{"id":2903,"date":"2026-07-07T15:17:48","date_gmt":"2026-07-07T15:17:48","guid":{"rendered":"https:\/\/tsubaki-jp.com\/?p=2903"},"modified":"2026-07-09T23:15:13","modified_gmt":"2026-07-09T23:15:13","slug":"%e6%97%a5%e6%9c%ac%e8%8d%af%e5%93%81%e5%8f%ac%e5%9b%9e%e5%92%8c%e5%ae%89%e5%85%a8%e8%ad%a6%e7%a4%ba%e6%80%8e%e4%b9%88%e7%9c%8b%ef%bc%9apmda-%e5%9b%9e%e6%94%b6%e4%bf%a1%e6%81%af%e3%80%81%e9%bb%84","status":"publish","type":"post","link":"https:\/\/tsubaki-jp.com\/zh-hans\/%e6%97%a5%e6%9c%ac%e8%8d%af%e5%93%81%e5%8f%ac%e5%9b%9e%e5%92%8c%e5%ae%89%e5%85%a8%e8%ad%a6%e7%a4%ba%e6%80%8e%e4%b9%88%e7%9c%8b%ef%bc%9apmda-%e5%9b%9e%e6%94%b6%e4%bf%a1%e6%81%af%e3%80%81%e9%bb%84\/","title":{"rendered":"\u65e5\u672c\u836f\u54c1\u53ec\u56de\u548c\u5b89\u5168\u8b66\u793a\u600e\u4e48\u770b\uff1aPMDA \u56de\u6536\u4fe1\u606f\u3001\u9ec4\u4fe1\u84dd\u4fe1\u4e0e\u7528\u6237\u5904\u7406\u6e05\u5355"},"content":{"rendered":"<div class=\"tsubaki-medical-note\">\n<p><strong>\u4fe1\u606f\u72b6\u6001\uff1a2026\u5e747\u67088\u65e5\u3002<\/strong>\u672c\u6587\u57fa\u4e8e PMDA\u3001\u539a\u751f\u52b3\u52a8\u7701\u516c\u5f00\u8d44\u6599\u6574\u7406\uff0c\u4ec5\u4f9b\u836f\u4e8b\u4fe1\u606f\u548c\u6d88\u8d39\u8005\u5b89\u5168\u6559\u80b2\u53c2\u8003\uff0c\u4e0d\u6784\u6210\u533b\u7597\u3001\u7528\u836f\u6216\u6cd5\u5f8b\u5efa\u8bae\u3002<\/p>\n<\/div>\n<figure class=\"wp-block-image size-large tsubaki-ai-illustration\" data-tsubaki-ai-cover=\"japan-drug-recall-safety-alert-pmda-yellow-blue-letter-guide\"><img src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/07\/tsubaki-ai-japan-drug-recall-safety-alert-pmda-yellow-blue-letter-guide-1024x576.jpg\" alt=\"\u65e5\u672c\u836f\u54c1\u53ec\u56de\u548c\u5b89\u5168\u8b66\u793a\u4e3b\u9898\u63d2\u56fe\" loading=\"lazy\" decoding=\"async\" \/><\/figure>\n<p>\u65e5\u672c\u836f\u54c1\u5b89\u5168\u4fe1\u606f\u6709\u4e00\u5957\u76f8\u5bf9\u6e05\u6670\u7684\u516c\u5f00\u6e20\u9053\u3002\u5bf9\u4e2d\u6587\u7528\u6237\u6765\u8bf4\uff0c\u6700\u5bb9\u6613\u6df7\u6dc6\u7684\u662f\u201c\u53ec\u56de\u201d\u201c\u4f7f\u7528\u4e0a\u6ce8\u610f\u4fee\u8ba2\u201d\u201c\u7d27\u6025\u5b89\u5168\u6027\u4fe1\u606f\u201d\u201c\u5b89\u5168\u6027\u901f\u5831\u201d\u3002\u8fd9\u4e9b\u8bcd\u770b\u8d77\u6765\u90fd\u50cf\u98ce\u9669\u63d0\u9192\uff0c\u4f46\u542b\u4e49\u548c\u5904\u7406\u65b9\u5f0f\u4e0d\u540c\u3002<\/p>\n<h2>\u4e00\u3001\u56de\u6536\u4fe1\u606f\uff1a\u5148\u770b\u662f\u5426\u6d89\u53ca\u81ea\u5df1\u624b\u91cc\u7684\u4ea7\u54c1<\/h2>\n<p>PMDA \u7684\u836f\u54c1\u56de\u6536\u9875\u9762\u53ef\u4ee5\u67e5\u8be2 2023 \u5e74\u5ea6\u4ee5\u540e\u533b\u836f\u54c1\u3001\u4f53\u5916\u8bca\u65ad\u7528\u533b\u836f\u54c1\u3001\u533b\u836f\u90e8\u5916\u54c1\u548c\u5316\u5986\u54c1\u7b49\u4ea7\u54c1\u7684\u56de\u6536\u4fe1\u606f\u3002\u56de\u6536\u901a\u5e38\u6309\u98ce\u9669\u7a0b\u5ea6\u533a\u5206\u7b49\u7ea7\uff0c\u9875\u9762\u4e5f\u63d0\u793a Class I\u3001Class II \u56de\u6536\u4fe1\u606f\u53ef\u901a\u8fc7 PMDA Medinavi \u90ae\u4ef6\u83b7\u53d6\u3002<\/p>\n<p>\u666e\u901a\u7528\u6237\u770b\u5230\u201c\u56de\u6536\u201d\u65f6\uff0c\u6700\u5148\u8981\u6838\u5bf9\u7684\u662f\u4ea7\u54c1\u540d\u3001\u751f\u4ea7\u4f01\u4e1a\u3001\u6279\u53f7\u3001\u6709\u6548\u671f\u548c\u5305\u88c5\u89c4\u683c\u3002\u4e0d\u8981\u53ea\u770b\u5230\u54c1\u724c\u76f8\u4f3c\u5c31\u6050\u614c\uff0c\u4e5f\u4e0d\u8981\u56e0\u4e3a\u201c\u836f\u8fd8\u6ca1\u8fc7\u671f\u201d\u5c31\u7ee7\u7eed\u4f7f\u7528\u3002\u56de\u6536\u4fe1\u606f\u901a\u5e38\u9488\u5bf9\u7279\u5b9a\u6279\u6b21\u6216\u7279\u5b9a\u95ee\u9898\u3002<\/p>\n<h2>\u4e8c\u3001\u9ec4\u4fe1\u548c\u84dd\u4fe1\uff1a\u4e0d\u662f\u666e\u901a\u65b0\u95fb\uff0c\u662f\u91cd\u8981\u5b89\u5168\u6c9f\u901a<\/h2>\n<p>PMDA \u5c06\u7d27\u6025\u5b89\u5168\u6027\u4fe1\u606f\u79f0\u4e3a Yellow Letter\uff0c\u5b89\u5168\u6027\u901f\u5831\u79f0\u4e3a Blue Letter\u3002\u5b83\u4eec\u901a\u5e38\u7528\u4e8e\u9700\u8981\u8f83\u5feb\u5411\u533b\u7597\u73b0\u573a\u6216\u60a3\u8005\u4f20\u8fbe\u7684\u91cd\u5927\u98ce\u9669\u3002PMDA \u9875\u9762\u663e\u793a\uff0c2026 \u5e74 5 \u6708 21 \u65e5\u66fe\u53d1\u5e03\u5173\u4e8e\u30bf\u30d6\u30cd\u30aa\u30b9\u30ab\u30d7\u30bb\u30eb10mg\u91cd\u7be4\u306a\u809d\u6a5f\u80fd\u969c\u5bb3\u7684\u5b89\u5168\u6027\u901f\u5831\u53ca\u60a3\u8005\u5bb6\u5c5e\u8d44\u6599\u3002<\/p>\n<p>\u8fd9\u7c7b\u4fe1\u606f\u901a\u5e38\u4e0d\u610f\u5473\u7740\u6240\u6709\u4eba\u90fd\u5fc5\u987b\u9a6c\u4e0a\u505c\u836f\u3002\u5904\u65b9\u836f\u60a3\u8005\u5c24\u5176\u4e0d\u80fd\u81ea\u884c\u505c\u836f\u6216\u6539\u5242\u91cf\uff0c\u5e94\u8054\u7cfb\u5904\u65b9\u533b\u751f\u3001\u836f\u5e08\u6216\u533b\u7597\u673a\u6784\uff0c\u786e\u8ba4\u4e2a\u4eba\u98ce\u9669\u548c\u4e0b\u4e00\u6b65\u5904\u7406\u3002<\/p>\n<h2>\u4e09\u3001PMDA Medinavi\uff1a\u7ed9\u533b\u7597\u673a\u6784\u548c\u8fd0\u8425\u8005\u7684\u5b89\u5168\u96f7\u8fbe<\/h2>\n<p>PMDA Medinavi \u662f PMDA \u7684\u4fe1\u606f\u90ae\u4ef6\u670d\u52a1\uff0c\u4f1a\u53d1\u9001\u7d27\u6025\u5b89\u5168\u6027\u4fe1\u606f\u3001\u5b89\u5168\u6027\u901f\u5831\u3001\u4f7f\u7528\u4e0a\u6ce8\u610f\u4fee\u8ba2\u3001\u56de\u6536\u4fe1\u606f\u3001\u627f\u8ba4\u4fe1\u606f\u3001RMP \u7b49\u91cd\u8981\u5185\u5bb9\u3002\u5bf9\u4e8e\u7ecf\u8425\u836f\u54c1\u76f8\u5173\u4e1a\u52a1\u6216\u5efa\u7acb\u836f\u54c1\u4fe1\u606f\u680f\u76ee\u7684\u7f51\u7ad9\uff0c\u6301\u7eed\u5173\u6ce8\u6b64\u7c7b\u6765\u6e90\u975e\u5e38\u91cd\u8981\u3002<\/p>\n<h2>\u56db\u3001\u7528\u6237\u5904\u7406\u6e05\u5355<\/h2>\n<ul>\n<li>\u6838\u5bf9\u4ea7\u54c1\u540d\u3001\u5242\u578b\u3001\u89c4\u683c\u3001\u6279\u53f7\u548c\u6709\u6548\u671f\u3002<\/li>\n<li>\u4e0d\u8981\u81ea\u884c\u5224\u65ad\u201c\u5dee\u4e0d\u591a\u7684\u836f\u90fd\u4e0d\u80fd\u7528\u201d\uff0c\u4e5f\u4e0d\u8981\u5ffd\u89c6\u6279\u53f7\u5b8c\u5168\u543b\u5408\u7684\u53ec\u56de\u3002<\/li>\n<li>\u5904\u65b9\u836f\u6216\u957f\u671f\u7528\u836f\u8005\uff0c\u5148\u8054\u7cfb\u533b\u751f\u6216\u836f\u5e08\uff0c\u4e0d\u8981\u81ea\u884c\u505c\u836f\u3002<\/li>\n<li>OTC \u6216\u5065\u5eb7\u4ea7\u54c1\u82e5\u547d\u4e2d\u53ec\u56de\uff0c\u505c\u6b62\u4f7f\u7528\u5e76\u8054\u7cfb\u9500\u552e\u65b9\u6216\u4f01\u4e1a\u54a8\u8be2\u7a97\u53e3\u3002<\/li>\n<li>\u4fdd\u7559\u5305\u88c5\u3001\u8d2d\u4e70\u8bb0\u5f55\u3001\u7167\u7247\u548c\u4e0d\u9002\u75c7\u72b6\u8bb0\u5f55\u3002<\/li>\n<li>\u5982\u51fa\u73b0\u4e25\u91cd\u4e0d\u9002\uff0c\u4f18\u5148\u5c31\u533b\uff0c\u800c\u4e0d\u662f\u7b49\u5f85\u5e73\u53f0\u5ba2\u670d\u56de\u590d\u3002<\/li>\n<\/ul>\n<p>\u5bf9 Tsubaki \u6765\u8bf4\uff0c\u836f\u4e8b\u65b0\u95fb\u680f\u76ee\u4e0d\u5e94\u53ea\u8f6c\u8f7d\u201c\u67d0\u836f\u88ab\u53ec\u56de\u201d\uff0c\u66f4\u5e94\u8be5\u8ba9\u7528\u6237\u5b66\u4f1a\u8bfb\u61c2\u5b89\u5168\u4fe1\u606f\u7684\u7ea7\u522b\u3001\u6765\u6e90\u548c\u4e2a\u4eba\u884c\u52a8\u6b65\u9aa4\u3002<\/p>\n<h2>\u53c2\u8003\u6765\u6e90<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/calling-attention\/recall-info\/0002.html\" target=\"_blank\" rel=\"noopener\">PMDA\uff1a\u56de\u53ce\u60c5\u5831\uff08\u533b\u85ac\u54c1\uff09<\/a><\/li>\n<li><a href=\"https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/calling-attention\/esc-rsc\/0001.html\" target=\"_blank\" rel=\"noopener\">PMDA\uff1a\u7dca\u6025\u5b89\u5168\u6027\u60c5\u5831\uff08\u30a4\u30a8\u30ed\u30fc\u30ec\u30bf\u30fc\uff09\u30fb\u5b89\u5168\u6027\u901f\u5831\uff08\u30d6\u30eb\u30fc\u30ec\u30bf\u30fc\uff09<\/a><\/li>\n<li><a href=\"https:\/\/www.pmda.go.jp\/safety\/info-services\/medi-navi\/0007.html\" target=\"_blank\" rel=\"noopener\">PMDA\uff1aPMDA\u30e1\u30c7\u30a3\u30ca\u30d3<\/a><\/li>\n<li><a href=\"https:\/\/www.pmda.go.jp\/english\/safety\/info-services\/0001.html\" target=\"_blank\" rel=\"noopener\">PMDA English\uff1aProvision of Information Regarding Post-marketing Safety<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>\u7528\u4e2d\u6587\u89e3\u91ca\u65e5\u672c PMDA \u836f\u54c1\u56de\u6536\u4fe1\u606f\u3001\u7d27\u6025\u5b89\u5168\u6027\u4fe1\u606f\u3001\u5b89\u5168\u6027\u901f\u5831\u548c PMDA Medinavi \u7684\u4f5c\u7528\uff0c\u5e76\u7ed9\u51fa\u666e\u901a\u7528\u6237\u9047\u5230\u53ec\u56de\u6216\u8b66\u793a\u65f6\u7684\u5904\u7406\u6e05\u5355\u3002<\/p>\n","protected":false},"author":1,"featured_media":2651,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[746,155,738],"tags":[],"class_list":["post-2903","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-safe-medicine-shopping-guide-zh","category-155","category-pharma-news-zh"],"_links":{"self":[{"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/posts\/2903","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=2903"}],"version-history":[{"count":1,"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/posts\/2903\/revisions"}],"predecessor-version":[{"id":3071,"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/posts\/2903\/revisions\/3071"}],"wp:attachment":[{"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=2903"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=2903"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tsubaki-jp.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=2903"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}