{"id":20274,"date":"2025-11-03T18:16:03","date_gmt":"2025-11-03T10:16:03","guid":{"rendered":"https:\/\/www.hjtdsm.cn\/?p=20274"},"modified":"2025-11-03T18:24:35","modified_gmt":"2025-11-03T10:24:35","slug":"2025%e5%b9%b4%e4%b8%ad%e5%9b%bd%e7%bb%86%e8%83%9e%e6%b2%bb%e7%96%97%e7%9b%91%e7%ae%a1%e4%b8%8e%e6%94%bf%e7%ad%96%e5%8f%91%e5%b1%95%e7%9a%84%e6%96%b0%e5%8a%a8%e6%80%81","status":"publish","type":"post","link":"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html","title":{"rendered":"2025\u5e74\u4e2d\u56fd\u7ec6\u80de\u6cbb\u7597\u76d1\u7ba1\u4e0e\u653f\u7b56\u53d1\u5c55\u7684\u65b0\u52a8\u6001"},"content":{"rendered":"<blockquote><p>\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff08CTPs\uff09\u5df2\u6210\u4e3a\u4e2d\u56fd\u518d\u751f\u533b\u5b66\u7814\u7a76\u9886\u57df\u4e2d\u6781\u5177\u53d1\u5c55\u524d\u666f\u7684\u65b9\u5411\u3002\u8fd1\u5e74\u6765\uff0c\u4e0e\u8fd9\u4e9b\u521b\u65b0\u4ea7\u54c1\u76f8\u5173\u7684\u65b0\u836f\u7533\u8bf7\u9700\u6c42\u663e\u8457\u589e\u957f\u3002\u7136\u800c\uff0cCTPs\u6765\u6e90\u5e7f\u6cdb\u3001\u751f\u7269\u5b66\u529f\u80fd\u591a\u6837\u3001\u4ea7\u54c1\u7c7b\u578b\u591a\u6837\uff0c\u4ee5\u53ca\u76f8\u5173\u6280\u672f\u590d\u6742\uff0c\u7ed9\u76d1\u7ba1\u5e26\u6765\u4e86\u8bf8\u591a\u6311\u6218\u3002<\/p><\/blockquote>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_79_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" 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href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#1%E3%80%81%E5%BC%95%E8%A8%80\" >1\u3001\u5f15\u8a00<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#2%E3%80%81CTP%E7%9A%84%E8%8C%83%E5%9B%B4\" >2\u3001CTP\u7684\u8303\u56f4<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#3%E3%80%81%E7%9B%91%E7%AE%A1%E8%B7%AF%E5%BE%84\" >3\u3001\u76d1\u7ba1\u8def\u5f84<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#%E5%BD%93%E5%89%8DCTP%E4%B8%8A%E5%B8%82%E7%9B%91%E7%AE%A1%E8%B7%AF%E5%BE%84\" >\u5f53\u524dCTP\u4e0a\u5e02\u76d1\u7ba1\u8def\u5f84<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#4%E3%80%81%E5%A6%82%E4%BD%95%E9%80%90%E6%AD%A5%E5%AE%8C%E5%96%84CTP%E7%9B%91%E7%AE%A1%EF%BC%8C%E5%AE%8C%E5%96%84CTP%E7%9B%91%E7%AE%A1%E7%9A%84%E8%BF%87%E7%A8%8B%E6%98%AF%E6%80%8E%E4%B9%88%E6%A0%B7%E7%9A%84%EF%BC%9F\" >4\u3001\u5982\u4f55\u9010\u6b65\u5b8c\u5584CTP\u76d1\u7ba1\uff0c\u5b8c\u5584CTP\u76d1\u7ba1\u7684\u8fc7\u7a0b\u662f\u600e\u4e48\u6837\u7684\uff1f<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#%E6%98%8E%E6%99%B0%E7%9B%91%E7%AE%A1%E5%AE%9A%E4%BD%8D%E4%B8%8E%E6%9C%BA%E6%9E%84%E8%81%8C%E8%83%BD\" >\u660e\u6670\u76d1\u7ba1\u5b9a\u4f4d\u4e0e\u673a\u6784\u804c\u80fd<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" 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href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#5%E3%80%81%E4%BF%83%E8%BF%9B%E6%9C%AA%E6%B3%A8%E5%86%8C%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E8%8D%AF%E7%89%A9%E7%9A%84%E4%B8%B4%E5%BA%8A%E7%A0%94%E7%A9%B6%E7%9B%91%E7%AE%A1%E5%8F%91%E5%B1%95%E7%9A%84%E8%BF%87%E7%A8%8B%E5%8F%8A%E5%85%B3%E9%94%AE%E8%A6%81%E7%B4%A0\" >5\u3001\u4fc3\u8fdb\u672a\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\u7684\u4e34\u5e8a\u7814\u7a76\u76d1\u7ba1\u53d1\u5c55\u7684\u8fc7\u7a0b\u53ca\u5173\u952e\u8981\u7d20<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#%E7%9B%91%E7%AE%A1%E5%8F%91%E5%B1%95%E8%BF%87%E7%A8%8B\" >\u76d1\u7ba1\u53d1\u5c55\u8fc7\u7a0b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#%E5%85%B3%E9%94%AE%E8%A6%81%E7%B4%A0%E5%88%86%E6%9E%90\" >\u5173\u952e\u8981\u7d20\u5206\u6790<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#6%E3%80%81%E5%AE%8C%E5%96%84%E5%9B%BD%E5%AE%B6CTP%E8%B4%A8%E9%87%8F%E6%8E%A7%E5%88%B6%E4%BD%93%E7%B3%BB%E7%9A%84%E6%96%B9%E6%B3%95%E6%9C%89%E5%93%AA%E4%BA%9B%EF%BC%9F\" >6\u3001\u5b8c\u5584\u56fd\u5bb6CTP\u8d28\u91cf\u63a7\u5236\u4f53\u7cfb\u7684\u65b9\u6cd5\u6709\u54ea\u4e9b\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20274.html\/#7%E3%80%81%E7%BB%93%E8%AE%BA\" >7\u3001\u7ed3\u8bba<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"2025%E5%B9%B4%E4%B8%AD%E5%9B%BD%E7%BB%86%E8%83%9E%E6%B2%BB%E7%96%97%E7%9B%91%E7%AE%A1%E4%B8%8E%E6%94%BF%E7%AD%96%E5%8F%91%E5%B1%95%E7%9A%84%E6%96%B0%E5%8A%A8%E6%80%81\"><\/span>2025\u5e74\u4e2d\u56fd\u7ec6\u80de\u6cbb\u7597\u76d1\u7ba1\u4e0e\u653f\u7b56\u53d1\u5c55\u7684\u65b0\u52a8\u6001<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u6b64\u80cc\u666f\u4e0b\uff0c\u8fd1\u671f\uff0c<strong><span dir=\"auto\">\u4e2d\u56fd\u5317\u4eac\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u6240\u8054\u5408<\/span><span dir=\"auto\">\u4e2d\u56fd\u5317\u4eac\u836f\u7269\u8c03\u63a7\u79d1\u5b66\u56fd\u5bb6\u91cd\u70b9\u5b9e\u9a8c\u5ba4\u3001<\/span><\/strong><span dir=\"auto\"><strong>\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a\u751f\u7269\u6280\u672f\u4ea7\u54c1\u68c0\u6d4b\u4e0e\u6807\u51c6\u5316\u91cd\u70b9\u5b9e\u9a8c\u5ba4<\/strong>\u7b49\u7814\u7a76\u673a\u6784\uff0c\u5728\u671f\u520a\u6742\u5fd7\u300a<\/span>Cell Therapy Manufacturing\u300b\u4e0a\u53d1\u8868\u4e86\u4e00\u7bc7<a href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#citeas\" target=\"_blank\" rel=\"noopener nofollow\"><strong>\u201c<\/strong><\/a><span dir=\"auto\"><strong>\u4e2d\u56fd\u7ec6\u80de\u6cbb\u7597\u76d1\u7ba1\u4e0e\u653f\u7b56\u53d1\u5c55\u201d<\/strong>\u7684\u7814\u7a76\u7efc\u8ff0\uff0c\u7efc\u8ff0\u6df1\u5165\u63a2\u8ba8\u4e86<strong>\u4e2d\u56fd\u76d1\u7ba1\u673a\u6784\u5982\u4f55\u4e0d\u65ad\u5b8c\u5584\u76d1\u7ba1\u6846\u67b6\u3001\u63d0\u5347\u8d28\u91cf\u8bc4\u4f30\u80fd\u529b\uff0c\u5e76\u52a0\u5f3a\u4e0e\u4e1a\u754c\u7684\u6c9f\u901a\u4e0e\u5408\u4f5c\uff0c\u4ee5\u5e94\u5bf9\u8fd9\u4e9b\u6311\u6218\u3002\u8fd9\u4e9b\u6301\u7eed\u7684\u76d1\u7ba1\u4e3e\u63aa\u5bf9\u4fc3\u8fdb\u4e2d\u56fdCTPs\u4e34\u5e8a\u8f6c\u5316\u5065\u5eb7\u5feb\u901f\u53d1\u5c55\u8d77\u5230\u4e86\u81f3\u5173\u91cd\u8981\u7684\u4f5c\u7528<\/strong>\u3002<\/span><\/p>\n<div id=\"attachment_20278\" style=\"width: 774px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-20278\" class=\"wp-image-20278 size-full\" src=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/wechat_2025-11-03_175150_244.png\" alt=\"2025\u5e74\u4e2d\u56fd\u7ec6\u80de\u6cbb\u7597\u76d1\u7ba1\u4e0e\u653f\u7b56\u53d1\u5c55\u7684\u65b0\u52a8\u6001\" width=\"764\" height=\"483\" title=\"\" srcset=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/wechat_2025-11-03_175150_244.png 764w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/wechat_2025-11-03_175150_244-300x190.png 300w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/wechat_2025-11-03_175150_244-18x12.png 18w\" sizes=\"(max-width: 764px) 100vw, 764px\" \/><p id=\"caption-attachment-20278\" class=\"wp-caption-text\">2025\u5e74\u4e2d\u56fd\u7ec6\u80de\u6cbb\u7597\u76d1\u7ba1\u4e0e\u653f\u7b56\u53d1\u5c55\u7684\u65b0\u52a8\u6001<\/p><\/div>\n<h2 