{"id":9350,"date":"2026-01-06T14:35:16","date_gmt":"2026-01-06T06:35:16","guid":{"rendered":"https:\/\/regask.com\/?p=9350"},"modified":"2026-01-06T14:35:16","modified_gmt":"2026-01-06T06:35:16","slug":"ema%e3%81%af%e5%8c%bb%e8%96%ac%e5%93%81%e3%83%a9%e3%82%a4%e3%83%95%e3%82%b5%e3%82%a4%e3%82%af%e3%83%ab%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9%e3%82%92%e5%bc%b7","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/ema-updates-guidance-on-post-approval-change-management-protocols-to-strengthen-medicinal-product-lifecycle-compliance\/","title":{"rendered":"EMA \u304c\u627f\u8a8d\u5f8c\u306e\u5909\u66f4\u7ba1\u7406\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u66f4\u65b0\u2026"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2025\u5e7412\u670811\u65e5,<\/strong> \u305d\u306e <a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\"><strong>\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09<\/strong><\/a> \u51fa\u7248\u3055\u308c\u305f <strong>\u627f\u8a8d\u5f8c\u5909\u66f4\u7ba1\u7406\u30d7\u30ed\u30c8\u30b3\u30eb\uff08PACMP\uff09\u306b\u95a2\u3059\u308b\u6539\u8a02\u30ac\u30a4\u30c0\u30f3\u30b9,<\/strong> \u6b27\u5dde\u9023\u5408\uff08EU\uff09\u306b\u304a\u3051\u308b\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u306e\u67a0\u7d44\u307f\u3092\u66f4\u65b0\u3059\u308b\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u30012012\u5e74\u4ee5\u964d\u306e\u898f\u5236\u7d4c\u9a13\u3092\u53cd\u6620\u3057\u3066\u304a\u308a\u3001 <strong>\u66f4\u65b0\u3055\u308c\u305fEU\u5909\u52d5\u898f\u5247\u304a\u3088\u3073\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3,<\/strong> \u767a\u52b9\u65e5 <strong>2026\u5e741\u670815\u65e5\u3002.<\/strong> \u3053\u308c\u306f\u3059\u3079\u3066\u306e\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306b\u9069\u7528\u3055\u308c\u3001\u9069\u683c\u306a\u54c1\u8cea\u5909\u66f4\u306b\u5bfe\u3059\u308b\u898f\u5236\u51e6\u7406\u3092\u3088\u308a\u8fc5\u901f\u304b\u3064\u4e88\u6e2c\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u3002.<\/p>\n<div class=\"row\"  id=\"row-1333965458\">\n\n\t<div id=\"col-652359590\" 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-1190240188\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1190240188 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u8aac\u660e<\/h2>\n\t<div id=\"gap-1190305078\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1190305078 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6539\u8a02\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001 <strong>PACMP\u306f\u63d0\u51fa\u3067\u304d\u308b<\/strong> \u521d\u671f\u306e\u4e00\u74b0\u3068\u3057\u3066 <strong><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/marketing-authorisation\">\u8ca9\u58f2\u627f\u8a8d<\/a> \u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\uff08MAA\uff09\u3001,<\/strong> \u3068\u3057\u3066 <strong>\u30e9\u30a4\u30f3\u62e1\u5f35\u3001,<\/strong> \u307e\u305f\u306f <strong>\u30bf\u30a4\u30d7II\u5909\u7570<\/strong>, \u3053\u308c\u306b\u3088\u308a\u3001\u4f01\u696d\u306f\u5c06\u6765\u306e\u54c1\u8cea\u5909\u66f4\u306b\u5bfe\u3059\u308b\u6226\u7565\u3092\u4e8b\u524d\u306b\u5b9a\u7fa9\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002\u627f\u8a8d\u3055\u308c\u305fPACMP\u306b\u57fa\u3065\u3044\u3066\u5b9f\u65bd\u3055\u308c\u308b\u5909\u66f4\u306f\u3001\u901a\u5e38\u3001\u4ee5\u4e0b\u306e\u624b\u9806\u3067\u51e6\u7406\u3055\u308c\u307e\u3059\u3002 <strong>\u4f4e\u30ea\u30b9\u30af\u5909\u7570\u578b\uff08\u30bf\u30a4\u30d7IA\u3001IAIN\u3001IB\u306a\u3069\uff09,<\/strong> \u6a19\u6e96\u7684\u306a\u5909\u52d5\u7d4c\u8def\u3067\u4f7f\u7528\u3055\u308c\u308b\u3088\u308a\u8907\u96d1\u306a\u624b\u9806\u3068\u306f\u7570\u306a\u308a\u307e\u3059\u3002.