{"id":10372,"date":"2026-06-30T10:33:30","date_gmt":"2026-06-30T02:33:30","guid":{"rendered":"https:\/\/regask.com\/?p=10372"},"modified":"2026-06-30T10:33:30","modified_gmt":"2026-06-30T02:33:30","slug":"gmp%e6%96%bd%e8%a1%8c%e3%81%af2026%e5%b9%b46%e6%9c%88","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/gmp-enforcement-june-2026\/","title":{"rendered":"GMP\uff08\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff09\u306e\u57f7\u884c\u304c\u5f37\u5316\uff1aFDA\u306e\u8b66\u544a\u66f8\u3001\u8f38\u5165\u898f\u5236\u2026"},"content":{"rendered":"<p id=\"ember1956\" class=\"ember-view reader-text-block__paragraph\"><span class=\"TextRun SCXW61959956 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW61959956 BCX0\"><strong>2026\u5e74\u534a\u3070\u306b\u306fGMP\uff08\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff09\u306e\u57f7\u884c\u304c\u8457\u3057\u304f\u5f37\u5316\u3055\u308c\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u5206\u91ce\u306e\u4e3b\u8981\u30c8\u30ec\u30f3\u30c9\u306e\u4e2d\u3067\u3001\u88fd\u9020\u691c\u67fb\u304c\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u898f\u5236\u8b66\u544a\u306e\u4e2d\u3067\u6700\u3082\u5927\u304d\u306a\u5272\u5408\u3092\u5360\u3081\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u3002.<\/strong> \u305d\u306e\u539f\u52d5\u529b\u306f\u3001\u7c73\u56fdFDA\u306e\u6d3b\u52d5\u306e\u660e\u3089\u304b\u306a\u6025\u5897\u3060\u3063\u305f\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">(<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">CGMP\u8b66\u544a\u66f8\u306e\u9023\u7d9a\u767a\u884c\u3068\u8f38\u5165\u5dee\u3057\u6b62\u3081\u63aa\u7f6e\u306e\u62e1\u5927<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">)<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u00a0\u65e5\u672c\u3068\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab\u3067\u306e\u691c\u67fb\u6d3b\u52d5\u3068\u4e26\u884c\u3057\u3066\u3002\u88fd\u9020\u304a\u3088\u3073\u54c1\u8cea\u30c1\u30fc\u30e0\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u306f\u6700\u3082\u76f4\u63a5\u7684\u306a\u696d\u52d9\u4e0a\u306e\u5f71\u97ff\u3092\u3082\u305f\u3089\u3059\u50be\u5411\u3067\u3059\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u3057\u306a\u3044<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u00a0\u751f\u6210\u3059\u308b\u3060\u3051\u00a0<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u66f8\u985e\u4f5c\u6210;<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u00a0\u6b62\u307e\u308b\u00a0<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u88fd\u54c1<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u00a0\u914d\u9001\u3002.<\/span><\/span><span class=\"EOP Selected SCXW61959956 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-18252410\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-18252410 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3><strong><span class=\"TextRun MacChromeBold SCXW170068198 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW170068198 BCX0\">FDA\u306fCGMP\u306b\u95a2\u3059\u308b\u8b66\u544a\u66f8\u3068\u8f38\u5165\u8b66\u544a\u3092\u5f37\u5316\u3057\u305f\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-819293055\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-819293055 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW80589066 