id=\"Sec1\" class=\"c-article-section__title js-section-title js-c-reading-companion-sections-item\"><span class=\"ez-toc-section\" id=\"1%E3%80%81%E5%BC%95%E8%A8%80\"><\/span><span dir=\"auto\">1\u3001\u5f15\u8a00<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div id=\"Sec1-content\" class=\"c-article-section__content\">\n<p><span dir=\"auto\">\u81ea2010\u5e74\u4ee5\u6765\uff0c<a href=\"https:\/\/www.hjtdsm.cn\/ar\/news\/egulatory-trends\/20269.html\/\" target=\"_blank\" rel=\"noopener\">\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff08CTP\uff09<\/a>\u7684\u7814\u53d1\u5728\u5168\u7403\u8303\u56f4\u5185\u8fc5\u901f\u53d1\u5c55\uff0c\u4e3a\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u3001\u764c\u75c7\u3001\u9057\u4f20\u6027\u75be\u75c5\u3001\u7f55\u89c1\u75c5\u548c\u5176\u4ed6\u4ee5\u5f80\u65e0\u6cd5\u6cbb\u6108\u7684\u75be\u75c5\u63d0\u4f9b\u4e86\u65b0\u7684\u6cbb\u7597\u673a\u9047\u548c\u9009\u62e9\u3002\u968f\u7740\u5bf9\u4e34\u5e8a\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7814\u7a76\u7684\u4e0d\u65ad\u6df1\u5165\uff0c\u5168\u7403\u7ec6\u80de\u6cbb\u7597\u5e02\u573a\u9884\u8ba1\u5c06\u4ece2021\u5e74\u768495\u4ebf\u7f8e\u5143\u589e\u957f\u52302028\u5e74\u7684230\u4ebf\u7f8e\u5143[\u00a0<\/span><a id=\"ref-link-section-d58746447e744\" title=\"El-Kadiry AE-H\u3001Rafei M\u3001Shammaa R. \u7ec6\u80de\u7597\u6cd5\uff1a\u7c7b\u578b\u3001\u8c03\u63a7\u548c\u4e34\u5e8a\u83b7\u76ca\u3002Front Med. 2021;8:756029\u3002https:\/\/doi.org\/10.3389\/fmed.2021.756029\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR1\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e 1\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">1<\/span><\/a><span dir=\"auto\">\u00a0]\u3002\u5c3d\u7ba1\u4e2d\u56fd\u5728\u7ec6\u80de\u6cbb\u7597\u7814\u7a76\u9886\u57df\u8d77\u6b65\u8f83\u665a\uff0c\u4f46\u5df2\u8fc5\u901f\u6210\u4e3a\u5168\u7403\u8be5\u9886\u57df\u6700\u6d3b\u8dc3\u7684\u5730\u533a\u4e4b\u4e00[\u00a0<\/span><a id=\"ref-link-section-d58746447e747\" title=\"\u9ad8\u6770\uff0c\u9ad8\u8d85. \u4e2d\u56fd\u5e72\u7ec6\u80de\u7597\u6cd5\u7684\u53d1\u5c55\u4e0e\u76d1\u7ba1. \u7ec6\u80de\u589e\u6b96. 2022;55(8):e13217. https:\/\/doi.org\/10.1111\/cpr.13217.\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR2\" 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CAR T \u7ec6\u80de\u6cbb\u7597\u540e\u7b2c\u4e8c\u539f\u53d1\u6027\u6076\u6027\u80bf\u7624\u7684\u7279\u5f81\uff1a\u6765\u81ea FAERS \u548c VigiBase \u8fd9\u4e24\u4e2a\u5168\u7403\u836f\u7269\u8b66\u6212\u6570\u636e\u5e93\u7684\u771f\u5b9e\u4e16\u754c\u89c1\u89e3\u3002EClinicalMedicine. 2024;73:102684. https:\/\/doi.org\/10.1016\/j.eclinm.2024.102684\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR4\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e4\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">4<\/span><\/a><span dir=\"auto\">\u00a0]\u3002\u4e3a\u6b64\uff0c\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u79ef\u6781\u63a8\u8fdb\u4e0eCTP\u76f8\u5173\u7684\u76d1\u7ba1\u7814\u7a76\u3002\u8fd9\u9879\u5de5\u4f5c\u65e8\u5728\u589e\u5f3a\u5bf9\u65b0\u5174\u6280\u672f\u7684\u9002\u5e94\u6027\uff0c\u5e76\u5e94\u5bf9\u65b0\u65b9\u6cd5\u548c\u65b0\u7406\u5ff5\u5e26\u6765\u7684\u6311\u6218\uff0c\u5c24\u5176\u662f\u5728\u4e0e\u56fd\u9645\u6280\u672f\u6807\u51c6\u63a5\u8f68\u65b9\u9762\u3002NMPA\uff08<\/span><a href=\"https:\/\/english.nmpa.gov.cn\/\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">https:\/\/english.nmpa.gov.cn\/<\/span><\/a><span dir=\"auto\">\uff09\u6b63\u79ef\u6781\u63a2\u7d22\u5236\u5b9a\u76d1\u7ba1\u653f\u7b56\uff0c\u5e76\u5f00\u53d1\u7b26\u5408\u4e2d\u56fd\u7ec6\u80de\u6cbb\u7597\u884c\u4e1a\u72ec\u7279\u9700\u6c42\u7684\u65b0\u5de5\u5177\u3001\u6807\u51c6\u548c\u65b9\u6cd5\u3002\u8fd9\u79cd\u65b9\u6cd5\u4e0d\u4ec5\u4fc3\u8fdb\u4e86\u521b\u65b0\uff0c\u4e5f\u6ee1\u8db3\u4e86\u91cd\u5927\u516c\u5171\u536b\u751f\u7a81\u53d1\u4e8b\u4ef6\u671f\u95f4\u7684\u7d27\u6025\u4e34\u5e8a\u9700\u6c42\uff0c\u5e76\u589e\u5f3a\u4e86\u7814\u53d1\u80fd\u529b\u3002\u81ea2015\u5e74\u4ee5\u6765\uff0c\u5728\u63a8\u8fdbCTP\u7684\u57fa\u7840\u7814\u7a76\u548c\u8bc4\u4ef7\u4f53\u7cfb\u65b9\u9762\u53d6\u5f97\u4e86\u663e\u8457\u8fdb\u5c55\u3002\u672c\u6587\u7b80\u8981\u6982\u8ff0\u4e86\u4e2d\u56fdCTP\u76d1\u7ba1\u653f\u7b56\u7684\u53d1\u5c55\u548c\u8d28\u91cf\u8bc4\u4ef7\u80fd\u529b\u7684\u63d0\u5347\u3002\u6709\u5173\u4e2d\u56fd\u6807\u51c6\u7684\u66f4\u591a\u8ba8\u8bba\uff0c\u8bf7\u53c2\u9605J Cao\u7b49\u4eba\u7684\u7ae0\u8282\u3002<\/span><\/p>\n<div id=\"attachment_20279\" style=\"width: 622px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-20279\" class=\"wp-image-20279 size-full\" src=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/istockphoto-1221032250-612x612-1.jpg\" alt=\"2025\u5e74\u4e2d\u56fd\u7ec6\u80de\u6cbb\u7597\u76d1\u7ba1\u4e0e\u653f\u7b56\u53d1\u5c55\u7684\u65b0\u52a8\u6001\" width=\"612\" height=\"339\" title=\"\" srcset=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/istockphoto-1221032250-612x612-1.jpg 612w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/istockphoto-1221032250-612x612-1-300x166.jpg 300w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/istockphoto-1221032250-612x612-1-18x10.jpg 18w\" sizes=\"(max-width: 612px) 100vw, 612px\" \/><p id=\"caption-attachment-20279\" class=\"wp-caption-text\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">2025\u5e74\u4e2d\u56fd\u7ec6\u80de\u6cbb\u7597\u76d1\u7ba1\u4e0e\u653f\u7b56\u53d1\u5c55\u7684\u65b0\u52a8\u6001<\/span><\/span><\/p><\/div>\n<h2 id=\"Sec2\" class=\"c-article-section__title js-section-title js-c-reading-companion-sections-item\"><span class=\"ez-toc-section\" id=\"2%E3%80%81CTP%E7%9A%84%E8%8C%83%E5%9B%B4\"><\/span><span class=\"c-article-section__title-number\"><span dir=\"auto\">2\u3001<\/span><\/span><span dir=\"auto\">CTP\u7684\u8303\u56f4<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div id=\"Sec2-content\" class=\"c-article-section__content\">\n<p><span dir=\"auto\">\u76ee\u524d\uff0c\u4e2d\u56fd\u5df2\u53d1\u5e03\u7684\u5b98\u65b9\u6587\u4ef6\u4e2d\u5c1a\u65e0\u5bf9\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff08CTP\uff09\u7684\u6b63\u5f0f\u76d1\u7ba1\u5b9a\u4e49\u3002\u7136\u800c\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u4e8e2017\u5e74\u53d1\u5e03\u7684\u300a\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u7814\u7a76\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5357\u300b\u5c06\u6b64\u7c7b\u4ea7\u54c1\u63cf\u8ff0\u4e3a\u53ef\u7528\u4e8e\u6cbb\u7597\u4eba\u7c7b\u75be\u75c5\u7684\u3001\u5177\u6709\u6d3b\u6027\u7684\u4eba\u7c7b\u6765\u6e90\u7ec6\u80de\u4ea7\u54c1\u3002\u8fd9\u4e9b\u7ec6\u80de\u7684\u6765\u6e90\u3001\u5904\u7406\u7a0b\u5e8f\u548c\u5df2\u6ce8\u518c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6d41\u7a0b\u5fc5\u987b\u7b26\u5408\u4f26\u7406\u6807\u51c6\u3002\u6b64\u5916\uff0c\u6b64\u7c7b\u4ea7\u54c1\u7684\u7814\u7a76\u3001\u5f00\u53d1\u548c\u6ce8\u518c\u5fc5\u987b\u7b26\u5408\u300a\u4e2d\u56fd\u836f\u54c1\u7ba1\u7406\u6cd5\u300b\uff08<\/span><a