{"id":9538,"date":"2026-02-24T23:28:30","date_gmt":"2026-02-24T15:28:30","guid":{"rendered":"https:\/\/regask.com\/?p=9538"},"modified":"2026-02-24T23:28:30","modified_gmt":"2026-02-24T15:28:30","slug":"%e3%83%90%e3%83%bc%e3%83%ac%e3%83%bc%e3%83%b3nhra%e3%80%81%e3%83%92%e3%83%88%e7%94%a8%e5%8c%bb%e8%96%ac%e5%93%81%e3%81%ae%e5%8c%bb%e8%96%ac%e5%93%81%e3%83%90%e3%83%aa%e3%82%a8%e3%83%bc%e3%82%b7","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/bahrain-nhra-publishes-updated-medicine-variations-guideline-for-human-medicines-version-3-2\/","title":{"rendered":"\u30d0\u30fc\u30ec\u30fc\u30f3 NHRA \u304c\u533b\u85ac\u54c1\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u30ac\u30a4\u30c9\u306e\u66f4\u65b0\u7248\u3092\u516c\u958b\u2026"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e741\u670821\u65e5,<\/strong> \u305d\u306e <strong>\u56fd\u5bb6\u4fdd\u5065\u898f\u5236\u5c40\uff08NHRA\uff09<\/strong> \u66f4\u65b0\u7248\u3092\u516c\u958b <strong>\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u533b\u85ac\u54c1\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3002.<\/strong> \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001, <strong>\u30d0\u30fc\u30b8\u30e7\u30f33.2\uff082026\u5e741\u6708\uff09\u3001,<\/strong> \u9069\u7528\u3055\u308c\u308b <strong>NHRA\u306e\u6709\u52b9\u306a\u8ca9\u58f2\u627f\u8a8d\u3092\u53d7\u3051\u305f\u4eba\u9593\u7528\u533b\u85ac\u54c1<\/strong> \u7ba1\u7406\u306b\u95a2\u3059\u308b\u898f\u5236\u8981\u4ef6\u3092\u5b9a\u3081\u3066\u3044\u308b<strong> \u627f\u8a8d\u5f8c\u306e\u5909\u52d5\u3001,<\/strong> \u5206\u985e\u3001\u63d0\u51fa\u7d4c\u8def\u3001\u6587\u66f8\u5316\u3001\u8a55\u4fa1\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3001\u5b9f\u88c5\u306e\u671f\u5f85\u306a\u3069\u3002.<\/p>\n<div class=\"row\"  id=\"row-1918118830\">\n\n\t<div id=\"col-1229865530\" 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-518307168\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-518307168 {\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-237558052\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-237558052 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001 <strong>\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u5909\u66f4<\/strong> NHRA\u306e\u8ca9\u58f2\u627f\u8a8d\u3068\u6709\u52b9\u306a\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u65e2\u306b\u4fdd\u6709\u3057\u3066\u3044\u308b\u4f01\u696d\u3002\u627f\u8a8d\u5f8c\u306e\u5909\u66f4\u304c\u3069\u306e\u3088\u3046\u306b\u5206\u985e\u3055\u308c\u308b\u304b\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002 <strong>IA\u578b\u3001IB\u578b\u3001, <\/strong>\u305d\u3057\u3066<strong> \u30bf\u30a4\u30d7II\u3001,<\/strong> \u5c0f\u3055\u306a\u5909\u5316\u3068\u91cd\u5927\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u5909\u5316\u3092\u533a\u5225\u3059\u308b <strong>\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u307e\u305f\u306f\u6709\u52b9\u6027\u3002.\u00a0<\/strong><\/p>\n<p>\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001 <strong>\u30bf\u30a4\u30d7IA\u306e\u5909\u7570<\/strong> \u300c\u5b9f\u884c\u3057\u3066\u4f1d\u3048\u308b\u300d\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u5f93\u3063\u3066\u3001\u4e8b\u524d\u306e\u627f\u8a8d\u306a\u3057\u3067\u5b9f\u65bd\u3067\u304d\u307e\u3059\u304c\u3001 <strong>60\u55b6\u696d\u65e5\u4ee5\u5185\u306b\u901a\u77e5<\/strong> \u5b9f\u65bd\u5f8c\u3001\u6761\u4ef6\u304c\u6e80\u305f\u3055\u308c\u306a\u3044\u5834\u5408\u306f\u62d2\u5426\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002. <strong>IB\u578b\u306e\u5909\u7570<\/strong> \u300c\u4f1d\u3048\u308b\u3001\u5f85\u3064\u3001\u5b9f\u884c\u3059\u308b\u300d\u30d7\u30ed\u30bb\u30b9\u3067\u51e6\u7406\u3055\u308c\u307e\u3059\u304c\u3001 <strong>\u30bf\u30a4\u30d7II\u306e\u5909\u7570<\/strong> \u5b9f\u88c5\u524d\u306b\u5b8c\u5168\u306a\u8a55\u4fa1\u3092\u5fc5\u8981\u3068\u3059\u308b\u4e3b\u8981\u306a\u5909\u66f4\u3092\u30ab\u30d0\u30fc\u3057\u307e\u3059\u3002.