{"id":8350,"date":"2025-06-23T16:21:17","date_gmt":"2025-06-23T08:21:17","guid":{"rendered":"https:\/\/regask.com\/?p=8350"},"modified":"2025-06-24T14:57:55","modified_gmt":"2025-06-24T06:57:55","slug":"ema%e3%81%af%e4%b8%ad%e5%a4%ae%e3%81%8a%e3%82%88%e3%81%b3%e5%9b%bd%e5%ae%b6%e3%81%ae%e8%aa%8d%e5%8f%af%e5%8c%bb%e8%96%ac%e5%93%81%e3%81%ae%e5%ae%89%e5%85%a8%e6%80%a7%e3%82%b7%e3%82%b0%e3%83%8a","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/ema-publishes-updated-prac-recommendations-on-safety-signals-for-centrally-and-nationally-authorized-medicines\/","title":{"rendered":"EMA\u3001EU \u627f\u8a8d\u6a5f\u95a2\u5411\u3051 2025 \u5e74 6 \u6708\u306e PRAC \u5b89\u5168\u6027\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3092\u767a\u8868"},"content":{"rendered":"<p data-start=\"375\" data-end=\"742\">\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306f\u3001PRAC\u59d4\u54e1\u4f1a\u306b\u3088\u308b\u6700\u65b0\u306e\u5b89\u5168\u6027\u30b7\u30b0\u30ca\u30eb\u52e7\u544a\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002 <strong>2025\u5e746\u67082\u65e5<\/strong>.<br class=\"yoast-text-mark\" data-start=\"285\" data-end=\"288\" \/>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306fEMA\u306e\u7d99\u7d9a\u7684\u306a\u52aa\u529b\u3092\u53cd\u6620\u3057\u3066\u3044\u307e\u3059\u3002 <strong>\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306e\u5f37\u5316<\/strong> \u307e\u305f\u3001\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u5168\u57df\u3067\u8a8d\u53ef\u533b\u85ac\u54c1\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3092\u5f37\u5316\u3057\u307e\u3059\u3002<\/p>\n<p data-start=\"744\" data-end=\"961\">\u3053\u306e\u6539\u8a02\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u4ee5\u4e0b\u306e\u76e3\u7763\u3092\u6539\u5584\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u308b\u3002 <strong>\u85ac\u7269\u6709\u5bb3\u53cd\u5fdc\uff08ADR\uff09<\/strong>\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u3092\u78ba\u5b9f\u306b <strong>\u627f\u8a8d\u53d6\u5f97\u8005\uff08MAH\uff09<\/strong> \u9032\u5316\u3059\u308b <strong>\u533b\u85ac\u54c1\u5b89\u5168\u898f\u5236<\/strong>.<\/p>\n<h4 data-start=\"968\" data-end=\"1029\">\ud83d\udd0d 2025\u5e746\u6708\u306ePRAC\u52e7\u544a\u306e\u4e3b\u306a\u30cf\u30a4\u30e9\u30a4\u30c8<\/h4>\n<ul data-start=\"1031\" data-end=\"2657\">\n<li data-start=\"1031\" data-end=\"1316\">\n<p data-start=\"1033\" data-end=\"1316\"><strong>\u66f4\u65b0\u3055\u308c\u305f\u5b89\u5168\u4fe1\u53f7:<\/strong> \u63a8\u5968\u4e8b\u9805\u306f\u3001\u8907\u6570\u306e\u88fd\u54c1\u60c5\u5831\u306e\u66f4\u65b0\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002 <strong>\u6cbb\u7642\u9818\u57df<\/strong>\u816b\u760d\u5b66\u3001\u5fc3\u8840\u7ba1\u6cbb\u7642\u3001\u30ef\u30af\u30c1\u30f3\u3001\u305d\u306e\u4ed6\u306e\u512a\u5148\u5ea6\u306e\u9ad8\u3044\u533b\u85ac\u54c1\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u3001EU\u5168\u4f53\u3067\u65b0\u305f\u306b\u767a\u8868\u3055\u308c\u305f\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306b\u95a2\u3059\u308b\u77e5\u898b\u3068\u4e00\u81f4\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"1318\" data-end=\"1688\">\n<p data-start=\"1320\" data-end=\"1370\"><strong>\u4e2d\u592e\u8a8d\u53ef\u533b\u85ac\u54c1\u3068\u56fd\u5bb6\u8a8d\u53ef\u533b\u85ac\u54c1\uff1a<\/strong><\/p>\n<ul data-start=\"1373\" data-end=\"1688\">\n<li data-start=\"1373\" data-end=\"1522\">\n<p data-start=\"1375\" data-end=\"1522\">\u306e\u305f\u3081\u306b <strong data-start=\"1379\" data-end=\"1413\">\u4e2d\u592e\u8a8d\u53ef\u533b\u85ac\u54c1<\/strong>\u63a8\u5968\u3055\u308c\u308b\u5909\u66f4\u306f\u3001 <strong data-start=\"1464\" data-end=\"1521\">\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u59d4\u54e1\u4f1a\uff08CHMP\uff09<\/strong>.