{"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%e5%8f%91%e5%b8%83%e5%85%b3%e4%ba%8e%e4%b8%ad%e5%a4%ae%e5%92%8c%e5%9b%bd%e5%ae%b6%e6%8e%88%e6%9d%83%e8%8d%af%e5%93%81%e5%ae%89%e5%85%a8%e4%bf%a1%e5%8f%b7%e7%9a%84%e6%9c%80%e6%96%b0%e5%ae%9e","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/ema-publishes-updated-prac-recommendations-on-safety-signals-for-centrally-and-nationally-authorized-medicines\/","title":{"rendered":"EMA \u53d1\u5e03 2025 \u5e74 6 \u6708\u6b27\u76df\u6388\u6743 PRAC \u5b89\u5168\u66f4\u65b0\u2026\u2026"},"content":{"rendered":"<p data-start=\"375\" data-end=\"742\">\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u53d1\u5e03\u4e86\u5176 PRAC \u59d4\u5458\u4f1a\u7684\u6700\u65b0\u5b89\u5168\u4fe1\u53f7\u5efa\u8bae <strong>2025\u5e746\u67082\u65e5<\/strong>.<br class=\"yoast-text-mark\" data-start=\"285\" data-end=\"288\" \/>\u6b64\u6b21\u66f4\u65b0\u4f53\u73b0\u4e86 EMA \u6301\u7eed\u52aa\u529b <strong>\u52a0\u5f3a\u836f\u7269\u8b66\u6212\u76d1\u6d4b<\/strong> \u5e76\u52a0\u5f3a\u6574\u4e2a\u6b27\u76df\u6388\u6743\u836f\u54c1\u7684\u4e0a\u5e02\u540e\u76d1\u6d4b\u3002<\/p>\n<p data-start=\"744\" data-end=\"961\">\u8fd9\u4e9b\u4fee\u8ba2\u7684\u6307\u5357\u65e8\u5728\u52a0\u5f3a\u5bf9 <strong>\u836f\u7269\u4e0d\u826f\u53cd\u5e94\uff08ADR\uff09<\/strong>. \u5b83\u4eec\u6709\u52a9\u4e8e\u786e\u4fdd\u8425\u9500 <strong>\u6388\u6743\u6301\u6709\u4eba\uff08MAH\uff09<\/strong> \u4fdd\u6301\u4e0e\u4e0d\u65ad\u53d1\u5c55\u7684 <strong>\u836f\u54c1\u5b89\u5168\u6cd5\u89c4<\/strong>.<\/p>\n<h4 data-start=\"968\" data-end=\"1029\">\ud83d\udd0d 2025 \u5e74 6 \u6708 PRAC \u5efa\u8bae\u7684\u91cd\u70b9<\/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\u7684\u5b89\u5168\u4fe1\u53f7\uff1a<\/strong> \u8fd9\u4e9b\u5efa\u8bae\u6db5\u76d6\u4e86\u591a\u4e2a\u4ea7\u54c1\u4fe1\u606f\u7684\u66f4\u65b0 <strong>\u6cbb\u7597\u9886\u57df<\/strong>\u5305\u62ec\u80bf\u7624\u6cbb\u7597\u3001\u5fc3\u8840\u7ba1\u6cbb\u7597\u3001\u75ab\u82d7\u548c\u5176\u4ed6\u9ad8\u4f18\u5148\u7ea7\u836f\u7269\u3002\u8fd9\u4e9b\u4e0e\u6b27\u76df\u5404\u5730\u65b0\u5174\u7684\u836f\u7269\u8b66\u6212\u53d1\u73b0\u76f8\u4e00\u81f4\u3002<\/p>\n<\/li>\n<li data-start=\"1318\" data-end=\"1688\">\n<p data-start=\"1320\" data-end=\"1370\"><strong>\u4e2d\u592e\u6388\u6743\u836f\u54c1\u4e0e\u56fd\u5bb6\u6388\u6743\u836f\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\">\u4e3a\u4e86 <strong data-start=\"1379\" data-end=\"1413\">\u4e2d\u592e\u6388\u6743\u836f\u54c1<\/strong>\uff0c\u4efb\u4f55\u5efa\u8bae\u7684\u53d8\u66f4\u90fd\u5fc5\u987b\u7ecf\u8fc7 <strong data-start=\"1464\" data-end=\"1521\">\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08CHMP\uff09<\/strong>.