<\/p>\n<p>\u3059\u3079\u3066\u306e\u5909\u66f4\u7533\u8acb\u306f\u3001 <strong>NHRA Adweya\u30aa\u30f3\u30e9\u30a4\u30f3\u30b7\u30b9\u30c6\u30e0\u3001,<\/strong> \u4f7f\u7528\u3057\u3066 <strong>\u96fb\u5b50\u5171\u901a\u6280\u8853\u6587\u66f8\uff08eCTD\uff09<\/strong> \u30b7\u30fc\u30b1\u30f3\u30b9\u3002\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u6587\u66f8\u5316\u306e\u671f\u5f85\u304c\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u3002 <strong>\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\u3001\u73fe\u72b6\u3068\u63d0\u6848\u3055\u308c\u305f\u72b6\u614b\u306e\u6bd4\u8f03\u3001,<\/strong> \u305d\u3057\u3066 <strong>\u539f\u7523\u56fd\u306e\u627f\u8a8d\u307e\u305f\u306f\u8a3c\u660e,<\/strong> \u8a72\u5f53\u3059\u308b\u5834\u5408\u3002.<\/p>\n<p>\u898f\u5236\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306b\u95a2\u3057\u3066\u3001NHRA\u306f\u4e88\u60f3\u3055\u308c\u308b\u8a55\u4fa1\u5b8c\u4e86\u671f\u9593\u3092\u6b21\u306e\u3088\u3046\u306b\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002 <strong>\u30bf\u30a4\u30d7IA\u306e\u5834\u54087\u55b6\u696d\u65e5<\/strong> \u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u3068 <strong>\u30bf\u30a4\u30d7IB\u304a\u3088\u3073\u30bf\u30a4\u30d7II\u306e\u5834\u5408\u306f40\u55b6\u696d\u65e5<\/strong> \u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u3002\u627f\u8a8d\u3055\u308c\u305f\u5909\u66f4\u306b\u3064\u3044\u3066\u306f\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u6b21\u306e\u3088\u3046\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <strong>\u30bf\u30a4\u30d7IB\u3068\u30bf\u30a4\u30d7II\u306e\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u306f12\u30f6\u6708\u4ee5\u5185\u306b\u5b9f\u88c5\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308b<\/strong> \u627f\u8a8d\u66f8\u306e\u767a\u884c\u65e5\u3088\u308a\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1229865530 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1016271784\" 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-1831644940\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1831644940 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u306e <strong>\u533b\u85ac\u54c1\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u30d0\u30fc\u30b8\u30e7\u30f33.2\uff09\u306f\u30012026\u5e741\u670821\u65e5\u3088\u308a\u767a\u52b9\u3057\u307e\u3059\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1016271784 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-714458722\" 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-1378711234\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1378711234 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u6539\u8a02\u306b\u3088\u308a\u3001\u30d0\u30fc\u30ec\u30fc\u30f3\u306b\u304a\u3051\u308b\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u5f8c\u306e\u5909\u66f4\u306e\u5206\u985e\u3001\u63d0\u51fa\u3001\u5be9\u67fb\u3001\u5b9f\u65bd\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u898f\u5236\u306e\u6574\u5408\u6027\u304c\u3088\u308a\u660e\u78ba\u306b\u306a\u308a\u307e\u3059\u3002 <strong>\u30c7\u30b8\u30bf\u30eb\u63d0\u51fa\u8981\u4ef6\u3001\u6a19\u6e96\u5316\u3055\u308c\u305f\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3001\u5b9f\u88c5\u671f\u9593\u3001,<\/strong> \u3053\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u7ba1\u7406\u3092\u7dad\u6301\u3057\u3001\u8ca9\u58f2\u627f\u8a8d\u4fdd\u6709\u8005\u306b\u5bfe\u3059\u308b\u7ba1\u7406\u4e0a\u306e\u4e0d\u78ba\u5b9f\u6027\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u306a\u304c\u3089\u3001\u3088\u308a\u52b9\u7387\u7684\u306a\u898f\u5236\u51e6\u7406\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-714458722 