{"id":9630,"date":"2026-03-11T15:38:40","date_gmt":"2026-03-11T07:38:40","guid":{"rendered":"https:\/\/regask.com\/?p=9630"},"modified":"2026-03-11T15:38:40","modified_gmt":"2026-03-11T07:38:40","slug":"fda%e3%80%81%e6%89%bf%e8%aa%8d%e5%be%8c%e3%81%ae%e5%8c%bb%e8%96%ac%e5%93%81%e8%a3%bd%e9%80%a0%e3%81%ae%e5%a4%89%e6%9b%b4%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8bsupac%e3%82%ac%e3%82%a4%e3%83%80%e3%83%b3","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/","title":{"rendered":"FDA\u3001SUPAC \u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u66f4\u65b0\u306b\u95a2\u3059\u308b\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u3092\u958b\u59cb"},"content":{"rendered":"<p><span data-contrast=\"auto\">\u306e\u4e0a\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e743\u67083\u65e5<\/span><\/b><span data-contrast=\"auto\">\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09<\/span><\/b><span data-contrast=\"auto\">\u00a0\u540c\u793e\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u304a\u3088\u3073\u627f\u8a8d\u5f8c\u5909\u66f4\uff08SUPAC\uff09\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><\/b><span data-contrast=\"auto\">\u00a0\u533b\u85ac\u54c1\u306b\u3064\u3044\u3066\u3002\u5354\u8b70\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u5316\u5b66\u3001\u88fd\u9020\u3001\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\uff08CMC\uff09<\/span><\/b><span data-contrast=\"auto\">\u00a0\u8981\u4ef6\u3068\u76ee\u7684\u306f\u3001\u65e2\u5b58\u306eSUPAC\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u304c\u4f9d\u7136\u3068\u3057\u3066\u9069\u5207\u3067\u3042\u308a\u3001\u73fe\u5728\u306e\u79d1\u5b66\u7684\u304a\u3088\u3073\u898f\u5236\u4e0a\u306e\u57fa\u6e96\u306b\u5408\u81f4\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u306e\u30ec\u30d3\u30e5\u30fc\u3067\u306f\u3001SUPAC\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3064\u3044\u3066\u53d6\u308a\u4e0a\u3052\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u5373\u6642\u30ea\u30ea\u30fc\u30b9<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">\u6539\u826f\u7248\u30ea\u30ea\u30fc\u30b9<\/span><\/b><span data-contrast=\"auto\">\u3001 \u305d\u3057\u3066\u00a0<\/span><b><span data-contrast=\"auto\">\u975e\u6ec5\u83cc\u534a\u56fa\u5f62\u5264\u5f62<\/span><\/b><span data-contrast=\"auto\">, \u304a\u3088\u3073\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u88fd\u9020\u8a2d\u5099<\/span><\/b><span data-contrast=\"auto\">. \u88fd\u85ac\u696d\u754c\u5168\u4f53\u306e\u95a2\u4fc2\u8005\u306e\u7686\u69d8\u306b\u306f\u3001\u6539\u8a02\u3001\u660e\u78ba\u5316\u3001\u307e\u305f\u306f\u8ffd\u52a0\u4e8b\u9805\u3092\u6700\u65b0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u76db\u308a\u8fbc\u3080\u3079\u304d\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306e\u3054\u610f\u898b\u3092\u304a\u5bc4\u305b\u3044\u305f\u3060\u304f\u3088\u3046\u304a\u9858\u3044\u3044\u305f\u3057\u307e\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u610f\u898b\u52df\u96c6\u671f\u9593\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e746\u67081\u65e5<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-1696146428\">\n\n\t<div id=\"col-2000420076\" 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-785558029\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-785558029 {\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-1489436025\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1489436025 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">FDA\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u5b9f\u7528\u6027\u3001\u660e\u77ad\u6027\u3001\u9069\u7528\u6027<\/span><\/b><span data-contrast=\"auto\">\u00a0\u533b\u85ac\u54c1\u306e\u88fd\u9020\u898f\u6a21\u62e1\u5927\u304a\u3088\u3073\u627f\u8a8d\u5f8c\u306e\u5909\u66f4\u306b\u95a2\u3059\u308b\u3001\u73fe\u5728\u306eSUPAC\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u306e\u30ec\u30d3\u30e5\u30fc\u3067\u306f\u3001\u65e2\u5b58\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u304c\u00a0<\/span><b><span data-contrast=\"auto\">\u5373\u6642\u30ea\u30ea\u30fc\u30b9<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">\u6539\u826f\u7248\u30ea\u30ea\u30fc\u30b9<\/span><\/b><span data-contrast=\"auto\">\u3001 \u305d\u3057\u3066\u00a0<\/span><b><span data-contrast=\"auto\">\u975e\u6ec5\u83cc\u534a\u56fa\u5f62\u5264\u5f62<\/span><\/b><span