<\/p>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001 <strong>\u591a\u76ee\u7684PACMP\u306f\u8a31\u53ef\u3055\u308c\u3066\u3044\u308b\u3002,<\/strong> \u305f\u3060\u3057\u3001\u4e8b\u524d\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u6761\u4ef6\u3068\u53d7\u3051\u5165\u308c\u57fa\u6e96\u306f\u6642\u9593\u306e\u7d4c\u904e\u3068\u3068\u3082\u306b\u5909\u66f4\u3055\u308c\u306a\u3044\u3082\u306e\u3068\u3059\u308b\u3002\u305f\u3060\u3057\u3001 <strong>PACMP\u306f\u4f7f\u7528\u3067\u304d\u307e\u305b\u3093<\/strong> \u81e8\u5e8a\u7684\u307e\u305f\u306f\u975e\u81e8\u5e8a\u7684\u306a\u5909\u66f4\u3092\u5fc5\u8981\u3068\u3059\u308b\u5834\u5408 <strong>\u30c7\u30fc\u30bf\u8a55\u4fa1<\/strong> \u3042\u308b\u3044\u306f\u5909\u5316\u305d\u306e\u3082\u306e\u304c<strong> \u5ef6\u9577\u7dda\u4e0a\u3067\u3002.\u00a0<\/strong><\/p>\n<p>\u900f\u660e\u6027\u3068\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u76e3\u8996\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u3001EMA\u306f\u4ee5\u4e0b\u3092\u8981\u6c42\u3057\u3066\u3044\u307e\u3059\u3002 <strong>\u3059\u3079\u3066\u306ePACMP\u306f\u66f8\u985e\u306e\u30e2\u30b8\u30e5\u30fc\u30eb3.2.R\u306b\u8a18\u8f09\u3055\u308c\u308b\u3002,<\/strong> \u627f\u8a8d\u3055\u308c\u305f\u5909\u66f4\u6226\u7565\u3092\u660e\u78ba\u306b\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u3092\u78ba\u4fdd\u3059\u308b\u3002\u3055\u3089\u306b\u3001\u6539\u8a02\u3055\u308c\u305f <strong>EU\u5909\u66f4\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u30012026\u5e741\u670815\u65e5\u4ee5\u964d\u306b\u63d0\u51fa\u3055\u308c\u305f\u5909\u66f4\u306e\u5b9f\u65bd\u306b\u306e\u307f\u9069\u7528\u3055\u308c\u308b\u3002,<\/strong> \u898f\u5236\u30c1\u30fc\u30e0\u5411\u3051\u306b\u660e\u78ba\u306a\u79fb\u884c\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3092\u78ba\u7acb\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-652359590 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1452000413\" 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-1398958196\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1398958196 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3084\u76f8\u8ac7\u306e\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-1452000413 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1261366450\" 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-160547763\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-160547763 {\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> PACMP\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308b\u30b5\u30dd\u30fc\u30c8 <strong>\u30c7\u30b8\u30bf\u30eb\u30a2\u30e9\u30a4\u30e1\u30f3\u30c8<\/strong> \u66f4\u65b0\u3055\u308c\u305fEU\u306e\u5909\u52d5\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u3088\u308a\u3001 <strong>\u52b9\u7387<\/strong> \u30ea\u30b9\u30af\u306e\u4f4e\u3044\u54c1\u8cea\u5909\u66f4\u304c\u4e88\u6e2c\u53ef\u80fd\u306a\u7d4c\u8def\u3092\u305f\u3069\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3059\u308b\u3002\u81e8\u5e8a\u8a55\u4fa1\u307e\u305f\u306f\u975e\u81e8\u5e8a\u8a55\u4fa1\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\u5909\u66f4\u306b\u7bc4\u56f2\u3092\u9650\u5b9a\u3059\u308b\u3053\u3068\u3067\u3001\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u898f\u5236\u306e\u53b3\u683c\u6027\u3092\u7dad\u6301\u3057\u306a\u304c\u3089\u3001\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u306b\u304a\u3051\u308b\u4e0d\u5fc5\u8981\u306a\u7ba1\u7406\u8ca0\u62c5\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1261366450 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1761250782\" 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>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u304c\u95a2\u4fc2\u3059\u308b\u4eba\u3005<\/h2>\n\t<div id=\"gap-14684065\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-14684065 