/strong><\/li>\n<li><strong>\u533b\u7642\u6a5f\u5668\u00a0<\/strong><\/li>\n<\/ul>\n<p>\u3069\u3053 <strong>\u6804\u990a\u88dc\u52a9\u98df\u54c1\u3084\u305d\u306e\u4ed6\u306e\u975e\u533b\u85ac\u54c1\u304c\u533b\u85ac\u54c1\u3068\u3057\u3066\u306e\u52b9\u80fd\u3092\u4e3b\u5f35\u3057\u3066\u3044\u308b\u3001,<\/strong> \u5f7c\u3089\u306f\u305d\u3046\u304b\u3082\u3057\u308c\u306a\u3044 <strong>\u533b\u85ac\u54c1\u3068\u3057\u3066\u518d\u5206\u985e<\/strong> \u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u306e\u5bfe\u8c61\u3068\u306a\u308b\u3002.<\/p>\n<p>MHRA\u306f\u3001\u82e6\u60c5\u306e\u512a\u5148\u9806\u4f4d\u306f\u4ee5\u4e0b\u306b\u57fa\u3065\u3044\u3066\u6c7a\u5b9a\u3059\u308b\u3068\u7e70\u308a\u8fd4\u3057\u8ff0\u3079\u3066\u3044\u308b\u3002 <strong>\u6d88\u8cbb\u8005\u306e\u5065\u5eb7\u3078\u306e\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af<\/strong>. \u5f53\u5c40\u306f\u81ea\u4e3b\u7684\u306a\u9075\u5b88\u3092\u91cd\u8996\u3057\u3066\u3044\u308b\u304c\u3001 <strong>\u8abf\u67fb\u306e\u7d50\u679c\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5f37\u5236\u63aa\u7f6e\u304c\u53d6\u3089\u308c\u308b\u53ef\u80fd\u6027\u3082\u3042\u308a\u307e\u3059\u3002.\u00a0<\/strong><\/p>\n<p>\u898f\u5236\u306e\u660e\u78ba\u5316\u3092\u6c42\u3081\u308b\u4f01\u696d\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u3001MHRA\u306f\u3001 <strong><a href=\"https:\/\/forms.mhra.gov.uk\/requestborderlineadvice\">\u85ac\u306e\u5883\u754c\u306b\u95a2\u3059\u308b\u30a2\u30c9\u30d0\u30a4\u30b9\u30d5\u30a9\u30fc\u30e0<\/a><\/strong>, \u3001\u3053\u308c\u306f\u3001 <strong>\u304a\u554f\u3044\u5408\u308f\u305b\u3054\u3068\u306b\u6700\u5927 4 \u3064\u306e\u88fd\u54c1\u304c\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002.<\/strong> \u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001 <strong>\u82f1\u56fd\u4ee5\u5916\u306e\u4f01\u696d\u304c\u82f1\u56fd\u306e\u6d88\u8cbb\u8005\u306b\u76f4\u63a5\u8f38\u51fa\u3059\u308b<\/strong> MHRA\u306e\u7ba1\u8f44\u5916\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u304c\u3001\u305d\u306e\u3088\u3046\u306a\u88fd\u54c1\u306f <strong>\u307e\u3060\u8abf\u67fb\u4e2d\u3067\u3042\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1931988064 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1788711012\" 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>\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u671f\u9650<\/h2>\n\t<div id=\"gap-2060097866\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2060097866 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>\u6b63\u5f0f\u306a\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u671f\u9650\u306f\u6307\u5b9a\u3055\u308c\u3066\u3044\u306a\u3044<\/strong> \u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u66f4\u65b0\u306b\u3064\u3044\u3066\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1788711012 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1572622582\" 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\u304c\u91cd\u8981\u306a\u306e\u304b<\/h2>\n\t<div id=\"gap-917650598\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-917650598 {\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>\u898f\u5236\u306e\u660e\u78ba\u3055<\/strong> \u82f1\u56fd\u306b\u304a\u3051\u308b\u5883\u754c\u7dda\u88fd\u54c1\u306e\u8a55\u4fa1\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u4f01\u696d\u304c\u88fd\u54c1\u958b\u767a\u3001\u4e3b\u5f35\u3001\u30e9\u30d9\u30eb\u8868\u793a\u3092\u9069\u5207\u306a\u6cd5\u7684\u67a0\u7d44\u307f\u306b\u6cbf\u3063\u3066\u884c\u3048\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002\u3088\u308a\u660e\u78ba\u306a\u57fa\u6e96\u304c\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002 <strong>\u30c7\u30b8\u30bf\u30eb\u5bfe\u5fdc\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ef\u30fc\u30af\u30d5\u30ed\u30fc<\/strong>, \u8aa4\u5206\u985e\u306e\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001\u7d44\u7e54\u304c\u4e0d\u5fc5\u8981\u306a\u898f\u5236\u4e0a\u306e\u8ca0\u62c5\u306a\u3057\u306b\u6f5c\u5728\u7684\u306a\u554f\u984c\u3092\u65e9\u671f\u306b\u89e3\u6c7a\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1572622582 