href=\"https:\/\/english.nmpa.gov.cn\/2019-09\/26\/c_773012_3.htm\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">https:\/\/english.nmpa.gov.cn\/2019-09\/26\/c_773012_3.htm<\/span><\/a><span dir=\"auto\">\uff09\u53ca\u76f8\u5173\u6cd5\u89c4\u3002\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u7528\u4e8e\u8f93\u8840\u7684\u8840\u6db2\u6210\u5206\u3001\u5df2\u5efa\u7acb\u7684\u9020\u8840\u5e72\u7ec6\u80de\u79fb\u690d\u3001\u751f\u6b96\u76f8\u5173\u7ec6\u80de\u4ee5\u53ca\u7ec6\u80de\u884d\u751f\u7684\u7ec4\u7ec7\u6216\u5668\u5b98\u4ea7\u54c1\u4e0d\u5305\u542b\u5728\u6b64\u5b9a\u4e49\u8303\u56f4\u5185[\u00a0<\/span><a id=\"ref-link-section-d58746447e840\" title=\"\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u7814\u7a76\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5357. 2017. https:\/\/www.nmpa.gov.cn\/xxgk\/ggtg\/ypggtg\/ypqtggtg\/20171222145101557.html . \u8bbf\u95ee\u65e5\u671f\uff1a2017\u5e7412\u670818\u65e5\u3002\" 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(FDA)\u3002\u4eba\u7c7b\u4f53\u7ec6\u80de\u7597\u6cd5\u548c\u57fa\u56e0\u7597\u6cd5\u6307\u5357\uff08\u884c\u4e1a\u6307\u5357\uff09\u30022018 \u5e74\u3002https:\/\/www.fda.gov\/media\/72402\/download\u3002\u8bbf\u95ee\u65e5\u671f\uff1a1998 \u5e74 3 \u6708\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR6\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e6\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">6<\/span><\/a><span dir=\"auto\">\u00a0]\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u4e2d\u56fd\u7684\u5206\u7c7b\u57fa\u4e8eCTP\u7684\u6709\u6548\u6cbb\u7597\u5f62\u5f0f\uff0c\u800c\u4e0e\u7ec6\u80de\u662f\u5426\u7ecf\u8fc7\u57fa\u56e0\u4fee\u9970\u65e0\u5173\u3002\u5728\u4e2d\u56fd\uff0c\u7ec6\u80de\u88ab\u8ba4\u4e3a\u662fCTP\u7684\u4e3b\u8981\u6d3b\u6027\u6210\u5206\uff0c\u65e0\u8bba\u662f\u5426\u7ecf\u8fc7\u57fa\u56e0\u4fee\u9970\uff0c\u6700\u7ec8\u7684\u6709\u6548\u5f62\u5f0f\u4ecd\u7136\u662f\u5177\u6709\u6d3b\u6027\u7684\u7ec6\u80de\u672c\u8eab[\u00a0<\/span><a id=\"ref-link-section-d58746447e849\" title=\"Lu J, Liu D, Kou Y, Wang X, Chen H, Wang W, et al. \u4e2d\u56fd\u5148\u8fdb\u6cbb\u7597\u836f\u7269\u7684\u8303\u56f4\u548c\u5206\u7c7b\u7814\u7a76\u4e0e\u5efa\u8bae. \u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u6742\u5fd7. 2024;5:10\u201325.\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR7\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e7\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">7<\/span><\/a><span dir=\"auto\">]\u3002\u56e0\u6b64\uff0c\u4e2d\u56fd\u76d1\u7ba1\u4e13\u5bb6\u5efa\u8bae\u5c06\u57fa\u56e0\u4fee\u9970\u7ec6\u80de\u7eb3\u5165CTP\u7684\u8303\u7574\uff0c\u4ee5\u7b80\u5316\u76d1\u7ba1\u7ba1\u7406\u3002\u4f8b\u5982\uff0c\u5d4c\u5408\u6297\u539f\u53d7\u4f53\uff08CAR\uff09-T\u7ec6\u80de[\u00a0<\/span><a id=\"ref-link-section-d58746447e860\" title=\"Ong MZ\u3001Kimberly SA\u3001Lee WH\u3001Ling M\u3001Lee M\u3001Tan KW \u7b49\u3002FDA \u6279\u51c6\u7684 CAR T \u7ec6\u80de\u7597\u6cd5\uff1a\u5341\u5e74\u7684\u8fdb\u5c55\u4e0e\u6311\u6218\u3002Curr Pharm Biotechnol. 2024;25(11):1377\u201393\u3002https:\/\/doi.org\/10.2174\/0113892010257212231001082741\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR8\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e8\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">8<\/span><\/a><span dir=\"auto\">\u00a0]\u5728\u4e2d\u56fd\u88ab\u5f52\u7c7b\u4e3aCTP[\u00a0<\/span><a id=\"ref-link-section-d58746447e864\" title=\"Lu J, Liu D, Kou Y, Wang X, Chen H, Wang W, et al. \u4e2d\u56fd\u5148\u8fdb\u6cbb\u7597\u836f\u7269\u7684\u8303\u56f4\u548c\u5206\u7c7b\u7814\u7a76\u4e0e\u5efa\u8bae. \u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u6742\u5fd7. 2024;5:10\u201325.\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR7\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e7\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">7<\/span><\/a><span dir=\"auto\">\u00a0]\u3002\u5bf9\u4e8e\u6e90\u81ea\u8bf1\u5bfc\u591a\u80fd\u5e72\u7ec6\u80de\uff08iPSC\uff09\u7684\u7ec6\u80de\u4ea7\u54c1\uff0c\u7528\u4e8e\u4ea7\u751fiPSC\u7684\u975e\u6574\u5408\u6027\u91cd\u7f16\u7a0b\u8fc7\u7a0b\u4e0d\u88ab\u89c6\u4e3a\u57fa\u56e0\u4fee\u9970\u3002\u5982\u679c\u5728\u8bf1\u5bfc\u591a\u80fd\u5e72\u7ec6\u80de\uff08iPSCs\uff09\u3001iPSC\u884d\u751f\u7ec6\u80de\u6216iPSC\u5206\u5316\u8fc7\u7a0b\u4e2d\u6d89\u53ca\u57fa\u56e0\u4fee\u9970\uff0c\u5219\u8fd9\u7c7b\u7ec6\u80de\u4ea7\u54c1\u88ab\u5f52\u7c7b\u4e3a\u57fa\u56e0\u4fee\u9970\u7684\u4e34\u5e8a\u6cbb\u7597\u4ea7\u54c1\uff08CTPs\uff09[\u00a0<\/span><a id=\"ref-link-section-d58746447e883\" title=\"Lu J, Liu D, Kou Y, Wang X, Chen H, Wang W, et al. \u4e2d\u56fd\u5148\u8fdb\u6cbb\u7597\u836f\u7269\u7684\u8303\u56f4\u548c\u5206\u7c7b\u7814\u7a76\u4e0e\u5efa\u8bae. \u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u6742\u5fd7. 2024;5:10\u201325.\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR7\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e7\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">7<\/span><\/a><span dir=\"auto\">\u00a0]\u3002\u5c3d\u7ba1\u57fa\u56e0\u4fee\u9970\u4ea7\u54c1\u88ab\u5f52\u7c7b\u4e3a\u4e34\u5e8a\u6cbb\u7597\u4ea7\u54c1\uff0c\u4f46\u4e2d\u56fd\u76d1\u7ba1\u673a\u6784\u660e\u786e\u8981\u6c42\uff0c\u5728\u7814\u7a76\u6027\u65b0\u836f\u7533\u8bf7\uff08IND\uff09\u6216\u65b0\u836f\u7533\u8bf7\uff08NDA\uff09\u7684\u6280\u672f\u5ba1\u67e5\u8fc7\u7a0b\u4e2d\uff0c\u5fc5\u987b\u89e3\u51b3\u4e0e\u5236\u5907\u8fc7\u7a0b\u4e2d\u8fdb\u884c\u7684\u4efb\u4f55\u57fa\u56e0\u64cd\u4f5c\u76f8\u5173\u7684\u5b89\u5168\u6027\u548c\u8d28\u91cf\u95ee\u9898\u3002<\/span><\/p>\n<p><span dir=\"auto\">\u836f\u7269\u548c\u533b\u7597\u5668\u68b0\u7ec4\u5408\u4ea7\u54c1\uff0c\u5373\u7531\u7ec6\u80de\u548c\u533b\u7597\u5668\u68b0\u7ec4\u6210\u7684\u529f\u80fd\u6027\u7edf\u4e00\u4ea7\u54c1\uff0c\u4e0e\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff08CTP\uff09\u4e00\u6837\uff0c\u53d7\u5230\u76f8\u540c\u7684\u76d1\u7ba1\u8003\u91cf\u30022021\u5e74\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u53d1\u5e03\u4e86\u300a\u5173\u4e8e\u836f\u7269\u548c\u533b\u7597\u5668\u68b0\u7ec4\u5408\u4ea7\u54c1\u6ce8\u518c\u7684\u901a\u77e5\u300b\uff0c\u5176\u4e2d\u89c4\u5b9a\u533b\u7597\u5668\u68b0\u6807\u51c6\u5316\u7ba1\u7406\u4e2d\u5fc3\u8d1f\u8d23\u754c\u5b9a\u6b64\u7c7b\u7ec4\u5408\u4ea7\u54c1\u7684\u5c5e\u6027\u3002\u5982\u679c\u7ec4\u5408\u4ea7\u54c1\u7684\u6cbb\u7597\u6548\u679c\u4e3b\u8981\u57fa\u4e8e\u7ec6\u80de\uff0c\u5219\u5c06\u5176\u5f52\u7c7b\u4e3a\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff0c\u53cd\u4e4b\u4ea6\u7136[\u00a0<\/span><a id=\"ref-link-section-d58746447e899\" title=\"\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u7ec4\u5408\u4ea7\u54c1\u6ce8\u518c\u901a\u77e5. 