{"id":7779,"date":"2024-11-18T10:58:36","date_gmt":"2024-11-18T02:58:36","guid":{"rendered":"https:\/\/regask.com\/?p=7779"},"modified":"2024-11-21T17:44:39","modified_gmt":"2024-11-21T09:44:39","slug":"%e6%97%a5%e6%9c%ac%e5%8e%9a%e7%94%9f%e5%8a%b3%e5%8a%a8%e7%9c%81%e6%8e%a8%e5%8a%a8-rwd-%e8%8d%af%e5%93%81%e5%ae%a1%e6%89%b9","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/japan-mhlw-promotes-rwd-pharma-approvals\/","title":{"rendered":"\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\u9f13\u52b1\u4f7f\u7528\u771f\u5b9e\u4e16\u754c\u6570\u636e (RWD) \u6765\u2026\u2026"},"content":{"rendered":"<p>2024 \u5e74 10 \u6708 7 \u65e5\uff0c\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701 (MHLW) \u53d1\u5e03\u4e86\u4e00\u4efd\u91cd\u8981\u901a\u77e5\uff0c\u9f13\u52b1\u4f7f\u7528\u771f\u5b9e\u4e16\u754c\u6570\u636e (RWD) \u652f\u6301\u836f\u54c1\u5ba1\u6279\u7684\u90e8\u5206\u4fee\u6539\u3002Pharma Japan \u7684\u4e00\u7bc7\u6587\u7ae0\u91cd\u70b9\u4ecb\u7ecd\u4e86\u8fd9\u4e00\u66f4\u65b0\uff0c\u5b83\u4ee3\u8868\u7740\u4e00\u9879\u6218\u7565\u4e3e\u63aa\uff0c\u5373\u5229\u7528\u60a3\u8005\u767b\u8bb0\u6570\u636e\uff08\u6db5\u76d6\u75be\u75c5\u6982\u51b5\u3001\u6cbb\u7597\u7ec6\u8282\u548c\u540e\u7eed\u7ed3\u679c\uff09\u4f5c\u4e3a\u67d0\u4e9b\u76d1\u7ba1\u53d8\u5316\u7684\u4f20\u7edf\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53ef\u9760\u66ff\u4ee3\u65b9\u6848\u3002\u8be5\u8ba1\u5212\u5f3a\u8c03\u4e86 MHLW \u81f4\u529b\u4e8e\u5728\u76d1\u7ba1\u51b3\u7b56\u4e2d\u4f7f\u7528\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\uff0c\u6700\u7ec8\u6539\u5584\u836f\u54c1\u7684\u533b\u7597\u521b\u65b0\u548c\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002<\/p>\n<p><strong>\u901a\u77e5\u8981\u70b9<\/strong><\/p>\n<p>\u8be5\u901a\u77e5\u9488\u5bf9\u7684\u662f\u5bfb\u6c42\u4fee\u6539\u4ea7\u54c1\u5ba1\u6279\uff08\u65e0\u9700\u8fdb\u884c\u5168\u9762\u4e34\u5e8a\u8bd5\u9a8c\uff09\u7684\u5236\u836f\u516c\u53f8\u3002\u8fd9\u4e9b\u53d8\u5316\u53ef\u80fd\u5305\u62ec\u4ee5\u4e0b\u65b9\u9762\u7684\u8c03\u6574\uff1a<\/p>\n<ul>\n<li><strong>\u9002\u5e94\u75c7<\/strong>\uff1a\u6269\u5927\u6216\u6307\u5b9a\u6cbb\u7597\u7528\u9014\u3002<\/li>\n<li><strong>\u5242\u91cf<\/strong>\uff1a\u4fee\u6539\u63a8\u8350\u5242\u91cf\u3002<\/li>\n<li><strong>\u5176\u4ed6\u5173\u952e\u65b9\u9762<\/strong>\uff1a\u539a\u751f\u52b3\u52a8\u7701\u5b9a\u4e49\u7684\u5404\u79cd\u91cd\u5927\u53d8\u5316\u3002<\/li>\n<\/ul>\n<p>RWD \u6db5\u76d6\u6765\u81ea\u7535\u5b50\u5065\u5eb7\u8bb0\u5f55 (EHR)\u3001\u75be\u75c5\u548c\u4ea7\u54c1\u767b\u8bb0\u3001\u60a3\u8005\u62a5\u544a\u7ed3\u679c\u4ee5\u53ca\u5bb6\u5ead\u4f7f\u7528\u73af\u5883\u6570\u636e\u7b49\u6765\u6e90\u7684\u6570\u636e\uff0c\u5b83\u4ece\u5b9e\u9645\u4e34\u5e8a\u73af\u5883\u4e2d\u63d0\u4f9b\u4e86\u5b9d\u8d35\u7684\u89c1\u89e3\uff0c\u4e3a\u4f20\u7edf\u4e34\u5e8a\u8bd5\u9a8c\u63d0\u4f9b\u4e86\u5b9e\u7528\u7684\u8865\u5145\u3002<\/p>\n<p><strong>\u8303\u56f4\u548c\u5efa\u8bae<\/strong><\/p>\n<p>\u867d\u7136\u6cbb\u7597\u9886\u57df\u6216\u4ea7\u54c1\u7c7b\u522b\u6ca1\u6709\u5177\u4f53\u5b9a\u4e49\uff0c\u4f46\u901a\u77e5\u8868\u660e\u8be5\u653f\u7b56\u53ef\u80fd\u9002\u7528\u4e8e\u5e7f\u6cdb\u7684\u836f\u54c1\u548c\u533b\u7597\u4ea7\u54c1\u3002\u5efa\u8bae\u8003\u8651\u5c06 RWD \u7528\u4e8e\u76d1\u7ba1\u63d0\u4ea4\u7684\u516c\u53f8\u5728\u6d41\u7a0b\u65e9\u671f\u54a8\u8be2\u539a\u751f\u52b3\u52a8\u7701\uff0c\u4ee5\u786e\u8ba4\u5176\u6570\u636e\u7b26\u5408\u539a\u751f\u52b3\u52a8\u7701\u7684\u8d28\u91cf\u3001\u76f8\u5173\u6027\u548c\u53ef\u9760\u6027\u6807\u51c6\u3002<\/p>\n<p><strong>\u7ed3\u8bba<\/strong><\/p>\n<p>\u539a\u751f\u52b3\u52a8\u7701\u7684\u8fd9\u9879\u4e3e\u63aa\u9f13\u52b1\u65e5\u672c\u5236\u836f\u516c\u53f8\u5229\u7528 RWD \u4f5c\u4e3a\u6709\u6548\u7684\u76d1\u7ba1\u8d44\u6e90\uff0c\u4fc3\u8fdb\u4ea7\u54c1\u5ba1\u6279\u4e2d\u9ad8\u6548\u3001\u6570\u636e\u9a71\u52a8\u7684\u8c03\u6574\u3002\u968f\u7740\u65e5\u672c\u7ee7\u7eed\u5728\u533b\u7597\u4fdd\u5065\u9886\u57df\u91c7\u7528\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\uff0c\u8fd9\u79cd\u65b9\u6cd5\u5c06\u52a0\u5feb <a href=\"https:\/\/regask.com\/zh\/%e6%97%a5%e6%9c%ac%e5%8c%96%e5%a6%86%e5%93%81%e6%88%90%e5%88%86%e7%99%bb%e8%ae%b0\/\">\u8c03\u8282\u901a\u8def<\/a> \u7528\u4e8e\u521b\u65b0\u6cbb\u7597\uff0c\u786e\u4fdd\u53ca\u65f6\u83b7\u5f97\u6539\u8fdb\u7684\u6cbb\u7597\u65b9\u6cd5\u3002<\/p>\n<hr \/>","protected":false},"excerpt":{"rendered":"<p>On October 7, 2024, Japan\u2019s Ministry of Health, Labor, and Welfare (MHLW) issued a significant notification encouraging the use of Real-World Data (RWD) to support partial modifications in pharmaceutical product approvals. This update, highlighted in an article by Pharma Japan, represents a strategic move towards utilizing patient registry data\u2014covering disease profiles, treatment specifics, and follow-up&#8230;<\/p>","protected":false},"author":43,"featured_media":7847,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,519],"tags":[387,496],"class_list":["post-7779","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-japan-regulations","tag-real-word-evidence-rwe","tag-market-authorization-regs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Japan MHLW Promotes RWD for Pharma Approvals | RegASK<\/title>\n<meta name=\"description\" content=\"Japan\u2019s MHLW encourages use of real-world data for pharma approval, boosting innovation. 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