<\/p>\n<\/li>\n<li data-start=\"1525\" data-end=\"1688\">\n<p data-start=\"1527\" data-end=\"1688\">\u4e3a\u4e86 <strong data-start=\"1531\" data-end=\"1565\">\u56fd\u5bb6\u6388\u6743\u4ea7\u54c1<\/strong>\uff0c\u5b9e\u65bd\u5c5e\u4e8e <strong data-start=\"1598\" data-end=\"1687\">\u76f8\u4e92\u8ba4\u53ef\u548c\u5206\u6563\u7a0b\u5e8f\u534f\u8c03\u5c0f\u7ec4 - \u4eba\u529b\uff08CMDh\uff09<\/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\">\u76d1\u7ba1\u5408\u89c4\u63d0\u9192<\/strong>\uff1a\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u5fc5\u987b <strong data-start=\"1765\" data-end=\"1803\">\u5b9a\u671f\u5ba1\u67e5 PRAC \u51fa\u7248\u7269<\/strong> \u5e76\u8fc5\u901f\u66f4\u65b0\u4ea7\u54c1\u6807\u7b7e\u3001\u4f20\u5355\u6216\u5176\u4ed6\u5b89\u5168\u4fe1\u606f\uff0c\u4ee5\u7b26\u5408\u6700\u65b0\u7684\u5b89\u5168\u76d1\u63a7\u534f\u8bae\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\">\u6f84\u6e05\u5b89\u5168\u4fe1\u53f7<\/strong>\uff1a\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u53d1\u73b0\u5b89\u5168\u4fe1\u53f7\u5e76\u4e0d\u80fd\u786e\u8ba4\u836f\u7269\u4e0e\u4e0d\u826f\u4e8b\u4ef6\u4e4b\u95f4\u7684\u56e0\u679c\u5173\u7cfb\uff0c\u800c\u662f\u8868\u660e\u9700\u8981\u8fdb\u4e00\u6b65\u8fdb\u884c\u79d1\u5b66\u8bc4\u4f30\u6216\u91c7\u53d6\u9884\u9632\u63aa\u65bd\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\u8bed\u8a00\u5b9e\u65bd<\/strong>\uff1a\u66f4\u65b0\u540e\u7684\u4ea7\u54c1\u4fe1\u606f\u4ee5\u6240\u6709\u6b27\u76df\u5b98\u65b9\u8bed\u8a00\u63d0\u4f9b\uff0c\u5305\u62ec\u632a\u5a01\u8bed\u548c\u51b0\u5c9b\u8bed\uff0c\u4ee5\u652f\u6301\u6240\u6709\u6210\u5458\u56fd\u7684\u534f\u8c03\u5b9e\u65bd\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\">\u836f\u7269\u8b66\u6212\u900f\u660e\u5ea6<\/strong>\uff1a\u7b54 <strong data-start=\"2456\" data-end=\"2497\">\u6240\u6709\u5b89\u5168\u4fe1\u53f7\u7684\u7d2f\u79ef\u5217\u8868<\/strong> \u81ea\u4ee5\u4e0b\u65e5\u671f\u8d77\u7531 PRAC \u5ba1\u6838 <strong data-start=\"2521\" data-end=\"2539\">2012\u5e749\u6708<\/strong> \u4fdd\u6301\u516c\u5f00\u53ef\u8bbf\u95ee\uff0c\u4e3a\u76d1\u7ba1\u673a\u6784\u548c\u533b\u7597\u4fdd\u5065\u5229\u76ca\u76f8\u5173\u8005\u63d0\u4f9b\u5386\u53f2\u80cc\u666f\u548c\u8d8b\u52bf\u53ef\u89c1\u6027\u3002<\/p>\n<\/li>\n<\/ul>\n<hr data-start=\"2659\" data-end=\"2662\" \/>\n<h4 data-start=\"2664\" data-end=\"2708\">\ud83c\udf10 \u4e3a\u4ec0\u4e48\u8fd9\u5bf9\u76d1\u7ba1\u56e2\u961f\u5f88\u91cd\u8981<\/h4>\n<p data-start=\"2710\" data-end=\"2948\">\u8fd9\u4e9b\u66f4\u65b0\u5728\u5b9e\u73b0 <strong data-start=\"2757\" data-end=\"2808\">\u66f4\u5feb\u5730\u5b9e\u65bd\u4e0e\u5b89\u5168\u76f8\u5173\u7684\u53d8\u9769\u3002 <\/strong>\u6539\u8fdb <strong data-start=\"2820\" data-end=\"2847\">\u76d1\u7ba1\u900f\u660e\u5ea6<\/strong>\u5e76\u652f\u6301 <strong data-start=\"2864\" data-end=\"2892\">\u516c\u5e73\u7684\u60a3\u8005\u5c31\u8bca<\/strong> \u4e86\u89e3\u6b27\u76df\u6700\u65b0\u7684\u836f\u54c1\u5b89\u5168\u6570\u636e\u3002<\/p>\n<p data-start=\"2950\" data-end=\"3107\">\u5bf9\u4e8e\u7ba1\u7406\u8fd9\u4e9b\u53d8\u5316\u7684\u76d1\u7ba1\u4e13\u4e1a\u4eba\u5458\u6765\u8bf4\uff0c\u53ca\u65f6\u4e86\u89e3\u8fd9\u4e9b\u53d8\u5316\u81f3\u5173\u91cd\u8981 <strong data-start=\"3034\" data-end=\"3056\">\u6b27\u76df\u836f\u54c1\u5408\u89c4\u6027<\/strong>, <strong data-start=\"3058\" data-end=\"3078\">\u6807\u7b7e\u66f4\u65b0<\/strong>\uff0c \u548c <strong data-start=\"3084\" data-end=\"3106\">\u98ce\u9669\u6c9f\u901a<\/strong>.