2021. https:\/\/www.nmpa.gov.cn\/xxgk\/fgwj\/xzhgfxwj\/20210727154135199.html . \u8bbf\u95ee\u65e5\u671f\uff1a2021\u5e747\u670827\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR9\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e9\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">9<\/span><\/a><span dir=\"auto\">\u00a0]\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"3%E3%80%81%E7%9B%91%E7%AE%A1%E8%B7%AF%E5%BE%84\"><\/span>3\u3001\u76d1\u7ba1\u8def\u5f84<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3 id=\"Sec4\" class=\"c-article__sub-heading\"><span class=\"ez-toc-section\" id=\"%E5%BD%93%E5%89%8DCTP%E4%B8%8A%E5%B8%82%E7%9B%91%E7%AE%A1%E8%B7%AF%E5%BE%84\"><\/span><span dir=\"auto\">\u5f53\u524dCTP\u4e0a\u5e02\u76d1\u7ba1\u8def\u5f84<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span dir=\"auto\">\u5728\u4e2d\u56fd\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\uff08CTP\uff09\u4e00\u76f4\u53d7\u300a\u836f\u54c1\u7ba1\u7406\u6cd5\u300b\u7684\u76d1\u7ba1\u3002\u8fc4\u4eca\u4e3a\u6b62\uff0c\u5df2\u53d1\u5e03\u7684\u5b98\u65b9\u6587\u4ef6\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\u5728\u5b8c\u6210\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u540e\u7684\u5546\u4e1a\u5316\u63d0\u4f9b\u4e86\u6e05\u6670\u7684\u8def\u7ebf\u56fe\u3002\u5982\u679c\u4ea7\u54c1\u88ab\u8bc1\u5b9e\u5b89\u5168\u6709\u6548\uff0c\u5219\u5fc5\u987b\u5411\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u63d0\u4ea4\u65b0\u836f\u7533\u8bf7\uff08NDA\uff09\u4ee5\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\u3002<\/span><\/p>\n<p><span dir=\"auto\">\u6839\u636e\u98ce\u9669\u8bc4\u4f30\u539f\u5219\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\uff08<\/span><a href=\"https:\/\/english.nmpa.gov.cn\/2019-07\/19\/c_389169.htm\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">https:\/\/english.nmpa.gov.cn\/2019-07\/19\/c_389169.htm<\/span><\/a><span dir=\"auto\">\uff09\u5728\u5ba1\u6838NDA\u6280\u672f\u8d44\u6599\u540e\uff0c\u5c06\u8fdb\u884c\u73b0\u573a\u68c0\u67e5\u548c\u4e0a\u5e02\u524d\u6d4b\u8bd5\u3002\u73b0\u573a\u68c0\u67e5\u7531\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08 NMPA\uff09\u4e0b\u5c5e\u7684\u98df\u54c1\u836f\u54c1\u68c0\u9a8c\u4e2d\u5fc3\uff08CFDI\uff09\uff08\u00a0<\/span><a href=\"https:\/\/english.nmpa.gov.cn\/2019-07\/19\/c_389170.htm\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">https:\/\/english.nmpa.gov.cn\/2019-07\/19\/c_389170.htm \uff09\u8fdb\u884c\uff0c\u800c\u4e0a\u5e02\u524d\u6388\u6743\u68c0\u6d4b\u5219\u7531\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u68c0\u9a8c\u7814\u7a76\u9662\uff08NIFDC\uff09\uff08\u00a0<\/span><\/a><a href=\"https:\/\/english.nmpa.gov.cn\/2019-07\/19\/c_389166.htm\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">https:\/\/english.nmpa.gov.cn\/2019-07\/19\/c_389166.htm<\/span><\/a><span dir=\"auto\">\uff09\u6839\u636e\u7533\u8bf7\u4eba\u7684\u4ea7\u54c1\u89c4\u683c\u8fdb\u884c\u3002\u5728\u4e2d\u56fd\uff0cNIFDC\u662f\u552f\u4e00\u96b6\u5c5e\u4e8eNMPA\u7684\u56fd\u5bb6\u7ea7\u68c0\u9a8c\u5b9e\u9a8c\u5ba4\uff08NCL\uff09\uff0c\u4e5f\u662f\u98df\u54c1\u3001\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u548c\u5316\u5986\u54c1\u8d28\u91cf\u63a7\u5236\u7684\u6700\u7ec8\u6280\u672f\u88c1\u5b9a\u673a\u6784\u3002\u836f\u54c1\u548c\u5316\u5986\u54c1\u76d1\u7ba1\u59d4\u5458\u4f1a\uff08CDE\uff09\u6839\u636e\u65b0\u836f\u7533\u8bf7\uff08NDA\uff09\u6280\u672f\u8d44\u6599\u7684\u5ba1\u67e5\u7ed3\u8bba\u3001\u73b0\u573a\u68c0\u67e5\u62a5\u544a\u4ee5\u53caNIFDC\u7684\u4e0a\u5e02\u524d\u6388\u6743\u68c0\u6d4b\u7ed3\u679c\uff0c\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u4ea7\u54c1\uff08CTP\uff09\u7684\u4e0a\u5e02\u8bb8\u53ef\u505a\u51fa\u6700\u7ec8\u51b3\u5b9a\uff08\u56fe<\/span><a href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#Fig1\" data-track=\"click\" data-track-label=\"link\" data-track-action=\"figure anchor\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">1<\/span><\/a><span dir=\"auto\">\uff09\u3002<\/span><\/p>\n<div id=\"attachment_20277\" style=\"width: 695px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-20277\" class=\"wp-image-20277 size-full\" src=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_174146_108.png\" alt=\"\u56fe1\uff1a\u4e2d\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\uff08CTP\uff09\u5f53\u524d\u76d1\u7ba1\u8def\u5f84\u6982\u8ff0\u3002IND\uff1a\u7814\u7a76\u6027\u65b0\u836f\uff1bNDA\uff1a\u65b0\u836f\u7533\u8bf7\uff1bCDE\uff1a\u836f\u54c1\u8bc4\u4ef7\u4e2d\u5fc3\uff1bCFDI\uff1a\u98df\u54c1\u836f\u54c1\u68c0\u9a8c\u4e2d\u5fc3\uff1bNIFDC\uff1a\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662\u3002\" width=\"685\" height=\"337\" title=\"\" srcset=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_174146_108.png 685w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_174146_108-300x148.png 300w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_174146_108-18x9.png 18w\" sizes=\"(max-width: 685px) 100vw, 685px\" \/><p id=\"caption-attachment-20277\" class=\"wp-caption-text\">\u56fe1\uff1a\u4e2d\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\uff08CTP\uff09\u5f53\u524d\u76d1\u7ba1\u8def\u5f84\u6982\u8ff0\u3002IND\uff1a\u7814\u7a76\u6027\u65b0\u836f\uff1bNDA\uff1a\u65b0\u836f\u7533\u8bf7\uff1bCDE\uff1a\u836f\u54c1\u8bc4\u4ef7\u4e2d\u5fc3\uff1bCFDI\uff1a\u98df\u54c1\u836f\u54c1\u68c0\u9a8c\u4e2d\u5fc3\uff1bNIFDC\uff1a\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662\u3002<\/p><\/div>\n<p><span dir=\"auto\">\u6b64\u5916\uff0c\u4e3a\u5c31\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u4e34\u5e8a\u7814\u53d1\u8fc7\u7a0b\u4e2d\u6c9f\u901a\u6587\u4ef6\u7684\u51c6\u5907\u548c\u4e34\u5e8a\u5f00\u53d1\u8981\u7d20\u7684\u8003\u91cf\u63d0\u4f9b\u5efa\u8bae\uff0c\u76d1\u7ba1\u673a\u6784\u53d1\u5e03\u4e86\u7814\u53d1\u4f01\u4e1a\u95f4\u6c9f\u901a\u7a0b\u5e8f\u6307\u5357[\u00a0<\/span><a id=\"ref-link-section-d58746447e959\" title=\"\u4e2d\u56fd\u836f\u7269\u4fe1\u606f\u4e2d\u5fc3 (CDE)\u3002\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u4e34\u5e8a\u76f8\u5173\u6c9f\u901a\u6280\u672f\u6307\u5357\u30022023\u3002https:\/\/www.cde.org.cn\/zdyz\/domesticinfopage?zdyzIdCODE=070ad6c2cba1ae39238ba1136ee63961\u30022023\u5e7412\u670829\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR10\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e10\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">10<\/span><\/a><span