{"id":9746,"date":"2026-04-01T10:27:48","date_gmt":"2026-04-01T02:27:48","guid":{"rendered":"https:\/\/regask.com\/?p=9746"},"modified":"2026-04-01T10:27:48","modified_gmt":"2026-04-01T02:27:48","slug":"%e6%97%a5%e6%9c%ac%e6%9b%b4%e6%96%b0%e4%ba%86jpma%e6%96%b0%e8%8d%af%e7%94%b3%e8%af%b7%e8%b4%a8%e9%87%8f%e6%a3%80%e6%b5%8b%e8%87%aa%e6%9f%a5%e6%b8%85%e5%8d%95","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications\/","title":{"rendered":"\u65e5\u672c\u66f4\u65b0JPMA\u8d28\u91cf\u81ea\u68c0\u6e05\u5355\u2026\u2026"},"content":{"rendered":"<p><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">\u5728\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">2026\u5e743\u670826\u65e5<\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\"><strong>,<\/strong> \u8fd9<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">\u65e5\u672c\u836f\u54c1\u5de5\u4e1a\u534f\u4f1a\uff08JPMA\uff09 <\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">\u5df2\u53d1\u5e03 <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">\u4fee\u8ba2\u540e\u7684\u8d28\u91cf\u68c0\u6d4b\u81ea\u68c0\u6e05\u5355<\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\"><strong>,<\/strong> \u5f15\u5165\u66f4\u65b0\u7684\u6846\u67b6\u4ee5\u652f\u6301\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW31536731 BCX0\">\u836f\u54c1\u8d28\u91cf\u6570\u636e\u7684\u53ef\u9760\u6027\u548c\u79d1\u5b66\u6709\u6548\u6027<\/span><\/span><\/strong><span class=\"TextRun SCXW31536731 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><strong><span class=\"NormalTextRun SCXW31536731 BCX0\">\u00a0<\/span><\/strong><span class=\"NormalTextRun SCXW31536731 BCX0\">\u63d0\u4ea4<\/span><span class=\"NormalTextRun SCXW31536731 BCX0\">\u00a0\u5728\u65e5\u672c\u7684\u65b0\u836f\u7533\u8bf7\u4e2d\u3002.<\/span><\/span><span class=\"EOP SCXW31536731 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-956089336\">\n\n\t<div id=\"col-1540954936\" 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-1202177144\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1202177144 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-1312875360\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1312875360 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u66f4\u65b0\u540e\u7684\u6e05\u5355\u53d6\u4ee3\u4e86\u4e4b\u524d\u7684\u6e05\u5355\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u57fa\u4e8e\u6587\u4ef6\u7684\u5408\u683c\u8bc4\u5b9a\u68c0\u67e5\u6e05\u5355<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5e76\u5de9\u56fa\u00a0<\/span><b><span data-contrast=\"auto\">\u5c06\u5206\u6790\u6d4b\u8bd5\u548c\u7a33\u5b9a\u6027\u6d4b\u8bd5\u6574\u5408\u5230\u4e00\u4e2a\u7edf\u4e00\u7684\u6846\u67b6\u4e2d<\/span><\/b><span data-contrast=\"auto\">. \u6b64\u6b21\u6574\u5408\u65e8\u5728\u7b80\u5316\u7533\u8bf7\u4eba\u8bc4\u4f30\u548c\u8bc1\u660e\u76d1\u7ba1\u6587\u4ef6\u4e2d\u9ad8\u8d28\u91cf\u6570\u636e\u53ef\u9760\u6027\u7684\u65b9\u5f0f\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4fee\u8ba2\u7248\u660e\u786e\u5220\u9664\u4e86\u4ee5\u4e0b\u5185\u5bb9\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u975e\u4e34\u5e8a\u7814\u7a76\u8981\u7d20<\/span><\/b><span data-contrast=\"auto\">, \u7f29\u5c0f\u4e86\u68c0\u67e5\u6e05\u5355\u7684\u8303\u56f4\uff0c\u4f7f\u5176\u4e13\u6ce8\u4e8e\u4e0e\u4ea7\u54c1\u5ba1\u6279\u76f8\u5173\u7684\u8d28\u91cf\u6d4b\u8bd5\u3002\u6b64\u5916\uff0c\u5b83\u8fd8\u660e\u786e\u6307\u51fa\u8be5\u68c0\u67e5\u6e05\u5355\u662f\u2026\u2026\u00a0<\/span><b><span