<\/p>\n<hr data-start=\"3109\" data-end=\"3112\" \/>\n<h4 data-start=\"3114\" data-end=\"3161\">\ud83d\udce5 \u60f3\u8981\u4e86\u89e3\u6b27\u76df\u5b89\u5168\u66f4\u65b0\u7684\u6700\u65b0\u52a8\u6001\u5417\uff1f<\/h4>\n<p data-start=\"3163\" data-end=\"3387\">\u8bbf\u95ee <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\u5b98\u65b9\u7f51\u7ad9<\/a> \u4ee5\u83b7\u53d6\u5b89\u5168\u4fe1\u53f7\u66f4\u65b0\u548c\u4ea7\u54c1\u7279\u5b9a\u6307\u5357\u7684\u5b8c\u6574\u5217\u8868\u3002<\/p>\n<p data-start=\"3389\" data-end=\"3534\">\u6216\u8005\u63a2\u7d22\u5982\u4f55 <a href=\"https:\/\/regask.com\/zh\/\">RegASK<\/a>\u7684\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u76d1\u7ba1\u667a\u80fd\u5e73\u53f0\u53ef\u4ee5\u5e2e\u52a9\u60a8\u5b9e\u65f6\u76d1\u63a7\u5168\u7403\u836f\u7269\u8b66\u6212\u53d8\u5316\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u4e8e 2025 \u5e74 6 \u6708 2 \u65e5\u53d1\u5e03\u4e86\u5176 PRAC \u59d4\u5458\u4f1a\u66f4\u65b0\u7684\u5b89\u5168\u4fe1\u53f7\u5efa\u8bae\u3002\u6b64\u66f4\u65b0\u53cd\u6620\u4e86 EMA \u4e3a\u52a0\u5f3a\u836f\u7269\u8b66\u6212\u76d1\u6d4b\u548c\u52a0\u5f3a\u6b27\u76df (EU) \u6388\u6743\u836f\u54c1\u4e0a\u5e02\u540e\u76d1\u7ba1\u800c\u505a\u51fa\u7684\u6301\u7eed\u52aa\u529b\u3002\u8fd9\u4e9b\u4fee\u8ba2\u6307\u5357\u65e8\u5728\u6539\u8fdb\u5bf9\u836f\u54c1\u4e0d\u826f\u53cd\u5e94 (ADR) \u7684\u76d1\u7ba1\u3002\u5b83\u4eec\u6709\u52a9\u4e8e\u2026\u2026<\/p>","protected":false},"author":30,"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 v27.2 (Yoast SEO v27.3) - 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 name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/zh\/ema\u53d1\u5e03\u5173\u4e8e\u4e2d\u592e\u548c\u56fd\u5bb6\u6388\u6743\u836f\u54c1\u5b89\u5168\u4fe1\u53f7\u7684\u6700\u65b0\u5b9e\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EMA Releases June 2025 PRAC Safety Updates for EU-Authorized Medicines\" \/>\n<meta property=\"og:description\" content=\"Discover the latest EMA PRAC safety updates for centrally and nationally authorized medicines, effective June 2025 across the EU.\" \/>\n<meta property=\"og:url\" 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content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Amandine Tricou\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/zh\\\/ema-publishes-updated-prac-recommendations-on-safety-signals-for-centrally-and-nationally-authorized-medicines\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/zh\\\/ema-publishes-updated-prac-recommendations-on-safety-signals-for-centrally-and-nationally-authorized-medicines\\\/\"},\"author\":{\"name\":\"Amandine 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