{"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-642465804\">\n\n\t<div id=\"col-724659786\" 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-1964248184\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1964248184 {\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-1374532259\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1374532259 {\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-724659786 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-208013079\" 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-717590811\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-717590811 {\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-208013079 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1329110520\" 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-420940746\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-420940746 {\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-1329110520 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-118200043\" 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-646783496\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-646783496 {\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-118200043 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-193306013\" 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-1902371245\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1902371245 {\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-193306013 > .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-381720001\">\n\n\t<div id=\"col-1124044327\" 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-670773801\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-670773801 {\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-366509479\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-366509479 {\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-1124044327 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1232195377\" 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-149865206\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-149865206 {\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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content=\"Explore the FDA&#039;s public consultation on updating SUPAC guidance for postapproval pharmaceutical manufacturing changes.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/fda\u3001\u627f\u8a8d\u5f8c\u306e\u533b\u85ac\u54c1\u88fd\u9020\u306e\u5909\u66f4\u306b\u95a2\u3059\u308bsupac\u30ac\u30a4\u30c0\u30f3\/\" \/>\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=\"2026-03-11T07:38:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.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 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