<\/p>\n<\/li>\n<li data-start=\"1525\" data-end=\"1688\">\n<p data-start=\"1527\" data-end=\"1688\">\u306e\u305f\u3081\u306b <strong data-start=\"1531\" data-end=\"1565\">\u56fd\u5bb6\u8a8d\u5b9a\u88fd\u54c1<\/strong>\u5b9f\u88c5\u306f\u3001 <strong data-start=\"1598\" data-end=\"1687\">\u76f8\u4e92\u627f\u8a8d\u304a\u3088\u3073\u5206\u6563\u624b\u7d9a\u304d\u8abf\u6574\u30b0\u30eb\u30fc\u30d7 \u2013 \u4eba\u9593 (CMDh)<\/strong>.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<li data-start=\"1690\" data-end=\"1943\">\n<p data-start=\"1692\" data-end=\"1943\"><strong data-start=\"1692\" data-end=\"1726\">\u898f\u5236\u9075\u5b88\u30ea\u30de\u30a4\u30f3\u30c0\u30fc<\/strong>: \u8ca9\u58f2\u627f\u8a8d\u53d6\u5f97\u8005\u306f <strong data-start=\"1765\" data-end=\"1803\">PRAC\u51fa\u7248\u7269\u3092\u5b9a\u671f\u7684\u306b\u30ec\u30d3\u30e5\u30fc\u3059\u308b<\/strong> \u6700\u65b0\u306e\u5b89\u5168\u6027\u76e3\u8996\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u6e96\u62e0\u3057\u7d9a\u3051\u308b\u305f\u3081\u306b\u3001\u88fd\u54c1\u30e9\u30d9\u30eb\u3001\u30ea\u30fc\u30d5\u30ec\u30c3\u30c8\u3001\u305d\u306e\u4ed6\u306e\u5b89\u5168\u6027\u60c5\u5831\u3092\u8fc5\u901f\u306b\u66f4\u65b0\u3057\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"1945\" data-end=\"2204\">\n<p data-start=\"1947\" data-end=\"2204\"><strong data-start=\"1947\" data-end=\"1976\">\u5b89\u5168\u4fe1\u53f7\u306e\u660e\u78ba\u5316<\/strong>\u5b89\u5168\u6027\u30b7\u30b0\u30ca\u30eb\u306e\u7279\u5b9a\u306f\u3001\u533b\u85ac\u54c1\u3068\u6709\u5bb3\u4e8b\u8c61\u3068\u306e\u56e0\u679c\u95a2\u4fc2\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3053\u3068\u306b\u7559\u610f\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u3080\u3057\u308d\u3001\u3055\u3089\u306a\u308b\u79d1\u5b66\u7684\u8a55\u4fa1\u3084\u4e88\u9632\u63aa\u7f6e\u306e\u5fc5\u8981\u6027\u3092\u793a\u3059\u3082\u306e\u3067\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"2206\" data-end=\"2414\">\n<p data-start=\"2208\" data-end=\"2414\"><strong data-start=\"2208\" data-end=\"2239\">\u591a\u8a00\u8a9e\u5b9f\u88c5<\/strong>: \u66f4\u65b0\u3055\u308c\u305f\u88fd\u54c1\u60c5\u5831\u306f\u3001\u30ce\u30eb\u30a6\u30a7\u30fc\u8a9e\u3084\u30a2\u30a4\u30b9\u30e9\u30f3\u30c9\u8a9e\u3092\u542b\u3080\u3059\u3079\u3066\u306e EU \u516c\u7528\u8a9e\u3067\u63d0\u4f9b\u3055\u308c\u3001\u3059\u3079\u3066\u306e\u52a0\u76df\u56fd\u3067\u306e\u7d71\u4e00\u3055\u308c\u305f\u5b9f\u88c5\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"2416\" data-end=\"2657\">\n<p data-start=\"2418\" data-end=\"2657\"><strong data-start=\"2418\" data-end=\"2452\">\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306e\u900f\u660e\u6027<\/strong>: A <strong data-start=\"2456\" data-end=\"2497\">\u3059\u3079\u3066\u306e\u5b89\u5168\u4fe1\u53f7\u306e\u7d2f\u7a4d\u30ea\u30b9\u30c8<\/strong> PRAC\u306b\u3088\u308b\u5be9\u67fb <strong data-start=\"2521\" data-end=\"2539\">2012\u5e749\u6708<\/strong> \u516c\u958b\u30a2\u30af\u30bb\u30b9\u304c\u7dad\u6301\u3055\u308c\u3001\u898f\u5236\u5f53\u5c40\u3084\u533b\u7642\u95a2\u4fc2\u8005\u306b\u6b74\u53f2\u7684\u80cc\u666f\u3084\u50be\u5411\u306e\u53ef\u8996\u6027\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n<\/li>\n<\/ul>\n<hr data-start=\"2659\" data-end=\"2662\" \/>\n<h4 data-start=\"2664\" data-end=\"2708\">\ud83c\udf10 \u898f\u5236\u30c1\u30fc\u30e0\u306b\u3068\u3063\u3066\u3053\u308c\u304c\u91cd\u8981\u306a\u7406\u7531<\/h4>\n<p data-start=\"2710\" data-end=\"2948\">\u3053\u308c\u3089\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001 <strong data-start=\"2757\" data-end=\"2808\">\u5b89\u5168\u95a2\u9023\u306e\u5909\u66f4\u3092\u3088\u308a\u8fc5\u901f\u306b\u5b9f\u88c5\u3057\u307e\u3059\u3002 <\/strong>\u6539\u5584\u4e2d <strong data-start=\"2820\" data-end=\"2847\">\u898f\u5236\u306e\u900f\u660e\u6027<\/strong>\u3001\u304a\u3088\u3073\u30b5\u30dd\u30fc\u30c8 <strong data-start=\"2864\" data-end=\"2892\">\u516c\u5e73\u306a\u60a3\u8005\u30a2\u30af\u30bb\u30b9<\/strong> EU \u5168\u57df\u306b\u304a\u3051\u308b\u6700\u65b0\u306e\u533b\u85ac\u54c1\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u3002<\/p>\n<p data-start=\"2950\" data-end=\"3107\">\u3053\u306e\u3088\u3046\u306a\u5909\u5316\u306b\u3064\u3044\u3066\u5e38\u306b\u60c5\u5831\u3092\u5f97\u308b\u3053\u3068\u306f\u3001\u898f\u5236\u5c02\u9580\u5bb6\u306b\u3068\u3063\u3066\u4e0d\u53ef\u6b20\u3067\u3042\u308a\u3001 <strong data-start=\"3034\" data-end=\"3056\">EU\u533b\u85ac\u54c1\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/strong>, <strong data-start=\"3058\" data-end=\"3078\">\u30e9\u30d9\u30eb\u306e\u66f4\u65b0<\/strong>\u3001 \u305d\u3057\u3066 <strong data-start=\"3084\" data-end=\"3106\">\u30ea\u30b9\u30af\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3<\/strong>.