data-contrast=\"auto\">\u00a0CMC\u5909\u66f4\u306b\u5bfe\u3059\u308b\u52b9\u679c\u7684\u306a\u898f\u5236\u76e3\u7763\u3092\u5f15\u304d\u7d9a\u304d\u652f\u63f4\u3059\u308b\u3002\u5f53\u5c40\u306f\u307e\u305f\u3001\u4ee5\u4e0b\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3082\u8a55\u4fa1\u3057\u3066\u3044\u308b\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u88fd\u9020\u8a2d\u5099\u306e\u5909\u66f4<\/span><\/b><span data-contrast=\"auto\">, \u3053\u308c\u306f\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3084\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3055\u3089\u306b\u3001FDA\u306f\u3053\u308c\u3089\u306e\u6587\u66f8\u304c\u3001\u3088\u308a\u6700\u8fd1\u306e\u56fd\u969b\u7684\u306a\u898f\u5236\u67a0\u7d44\u307f\u3001\u7279\u306b\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1) \u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/span><\/b><span data-contrast=\"auto\">\u00a0\u305d\u3057\u3066\u00a0<\/span><b><span data-contrast=\"auto\">\u533b\u85ac\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u95a2\u3059\u308bICH Q12<\/span><\/b><span data-contrast=\"auto\">. \u540c\u6a5f\u95a2\u306f\u3001\u95a2\u4fc2\u8005\u306b\u5bfe\u3057\u3001SUPAC\u52e7\u544a\u306e\u89e3\u91c8\u3084\u5b9f\u65bd\u306b\u304a\u3051\u308b\u8ab2\u984c\u3092\u3001\u73fe\u5728\u306e\u67a0\u7d44\u307f\u306e\u4e2d\u3067\u7279\u5b9a\u3059\u308b\u3088\u3046\u4fc3\u3057\u3066\u3044\u308b\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u696d\u754c\u95a2\u4fc2\u8005\u306f\u3001\u6b21\u306e\u3088\u3046\u306b\u63d0\u6848\u3059\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u65b0\u3057\u3044\u30c8\u30d4\u30c3\u30af\u3001\u66f4\u65b0\u3001\u307e\u305f\u306f\u6539\u8a02<\/span><\/b><span data-contrast=\"auto\">\u00a0\u305d\u308c\u306f\u3001\u898f\u5236\u306e\u8907\u96d1\u3055\u3084\u4e0d\u5fc5\u8981\u306a\u8ca0\u62c5\u3092\u8efd\u6e1b\u3059\u308b\u3068\u540c\u6642\u306b\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u59a5\u5f53\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/span><span 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-2000420076 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1998149431\" 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-949872949\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-949872949 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">\u95a2\u4fc2\u8005\u306f\u3001\u00a0<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">\u63d0\u51fa\u3059\u308b<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">\u00a0FDA\u306eSUPAC\u30ac\u30a4\u30c0\u30f3\u30b9\u30ec\u30d3\u30e5\u30fc\u306b\u95a2\u3059\u308b\u30b3\u30e1\u30f3\u30c8\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">2026\u5e746\u67081\u65e5<\/span><\/span><\/strong><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\"><strong>.<\/strong> \u5fdc\u52df\u306f\u4ee5\u4e0b\u306e\u65b9\u6cd5\u3067\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">FDA\u304c\u6307\u5b9a\u3059\u308b\u96fb\u5b50\u7684\u307e\u305f\u306f\u66f8\u9762\u306b\u3088\u308b\u7d4c\u8def<\/span><\/span><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">.<\/span><\/span><span class=\"EOP SCXW54403655 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1998149431 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1750871588\" 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-1325036633\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1325036633 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">SUPAC\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u88fd\u85ac\u30e1\u30fc\u30ab\u30fc\u304c\u3069\u306e\u3088\u3046\u306b\u7ba1\u7406\u3059\u308b\u304b\u3092\u5b9a\u3081\u308b\u4e0a\u3067\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u627f\u8a8d\u5f8c\u306e\u88fd\u9020\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u306e\u5909\u66f4<\/span><\/b><span data-contrast=\"auto\">. \u3053\u308c\u3089\u306e\u6587\u66f8\u3092\u5be9\u67fb\u3059\u308b\u3053\u3068\u3067\u3001FDA\u306f\u305d\u308c\u3089\u304c\u53cd\u6620\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u6700\u65b0\u306e\u79d1\u5b66\u7684\u57fa\u6e96\u3001\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u898f\u5236\u30a2\u30d7\u30ed\u30fc\u30c1\u3001\u304a\u3088\u3073\u56fd\u969b\u7684\u306a\u67a0\u7d44\u307f\u3068\u306e\u6574\u5408\u6027<\/span><\/b><span data-contrast=\"auto\">\u00a0\u306e\u3088\u3046\u306a\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1)<\/span><\/b><span