BCX0\">FDA\u306f\u3001\u91cd\u5927\u306aCGMP\u9055\u53cd\u3092\u6307\u6458\u3059\u308b\u8b66\u544a\u66f8\u3092\u76f8\u6b21\u3044\u3067\u767a\u884c\u3057\u305f\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">(<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u7121\u83cc\u88fd\u9020\u3001\u539f\u85ac\uff08API\uff09\u88fd\u9020\u3001\u304a\u3088\u3073\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u65bd\u8a2d\u5168\u4f53\u306b\u308f\u305f\u3063\u3066<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u3055\u3089\u306b\u3001\u56fd\u5883\u3067\u306eGMP\u975e\u6e96\u62e0\u533b\u85ac\u54c1\u306b\u5bfe\u3059\u308b\u8eab\u4f53\u691c\u67fb\u306a\u3057\u306e\u62d8\u7559\u62e1\u5927\u3082\u5b9f\u65bd\u3055\u308c\u305f\u3002\u3053\u306e\u7d44\u307f\u5408\u308f\u305b\u304c\u6df1\u523b\u306a\u554f\u984c\u3068\u306a\u3063\u3066\u3044\u308b\u3002\u8b66\u544a\u66f8\u306f\u65bd\u8a2d\u306e\u8a55\u5224\u3092\u640d\u306a\u3046\u4e00\u65b9\u3001\u8f38\u5165\u62d8\u7559\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u9055\u53cd\u306e\u767a\u898b\u3092\u5373\u5ea7\u306b\u9055\u53cd\u3078\u3068\u5909\u3048\u3066\u3057\u307e\u3046\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u4f9b\u7d66<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u00a0\u4e2d\u65ad\u3002\u7121\u83cc\u6027\u4fdd\u8a3c\u3001\u30c7\u30fc\u30bf\u6574\u5408\u6027\u3001\u304a\u3088\u3073API\u5236\u5fa1\u306f\u3001\u624b\u7d19\u5168\u4f53\u3092\u901a\u3057\u3066\u7e70\u308a\u8fd4\u3057\u8a00\u53ca\u3055\u308c\u305f\u3002<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">,\u00a0<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u307e\u3055\u306b\u3001\u662f\u6b63\u63aa\u7f6e\u304c\u6700\u3082\u9045\u308c\u308b\u7b87\u6240\u3060\u3002\u8f38\u5165\u8b66\u544a\u3092\u53d7\u3051\u305f\u30b5\u30a4\u30c8\u306f\u3001\u6839\u672c\u7684\u306a\u554f\u984c\u304c\u89e3\u6c7a\u3055\u308c\u308b\u305a\u3063\u3068\u524d\u306b\u3001\u7c73\u56fd\u5e02\u5834\u304b\u3089\u7de0\u3081\u51fa\u3055\u308c\u3066\u3057\u307e\u3046\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW76108789 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW76108789 BCX0\">\u65e5\u672c\u306e\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u304cGMP\uff08\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff09\u67fb\u5bdf\u7d50\u679c\u3092\u516c\u8868\u3057\u305f\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1616578316\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1616578316 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW28283816 BCX0\">\u65e5\u672c\u306e\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u306f\u3001\u539f\u85ac\u7ba1\u7406\u306b\u7126\u70b9\u3092\u5f53\u3066\u305fGMP\u67fb\u5bdf\u4e8b\u4f8b\u5831\u544a\u66f8\u3092\u516c\u8868\u3057\u305f\u3002\u4e8b\u4f8b\u5831\u544a\u66f8\u306f\u3001\u4e00\u822c\u7684\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3068\u306f\u7570\u306a\u308a\u3001\u9759\u304b\u306b\u8cb4\u91cd\u306a\u4fa1\u5024\u3092\u6301\u3064\u3002\u67fb\u5bdf\u5b98\u306e\u5b9f\u969b\u306e\u671f\u5f85\u3068\u3001\u6307\u6458\u3055\u308c\u305f\u5177\u4f53\u7684\u306a\u4e0d\u5099\u306e\u30e2\u30fc\u30c9\u304c\u793a\u3055\u308c\u3066\u304a\u308a\u3001\u62bd\u8c61\u7684\u306a\u539f\u5247\u3088\u308a\u3082\u306f\u308b\u304b\u306b\u5b9f\u8df5\u7684\u3067\u3042\u308b\u3002\u54c1\u8cea\u7ba1\u7406\u30c1\u30fc\u30e0\u306f\u3001\u67fb\u5bdf\u5b98\u304c\u91cd\u8996\u3059\u308b\u5177\u4f53\u7684\u306a\u7ba1\u7406\u30dd\u30a4\u30f3\u30c8\u3092\u3001\u3053\u306e\u3088\u3046\u306a\u5831\u544a\u66f8\u304b\u3089\u62bd\u51fa\u3059\u3079\u304d\u3067\u3042\u308b\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW28283816 BCX0\">(<\/span><span class=\"NormalTextRun SCXW28283816 