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5f7c\u306e\u6307\u5c0e\u306f\u3001 <strong>\u85ac\u4e8b\u696d\u52d9\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001CMC\u3001,<\/strong> \u305d\u3057\u3066 <strong>\u898f\u5236\u696d\u52d9<\/strong> EU \u5185\u3067\u306e\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u5f8c\u306e\u5909\u66f4\u3001\u66f8\u985e\u306e\u4fdd\u5b88\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u8a08\u753b\u306e\u7ba1\u7406\u3092\u62c5\u5f53\u3059\u308b\u30c1\u30fc\u30e0\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1761250782 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1894029395\" 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-1238291474\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1238291474 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7d44\u7e54\u306f\u65e2\u5b58\u304a\u3088\u3073\u8a08\u753b\u4e2d\u306e <strong>PACMP<\/strong> \u6539\u8a02\u3055\u308c\u305fEMA\u30ac\u30a4\u30c0\u30f3\u30b9\u3068\u66f4\u65b0\u3055\u308c\u305f <strong>EU \u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u898f\u5236\u3002.<\/strong> \u898f\u5236\u5f53\u5c40\u306fPACMP\u30ea\u30b9\u30c8\u304c\u6b63\u78ba\u306b\u7dad\u6301\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002 <strong>\u30e2\u30b8\u30e5\u30fc\u30eb 3.2.R<\/strong> \u63d0\u51fa\u3055\u308c\u305f\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u306e\u5b9f\u88c5\u6e96\u5099\u306e\u305f\u3081\u306b\u3001\u6a5f\u80fd\u9593\u3067\u8abf\u6574\u3092\u884c\u3044\u307e\u3059\u3002 <strong>2026\u5e741\u670815\u65e5<\/strong> \u524d\u9032\u3002.<\/p>\n<p>\u898f\u5236\u5f53\u5c40\u304c\u6539\u8a02\u3055\u308c\u305f\u67a0\u7d44\u307f\u306e\u4e0b\u3067PACMP\u306e\u9069\u683c\u6027\u3001\u5909\u66f4\u7d4c\u8def\u3001\u66f8\u985e\u306e\u6e96\u5099\u72b6\u6cc1\u3092\u8a55\u4fa1\u3059\u308b\u4e2d\u3067\u3001, <a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u7d99\u7d9a\u7684\u306a\u76e3\u8996\u3068\u69cb\u9020\u5316\u3055\u308c\u305f\u5b9f\u88c5\u3092\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u307e\u3059\u3002.<\/p>\n<p><strong><a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u306f\u3001\u4e3b\u8981\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI\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> \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 <strong>\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI<\/strong> \u5c02\u9580\u5bb6\u306e\u5354\u529b\u3092\u5f97\u3066\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. <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><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1894029395 > .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-906357413\">\n\n\t<div id=\"col-1496336401\" 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-1276881191\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1276881191 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u627f\u8a8d\u5f8c\u5909\u66f4\u7ba1\u7406\u30d7\u30ed\u30c8\u30b3\u30eb (PACMP) \u3068\u306f\u4f55\u3067\u3059\u304b?<\/h4>\n\t<div id=\"gap-2120720818\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2120720818 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3042 <strong>PACMP<\/strong> \u5408\u610f\u3055\u308c\u305f\u6761\u4ef6\u3068\u627f\u8a8d\u57fa\u6e96\u3092\u4f7f\u7528\u3057\u3066\u3001\u533b\u85ac\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u4e2d\u306b\u533b\u85ac\u54c1\u306e\u7279\u5b9a\u306e\u54c1\u8cea\u5909\u66f4\u3092\u3069\u306e\u3088\u3046\u306b\u5b9f\u88c5\u3067\u304d\u308b\u304b\u3092\u5b9a\u7fa9\u3059\u308b\u3001\u69cb\u9020\u5316\u3055\u308c\u305f\u4e8b\u524d\u627f\u8a8d\u306e\u898f\u5236\u6226\u7565\u3067\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1496336401 