data-contrast=\"auto\">\u00a0\u305d\u3057\u3066\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q12<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u66f4\u65b0\u3059\u308b\u3053\u3068\u3067\u3001\u3088\u308a\u5927\u304d\u306a\u52b9\u679c\u304c\u671f\u5f85\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u898f\u5236\u306e\u660e\u78ba\u5316\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3051\u308b\u30c7\u30b8\u30bf\u30eb\u5316\u306e\u6574\u5408\u6027\u3001\u304a\u3088\u3073\u533b\u85ac\u54c1\u306e\u52b9\u7387\u7684\u306a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406<\/span><\/b><span data-contrast=\"auto\">, \u540c\u6642\u306b\u3001\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u4e0d\u5fc5\u8981\u306a\u898f\u5236\u8ca0\u62c5\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3002.<\/span><span 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-1750871588 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-390542139\" 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-1113259233\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1113259233 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u3053\u306e\u5354\u8b70\u306f\u7279\u306b\u4ee5\u4e0b\u306e\u4eba\u3005\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3059\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u898f\u5236\u95a2\u9023\u30c1\u30fc\u30e0\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u5c02\u9580\u5bb6\u3001\u88fd\u9020\u304a\u3088\u3073CMC\u5c02\u9580\u5bb6\u3001\u533b\u85ac\u54c1\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ea\u30fc\u30c0\u30fc<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\"><strong>\u00a0<\/strong>\u7ba1\u7406\u3092\u62c5\u5f53\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u6d3b\u52d5\u3068\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW159808703 BCX0\">\u627f\u8a8d\u5f8c<\/span><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0\u5909\u66f4<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0\u898f\u5236\u3055\u308c\u305f\u533b\u85ac\u54c1\u88fd\u9020\u74b0\u5883\u5185\u306b\u304a\u3044\u3066\u3002.<\/span><\/span><span class=\"EOP SCXW159808703 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-390542139 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1176903203\" 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-1944410618\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1944410618 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u7d44\u7e54\u306f\u73fe\u72b6\u3092\u898b\u76f4\u3059\u5fc5\u8981\u304c\u3042\u308b\u00a0<\/span><b><span data-contrast=\"auto\">\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u304a\u3088\u3073\u627f\u8a8d\u5f8c\u306e\u88fd\u9020\u5909\u66f4\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u5185\u90e8\u624b\u9806<\/span><\/b><span data-contrast=\"auto\">\u00a0\u65e2\u5b58\u306eSUPAC\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u53cd\u3059\u308b\u3002\u898f\u5236\u30c1\u30fc\u30e0\u3068\u54c1\u8cea\u30c1\u30fc\u30e0\u306f\u3001\u4ee5\u4e0b\u306e\u9818\u57df\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u3092\u691c\u8a0e\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u660e\u78ba\u5316\u3001\u8fd1\u4ee3\u5316\u3001\u307e\u305f\u306f\u8ffd\u52a0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5b9f\u88c5\u3092\u6539\u5584\u3057\u305f\u308a\u3001\u904b\u7528\u4e0a\u306e\u8907\u96d1\u3055\u3092\u8efd\u6e1b\u3057\u305f\u308a\u3059\u308b\u3060\u308d\u3046\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4f01\u696d\u306f\u9023\u643a\u3059\u308b\u3053\u3068\u3067\u5229\u76ca\u3092\u5f97\u308b\u53ef\u80fd\u6027\u3082\u3042\u308b\u00a0<\/span><b><span data-contrast=\"auto\">\u898f\u5236\u3001\u54c1\u8cea\u3001\u88fd\u9020\u30c1\u30fc\u30e0\u9593\u306e\u90e8\u9580\u6a2a\u65ad\u7684\u306a\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af<\/span><\/b><span data-contrast=\"auto\">\u00a0FDA\u306b\u30b3\u30e1\u30f3\u30c8\u3092\u63d0\u51fa\u3059\u308b\u524d\u306b\u3001\u5305\u62ec\u7684\u306a\u56de\u7b54\u3092\u4f5c\u6210\u3059\u308b\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e746\u67081\u65e5\u304c\u7de0\u3081\u5207\u308a<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u898f\u5236\u5f53\u5c40\u306e\u671f\u5f85\u00a0<\/span><b><span data-contrast=\"auto\">CMC\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u3068\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u5909\u66f4\u7ba1\u7406<\/span><\/b><span