dir=\"auto\">\u00a0]\u3002\u8be5\u6307\u5357\u63d0\u9ad8\u4e86\u6c9f\u901a\u6548\u7387\uff0c\u4fc3\u8fdb\u4e86\u4e34\u5e8a\u7814\u7a76\u548c\u4ea7\u54c1\u5f00\u53d1\u7684\u987a\u5229\u8fdb\u884c\u3002\u591a\u5e74\u6765\uff0c\u4e2d\u56fd\u76d1\u7ba1\u673a\u6784\u901a\u8fc7\u4e0d\u65ad\u63a2\u7d22\u548c\u5b8c\u5584\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u5404\u65b9\u9762\u7684\u76d1\u7ba1\u4f53\u7cfb\uff0c\u9010\u6b65\u5efa\u7acb\u4e86\u73b0\u884c\u7684\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u76d1\u7ba1\u8def\u5f84\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4%E3%80%81%E5%A6%82%E4%BD%95%E9%80%90%E6%AD%A5%E5%AE%8C%E5%96%84CTP%E7%9B%91%E7%AE%A1%EF%BC%8C%E5%AE%8C%E5%96%84CTP%E7%9B%91%E7%AE%A1%E7%9A%84%E8%BF%87%E7%A8%8B%E6%98%AF%E6%80%8E%E4%B9%88%E6%A0%B7%E7%9A%84%EF%BC%9F\"><\/span>4\u3001\u5982\u4f55\u9010\u6b65\u5b8c\u5584CTP\u76d1\u7ba1\uff0c\u5b8c\u5584CTP\u76d1\u7ba1\u7684\u8fc7\u7a0b\u662f\u600e\u4e48\u6837\u7684\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ds-markdown-paragraph\">\u4e2d\u56fd\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff08CTP\uff09\u7684\u76d1\u7ba1\u6f14\u8fdb\uff0c\u662f\u4e00\u4e2a\u4ece\u63a2\u7d22\u8d77\u6b65\u5230\u9010\u6b65\u6784\u5efa<strong>\u7cfb\u7edf\u5316\u3001\u5168\u94fe\u6761\u76d1\u7ba1\u4f53\u7cfb<\/strong>\u7684\u8fc7\u7a0b\uff0c\u5176\u5b8c\u5584\u8fc7\u7a0b\u5e76\u975e\u4e00\u8e74\u800c\u5c31\uff0c\u800c\u662f\u4f34\u968f\u7740\u79d1\u5b66\u8ba4\u77e5\u7684\u6df1\u5316\u548c\u4ea7\u4e1a\u53d1\u5c55\u7684\u9700\u6c42\uff0c\u901a\u8fc7<strong>\u660e\u786e\u76d1\u7ba1\u5c5e\u6027\u3001\u5065\u5168\u673a\u6784\u804c\u80fd\u3001\u7ec6\u5316\u6280\u672f\u6307\u5357\u3001\u8986\u76d6\u4ea7\u54c1\u5168\u751f\u547d\u5468\u671f<\/strong>\u7b49\u591a\u4e2a\u5173\u952e\u6b65\u9aa4\u9010\u6b65\u5b9e\u73b0\u7684\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E6%98%8E%E6%99%B0%E7%9B%91%E7%AE%A1%E5%AE%9A%E4%BD%8D%E4%B8%8E%E6%9C%BA%E6%9E%84%E8%81%8C%E8%83%BD\"><\/span>\u660e\u6670\u76d1\u7ba1\u5b9a\u4f4d\u4e0e\u673a\u6784\u804c\u80fd<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ds-markdown-paragraph\">CTP\u76d1\u7ba1\u7684\u5b8c\u5584\uff0c\u9996\u5148\u5728\u4e8e\u786e\u7acb\u4e86\u5176\u4f5c\u4e3a\u00a0<strong>\u201c\u836f\u54c1\u201d<\/strong>\u00a0\u7684\u6839\u672c\u76d1\u7ba1\u5c5e\u6027\uff0c\u5e76\u968f\u4e4b\u6784\u5efa\u4e86\u4e13\u4e1a\u7684\u76d1\u7ba1\u673a\u6784\u3002<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u786e\u7acb\u836f\u54c1\u76d1\u7ba1\u6839\u672c\u5c5e\u6027<\/strong>\uff1a\u65e9\u57281993\u5e74\uff0c\u539f\u536b\u751f\u90e8\u53d1\u5e03\u7684\u300a\u4eba\u7c7b\u4f53\u7ec6\u80de\u6cbb\u7597\u548c\u57fa\u56e0\u6cbb\u7597\u4e34\u5e8a\u7814\u7a76\u8d28\u91cf\u63a7\u5236\u4e3b\u8981\u8003\u8651\u56e0\u7d20\u300b\u5c31\u6807\u5fd7\u7740CTP\u5728\u4e2d\u56fd\u88ab\u6b63\u5f0f\u7eb3\u5165<strong>\u836f\u54c1\u76d1\u7ba1\u8303\u7574<\/strong>\u3002\u8fd9\u4e00\u6839\u672c\u5b9a\u4f4d\u51b3\u5b9a\u4e86CTP\u540e\u7eed\u7684\u7814\u53d1\u3001\u4e34\u5e8a\u8bd5\u9a8c\u548c\u5ba1\u6279\u4e0a\u5e02\u90fd\u5fc5\u987b\u9075\u5faa\u836f\u54c1\u76d1\u7ba1\u7684\u901a\u7528\u89c4\u5219\u548c\u7279\u6b8a\u8981\u6c42\u3002<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u76d1\u7ba1\u673a\u6784\u7684\u4e13\u4e1a\u5316\u6f14\u8fdb<\/strong>\uff1a\u76d1\u7ba1\u673a\u6784\u7684\u6f14\u53d8\u4f53\u73b0\u4e86\u5bf9CTP\u76d1\u7ba1\u4e13\u4e1a\u6027\u548c\u72ec\u7acb\u6027\u7684\u6301\u7eed\u52a0\u5f3a\uff1a<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">1998\u5e74\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08SDA\uff09\u6210\u7acb\uff0c\u7edf\u4e00\u8d1f\u8d23\u836f\u54c1\u76d1\u7ba1\u3002<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u7ecf\u8fc72003\u5e74\uff08\u66f4\u540d\u4e3aSFDA\uff09\u548c2013\u5e74\uff08\u66f4\u540d\u4e3aCFDA\uff09\u7684\u804c\u80fd\u6574\u5408\u4e0e\u6269\u5145\uff0c\u5230\u4e862018\u5e74\uff0c\u4e13\u95e8\u7684\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6210\u7acb\uff0c\u96b6\u5c5e\u4e8e\u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u3002\u8fd9\u4e00\u7cfb\u5217\u8c03\u6574\u4f7f\u5f97\u76d1\u7ba1\u804c\u8d23\u66f4\u52a0\u96c6\u4e2d\u548c\u6e05\u6670\u3002<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E6%9E%84%E5%BB%BA%E4%B8%8E%E7%BB%86%E5%8C%96%E6%8A%80%E6%9C%AF%E6%8C%87%E5%AF%BC%E4%BD%93%E7%B3%BB\"><\/span>\u6784\u5efa\u4e0e\u7ec6\u5316\u6280\u672f\u6307\u5bfc\u4f53\u7cfb<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ds-markdown-paragraph\">\u5728\u660e\u786e\u76d1\u7ba1\u6846\u67b6\u540e\uff0c\u901a\u8fc7\u6301\u7eed\u53d1\u5e03\u548c\u66f4\u65b0\u6280\u672f\u6307\u5357\uff0c\u4f7f\u76d1\u7ba1\u8981\u6c42\u5177\u4f53\u5316\u3001\u53ef\u64cd\u4f5c\uff0c\u662f\u5b8c\u5584CTP\u76d1\u7ba1\u7684\u6838\u5fc3\u73af\u8282\u3002<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u65e9\u671f\u6280\u672f\u6307\u5bfc\u7684\u63a2\u7d22<\/strong>\uff1a2003\u5e74\uff0c\u539fSFDA\u53d1\u5e03\u7684\u300a\u4eba\u7c7b\u7ec6\u80de\u6cbb\u7597\u7814\u7a76\u53ca\u5236\u5242\u8d28\u91cf\u63a7\u5236\u6280\u672f\u6307\u5357\u300b\u4e3aCTP\u7684\u7814\u53d1\u548c\u8d28\u91cf\u63a7\u5236\u63d0\u4f9b\u4e86\u521d\u6b65\u7684\u6280\u672f\u4f9d\u636e\uff0c\u652f\u6301\u4e86\u65e9\u671f\u5982\u95f4\u5145\u8d28\u5e72\u7ec6\u80de\uff08MSCs\uff09\u7b49\u4ea7\u54c1\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08IND\uff09\u3002<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u5173\u952e\u653f\u7b56\u4e0e\u7cfb\u7edf\u6027\u6587\u4ef6\u7684\u5bc6\u96c6\u51fa\u53f0<\/strong>\uff1a2017\u5e74\u662f\u653f\u7b56\u6df1\u5316\u7684\u91cd\u8981\u8282\u70b9\u3002NMPA\u53d1\u5e03\u7684\u300a\u751f\u7269\u5236\u54c1\u6ce8\u518c\u5206\u7c7b\u53ca\u7533\u8bf7\u6750\u6599\u8981\u6c42\uff08\u8bd5\u884c\u5b9e\u65bd\uff09\u300b\u548c\u300a\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\u7814\u7a76\u4e0e\u8bc4\u4ef7\u6280\u672f\u6307\u5357\uff08\u8bd5\u884c\uff09\u300b\u7b49\u6587\u4ef6\uff0c\u8fdb\u4e00\u6b65<strong>\u660e\u786e\u4e86CTP\u4f5c\u4e3a\u6cbb\u7597\u6027\u751f\u7269\u5236\u54c1\u7684\u6ce8\u518c\u7533\u62a5\u8def\u5f84\uff0c\u5e76\u4e3a\u6574\u4e2a\u7814\u53d1\u548c\u8bc4\u4ef7\u6d41\u7a0b\u63d0\u4f9b\u4e86\u7cfb\u7edf\u6307\u5bfc<\/strong>\u3002<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u5168\u94fe\u6761\u76d1\u7ba1\u6307\u5357\u7684\u5b8c\u5584<\/strong>\uff1a\u81ea2020\u5e74\u4ee5\u6765\uff0c\u76d1\u7ba1\u653f\u7b56\u548c\u6280\u672f\u6307\u5357\u7684\u53d1\u5e03\u8fdb\u5165\u9ad8\u5cf0\u671f\uff08\u88681\uff09\uff0c\u8986\u76d6\u4e86<strong>\u836f\u7269\u7814\u53d1\u3001\u975e\u4e34\u5e8a\u7814\u7a76\u3001\u4e34\u5e8a\u7814\u7a76\u3001\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GMP\uff09\u4ee5\u53ca\u73b0\u573aGMP\u68c0\u67e5<\/strong>\u7b49\u591a\u4e2a\u65b9\u9762\u3002\u8fd9\u4e9b\u6587\u4ef6\u5171\u540c\u6784\u6210\u4e86CTP\u4ece\u5b9e\u9a8c\u5ba4\u7814\u7a76\u5230\u4ea7\u54c1\u4e0a\u5e02\u7684\u5168\u94fe\u6761\u76d1\u7ba1\u6280\u672f\u652f\u6491\u3002<\/p>\n<\/li>\n<\/ul>\n<p