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-17177895\" 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-1349246067\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1349246067 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306fR\u306b\u95a2\u9023\u3057\u3066\u3044\u308b<strong>\u898f\u5236\u696d\u52d9\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u88fd\u54c1\u958b\u767a\u3001\u6cd5\u52d9\u3001\u30c7\u30b8\u30bf\u30eb\u307e\u305f\u306fAI\u30c1\u30fc\u30e0<\/strong> \u5316\u7ca7\u54c1\u3001\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3001\u533b\u7642\u6a5f\u5668\u3001\u95a2\u9023\u88fd\u54c1\u306e\u88fd\u54c1\u5206\u985e\u3001\u30af\u30ec\u30fc\u30e0\u30ec\u30d3\u30e5\u30fc\u3001\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u306b\u643a\u308f\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-17177895 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-530898350\" 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-956228749\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-956228749 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7d44\u7e54\u306f<strong> \u65e2\u5b58\u304a\u3088\u3073\u8a08\u753b\u4e2d\u306e\u88fd\u54c1\u306e\u4e3b\u5f35\u3092\u78ba\u8a8d\u3057\u3001\u6709\u52b9\u6210\u5206\u306e\u7279\u6027\u3092\u8a55\u4fa1\u3057\u3001,<\/strong> \u66f4\u65b0\u3055\u308c\u305fMHRA\u57fa\u6e96\u306b\u7167\u3089\u3057\u3066\u3001\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u3068\u63d0\u793a\u65b9\u6cd5\u3092\u8a55\u4fa1\u3059\u308b\u3002\u5206\u985e\u304c\u4e0d\u660e\u77ad\u306a\u5834\u5408\u306f\u3001\u95a2\u4fc2\u8005\u306f\u4e0b\u8a18\u306e\u30d5\u30a9\u30fc\u30e0\u304b\u3089\u30ea\u30af\u30a8\u30b9\u30c8\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3092\u691c\u8a0e\u3059\u3079\u304d\u3067\u3042\u308b\u3002 <strong>\u85ac\u306e\u5883\u754c\u306b\u95a2\u3059\u308b\u30a2\u30c9\u30d0\u30a4\u30b9\u30d5\u30a9\u30fc\u30e0<\/strong> \u5e02\u5834\u6295\u5165\u3084\u4e3b\u5f35\u306e\u5909\u66f4\u306e\u524d\u306b\u3001\u6b63\u5f0f\u306a\u898f\u5236\u5f53\u5c40\u306e\u610f\u898b\u3092\u5f97\u308b\u305f\u3081\u3002.<\/p>\n<p>\u88fd\u54c1\u5206\u985e\u306b\u95a2\u3059\u308b\u898f\u5236\u4e0a\u306e\u671f\u5f85\u304c\u9032\u5316\u3057\u7d9a\u3051\u308b\u306b\u3064\u308c\u3066\u3001, <a href=\"https:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u66f4\u65b0\u3092\u76e3\u8996\u3057\u3001\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u5168\u4f53\u306b\u308f\u305f\u308b\u898f\u5236\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001\u5883\u754c\u7dda\u306e\u5206\u985e\u306b\u95a2\u3059\u308b\u60c5\u5831\u306b\u57fa\u3065\u3044\u305f\u610f\u601d\u6c7a\u5b9a\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u3053\u3068\u3067\u3001\u7d44\u7e54\u304c\u5e38\u306b\u5148\u624b\u3092\u6253\u3064\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002.<\/p>\n<p><a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u306f\u4e00\u6d41\u306e <strong>\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<\/strong> \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\u3057\u307e\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\u3001157 \u304b\u56fd\u4ee5\u4e0a\u3067\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3057\u307e\u3059\u3002.<\/p>\n<p><strong><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\/\">\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-530898350 > .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-1915052149\">\n\n\t<div id=\"col-815676473\" 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-1912651062\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1912651062 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u82f1\u56fd MHRA \u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u304a\u3051\u308b\u5883\u754c\u7dda\u88fd\u54c1\u3068\u306f\u4f55\u3067\u3059\u304b?