data-contrast=\"auto\">\u00a0\u898f\u5236\u306f\u9032\u5316\u3057\u7d9a\u3051\u3066\u304a\u308a\u3001\u898f\u5236\u60c5\u5831\u3084\u76e3\u8996\u30c4\u30fc\u30eb\u306f\u3001\u7d44\u7e54\u304c\u5354\u8b70\u72b6\u6cc1\u3092\u8ffd\u8de1\u3057\u3001\u6f5c\u5728\u7684\u306a\u898f\u5236\u5909\u66f4\u3092\u4e88\u6e2c\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><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\u9ad8\u5ea6\u306b\u898f\u5236\u3055\u308c\u305f\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\u5207\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3059\u308b\u3001\u6700\u5148\u7aef\u306e\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\u3067\u3059\u3002 <strong>\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI<\/strong> \u5c02\u9580\u5bb6\u306e\u5354\u529b\u3092\u5f97\u3066\u3001, <a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/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\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<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1176903203 > .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-1701956802\">\n\n\t<div id=\"col-1193579610\" 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-930569544\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-930569544 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW116607224 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">FDA\u306f\u4f55\u3092\u8981\u6c42\u3057\u3066\u3044\u308b\u306e\u304b\u00a0<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0SUPAC\u5354\u8b70\u306b\u304a\u3044\u3066\uff1f<\/span><\/span><span class=\"EOP SCXW116607224 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1390140948\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1390140948 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">FDA\u306f\u3001<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u65e2\u5b58\u306eSUPAC\u306e\u95a2\u9023\u6027\u3001\u660e\u78ba\u6027\u3001\u6709\u7528\u6027\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0\u305d\u306e\u4f4f\u6240\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u3068\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">\u627f\u8a8d\u5f8c<\/span><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0\u5909\u66f4<\/span><\/span><\/strong><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\"><strong>\u00a0<\/strong>\u533b\u85ac\u54c1\u3001\u7279\u306b\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u5316\u5b66\u3001\u88fd\u9020\u3001\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\uff08CMC\uff09<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">.<\/span><\/span><span class=\"EOP SCXW27174500 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1193579610 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1400188784\" 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><span class=\"TextRun MacChromeBold SCXW185224076 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW185224076 BCX0\" data-ccp-parastyle=\"heading 3\">SUPAC\u306e\u5be9\u67fb\u3067\u306f\u3001\u3069\u306e\u533b\u85ac\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\u304c\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u304b\uff1f<\/span><\/span><span class=\"EOP SCXW185224076 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-2000786621\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2000786621 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 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(SUPAC)\u00a0guidances\u00a0for pharmaceutical products. The consultation focuses on\u00a0chemistry, manufacturing, and controls (CMC)\u00a0requirements and aims to evaluate whether existing SUPAC guidance documents\u00a0remain\u00a0relevant and aligned with current scientific and regulatory standards.\u00a0 The review covers SUPAC\u00a0guidances\u00a0for\u00a0immediate release,\u00a0modified release, and\u00a0nonsterile semisolid dosage forms, as well as changes related to\u00a0manufacturing equipment. Stakeholders across the pharmaceutical industry are invited to\u00a0submit\u00a0feedback to help\u00a0determine\u00a0whether revisions, clarifications, or\u00a0additional\u00a0topics should be incorporated into updated guidance.\u00a0 The consultation period\u00a0remains\u00a0open until\u00a0June 1, 2026.\u00a0<\/p>","protected":false},"author":41,"featured_media":9631,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9630","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-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 v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Opens Public Consultation on Pharmaceutical 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