data-contrast=\"auto\">\u5e76\u975e\u6240\u9700\u6587\u4ef6\u7684\u5177\u4f53\u6e05\u5355<\/span><\/b><span data-contrast=\"auto\">, \u800c\u662f\u4e00\u4e2a\u65e8\u5728\u652f\u6301\u7684\u5de5\u5177\u00a0<\/span><b><span data-contrast=\"auto\">\u603b\u4f53\u53ef\u9760\u6027\u8bc4\u4f30<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5df2\u63d0\u4ea4\u7684\u6570\u636e\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u6b64\u5916\uff0c\u8be5\u6e05\u5355\u5f3a\u8c03\u7533\u8bf7\u4eba\u5fc5\u987b\u786e\u4fdd\u00a0<\/span><b><span data-contrast=\"auto\">\u6d4b\u8bd5\u7684\u51c6\u5907\u3001\u5b9e\u65bd\u548c\u8bb0\u5f55<\/span><\/b><span data-contrast=\"auto\">\u00a0\u7b26\u5408\u65e2\u5b9a\u7684\u53ef\u9760\u6027\u6807\u51c6\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u5408\u540c\u6d4b\u8bd5<\/span><\/b><span data-contrast=\"auto\">, \u7533\u8bf7\u4eba\u987b\u4fdd\u6301\u00a0<\/span><b><span data-contrast=\"auto\">\u5df2\u8bb0\u5f55\u7684\u7528\u4e8e\u786e\u8ba4\u6d4b\u8bd5\u53ef\u9760\u6027\u7684\u65b9\u6cd5<\/span><\/b><span data-contrast=\"auto\">, \u5373\u4f7f\u5916\u5305\uff0c\u4e5f\u8981\u52a0\u5f3a\u95ee\u8d23\u5236\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u6b64\u6b21\u66f4\u65b0\u8fdb\u4e00\u6b65\u51f8\u663e\u4e86\u4ee5\u4e0b\u65b9\u9762\u7684\u91cd\u8981\u6027\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u7535\u5b50\u8bb0\u5f55\u5408\u89c4\u6027<\/span><\/b><span data-contrast=\"auto\">, \u8981\u6c42\u9075\u5b88\u65e2\u5b9a\u7a0b\u5e8f\uff0c\u5305\u62ec\u4e0e\u4ee5\u4e0b\u65b9\u9762\u4e00\u81f4\u7684\u7a0b\u5e8f\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u7535\u5b50\u8bb0\u5f55\u548c\u7535\u5b50\u7b7e\u540d\u6307\u5357<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u8fd9\u00a0<\/span><b><span data-contrast=\"auto\">JPMA<\/span><\/b><span data-contrast=\"auto\">\u00a0\u6ce8\u610f\u5230\u00a0<\/span><b><span data-contrast=\"auto\">\u9884\u8ba1\u4f1a\u6301\u7eed\u8fdb\u884c\u4fee\u8ba2\u3002<\/span><\/b><span data-contrast=\"auto\">\u00a0\u968f\u7740\u884c\u4e1a\u5b9e\u8df5\u7684\u4e0d\u65ad\u53d1\u5c55\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1540954936 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-516926041\" 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-1305676013\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1305676013 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u672c\u6b21\u66f4\u65b0\u6709\u6240\u6539\u8fdb<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u76d1\u7ba1\u900f\u660e\u5ea6<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\"><strong>\u00a0<\/strong>\u7ecf\u8fc7\u00a0<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">\u5de9\u56fa<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0\u5c06\u8d28\u91cf\u6d4b\u8bd5\u9884\u671f\u6574\u5408\u5230\u4e00\u4e2a\u7edf\u4e00\u7684\u6846\u67b6\u4e2d\uff0c\u5e76\u79fb\u9664\u4e0d\u76f8\u5173\u7684\u5143\u7d20\u3002\u5b83\u652f\u6301\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u6570\u5b57\u5bf9\u51c6<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0\u901a\u8fc7\u66f4\u6e05\u6670\u7684\u7535\u5b50\u8bb0\u5f55\u9884\u671f\u548c\u6539\u8fdb\u63aa\u65bd\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u8fd0\u8425\u6548\u7387<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0\u901a\u8fc7\u7b80\u5316\u81ea\u68c0\u6d41\u7a0b\u3002\u540c\u65f6\uff0c\u5b83\u00a0<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">\u4fdd\u6301<\/span><span