{"id":9534,"date":"2026-02-24T22:52:46","date_gmt":"2026-02-24T14:52:46","guid":{"rendered":"https:\/\/regask.com\/?p=9534"},"modified":"2026-02-25T16:46:25","modified_gmt":"2026-02-25T08:46:25","slug":"%e6%ac%a7%e6%b4%b2%e8%8d%af%e5%93%81%e7%ae%a1%e7%90%86%e5%b1%80-ema-%e5%8f%91%e5%b8%83%e4%ba%86%e5%85%bd%e8%8d%af%e4%ba%a7%e5%93%81%e5%85%83%e7%b4%a0%e6%9d%82%e8%b4%a8%e9%a3%8e%e9%99%a9%e7%ae%a1","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/ema-issues-final-elemental-impurity-risk-management-guidance-for-veterinary-medicinal-products\/","title":{"rendered":"EMA\u53d1\u5e03\u6700\u7ec8\u7248\u5143\u7d20\u6742\u8d28\u98ce\u9669\u7ba1\u7406\u6307\u5357\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026\u5e742\u670820\u65e5,<\/strong> \u8fd9 <strong>\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40<\/strong> \u5df2\u53d1\u5e03 <strong>\u6700\u7ec8\u6307\u5357<\/strong> \u5236\u5b9a\u98ce\u9669\u7ba1\u7406\u8981\u6c42 <strong>\u6240\u6709\u517d\u836f\u4ea7\u54c1\uff08VMP\uff09\u4e2d\u7684\u5143\u7d20\u6742\u8d28\uff0c,<\/strong> \u5305\u62ec <strong>\u751f\u7269\u5236\u5242\u3001\u514d\u75ab\u5236\u5242\uff08\u5982\u75ab\u82d7\uff09\u548c\u65b0\u578b\u7597\u6cd5\u3002.<\/strong> \u8be5\u6307\u5357\u9002\u7528\u4e8e\u5bf9\u52a8\u7269\u7528\u517d\u836f\u7684\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u76d1\u7ba1\u5408\u89c4\u6027\u8d1f\u8d23\u7684\u751f\u4ea7\u5546\u3002.<\/p>\n<div class=\"row\"  id=\"row-304710702\">\n\n\t<div id=\"col-336473903\" 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-2074704927\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2074704927 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-1824679210\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1824679210 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u6307\u5357\u786e\u7acb\u4e86\u4e00\u79cd\u534f\u8c03\u4e00\u81f4\u7684\u65b9\u6cd5\uff0c\u7528\u4e8e\u2026\u2026 <strong>\u5143\u7d20\u6742\u8d28\u7684\u8bc6\u522b\u3001\u8bc4\u4f30\u548c\u63a7\u5236,<\/strong> \u5305\u62ec\u91cd\u91d1\u5c5e\u5728\u5185\u7684\u6240\u6709VMP\u7c7b\u522b\u3002\u5b83\u660e\u786e\u89c4\u5b9a\u5236\u9020\u5546\u5fc5\u987b\u9075\u5b88 <strong>\u98ce\u9669\u7ba1\u7406\u539f\u5219\u7b26\u5408\u6b27\u6d32\u836f\u5178\u7684\u8981\u6c42\uff0c,<\/strong> \u5373\u4f7f\u662f\u4ee5\u524d\u88ab\u6392\u9664\u5728\u7c7b\u4f3c\u4eba\u7528\u836f\u54c1\u6307\u5357\u4e4b\u5916\u7684\u517d\u7528\u4ea7\u54c1\u7c7b\u578b\u3002.<\/p>\n<p>\u8be5\u6587\u4ef6\u89c4\u5b9a\u4e86\u5bf9\u4ee5\u4e0b\u65b9\u9762\u7684\u9884\u671f\uff1a<strong> \u5e94\u8fdb\u884c\u98ce\u9669\u8bc4\u4f30\u5e76\u505a\u597d\u8bb0\u5f55\u3002,<\/strong> \u5176\u4e2d\u5305\u62ec\u8981\u6c42\u5728\u4e00\u5b9a\u65f6\u95f4\u5185\u603b\u7ed3\u98ce\u9669\u8bc4\u4f30\u7ed3\u679c\u3002<strong> \u65b0\u4ea7\u54c1\u7533\u62a5\u7684\u76d1\u7ba1\u6587\u4ef6\u3002.