{"id":9337,"date":"2025-12-17T16:04:29","date_gmt":"2025-12-17T08:04:29","guid":{"rendered":"https:\/\/regask.com\/?p=9337"},"modified":"2025-12-17T16:04:29","modified_gmt":"2025-12-17T08:04:29","slug":"eu%e3%80%81%e5%8c%bb%e8%96%ac%e5%93%81%e6%b3%95%e3%81%ae%e7%94%bb%e6%9c%9f%e7%9a%84%e3%81%aa%e6%94%b9%e9%9d%a9%e3%82%92%e7%99%ba%e8%a1%a8","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/eu-announces-landmark-reform-of-pharmaceutical-legislation\/","title":{"rendered":"EU\u3001\u533b\u85ac\u54c1\u6cd5\u306e\u753b\u671f\u7684\u306a\u6539\u9769\u3092\u767a\u8868\u2026"},"content":{"rendered":"<p>2025\u5e7412\u670811\u65e5\u3001 <strong><a href=\"https:\/\/commission.europa.eu\/index_en\">\u6b27\u5dde\u59d4\u54e1\u4f1a<\/a> <\/strong>\u653f\u6cbb\u5408\u610f\u3092\u767a\u8868\u3057\u305f <strong>EU\u533b\u85ac\u54c1\u6cd5\u306e\u5927\u5e45\u306a\u6539\u9769<\/strong>, \u3053\u308c\u306f20\u5e74\u4ee5\u4e0a\u3076\u308a\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u5927\u5e45\u306a\u898b\u76f4\u3057\u3068\u306a\u308b\u3002\u4eca\u56de\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001 <strong>\u88fd\u85ac\u30a8\u30b3\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u306e\u30b9\u30c6\u30fc\u30af\u30db\u30eb\u30c0\u30fc<\/strong>, \u88fd\u9020\u696d\u8005\u3001\u898f\u5236\u5f53\u5c40\u3001\u533b\u7642\u63d0\u4f9b\u8005\u3001\u60a3\u8005\u306a\u3069\u3092\u542b\u3080\u95a2\u4fc2\u8005\u3001 <strong>\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3001\u5b89\u5168\u6027\u3001\u533b\u85ac\u54c1\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3001\u4f9b\u7d66\u306e\u56de\u5fa9\u529b\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306b\u898f\u5247\u3092\u8fd1\u4ee3\u5316\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002.<\/strong> \u6539\u9769\u304c\u65bd\u884c\u3055\u308c\u308b\u306b\u306f\u3001\u6b27\u5dde\u8b70\u4f1a\u3068\u6b27\u5dde\u7406\u4e8b\u4f1a\u306b\u3088\u308b\u6b63\u5f0f\u306a\u63a1\u629e\u304c\u307e\u3060\u5fc5\u8981\u3067\u3042\u308b\u3002.<\/p>\n<div class=\"row\"  id=\"row-1140120443\">\n\n\t<div id=\"col-1824449472\" 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-46140134\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-46140134 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2><span class=\"TextRun MacChromeBold SCXW150983442 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW150983442 BCX0\" data-ccp-parastyle=\"heading 3\">EU\u533b\u85ac\u54c1\u898f\u5236\u306e\u67a0\u7d44\u307f\u3067\u4f55\u304c\u5909\u308f\u308b\u306e\u304b<\/span><\/span><span class=\"EOP SCXW150983442 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><\/h2>\n\t<div id=\"gap-514070415\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-514070415 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u6539\u9769\u306b\u3088\u308a\u3001\u9577\u5e74\u306b\u308f\u305f\u308b EU \u306e\u533b\u85ac\u54c1\u898f\u5247\u304c\u66f4\u65b0\u3055\u308c\u3001\u4eca\u65e5\u306e\u79d1\u5b66\u3001\u30c7\u30b8\u30bf\u30eb\u3001\u30b5\u30d7\u30e9\u30a4 \u30c1\u30a7\u30fc\u30f3\u306e\u73fe\u5b9f\u3092\u3088\u308a\u9069\u5207\u306b\u53cd\u6620\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n<p>\u7d39\u4ecb\u3059\u308b <strong>\u5408\u7406\u5316\u3055\u308c\u305f\u898f\u5236\u624b\u7d9a\u304d<\/strong> \u4e21\u65b9\u306e\u8a55\u4fa1\u671f\u9593\u3092\u77ed\u7e2e\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f <strong>\u65b0\u85ac\u304a\u3088\u3073\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u3001,<\/strong> \u30b5\u30dd\u30fc\u30c8 <a href=\"https:\/\/regask.com\/ja\/%e8%a3%bd%e5%93%81%e5%88%86%e9%a1%9e%e5%b8%82%e5%a0%b4%e5%8f%82%e5%85%a5\/\">\u3088\u308a\u8fc5\u901f\u306a\u5e02\u5834\u53c2\u5165<\/a> \u60a3\u8005\u306e\u5b89\u5168\u57fa\u6e96\u3092\u7dad\u6301\u3057\u306a\u304c\u3089\u3002.