{"id":1147,"date":"2019-09-17T12:09:20","date_gmt":"2019-09-17T04:09:20","guid":{"rendered":"https:\/\/regask.com\/?p=1147"},"modified":"2024-11-16T05:12:39","modified_gmt":"2024-11-15T21:12:39","slug":"%e7%be%8e%e5%9b%bd-%e6%ac%a7%e7%9b%9f-mra-%e6%9b%b4%e6%96%b0","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/us-eu-mra-update\/","title":{"rendered":"\u66f4\u65b0\uff1a\u7f8e\u56fd\u548c\u6b27\u76df\u4e4b\u95f4\u7684\u76f8\u4e92\u627f\u8ba4\u534f\u8bae\u2026"},"content":{"rendered":"<p>\u81ea 2019 \u5e74 7 \u6708 11 \u65e5\u8d77\uff0c\u8fc7\u6e21\u671f\u7ed3\u675f\uff0c\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/mutual-recognition-agreements-mra#united-states-section\" target=\"_blank\" rel=\"noopener noreferrer\">\u76f8\u4e92\u8ba4\u53ef\u534f\u8bae<\/a>\u00a0\u7f8e\u56fd\u548c\u6b27\u76df\u4e4b\u95f4\u8fbe\u6210\u7684MRA\uff08\u76f8\u4e92\u627f\u8ba4\u4e0e\u8865\u507f\u534f\u8bae\uff09\u6b63\u5728\u8c08\u5224\u4e2d\u3002<\/p>\n<h2 class=\"h4\">\u8fd9 <strong>\u6211\u4eec<\/strong> \u548c <strong>\u6b27\u76df<\/strong><\/h2>\n<p>\u7ecf\u8fc7\u591a\u5e74\u5ba1\u67e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40 (FDA) \u5df2\u786e\u8ba4\u6b27\u76df 28 \u4e2a\u6210\u5458\u56fd\u5747\u6709\u80fd\u529b\u5728\u7b26\u5408\u4ee5\u4e0b\u8981\u6c42\u7684\u8bbe\u65bd\u4e2d\u751f\u4ea7\u4eba\u7c7b\u836f\u54c1\uff1a\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\" target=\"_blank\" rel=\"noopener noreferrer\">\u826f\u597d\u751f\u4ea7\u89c4\u8303 (GMP)<\/a>\u540c\u6837\uff0c\u6b27\u76df\u59d4\u5458\u4f1a\uff08EC\uff09\u4e5f\u786e\u8ba4\uff0cFDA \u5df2\u5236\u5b9a\u5145\u5206\u7684\u7a0b\u5e8f\u6765\u6267\u884c\u4e0e\u6b27\u76df\u540c\u7b49\u7ea7\u522b\u7684 GMP \u68c0\u67e5\u3002<\/p>\n<h2 class=\"h4\">\u8fd9\u662f\u4ec0\u4e48\u610f\u601d <strong>\u610f\u601d\u662f<\/strong>?<\/h2>\n<p>\u56e0\u6b64\uff0c\u6b27\u76df\u6210\u5458\u56fd\u4e0d\u518d\u6709\u4e49\u52a1\u5bf9 MRA \u6db5\u76d6\u7684\u4eba\u7c7b\u836f\u7269\u8fdb\u884c\u6279\u91cf\u6d4b\u8bd5\uff1bFDA \u53ef\u4ee5\u4f9d\u8d56\u6b27\u76df\u7684\u68c0\u67e5\u7ed3\u679c\uff0c\u4ece\u800c\u6d88\u9664\u591a\u4f59\u7684\u63aa\u65bd\u3002MRA \u4f7f FDA \u548c\u6b27\u76df\u80fd\u591f\u5c06\u68c0\u67e5\u5de5\u4f5c\u91cd\u70b9\u653e\u5728\u5728\u00a0<a href=\"https:\/\/www.oncozine.com\/united-states-and-europe-reach-milestone-agreement-on-mutual-recognition-of-inspections\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u5176\u4ed6\u56fd\u5bb6\u7684\u8bbe\u65bd<\/a>.<\/p>\n<p>\u65b0\u6307\u5357\u4e3b\u8981\u6db5\u76d6\u4eba\u7c7b\u836f\u7269\u3001\u751f\u7269\u5236\u5242\u548c\u517d\u836f\uff0c\u4f46\u6709\u4e00\u4e9b\u4f8b\u5916\u3002\u517d\u836f\u76ee\u524d\u4e0d\u5305\u62ec\u5728\u5185\uff0c\u4f46\u53ef\u80fd\u4f1a\u5728 2019 \u5e74 12 \u6708 15 \u65e5\u4e4b\u524d\u4e88\u4ee5\u8003\u8651\u3002\u75ab\u82d7\u548c\u8840\u6d46\u884d\u751f\u4ea7\u54c1\u751f\u4ea7\u8bbe\u65bd\u7684\u73b0\u884c\u826f\u597d\u751f\u4ea7\u89c4\u8303 (CGMP) \u4e5f\u4e0d\u5305\u62ec\u5728\u5185\uff0c\u4f46\u5c06\u5728 2022 \u5e74 7 \u6708 15 \u65e5\u4e4b\u524d\u4e88\u4ee5\u8003\u8651\u3002\u4ee5\u4e0b\u4ea7\u54c1\u4e0d\u5305\u62ec\u5728\u5185\uff0c\u4e5f\u4e0d\u4f1a\u88ab\u8003\u8651\uff1a<\/p>\n<ul>\n<li>1. \u4eba\u7c7b\u8840\u6db2<\/li>\n<li>2. \u4eba\u7c7b\u8840\u6d46<\/li>\n<li>3. \u4eba\u4f53\u7ec4\u7ec7\u548c\u5668\u5b98<\/li>\n<li>4. \u517d\u533b\u514d\u75ab\u836f\u7269<\/li>\n<\/ul>\n<p>\u5982\u9700\u67e5\u770b MRA \u6db5\u76d6\u7684\u836f\u54c1\u5b8c\u6574\u5217\u8868\uff0c\u8bf7\u70b9\u51fb\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/mutual-recognition-agreements-mra#united-states-section\" target=\"_blank\" rel=\"noopener noreferrer\">\u8fd9\u91cc<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>\u622a\u81f32019\u5e747\u670811\u65e5\uff0c\u8fc7\u6e21\u671f\u7ed3\u675f\uff0c\u7f8e\u56fd\u4e0e\u6b27\u76df\u7b7e\u7f72\u7684\u300a\u76f8\u4e92\u627f\u8ba4\u534f\u8bae\u300b\uff08MRA\uff09\u6b63\u5f0f\u751f\u6548\u3002\u7ecf\u8fc7\u591a\u5e74\u7684\u5ba1\u67e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5df2\u786e\u8ba4\u6b27\u76df28\u4e2a\u6210\u5458\u56fd\u5747\u5177\u5907\u2026\u2026<\/p>","protected":false},"author":39,"featured_media":2207,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,30],"tags":[],"class_list":["post-1147","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-and-biotech-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.2) - 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