{"id":9541,"date":"2026-02-25T10:58:43","date_gmt":"2026-02-25T02:58:43","guid":{"rendered":"https:\/\/regask.com\/?p=9541"},"modified":"2026-02-25T10:58:43","modified_gmt":"2026-02-25T02:58:43","slug":"%e3%82%a4%e3%82%bf%e3%83%aa%e3%82%a2aifa%e3%80%81otc%e5%8c%bb%e8%96%ac%e5%93%81%e3%81%a8%e9%9d%9e%e5%87%a6%e6%96%b9%e8%96%ac%e3%81%ae%e5%88%86%e9%a1%9e%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e3%82%ac","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/italys-aifa-updates-guidance-on-otc-and-non-prescription-medicine-classification\/","title":{"rendered":"\u30a4\u30bf\u30ea\u30a2\u306e AIFA \u304c OTC \u85ac\u3068\u975e\u51e6\u65b9\u85ac\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u66f4\u65b0"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e742\u670823\u65e5, <\/strong>\u305d\u306e<strong> \u30a4\u30bf\u30ea\u30a2\u533b\u85ac\u54c1\u5e81\uff08AIFA\uff09<\/strong> \u6539\u8a02\u7248\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u958b\u3057\u3001 <strong>\u5e02\u8ca9\u85ac\uff08OTC\uff09\u3068\u975e\u51e6\u65b9\u85ac\uff08SOP\uff09\u306e\u5b9a\u7fa9\u3068\u5206\u985e<\/strong> \u30a4\u30bf\u30ea\u30a2\u306b\u304a\u3044\u3066\u3001\u3053\u306e\u66f4\u65b0\u306f\u4fdd\u5065\u7701\u306e\u4ee5\u524d\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u4ee3\u308f\u308b\u3082\u306e\u3067\u3001\u533b\u85ac\u54c1\u30e1\u30fc\u30ab\u30fc\u3001\u8ca9\u58f2\u696d\u8005\u3001\u304a\u3088\u3073\u88fd\u54c1\u306e\u767b\u9332\u3068\u8ca9\u58f2\u306b\u643a\u308f\u308b\u95a2\u4fc2\u8005\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002.<\/p>\n<div class=\"row\"  id=\"row-1787126535\">\n\n\t<div id=\"col-839556467\" 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-1043697757\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1043697757 {\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-1214288081\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1214288081 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u65b0\u3057\u3044\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001 <strong>\u6539\u8a02\u3055\u308c\u305f\u5b9a\u7fa9\u3068\u5206\u985e\u539f\u5247<\/strong> OTC\u533b\u85ac\u54c1\u3068SOP\u533b\u85ac\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u88fd\u54c1\u3092\u533a\u5225\u3059\u308b\u305f\u3081\u306e\u3088\u308a\u660e\u78ba\u306a\u57fa\u6e96\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<strong> \u533b\u5e2b\u306e\u51e6\u65b9\u7b8b\u306e\u5bfe\u8c61\u5916<\/strong>. \u307e\u305f\u3001 <strong>\u898f\u5236\u8981\u4ef6<\/strong> \u3053\u308c\u3089\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u5f53\u3066\u306f\u307e\u308b\u3082\u306e\u3001\u305d\u3057\u3066\u305d\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066 <strong>\u898f\u5236\u7533\u8acb\u3001\u30e9\u30d9\u30eb\u8868\u793a\u65b9\u6cd5\u3001, <\/strong>\u305d\u3057\u3066<strong> \u5e02\u5834\u30a2\u30af\u30bb\u30b9\u6226\u7565\u3002.<\/strong> \u65e2\u5b58\u306e\u88fd\u54c1\u306f\u3001 <strong>\u898b\u76f4\u3057\u307e\u305f\u306f\u518d\u5206\u985e<\/strong> \u66f4\u65b0\u3055\u308c\u305f\u57fa\u6e96\u306b\u5408\u308f\u305b\u308b\u305f\u3081\u3067\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-839556467 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-909855092\" 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-1336864242\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1336864242 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u6709\u52b9\u306b\u306a\u308b <strong>\u30a4\u30bf\u30ea\u30a2\u5171\u548c\u56fd\u5b98\u5831\u306b\u901a\u77e5\u304c\u63b2\u8f09\u3055\u308c\u3066\u304b\u308930\u65e5\u5f8c<\/strong> AIFA\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306e\u30ea\u30ea\u30fc\u30b9\u3092\u53c2\u7167\u3057\u3066\u3044\u307e\u3059\u3002\u95a2\u4fc2\u8005\u306f\u3001\u958b\u59cb\u65e5\u304c\u6b63\u78ba\u306b\u9075\u5b88\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u3001\u5b98\u5831\u3092\u5b9a\u671f\u7684\u306b\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-909855092 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-141805343\" 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-543741460\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-543741460 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4ee5\u524d\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u7f6e\u304d\u63db\u3048\u3001\u5206\u985e\u57fa\u6e96\u3092\u660e\u78ba\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u5f37\u5316\u3055\u308c\u307e\u3059\u3002 <strong>\u898f\u5236\u306e\u660e\u78ba\u3055<\/strong> \u305d\u3057\u3066\u30b5\u30dd\u30fc\u30c8 <strong>\u4e00\u8cab\u3057\u305f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/strong> OTC\u3068SOP\u306e\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u3002\u3088\u308a\u660e\u78ba\u306a\u5b9a\u7fa9\u306b\u3088\u308a\u3001 <strong>\u3088\u308a\u52b9\u7387\u7684\u306a\u898f\u5236\u306e\u8abf\u6574<\/strong> \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3057\u306a\u304c\u3089\u3001\u4e0d\u8981\u306a\u8ca0\u62c5\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059 <strong>\u30e9\u30d9\u30eb\u8868\u793a\u3068\u5e02\u5834\u30a2\u30af\u30bb\u30b9<\/strong> \u7d4c\u8def\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-141805343 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1089913414\" 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-481412712\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-481412712 {\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>\u54c1\u8cea\u4fdd\u8a3c\u3001\u898f\u5236\u696d\u52d9\u3001\u6cd5\u52d9\u30fb\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u60a3\u8005\u5b89\u5168\u3001\u55b6\u696d\u30fb\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u3001, <\/strong>\u305d\u3057\u3066<strong> \u7814\u7a76\u958b\u767a\u30c1\u30fc\u30e0<\/strong> \u30a4\u30bf\u30ea\u30a2\u306b\u304a\u3051\u308bOTC\u304a\u3088\u3073SOP\u88fd\u54c1\u306e\u7ba1\u7406\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1089913414 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-803501915\" 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-1055418345\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1055418345 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u5bb3\u95a2\u4fc2\u8005\u306f <strong>\u5b98\u5831\u3092\u76e3\u8996\u3059\u308b<\/strong> \u51fa\u7248\u65e5\u306b\u3064\u3044\u3066\u306f\u3001, <strong>\u73fe\u5728\u306e\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3092\u78ba\u8a8d\u3059\u308b<\/strong> \u6539\u8a02\u3055\u308c\u305f\u57fa\u6e96\u306b\u7167\u3089\u3057\u3066\u3001 <strong>\u90e8\u9580\u6a2a\u65ad\u7684\u306b\u8abf\u6574\u3059\u308b<\/strong> \u518d\u5206\u985e\u3084\u6587\u66f8\u304a\u3088\u3073\u30e9\u30d9\u30eb\u306e\u66f4\u65b0\u304c\u5fc5\u8981\u306a\u88fd\u54c1\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002.<\/p>\n<p>\u30c1\u30fc\u30e0\u304c\u30aa\u30d5\u30a3\u30b7\u30e3\u30eb\u30b8\u30e3\u30fc\u30ca\u30eb\u306e\u901a\u77e5\u306b\u95a2\u9023\u3059\u308b\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306e\u5f71\u97ff\u3068\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3092\u8a55\u4fa1\u3059\u308b\u969b\u3001, <a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u30d7\u30ed\u30a2\u30af\u30c6\u30a3\u30d6\u306a\u8ffd\u8de1\u3068\u69cb\u9020\u5316\u3055\u308c\u305f\u30ec\u30d3\u30e5\u30fc\u3092\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u307e\u3059\u3002. <a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u306f\u3001\u6d88\u8cbb\u8ca1\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306a\u3069\u306e\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u306b\u7a4d\u6975\u7684\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3001\u4e3b\u8981\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8 AI \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>\u9ad8\u5ea6\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI\u3068\u5c02\u9580\u5bb6\u306e\u5354\u529b\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001, <a href=\"http:\/\/regask.com\/ja\/\">RegASK<\/a><\/strong> \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=\"http:\/\/regask.com\/ja\/\"><strong>\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b <\/strong><\/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\/\"><strong> \u4eca\u3059\u3050\u30c7\u30e2\u3092\u4e88\u7d04\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-803501915 > .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-1615865987\">\n\n\t<div id=\"col-1136755823\" 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-26602423\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-26602423 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>AIFA \u306e OTC \u533b\u85ac\u54c1\u304a\u3088\u3073 SOP \u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u7bc4\u56f2\u306f\u4f55\u3067\u3059\u304b?