<\/strong> \u5bf9\u4e8e\u73b0\u6709\u4ea7\u54c1\uff0c\u53ea\u6709\u5f53\u91cd\u65b0\u8bc4\u4f30\u5bfc\u81f4\u63d0\u4ea4\u7684\u4fe1\u606f\u53d1\u751f\u53d8\u5316\u65f6\uff0c\u624d\u9700\u8981\u66f4\u65b0\u8d44\u6599\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-336473903 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2118028440\" 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-1372947976\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1372947976 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u5206\u9636\u6bb5\u5b9e\u65bd\u548c\u7075\u6d3b\u6027<\/h2>\n\t<div id=\"gap-223396268\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-223396268 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4e3a\u4e86 <strong>\u514d\u75ab\u517d\u836f\u4ea7\u54c1,<\/strong> \u4f8b\u5982\u75ab\u82d7\uff0c\u8be5\u6307\u5357\u5f15\u5165\u4e86 <strong>\u5206\u9636\u6bb5\u5b9e\u65bd\u65b9\u6cd5\u3002.<\/strong> \u8fd9\u53cd\u6620\u4e86\u5b83\u4eec\u603b\u4f53\u4e0a\u8f83\u4f4e\u7684\u98ce\u9669\u72b6\u51b5\uff0c\u5e76\u5728\u4fdd\u6301\u4e0e\u6574\u4f53\u8d28\u91cf\u548c\u5b89\u5168\u76ee\u6807\u4e00\u81f4\u7684\u540c\u65f6\uff0c\u63d0\u4f9b\u4e86\u66f4\u5927\u7684\u76d1\u7ba1\u7075\u6d3b\u6027\u3002.<\/p>\n<p>\u8be5\u6307\u5357\u8fd8\u5141\u8bb8 <strong>\u6bcf\u65e5\u5141\u8bb8\u66b4\u9732\u91cf<\/strong> \u5728\u79d1\u5b66\u8bba\u8bc1\u5408\u7406\u7684\u60c5\u51b5\u4e0b\uff0c\u5e94\u91cd\u65b0\u8ba1\u7b97\u5143\u7d20\u6742\u8d28\u542b\u91cf\uff0c\u5e76\u8003\u8651\u4ee5\u4e0b\u56e0\u7d20 <strong>\u52a8\u7269\u79cd\u7c7b\u3001\u4f53\u91cd\u3001\u5242\u91cf\u4f53\u79ef\u548c\u7ed9\u836f\u9891\u7387\u3002.<\/strong> \u5728\u76f4\u63a5\u68c0\u6d4b\u4e0d\u53ef\u884c\u6216\u4e0d\u76f8\u5173\u7684\u60c5\u51b5\u4e0b\uff0c, <strong>\u4e66\u76ee\u6570\u636e<\/strong> \u53ef\u7528\u4e8e\u652f\u6301\u98ce\u9669\u53ef\u5ffd\u7565\u4e0d\u8ba1\u7684\u7ed3\u8bba\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2118028440 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-866059206\" 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>\u53cd\u9988\u622a\u6b62\u65e5\u671f<\/h2>\n\t<div id=\"gap-1315273348\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1315273348 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>\u4e0d\u9002\u7528\u3002.<\/strong> \u672c\u6307\u5357\u53d1\u5e03\u5982\u4e0b\uff1a <strong>\u6700\u7ec8\u7684<\/strong> \u800c\u4e14\u6ca1\u6709\u89c4\u5b9a\u516c\u4f17\u610f\u89c1\u53cd\u9988\u6216\u54a8\u8be2\u7684\u622a\u6b62\u65e5\u671f\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-866059206 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1032301636\" 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>\u4e3a\u4ec0\u4e48\u91cd\u8981<\/h2>\n\t<div id=\"gap-1970186177\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1970186177 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u6307\u5357\u63d0\u4f9b\u4e86 <strong>\u76d1\u7ba1\u900f\u660e\u5ea6<\/strong> \u901a\u8fc7\u786e\u8ba4\u5143\u7d20\u6742\u8d28\u98ce\u9669\u7ba1\u7406\u5728\u6240\u6709\u517d\u836f\u4ea7\u54c1\u4e2d\u5f97\u5230\u4e00\u81f4\u5e94\u7528\u3002\u901a\u8fc7\u4f7f\u9884\u671f\u4e0e\u73b0\u6709\u6807\u51c6\u4fdd\u6301\u4e00\u81f4\u3002 <strong>\u6b27\u6d32\u836f\u5178\u6807\u51c6,<\/strong> \u5b83\u652f\u6301\u8d28\u91cf\u4f53\u7cfb\u5185\u7684\u6570\u5b57\u5316\u548c\u7a0b\u5e8f\u4e00\u81f4\u6027\uff0c\u63d0\u9ad8\u76d1\u7ba1\u7533\u62a5\u7684\u6548\u7387\uff0c\u5e76\u901a\u8fc7\u5f15\u5165\u7075\u6d3b\u6027\u548c\u5206\u9636\u6bb5\u5b9e\u65bd\uff08\u5728\u79d1\u5b66\u5408\u7406\u7684\u60c5\u51b5\u4e0b\uff09\u6765\u9650\u5236\u989d\u5916\u7684\u8d1f\u62c5\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1032301636 