<\/p>\n<p>\u3053\u306e\u5354\u5b9a\u3067\u306f\u3001 <strong>\u898f\u5236\u30b5\u30f3\u30c9\u30dc\u30c3\u30af\u30b9\u3001,<\/strong> \u9769\u65b0\u7684\u306a\u6cbb\u7642\u6cd5\u3092\u898f\u5236\u5f53\u5c40\u306e\u76e3\u7763\u4e0b\u3067\u5b89\u5168\u306b\u8a66\u9a13\u3067\u304d\u308b\u3001\u7ba1\u7406\u3055\u308c\u305f\u74b0\u5883\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30b5\u30f3\u30c9\u30dc\u30c3\u30af\u30b9\u306f\u3001\u5b89\u5168\u6027\u3068\u54c1\u8cea\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u652f\u63f4\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n<p>\u7d99\u7d9a\u7684\u306a\u4f9b\u7d66\u4e0a\u306e\u8ab2\u984c\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u3001\u3053\u306e\u6539\u9769\u3067\u306f\u3001\u4e0d\u8db3\u306e\u9632\u6b62\u3068\u76e3\u8996\u306b\u5bfe\u3059\u308b\u6b21\u306e\u3088\u3046\u306a\u5f37\u5316\u3055\u308c\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u78ba\u7acb\u3057\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u65b0\u3057\u3044 <strong>\u533b\u85ac\u54c1\u4e0d\u8db3\u3092\u76e3\u8996\u3059\u308b\u305f\u3081\u306eEU\u30ec\u30d9\u30eb\u306e\u67a0\u7d44\u307f\u00a0<\/strong><\/li>\n<li>\u4f01\u696d\u306b\u5bfe\u3059\u308b\u3088\u308a\u5f37\u3044\u7fa9\u52d9<\/li>\n<li>\u5f37\u5316\u3055\u308c\u305f\u8abf\u6574 <a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\"><strong>\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09<\/strong><\/a><\/li>\n<\/ul>\n<p>\u4e26\u884c\u3057\u3066\u3001EU\u306f <strong>\u91cd\u8981\u306a\u533b\u85ac\u54c1\u306e\u30ea\u30b9\u30c8\u3001,<\/strong> \u8106\u5f31\u6027\u8a55\u4fa1\u306b\u3088\u3063\u3066\u30b5\u30dd\u30fc\u30c8\u3055\u308c\u3001\u4f9b\u7d66\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3066\u8efd\u6e1b\u3057\u307e\u3059\u3002.<\/p>\n<p>\u3053\u306e\u6539\u9769\u306b\u3088\u308a\u3001 <strong>\u30dc\u30e9\u30fc\u514d\u9664\u3001,<\/strong> \u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u30e1\u30fc\u30ab\u30fc\u304c\u7279\u8a31\u6e80\u4e86\u524d\u306b\u5e02\u5834\u53c2\u5165\u306e\u6e96\u5099\u3092\u6574\u3048\u3001\u624b\u9803\u306a\u4fa1\u683c\u306e\u533b\u85ac\u54c1\u3078\u306e\u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u30a2\u30af\u30bb\u30b9\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002.<\/p>\n<p>\u52a0\u3048\u3066\u3001, <strong>\u65b0\u305f\u306a\u30a4\u30f3\u30bb\u30f3\u30c6\u30a3\u30d6<\/strong> \u9769\u65b0\u7684\u306a\u88fd\u54c1\u306e\u305f\u3081\u306b\u5c0e\u5165\u3055\u308c\u3001 <strong>\u6e80\u305f\u3055\u308c\u3066\u3044\u306a\u3044\u533b\u7642\u30cb\u30fc\u30ba\u3001,<\/strong> \u533b\u85ac\u54c1\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306b\u304a\u3051\u308b\u7af6\u4e89\u529b\u3092\u7dad\u6301\u3059\u308b\u3068\u3044\u3046EU\u306e\u91ce\u5fc3\u3092\u5f37\u5316\u3059\u308b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1824449472 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1586913709\" 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-1484035817\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1484035817 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u6539\u9769\u306b\u3088\u308a\u3001 <strong>\u898f\u5236\u306e\u660e\u78ba\u3055\u3001,<\/strong> \u533b\u85ac\u54c1\u6cd5\u3092\u4ee5\u4e0b\u306e\u901a\u308a\u3068\u3059\u308b <strong>\u73fe\u4ee3\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3068\u30c7\u30b8\u30bf\u30eb\u958b\u767a\u3001,<\/strong> \u305d\u3057\u3066\u6539\u5584\u3059\u308b <strong>\u898f\u5236\u306e\u52b9\u7387\u6027<\/strong> \u4e0d\u5fc5\u8981\u306a\u884c\u653f\u8ca0\u62c5\u3092\u5897\u3084\u3059\u3053\u3068\u306a\u304f\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u76e3\u8996\u3092\u5f37\u5316\u3057\u3001\u533b\u85ac\u54c1\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3059\u308b\u3053\u3068\u3067\u3001\u3053\u306e\u67a0\u7d44\u307f\u306fEU\u5168\u4f53\u306e\u60a3\u8005\u306e\u5b89\u5168\u3068\u30b7\u30b9\u30c6\u30e0\u306e\u30ec\u30b8\u30ea\u30a8\u30f3\u30b9\uff08\u56de\u5fa9\u529b\uff09\u306e\u5411\u4e0a\u3092\u76ee\u6307\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1586913709 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1075607344\" 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-289715166\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-289715166 {\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\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3001\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3001\u7814\u7a76\u958b\u767a\u3001, <\/strong>\u305d\u3057\u3066<strong> \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30fc\u30e0\u3001,<\/strong> \u540c\u69d8\u306b <strong>IT\u304a\u3088\u3073\u30c7\u30fc\u30bf\u30c1\u30fc\u30e0<\/strong> \u88fd\u85ac\u7d44\u7e54\u5185\u306e\u898f\u5236\u696d\u52d9\u304a\u3088\u3073\u4e0d\u8db3\u76e3\u8996\u7fa9\u52d9\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1075607344 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1144614999\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  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\u99c6\u52d5\u578b\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3068\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u81ea\u52d5\u5316\u3092\u901a\u3058\u3066\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-864090592 > .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 Commission announced a political agreement on a major reform of EU pharmaceutical legislation, marking the most significant overhaul of the framework in over 20 years. The update affects stakeholders across the pharmaceutical ecosystem, including manufacturers, regulators, healthcare providers, and patients, and aims to modernize rules to improve innovation, safety, access to medicines, and supply resilience. Formal adoption by the European Parliament and the Council is still required before the reforms enter into force.<\/p>","protected":false},"author":41,"featured_media":9339,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,35],"tags":[],"class_list":["post-9337","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","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>EU Announces Landmark Reform of Pharmaceutical Regulations<\/title>\n<meta name=\"description\" content=\"The EU announces landmark reform of pharmaceutical legislation to enhance safety and access to medicines for all stakeholders.\" \/>\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\/eu\u3001\u533b\u85ac\u54c1\u6cd5\u306e\u753b\u671f\u7684\u306a\u6539\u9769\u3092\u767a\u8868\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU Announces Landmark Reform of Pharmaceutical Legislation\" \/>\n<meta property=\"og:description\" content=\"The EU announces landmark reform of pharmaceutical legislation to enhance safety and access to medicines for all stakeholders.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/eu\u3001\u533b\u85ac\u54c1\u6cd5\u306e\u753b\u671f\u7684\u306a\u6539\u9769\u3092\u767a\u8868\/\" \/>\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=\"2025-12-17T08:04:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/12\/eu-announces-landmark-reform-pharmaceutical-legislation.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=\"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 name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"4\u5206\" \/>\n<script type=\"application\/ld+json\" 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