BCX0\">\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u3001\u6587\u66f8\u5316\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u8cc7\u683c\u8a8d\u5b9a<\/span><span class=\"NormalTextRun SCXW28283816 BCX0\">)<\/span><span class=\"NormalTextRun SCXW28283816 BCX0\">\u00a0\u305d\u3057\u3066\u3001\u691c\u67fb\u5b98\u304c\u8abf\u67fb\u3092\u884c\u3046\u524d\u306b\u3001\u81ea\u793e\u306eAPI\u76e3\u8996\u4f53\u5236\u3092\u8abf\u67fb\u7d50\u679c\u3068\u7167\u3089\u3057\u5408\u308f\u305b\u3066\u30d9\u30f3\u30c1\u30de\u30fc\u30af\u8a55\u4fa1\u3059\u308b\u3002.<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW154821105 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW154821105 BCX0\">\u30c9\u30df\u30cb\u30ab\u5171\u548c\u56fd\u306f\u8f38\u5165\u533b\u85ac\u54c1\u306b\u5bfe\u3059\u308b\u691c\u67fb\u3092\u62e1\u5927\u3057\u305f\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-38091081\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-38091081 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW41450848 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW41450848 BCX0\">\u30c9\u30df\u30cb\u30ab\u5171\u548c\u56fd\u306eDIGEMAPS\u306f\u3001GMP\u691c\u67fb\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u5916\u56fd\u3067\u88fd\u9020\u30fb\u8f38\u5165\u3055\u308c\u305f\u533b\u85ac\u54c1\u306b\u3082\u62e1\u5927\u3057\u305f\u3002\u5916\u56fd\u306e\u65bd\u8a2d\u3078\u306e\u9069\u7528\u7bc4\u56f2\u62e1\u5927\u306f\u3001\u3088\u308a\u5e83\u7bc4\u306a\u5730\u57df\u7684\u50be\u5411\u306e\u4e00\u90e8\u3067\u3042\u308a\u3001\u898f\u5236\u5f53\u5c40\u306f\u56fd\u5185\u65bd\u8a2d\u3060\u3051\u3067\u306a\u304f\u3001\u88fd\u9020\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u306b\u5bfe\u3059\u308b\u4fdd\u8a3c\u3092\u307e\u3059\u307e\u3059\u6c42\u3081\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u5e02\u5834\u306b\u8f38\u51fa\u3059\u308b\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u3001\u5916\u56fd\u65bd\u8a2d\u306eGMP\u30b9\u30c6\u30fc\u30bf\u30b9\u306f\u3001\u00a0<\/span><span class=\"NormalTextRun SCXW41450848 BCX0\">\u6c7a\u5b9a\u3059\u308b<\/span><span class=\"NormalTextRun SCXW41450848 BCX0\"> \u3053\u308c\u307e\u3067\u8f38\u51fa\u56fd\u306e\u76e3\u7763\u306b\u4f9d\u5b58\u3057\u3066\u3044\u305f\u5730\u57df\u3078\u306e\u30a2\u30af\u30bb\u30b9\u304c\u5236\u9650\u3055\u308c\u3001\u4e00\u3064\u306e\u5de5\u5834\u3067\u554f\u984c\u304c\u767a\u751f\u3059\u308c\u3070\u3001\u4e00\u5ea6\u306b\u8907\u6570\u306e\u5e02\u5834\u304c\u9589\u9396\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/span><\/span><span class=\"EOP SCXW41450848 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"NormalTextRun SCXW224609958 BCX0\">\u4f55\u00a0<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u3053\u308c\u306f<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u5e73\u5747<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u00a0\u306e\u305f\u3081\u306b\u00a0<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u88fd\u9020\u696d\u8005\uff1f<\/span><\/strong><\/h3>\n\t<div id=\"gap-664184897\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-664184897 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW116620405 BCX0\">FDA\u304c\u56fd\u5883\u3092\u8d8a\u3048\u3066\u6d3b\u52d5\u3092\u62e1\u5927\u3057\u3001\u65e5\u672c\u3068\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab\u306e\u67fb\u5bdf\u6a5f\u95a2\u304c\u6d3b\u52d5\u7bc4\u56f2\u3092\u5e83\u3052\u308b\u306b\u3064\u308c\u3066\u3001GMP\u306e\u57f7\u884c\u306f\u5f37\u5316\u3055\u308c\u3001 <\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">\u30b0\u30ed\u30fc\u30d0\u30eb\u5316\u3059\u308b<\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">. \u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30ec\u30ae\u30e5\u30ec\u30fc\u30bf\u30fc\u306e\u5727\u529b\u30c6\u30b9\u30c8\u306f\u00a0<\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">\u5f15\u7528<\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">(<\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">\u7121\u83cc\u6027\u4fdd\u8a3c\u3001\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3001\u304a\u3088\u3073API\u7ba1\u7406<\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">)<\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">\u00a0\u8ca8\u7269\u304c\u5dee\u3057\u6b62\u3081\u3089\u308c\u308b\u524d\u306b\u3001\u8f38\u5165\u898f\u5236\u3078\u306e\u9069\u5408\u72b6\u6cc1\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u898f\u5236\u304c\u53b3\u3057\u304f\u306a\u308b\u72b6\u6cc1\u3067\u306f\u3001GMP\u9055\u53cd\u306e\u30b3\u30b9\u30c8\u306f\u3001\u662f\u6b63\u63aa\u7f6e\u306b\u304b\u304b\u308b\u6642\u9593\u3060\u3051\u3067\u306a\u304f\u3001\u88fd\u54c1\u306e\u8ca9\u58f2\u505c\u6b62\u3084\u5e02\u5834\u306e\u9589\u9396\u3068\u3044\u3046\u5f62\u3067\u73fe\u308c\u307e\u3059\u3002.\u00a0<\/span><a href=\"http:\/\/regask.com\/ja\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW116620405 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW116620405 BCX0\">\u00a0\u4e16\u754c\u4e2d\u306e\u898f\u5236\u5f53\u5c40\u306b\u3088\u308bGMP\u67fb\u5bdf\u7d50\u679c\u3001\u8b66\u544a\u66f8\u3001\u8f38\u5165\u8b66\u544a\u3092\u8ffd\u8de1\u3057\u3001\u88fd\u9020\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u30c1\u30fc\u30e0\u304c\u5f37\u5316\u3055\u308c\u308b\u898f\u5236\u57f7\u884c\u306b\u5148\u624b\u3092\u6253\u3066\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002.<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>GMP enforcement escalated noticeably in mid-2026, and manufacturing inspections carried the highest share of risky regulatory alerts among our top Life Sciences trends. The driver was a clear surge in US FDA action\u00a0(a run of CGMP warning letters paired with expanded import detentions)\u00a0alongside inspection activity in Japan and Latin America. For manufacturing and quality teams, this is the trend with the most direct operational consequence: enforcement here\u00a0doesn&#8217;t\u00a0just generate\u00a0paperwork;\u00a0it stops\u00a0product\u00a0shipping.\u00a0 The FDA escalated CGMP warning letters and import alerts The FDA issued a wave of warning letters citing significant CGMP deficiencies\u00a0(across sterile manufacturing, active pharmaceutical ingredient (API) production, and outsourcing facilities)\u00a0and expanded detention without physical examination for GMP-noncompliant drugs at the&#8230;<\/p>","protected":false},"author":46,"featured_media":10375,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10372","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO 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content=\"https:\/\/regask.com\/ja\/gmp\u65bd\u884c\u306f2026\u5e746\u6708\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-30T02:33:30+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/06\/gmp-enforcement-escalates_-fda-warning-letters-import-alerts-global-inspections.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=\"Shaffa Renaningtyas\" \/>\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\" 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