id=\"table-1-title\"><span dir=\"auto\">\u88681\uff1a2020\u5e74\u4ee5\u6765\u53d1\u5e03\u7684\u4e0eCTP\u5bc6\u5207\u76f8\u5173\u7684\u76d1\u7ba1\u6587\u4ef6\u6e05\u5355<\/span><\/p>\n<table class=\"data last-table\" style=\"width: 76.5368%; height: 1024px;\">\n<thead class=\"c-article-table-head\">\n<tr style=\"height: 56px;\">\n<th class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u5e8f\u53f7<\/span><\/th>\n<th class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u7b7e\u53d1\u65e5\u671f<\/span><\/th>\n<th class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u6587\u4ef6<\/span><\/th>\n<th class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u5206\u914d<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">1<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2020\u5e7412\u670831\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u533b\u7597\u536b\u751f\u673a\u6784\u5f00\u5c55\u7814\u7a76\u8005\u53d1\u8d77\u8bd5\u9a8c\u7684\u76d1\u7ba1\u63aa\u65bd\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1183\" title=\"\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a. \u533b\u7597\u536b\u751f\u673a\u6784\u5f00\u5c55\u7814\u7a76\u8005\u53d1\u8d77\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7684\u76d1\u7ba1\u63aa\u65bd\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09. 2020. http:\/\/www.nhc.gov.cn\/qjjys\/s7945\/202012\/630fa2bf316d48a4856f8727450c429b.shtml . \u8bbf\u95ee\u65e5\u671f\uff1a2020\u5e7412\u670831\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR22\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e22\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">22<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">DMSTC\uff0cNHC<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">2<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2021\u5e742\u670810\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u514d\u75ab CTP \u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1214\" title=\"\u4e2d\u56fd\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u7814\u7a76\u6240 (CDE)\u3002\u514d\u75ab\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\u7248\uff09\u30022021\u3002https:\/\/www.cde.org.cn\/zdyz\/domesticinfopage?zdyzIdCODE=cd15d9b4d5305683f507d15029e36895\u3002\u8bbf\u95ee\u65e5\u671f\uff1a2021\u5e742\u670810\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR23\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e23\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">23<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">3<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2021\u5e7412\u670823\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u57fa\u56e0\u4fee\u9970 CTP \u975e\u4e34\u5e8a\u7814\u7a76\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1241\" title=\"\u4e2d\u56fd\u836f\u7269\u5f00\u53d1\u7f72. \u57fa\u56e0\u4fee\u9970\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u975e\u4e34\u5e8a\u7814\u7a76\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\u7248\uff09. 2021. https:\/\/www.cde.org.cn\/zdyz\/domesticinfopage?zdyzIdCODE=b7dfbba537d5ecc30659d715f5045acb . \u8bbf\u95ee\u65e5\u671f\uff1a2021\u5e7412\u670823\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR24\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e24\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">24<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 80px;\">\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">5<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\">2022\u5e741\u670829\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\">\u5d4c\u5408\u6297\u539f\u53d7\u4f53T\u7ec6\u80de\uff08CAR-T\uff09\u6cbb\u7597\u4ea7\u54c1\u4e34\u5e8a\u98ce\u9669\u7ba1\u7406\u8ba1\u5212\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7\u6280\u672f\u6307\u5357[\u00a0<\/span><a id=\"ref-link-section-d65748906e1272\" title=\"\u4e2d\u56fd\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u7814\u7a76\u6240 (CDE)\u3002\u5d4c\u5408\u6297\u539f\u53d7\u4f53T\u7ec6\u80de (CAR-T) \u6cbb\u7597\u4ea7\u54c1\u4e34\u5e8a\u98ce\u9669\u7ba1\u7406\u8ba1\u5212\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7\u6280\u672f\u6307\u5357\u30022022\u3002https:\/\/www.cde.org.cn\/zdyz\/domesticinfopage?zdyzIdCODE=9c18eb2d5f9bb96423052d104e80665a\u3002\u8bbf\u95ee\u65e5\u671f\uff1a2022\u5e741\u670829\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR25\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e25\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">25<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">6<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2022\u5e745\u670831\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u514d\u75ab CTP \u836f\u7269\u7814\u7a76\u548c\u8bc4\u4ef7\u7684\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1299\" title=\"\u4e2d\u56fd\u836f\u54c1\u5f00\u53d1\u7f72. \u514d\u75ab\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u836f\u7269\u7814\u53d1\u548c\u8bc4\u4ef7\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\u7248\uff09. 2022. https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/0584963a84e01bb4d83022f559d22144 . \u8bbf\u95ee\u65e5\u671f\uff1a2022\u5e745\u670831\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR26\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e26\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">26<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">7<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2022\u5e7410\u670831\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\u7684GMP\u6307\u5357\uff08\u7528\u4e8e\u8bd5\u9a8c\u5b9e\u65bd\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1327\" title=\"\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1GMP\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\u7248\uff09. 2022. https:\/\/www.cfdi.org.cn\/resource\/news\/14938.html . \u8bbf\u95ee\u65e5\u671f\uff1a2022\u5e7410\u670831\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR19\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e19\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">19<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CFDI\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">8<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2023\u5e744\u670827\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u4eba\u7c7b\u5e72\u7ec6\u80de\u4ea7\u54c1\u836f\u7269\u7814\u7a76\u548c\u6280\u672f\u6280\u672f\uff08\u8bd5\u9a8c\u5b9e\u65bd\uff09\u7684\u6280\u672f\u6307\u5bfc[\u00a0<\/span><a id=\"ref-link-section-d65748906e1354\" title=\"\u4e2d\u56fd\u836f\u7269\u5f00\u53d1\u7f72. \u4eba\u7c7b\u5e72\u7ec6\u80de\u4ea7\u54c1\u836f\u7269\u7814\u53d1\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\u7248\uff09. 