<\/h4>\n\t<div id=\"gap-1109744466\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1109744466 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u30a4\u30bf\u30ea\u30a2\u3067\u8ca9\u58f2\u3055\u308c\u308b\u5e02\u8ca9\u85ac\u304a\u3088\u3073\u975e\u51e6\u65b9\u85ac\u306e\u5b9a\u7fa9\u3001\u5206\u985e\u539f\u5247\u3001\u304a\u3088\u3073\u898f\u5236\u8981\u4ef6\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1136755823 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1883953071\" 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>\u65b0\u3057\u3044 AIFA \u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3044\u3064\u767a\u52b9\u3057\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-411501652\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-411501652 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u52b9\u679c\u3092\u767a\u63ee\u3059\u308b <strong>30\u65e5\u9593<\/strong> AIFA \u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306e\u30ea\u30ea\u30fc\u30b9\u3092\u53c2\u7167\u3057\u3066\u30a4\u30bf\u30ea\u30a2\u5171\u548c\u56fd\u306e\u5b98\u5831\u306b\u901a\u77e5\u304c\u63b2\u8f09\u3055\u308c\u305f\u5f8c\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1883953071 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-854575757\" 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>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u306e\u306f\u3069\u306e\u30c1\u30fc\u30e0\u3067\u3059\u304b?<\/h4>\n\t<div id=\"gap-1239623019\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1239623019 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u54c1\u8cea\u4fdd\u8a3c\u3001\u898f\u5236\u696d\u52d9\u3001\u6cd5\u52d9\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u60a3\u8005\u306e\u5b89\u5168\u3001\u55b6\u696d\u304a\u3088\u3073\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u3001\u304a\u3088\u3073\u7814\u7a76\u958b\u767a\u306e\u5404\u30c1\u30fc\u30e0\u304c\u5f71\u97ff\u3092\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-854575757 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-243790586\" 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\u7d44\u7e54\u304c\u3053\u306e\u66f4\u65b0\u306b\u5bfe\u5fdc\u3059\u308b\u306e\u306b\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3061\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-1499348136\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1499348136 {\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\u3092\u52a9\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u308b <strong>\u5b98\u5831\u306e\u767a\u884c\u3092\u76e3\u8996\u3057\u3001\u66f4\u65b0\u3055\u308c\u305f\u57fa\u6e96\u306b\u88fd\u54c1\u3092\u30de\u30c3\u30d4\u30f3\u30b0\u3057\u3001, <\/strong>\u305d\u3057\u3066<strong> \u90e8\u9580\u6a2a\u65ad\u7684\u306a\u30ec\u30d3\u30e5\u30fc\u3092\u8abf\u6574\u3059\u308b<\/strong> \u30bf\u30a4\u30e0\u30ea\u30fc\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u62e0\u3057\u305f\u5b9f\u88c5\u3092\u78ba\u5b9f\u306b\u3059\u308b\u305f\u3081\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-243790586 > .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 February 23, 2026, the Italian Medicines Agency (AIFA) published revised guidance clarifying the definition and classification of over-the-counter (OTC) and non-prescription (SOP) medicines in Italy. The update replaces prior Ministry of Health guidelines and affects pharmaceutical manufacturers, distributors, and stakeholders involved in product registration and commercialization.<\/p>","protected":false},"author":41,"featured_media":9544,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[518,33,35],"tags":[],"class_list":["post-9541","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-italy-regulations","category-news","category-pharma-biotech-latest-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>Italy\u2019s AIFA Updates Guidance on OTC Regulations<\/title>\n<meta name=\"description\" content=\"Italy&#039;s AIFA updates guidance on OTC and non-prescription medicine classification, impacting stakeholders and product registration.\" \/>\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\/\u30a4\u30bf\u30ea\u30a2aifa\u3001otc\u533b\u85ac\u54c1\u3068\u975e\u51e6\u65b9\u85ac\u306e\u5206\u985e\u306b\u95a2\u3059\u308b\u30ac\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Italy\u2019s AIFA Updates Guidance on OTC and Non-Prescription Medicine Classification\" \/>\n<meta property=\"og:description\" content=\"Italy&#039;s AIFA updates guidance on OTC and non-prescription medicine classification, impacting stakeholders and product registration.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/\u30a4\u30bf\u30ea\u30a2aifa\u3001otc\u533b\u85ac\u54c1\u3068\u975e\u51e6\u65b9\u85ac\u306e\u5206\u985e\u306b\u95a2\u3059\u308b\u30ac\/\" \/>\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=\"2026-02-25T02:58:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/italys-aifa-updates-guidance-otc-non-prescription-medicine-classification.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"594\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Shaffa Renaningtyas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Shaffa Renaningtyas\" \/>\n\t<meta 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