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1111964205\" 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>\u6539\u8a02\u3055\u308c\u305f EMA PACMP \u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3044\u3064\u767a\u52b9\u3057\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-1577915932\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1577915932 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6539\u8a02\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001 <strong>2026\u5e741\u670815\u65e5\u304b\u3089\u767a\u52b9\u3059\u308bEU\u306e\u5909\u66f4\u898f\u5247\u304a\u3088\u3073\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/strong>, \u3001\u305d\u306e\u65e5\u4ee5\u964d\u306b\u63d0\u51fa\u3055\u308c\u305f\u5909\u66f4\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1111964205 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1299234918\" 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>\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u3069\u306e\u5909\u66f4\u304c PACMP \u304b\u3089\u9664\u5916\u3055\u308c\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-687740040\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-687740040 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>PACMP <strong>\u81e8\u5e8a\u307e\u305f\u306f\u975e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1\u3092\u5fc5\u8981\u3068\u3059\u308b\u5909\u66f4\u306b\u306f\u4f7f\u7528\u3067\u304d\u307e\u305b\u3093<\/strong> \u307e\u305f\u306f\u3001 <strong>\u5ef6\u9577\u7dda\u3002.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1299234918 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1163609940\" 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\u30c1\u30fc\u30e0\u304c PACMP \u95a2\u9023\u306e\u898f\u5236\u66f4\u65b0\u3092\u7ba1\u7406\u3059\u308b\u306e\u306b\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3061\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-759221555\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-759221555 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> AI \u99c6\u52d5\u578b\u306e\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3068\u81ea\u52d5\u5316\u3055\u308c\u305f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30d7\u30ed\u30bb\u30b9\u3092\u901a\u3058\u3066\u3001\u898f\u5236\u304a\u3088\u3073\u54c1\u8cea\u30c1\u30fc\u30e0\u304c EMA \u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u66f4\u65b0\u3092\u8ffd\u8de1\u3057\u3001PACMP \u306e\u9069\u683c\u6027\u3092\u8a55\u4fa1\u3057\u3001\u66f8\u985e\u3068\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u8abf\u6574\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1163609940 > .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 11 December 2025, the European Medicines Agency (EMA) published revised guidance on Post-Approval Change Management Protocols (PACMPs), updating the framework for lifecycle management of human medicinal products across the European Union. The guidance incorporates regulatory experience gained since 2012 and aligns with the updated EU Variations Regulation and Guidelines, which take effect on 15 January 2026. It applies to all human medicinal products and focuses on enabling faster and more predictable regulatory handling of qualifying quality changes.<\/p>","protected":false},"author":41,"featured_media":9367,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33,35],"tags":[],"class_list":["post-9350","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EMA Updates Guidance on Post-Approval Change Management<\/title>\n<meta name=\"description\" content=\"Explore the EMA updates on Post-Approval Change Management Protocols to enhance compliance in medicinal product lifecycles.\" \/>\n<meta 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