2023. https:\/\/www.cde.org.cn\/zdyz\/domesticinfopage?zdyzIdCODE=94f1fb29e735dcaa87abd0f67a5c448b . \u8bbf\u95ee\u65e5\u671f\uff1a2023\u5e744\u670827\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR27\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e27\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">27<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">9<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2023\u5e745\u670826\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u300a\u4eba\u7c7b\u9057\u4f20\u8d44\u6e90\u7ba1\u7406\u6761\u4f8b\u300b\u5b9e\u65bd\u7ec6\u5219[\u00a0<\/span><a id=\"ref-link-section-d65748906e1385\" title=\"\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u79d1\u5b66\u6280\u672f\u90e8\u3002\u300a\u4eba\u7c7b\u9057\u4f20\u8d44\u6e90\u7ba1\u7406\u6761\u4f8b\u5b9e\u65bd\u7ec6\u5219\u300b\u30022023\u5e74\u3002https:\/\/www.gov.cn\/gongbao\/2023\/issue_10606\/202307\/content_6894768.html\u3002\u8bbf\u95ee\u65e5\u671f\uff1a2023\u5e745\u670826\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR28\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e28\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">28<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">\u5c71\u533a\u6807\u51c6\u65f6\u95f4<\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">10<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2023\u5e746\u670821\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u4eba\u7c7b\u5e72\u7ec6\u80de\u53ca\u5176\u884d\u751f CTP \u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1416\" title=\"\u4e2d\u56fd\u836f\u7269\u5f00\u53d1\u7f72. \u4eba\u7c7b\u5e72\u7ec6\u80de\u53ca\u5176\u884d\u751f\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\u7248\uff09. 2023. https:\/\/www.cde.org.cn\/zdyz\/domesticinfopage?zdyzIdCODE=6917d4d20eb99762471bcd31aafac182 . \u8bbf\u95ee\u65e5\u671f\uff1a2023\u5e746\u670821\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR29\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e29\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">29<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">11<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2023\u5e748\u670818\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u4f53\u7ec6\u80de\u4e34\u5e8a\u7814\u7a76\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1443\" title=\"\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a. \u4f53\u7ec6\u80de\u4e34\u5e8a\u7814\u7a76\u6307\u5357\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09. 2023. http:\/\/www.nhc.gov.cn\/wjw\/yjzj\/202305\/7da5d0968ee94085b034eab2bb1cfa58.shtml . \u8bbf\u95ee\u65e5\u671f\uff1a2023\u5e745\u67089\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR30\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e30\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">30<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">NHC\u7684DMSTC<\/span><\/td>\n<\/tr>\n<tr style=\"height: 80px;\">\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">12<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\">2023\u5e7412\u670829\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\">\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u4e34\u5e8a\u76f8\u5173\u6c9f\u901a\u7684\u6280\u672f\u6307\u5357[\u00a0<\/span><a id=\"ref-link-section-d65748906e1474\" title=\"\u4e2d\u56fd\u836f\u7269\u4fe1\u606f\u4e2d\u5fc3(CDE)\u3002\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u4e34\u5e8a\u76f8\u5173\u6c9f\u901a\u6280\u672f\u6307\u5357\u3002 2023\u3002 https:\/\/www.cde.org.cn\/zdyz\/domesticinfopage?zdyzIdCODE=070ad6c2cba1ae39238ba1136ee63961\u30022023\u5e7412\u670829\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR10\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e10\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">10<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">13<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2024\u5e741\u670818\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u4eba\u7c7b\u5e72\u7ec6\u80de\u4ea7\u54c1\u975e\u4e34\u5e8a\u7814\u7a76\u6280\u672f\u6307\u5357[\u00a0<\/span><a id=\"ref-link-section-d65748906e1502\" title=\"\u4e2d\u56fd\u73af\u5883\u7f72. \u4eba\u7c7b\u5e72\u7ec6\u80de\u4ea7\u54c1\u975e\u4e34\u5e8a\u7814\u7a76\u6280\u672f\u6307\u5357. 2024. https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/e3fad3babbb1eee021494aaef0a93b14. \u8bbf\u95ee\u65e5\u671f\uff1a2024\u5e741\u670818\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR17\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e17\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">17<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">14<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">2024\u5e741\u670818\u65e5<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">\u95f4\u5145\u8d28\u5e72\u7ec6\u80de\u9884\u9632\u548c\u6cbb\u7597\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1533\" title=\"\u4e2d\u56fd\u836f\u7269\u5f00\u53d1\u7f72. \u95f4\u5145\u8d28\u5e72\u7ec6\u80de\u9884\u9632\u548c\u6cbb\u7597\u79fb\u690d\u7269\u6297\u5bbf\u4e3b\u75c5\u4e34\u5e8a\u8bd5\u9a8c\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\u7248\uff09. 2024. https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/08bd57e996a5e9de6f920f626d9ab149 . 2024\u5e741\u670818\u65e5.\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR18\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e18\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">18<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">15<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2024\u5e747\u670812\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">CTP\u73b0\u573aGMP\u68c0\u67e5\u6307\u5357\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1560\" title=\"CFDI. \u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u73b0\u573aGMP\u68c0\u67e5\u6307\u5357\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09. 2024. https:\/\/www.cfdi.org.cn\/resource\/news\/16005.html . \u8bbf\u95ee\u65e5\u671f\uff1a2024\u5e747\u670812\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR20\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e20\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">20<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CFDI\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 80px;\">\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">16<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\">2024\u5e749\u670818\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\">\u533b\u7597\u536b\u751f\u673a\u6784\u4e2d\u7814\u7a76\u8005\u53d1\u8d77\u7684\u4e34\u5e8a\u7814\u7a76\u7684\u884c\u653f\u63aa\u65bd[\u00a0<\/span><a id=\"ref-link-section-d65748906e1587\" title=\"\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a-\u56fd\u5bb6\u4e2d\u533b\u836f\u536b\u751f\u5c40-\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40. \u533b\u7597\u536b\u751f\u673a\u6784\u7814\u7a76\u8005\u53d1\u8d77\u7684\u4e34\u5e8a\u7814\u7a76\u7ba1\u7406\u529e\u6cd5. 