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1950926682\" 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-1529329141\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1529329141 {\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\u696d\u52d9\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001CMC\u3001IT\u307e\u305f\u306f\u898f\u5236\u904b\u7528\u30c1\u30fc\u30e0<\/strong> \u30d0\u30fc\u30ec\u30fc\u30f3\u3067\u8a8d\u53ef\u3055\u308c\u305f\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u5f8c\u306e\u5909\u66f4\u304a\u3088\u3073\u96fb\u5b50\u7533\u8acb\u306e\u7ba1\u7406\u3092\u62c5\u5f53\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1950926682 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1410093471\" 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-169626553\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-169626553 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4f01\u696d\u306f\u3001 <strong>\u5909\u52d5\u7ba1\u7406\u624b\u9806<\/strong> \u66f4\u65b0\u3055\u308c\u305fNHRA\u8981\u4ef6\u3068\u306e\u6574\u5408\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3002\u3053\u308c\u306b\u306f\u3001\u6b63\u3057\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u542b\u307e\u308c\u307e\u3059\u3002 <strong>\u5909\u7570\u5206\u985e\u3001,<\/strong> \u30df\u30fc\u30c6\u30a3\u30f3\u30b0 <strong>\u30bf\u30a4\u30d7IA\u306e\u901a\u77e5\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3,<\/strong> \u6e96\u5099\u4e2d <strong>eCTD\u6e96\u62e0\u306e\u63d0\u51fa<\/strong> Adweya\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u3001\u5185\u90e8\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u8abf\u6574\u3057\u3001\u898f\u5b9a\u3092\u6e80\u305f\u3059\u3088\u3046\u306b\u3059\u308b <strong>\u8a55\u4fa1\u3068\u5b9f\u88c5\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3002. <\/strong><\/p>\n<p><span class=\"TextRun SCXW200731050 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW200731050 BCX0\">\u7d44\u7e54\u304c\u3053\u308c\u3089\u306e\u66f4\u65b0\u3055\u308c\u305f\u627f\u8a8d\u5f8c\u306e\u8981\u4ef6\u306b\u9069\u5fdc\u3059\u308b\u306b\u3064\u308c\u3066\u3001,\u00a0<\/span><\/span><a href=\"http:\/\/regask.com\/ja\/\"><strong><span class=\"TextRun MacChromeBold SCXW200731050 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW200731050 BCX0\">RegASK<\/span><\/span><\/strong><\/a><span class=\"TextRun SCXW200731050 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW200731050 BCX0\">\u00a0\u3088\u308a\u69cb\u9020\u5316\u3055\u308c\u305f\u30d7\u30ed\u30a2\u30af\u30c6\u30a3\u30d6\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u7ba1\u7406\u3092\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u307e\u3059\u3002.\u00a0<\/span><a href=\"http:\/\/regask.com\/ja\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW200731050 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW200731050 BCX0\"> \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. 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NHRA publishes updated Medicine Variations Guideline for Human Medicines, Version 3.2, outlining key regulatory changes.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/\u30d0\u30fc\u30ec\u30fc\u30f3nhra\u3001\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u533b\u85ac\u54c1\u30d0\u30ea\u30a8\u30fc\u30b7\/\" \/>\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=\"2026-02-24T15:28:30+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/bahrain-nhra-publishes-updated-medicine-variations-guideline-human-medicines-version-3-2.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Reva Ananda\" 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