class=\"NormalTextRun SCXW96147886 BCX0\">\u00a0a\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\">\u975e\u89c4\u8303\u6027\u65b9\u6cd5<\/span><\/span><\/strong><span class=\"TextRun SCXW96147886 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW96147886 BCX0\"><strong>,<\/strong> \u5728\u786e\u4fdd\u6570\u636e\u53ef\u9760\u6027\u7684\u540c\u65f6\uff0c\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u4e0d\u5fc5\u8981\u7684\u5408\u89c4\u8d1f\u62c5\u3002.<\/span><\/span><span class=\"EOP SCXW96147886 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-516926041 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-964179322\" 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\u4f1a\u5f71\u54cd\u54ea\u4e9b\u4eba<\/h2>\n\t<div id=\"gap-443573301\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-443573301 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u66f4\u65b0\u9002\u7528\u4e8e<strong> \u8d28\u91cf\u4fdd\u8bc1 (QA)\u3001\u6cd5\u89c4\u4e8b\u52a1 (RA) \u548c\u7814\u53d1\u56e2\u961f<\/strong> \u5728\u5236\u836f\u516c\u53f8\u5185\u90e8\u8fdb\u884c\u51c6\u5907<strong> \u65e5\u672c\u65b0\u836f\u7533\u8bf7,<\/strong> \u7279\u522b\u662f\u90a3\u4e9b\u53c2\u4e0e\u5176\u4e2d\u7684\u4eba <strong>\u8d28\u91cf\u6d4b\u8bd5\u3001\u6570\u636e\u5b8c\u6574\u6027\u548c\u63d0\u4ea4\u51c6\u5907\u60c5\u51b5\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-964179322 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-119706392\" 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>\u4e0b\u4e00\u6b65<\/h2>\n\t<div id=\"gap-1018854254\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1018854254 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span 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0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On\u00a0March 26, 2026, the\u00a0Japan Pharmaceutical Manufacturers Association (JPMA) published a revised self-inspection checklist for quality testing, introducing an updated framework to support the\u00a0reliability and scientific validity of pharmaceutical quality data\u00a0submitted\u00a0in new drug applications in Japan.\u00a0<\/p>","protected":false},"author":41,"featured_media":9747,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,35,519],"tags":[],"class_list":["post-9746","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-pharma-biotech-latest-insights","category-japan-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - 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its self-inspection checklist for quality testing in new drug applications, integrating analytical and stability testing to improve data reliability.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/\u65e5\u672c\u66f4\u65b0\u4e86jpma\u65b0\u836f\u7533\u8bf7\u8d28\u91cf\u68c0\u6d4b\u81ea\u67e5\u6e05\u5355\/\" \/>\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=\"2026-04-01T02:27:48+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/04\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications.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=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Shaffa Renaningtyas\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/japan-updates-jpma-self-inspection-checklist-for-quality-testing-in-new-drug-applications\\\/\"},\"author\":{\"name\":\"Shaffa 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