<\/p>\n<hr data-start=\"3109\" data-end=\"3112\" \/>\n<h4 data-start=\"3114\" data-end=\"3161\">\ud83d\udce5 EU \u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u6700\u65b0\u60c5\u5831\u3092\u3044\u3061\u65e9\u304f\u5165\u624b\u3057\u305f\u3044\u3067\u3059\u304b?<\/h4>\n<p data-start=\"3163\" data-end=\"3387\">\u8a2a\u554f <a class=\"\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/pharmacovigilance-post-authorisation\/signal-management\/prac-recommendations-safety-signals\" target=\"_new\" rel=\"noopener\" data-start=\"3173\" data-end=\"3313\">EMA\u516c\u5f0f\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8<\/a> \u5b89\u5168\u4fe1\u53f7\u306e\u66f4\u65b0\u3068\u88fd\u54c1\u56fa\u6709\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u5b8c\u5168\u306a\u30ea\u30b9\u30c8\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/p>\n<p data-start=\"3389\" data-end=\"3534\">\u3042\u308b\u3044\u306f\u3001 <a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a>\u306e AI \u99c6\u52d5\u578b\u898f\u5236\u60c5\u5831\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u3001\u4e16\u754c\u4e2d\u306e\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306e\u5909\u66f4\u3092\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u3067\u76e3\u8996\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>The European Medicines Agency (EMA) has released updated safety signal recommendations from its PRAC committee on June 2, 2025.This update reflects the EMA\u2019s continued efforts to enhance pharmacovigilance monitoring and strengthens post-marketing surveillance for authorized medicines across the European Union (EU). These revised guidelines aim to improve oversight of adverse drug reactions (ADRs). They help ensure that marketing authorization holders (MAHs) stay compliant with evolving medicine safety regulations. \ud83d\udd0d Key Highlights from the June 2025 PRAC Recommendations Updated Safety Signals: The recommendations cover updates to product information across multiple therapeutic areas, including oncology, cardiovascular treatments, vaccines, and other high-priority medicines. These align with emerging pharmacovigilance findings across the EU. Centrally&#8230;<\/p>","protected":false},"author":43,"featured_media":8413,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[538,35],"tags":[225,227,496,497],"class_list":["post-8350","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-european-union","category-pharma-biotech-latest-insights","tag-drug-safety","tag-pharmacovigilance","tag-market-authorization-regs","tag-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EMA Releases June 2025 PRAC Safety Updates for EU-Authorized Medicines | RegASK<\/title>\n<meta name=\"description\" content=\"Discover the latest EMA PRAC safety updates for centrally and nationally authorized medicines, effective June 2025 across the EU.\" \/>\n<meta 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content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-23T08:21:17+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-24T06:57:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/06\/ema-publishes-updated-prac-recommendations-on-safety-signals-for-centrally-and-nationally-authorized-medicines-12.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\" \/>\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=\"Reva Ananda\" \/>\n\t<meta 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