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1366108232\" 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>\u8fd9\u9002\u7528\u4e8e\u54ea\u4e9b\u4eba\u7fa4<\/h2>\n\t<div id=\"gap-1653646500\" class=\"gap-element clearfix\" style=\"display:block; 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height:auto;\">\n\t\t\n<style>\n#gap-622987879 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u517d\u836f\u4ea7\u54c1\u4e2d\u7684\u5143\u7d20\u6742\u8d28\u6709\u54ea\u4e9b\uff1f<\/h4>\n\t<div id=\"gap-372391989\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-372391989 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5143\u7d20\u6742\u8d28\u662f\u6307\u517d\u836f\u4ea7\u54c1\u4e2d\u53ef\u80fd\u5b58\u5728\u7684\u6709\u5bb3\u65e0\u673a\u5143\u7d20\uff0c\u4f8b\u5982\u91cd\u91d1\u5c5e\uff0c\u9700\u8981\u8fdb\u884c\u8bc4\u4f30\u548c\u63a7\u5236\uff0c\u4ee5\u786e\u4fdd\u4ea7\u54c1\u5b89\u5168\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1774154982 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1590107140\" 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>EMA \u6307\u5357\u6db5\u76d6\u54ea\u4e9b\u517d\u836f\u4ea7\u54c1\uff1f<\/h4>\n\t<div id=\"gap-173890368\" class=\"gap-element clearfix\" style=\"display:block; 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height:auto;\">\n\t\t\n<style>\n#gap-933775732 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u901a\u8fc7\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u76d1\u7ba1\u667a\u80fd\u548c\u5de5\u4f5c\u6d41\u7a0b\u81ea\u52a8\u5316\uff0c\u5e2e\u52a9\u76d1\u7ba1\u548c\u8d28\u91cf\u56e2\u961f\u8ddf\u8e2a EMA \u6307\u5357\u66f4\u65b0\uff0c\u8bc4\u4f30\u5176\u5bf9\u517d\u836f\u4ea7\u54c1\u7ec4\u5408\u7684\u5f71\u54cd\uff0c\u5e76\u7ba1\u7406\u98ce\u9669\u8bc4\u4f30\u548c\u6587\u4ef6\u8981\u6c42\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1479299277 > .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 February 20, 2026, the European Medicines Agency published final guidance setting out risk management requirements for elemental impurities in all veterinary medicinal products (VMPs), including biologicals, immunologicals such as vaccines, and novel therapies. The guidance applies to manufacturers responsible for the quality, safety, and regulatory compliance of veterinary pharmaceuticals used in animals.<\/p>","protected":false},"author":41,"featured_media":9535,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33,39],"tags":[],"class_list":["post-9534","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news","category-medical-devices-insights"],"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 Issues Final Elemental Impurity Guidance Released<\/title>\n<meta name=\"description\" content=\"Explore the EMA&#039;s final guidance on elemental impurity risk management for veterinary medicinal products and its impact on manufacturers.\" 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