<\/h4>\n\t<div id=\"gap-248025031\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-248025031 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5883\u754c\u7dda\u88fd\u54c1\u3068\u306f\u3001\u305d\u306e\u4e3b\u5f35\u3001\u7d44\u6210\u3001\u4f7f\u7528\u76ee\u7684\u306b\u5fdc\u3058\u3066\u3001\u533b\u85ac\u54c1\u898f\u5236\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u67a0\u7d44\u307f\uff08\u5316\u7ca7\u54c1\u3001\u6804\u990a\u88dc\u52a9\u98df\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001\u30cf\u30fc\u30d6\u88fd\u54c1\u3001\u6bba\u751f\u7269\u5264\u306a\u3069\uff09\u306b\u8a72\u5f53\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u88fd\u54c1\u3067\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-815676473 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-983537604\" 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>MHRA \u306f\u3069\u306e\u3088\u3046\u306b\u3057\u3066\u88fd\u54c1\u304c\u533b\u85ac\u54c1\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u306e\u3067\u3057\u3087\u3046\u304b?<\/h4>\n\t<div id=\"gap-83114643\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-83114643 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>MHRA \u306f\u3001\u4e3b\u5f35\u5185\u5bb9\u3001\u6709\u52b9\u6210\u5206\u306e\u7279\u6027\u3001\u4f7f\u7528\u76ee\u7684\u3001\u6d88\u8cbb\u8005\u3078\u306e\u63d0\u793a\u3001\u88fd\u54c1\u304c\u85ac\u7406\u5b66\u7684\u3001\u514d\u75ab\u5b66\u7684\u3001\u307e\u305f\u306f\u4ee3\u8b1d\u7684\u624b\u6bb5\u3092\u901a\u3058\u3066\u4f5c\u7528\u3059\u308b\u304b\u3069\u3046\u304b\u306a\u3069\u306e\u8981\u7d20\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-983537604 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1335713229\" 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>\u82f1\u56fd\u3067\u306f\u6804\u990a\u88dc\u52a9\u98df\u54c1\u3092\u533b\u85ac\u54c1\u3068\u3057\u3066\u898f\u5236\u3067\u304d\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-984390720\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-984390720 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u306f\u3044\u3002\u85ac\u52b9\u3092\u4e3b\u5f35\u3057\u305f\u308a\u3001\u85ac\u52b9\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3057\u305f\u308a\u3059\u308b\u6804\u990a\u88dc\u52a9\u98df\u54c1\u306f\u3001\u533b\u85ac\u54c1\u3068\u3057\u3066\u518d\u5206\u985e\u3055\u308c\u3001\u898f\u5236\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1335713229 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-523998400\" 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\u3001\u5883\u754c\u7dda\u4e0a\u306e\u88fd\u54c1\u5206\u985e\u3092\u7ba1\u7406\u3059\u308b\u30c1\u30fc\u30e0\u3092\u3069\u306e\u3088\u3046\u306b\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-1153679344\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1153679344 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u30c1\u30fc\u30e0\u304c MHRA \u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u66f4\u65b0\u3092\u8ffd\u8de1\u3057\u3001\u88fd\u54c1\u5168\u4f53\u306e\u5206\u985e\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3057\u3001\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8 AI \u3068\u5c02\u9580\u5bb6\u306e\u76e3\u8996\u3092\u7d44\u307f\u5408\u308f\u305b\u3066\u898f\u5236\u60c5\u5831\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u5408\u7406\u5316\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-523998400 > .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 17 October 2025, the Medicines &amp; Healthcare products Regulatory Agency (MHRA) published updated guidance on borderline products, clarifying how it determines whether a product should be regulated as a medicinal product or falls under other frameworks such as medical devices, cosmetics, food supplements, herbal products, or biocides. The update is particularly relevant for manufacturers and sellers whose products sit at the intersection of multiple regulatory regimes or are subject to complaints about being marketed as medicines.<\/p>","protected":false},"author":41,"featured_media":9413,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[37,33,526,39],"tags":[],"class_list":["post-9356","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-personal-care-cosmetics","category-news","category-united-kingdom-regulations","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Updates Guidance on Borderline Product Classification<\/title>\n<meta name=\"description\" content=\"Learn about the UK MHRA updates 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