2024. https:\/\/www.gov.cn\/zhengce\/zhengceku\/202409\/content_6976872.htm . 2024\u5e749\u670818\u65e5.\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR31\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e31\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">31<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 80px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">NHC\uff1bNATCM\uff1bNDCPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<tr style=\"height: 56px;\">\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">17<\/span><\/span><\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">2024\u5e7411\u670819\u65e5<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\">CTP \u4e34\u5e8a\u836f\u7406\u5b66\u7814\u7a76\u6280\u672f\u6307\u5357\uff08\u8bd5\u9a8c\u5b9e\u65bd\uff09[\u00a0<\/span><a id=\"ref-link-section-d65748906e1614\" title=\"\u4e2d\u56fd\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u7814\u7a76\u6240 (CDE)\u3002\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u4e34\u5e8a\u836f\u7406\u5b66\u7814\u7a76\u6280\u672f\u6307\u5357\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u30022024\u3002https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/6eda537828949a51a4a56e341423f7c3\u3002\u8bbf\u95ee\u65e5\u671f\uff1a2024\u5e7411\u670819\u65e5\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5\/tables\/1#ref-CR16\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e16\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">16<\/span><\/a><span dir=\"auto\">\u00a0]<\/span><\/td>\n<td class=\"u-text-left\" style=\"height: 56px;\"><span dir=\"auto\"><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">CDE\uff0cNMPA<\/span><\/span><\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3><span class=\"ez-toc-section\" id=\"%E8%A6%86%E7%9B%96%E4%BA%A7%E5%93%81%E5%85%A8%E7%94%9F%E5%91%BD%E5%91%A8%E6%9C%9F\"><\/span>\u8986\u76d6\u4ea7\u54c1\u5168\u751f\u547d\u5468\u671f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ds-markdown-paragraph\">\u5b8c\u5584\u7684CTP\u76d1\u7ba1\u4f53\u7cfb\uff0c\u6700\u7ec8\u4f53\u73b0\u5728\u5bf9\u4ea7\u54c1\u4ece\u7533\u62a5\u5230\u4e0a\u5e02\u540e\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u6709\u6548\u7ba1\u7406\u548c\u4fc3\u8fdb\u3002<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u4e34\u5e8a\u8f6c\u5316\u6548\u7387\u663e\u8457\u63d0\u5347<\/strong>\uff1a\u76d1\u7ba1\u4f53\u7cfb\u7684\u5b8c\u5584\u6700\u76f4\u63a5\u7684\u6210\u679c\u662f\u663e\u8457\u4fc3\u8fdb\u4e86CTP\u7684\u4e34\u5e8a\u8f6c\u5316\u3002\u6570\u636e\u663e\u793a\uff0c2017\u5e74\u4e4b\u540e\u7684\u8fd17\u5e74\u95f4\uff0cMSC\u4ea7\u54c1\u7684IND\u7533\u8bf7\u6570\u91cf\u6fc0\u589e\uff0c\u8d85\u8fc7\u6b64\u524d\u5341\u5e74\u603b\u548c\u7684\u5341\u500d\uff0c\u5e76\u4e14\u5404\u7c7b\u7ec6\u80de\u6cbb\u7597\u7684IND\u7533\u8bf7\u603b\u91cf\u4e5f\u8d85\u8fc7\u4e86200\u4efd\uff08\u56fe2\uff09\u3002<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u6db5\u76d6\u591a\u79cd\u7ec6\u80de\u6cbb\u7597\u7c7b\u578b<\/strong>\uff1a\u65e9\u671f\u7684IND\u7533\u8bf7\u4e3b\u8981\u96c6\u4e2d\u4e8eMSC\u548c\u81ea\u4f53\u514d\u75ab\u7ec6\u80de\uff08\u5982LAK\u3001CIK\u7ec6\u80de\uff09\u7b49\u4ea7\u54c1\u3002\u968f\u7740\u76d1\u7ba1\u8def\u5f84\u7684\u6e05\u6670\u548c\u6280\u672f\u8981\u6c42\u7684\u660e\u786e\uff0c\u66f4\u591a\u6837\u5316\u7684\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u7c7b\u578b\u4e5f\u5f00\u59cb\u8fdb\u5165\u4e34\u5e8a\u7814\u7a76\u548c\u7533\u62a5\u7684\u8f68\u9053\u3002<\/p>\n<\/li>\n<\/ul>\n<div id=\"attachment_20275\" style=\"width: 1516px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-20275\" class=\"wp-image-20275 size-full\" src=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_172921_341.png\" alt=\"\" width=\"1506\" height=\"628\" title=\"\" srcset=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_172921_341.png 1506w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_172921_341-300x125.png 300w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_172921_341-1024x427.png 1024w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_172921_341-768x320.png 768w, https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_172921_341-18x8.png 18w\" sizes=\"(max-width: 1506px) 100vw, 1506px\" \/><p id=\"caption-attachment-20275\" class=\"wp-caption-text\">\u56fe2\uff1a\u4e2d\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\u65b0\u836f\u7533\u8bf7\u7edf\u8ba1\u6570\u636e\u3002( a ) \u95f4\u5145\u8d28\u5e72\u7ec6\u80de (MSC) \u65b0\u836f\u7533\u8bf7\u5e74\u5ea6\u7edf\u8ba1\u6570\u636e\u3002( b ) 2017 \u5e74\u4ee5\u6765\u4e3b\u8981\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\u65b0\u836f\u7533\u8bf7\u7edf\u8ba1\u6570\u636e\u3002PSC\uff1a\u591a\u80fd\u5e72\u7ec6\u80de\uff1bNK\uff1a\u81ea\u7136\u6740\u4f24\u7ec6\u80de\uff1bTCRT\uff1aT \u7ec6\u80de\u53d7\u4f53\u7597\u6cd5\uff1bTIL\uff1a\u80bf\u7624\u6d78\u6da6\u6dcb\u5df4\u7ec6\u80de\u3002\uff08\u56fe ( a ) \u4e2d 2024 \u5e74\u7684\u7edf\u8ba1\u6570\u636e\u622a\u81f3 8 \u6708\uff09<\/p><\/div>\n<p>\u5c0f\u7ed3\uff1a\u603b\u7684\u6765\u8bf4\uff0c\u4e2d\u56fdCTP\u76d1\u7ba1\u7684\u5b8c\u5584\u662f\u4e00\u4e2a\u52a8\u6001\u3001\u6e10\u8fdb\u7684\u8fc7\u7a0b\u3002\u901a\u8fc7<strong>\u660e\u786e\u836f\u54c1\u5c5e\u6027\u3001\u4f18\u5316\u76d1\u7ba1\u673a\u6784\u3001\u6301\u7eed\u51fa\u53f0\u7ec6\u5316\u6280\u672f\u6307\u5357<\/strong>\uff0c\u9010\u6b65\u6784\u5efa\u8d77\u4e00\u4e2a\u8986\u76d6CTP\u7814\u53d1\u3001\u4e34\u5e8a\u3001\u751f\u4ea7\u5168\u94fe\u6761\u7684\u76d1\u7ba1\u4f53\u7cfb\u3002\u8fd9\u4e00\u4f53\u7cfb\u4e0d\u4ec5\u4e3a\u4ea7\u4e1a\u53d1\u5c55\u63d0\u4f9b\u4e86\u6e05\u6670\u7684\u9884\u671f\u548c\u89c4\u8303\uff0c\u4e5f\u5207\u5b9e\u52a0\u901f\u4e86\u524d\u6cbf\u79d1\u5b66\u6210\u679c\u5411\u4e34\u5e8a\u6709\u6548\u7597\u6cd5\u7684\u8f6c\u5316\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5%E3%80%81%E4%BF%83%E8%BF%9B%E6%9C%AA%E6%B3%A8%E5%86%8C%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E8%8D%AF%E7%89%A9%E7%9A%84%E4%B8%B4%E5%BA%8A%E7%A0%94%E7%A9%B6%E7%9B%91%E7%AE%A1%E5%8F%91%E5%B1%95%E7%9A%84%E8%BF%87%E7%A8%8B%E5%8F%8A%E5%85%B3%E9%94%AE%E8%A6%81%E7%B4%A0\"><\/span>5\u3001\u4fc3\u8fdb\u672a\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\u7684\u4e34\u5e8a\u7814\u7a76\u76d1\u7ba1\u53d1\u5c55\u7684\u8fc7\u7a0b\u53ca\u5173\u952e\u8981\u7d20<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"%E7%9B%91%E7%AE%A1%E5%8F%91%E5%B1%95%E8%BF%87%E7%A8%8B\"><\/span><strong>\u76d1\u7ba1\u53d1\u5c55\u8fc7\u7a0b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ds-markdown-paragraph\">\u4e2d\u56fd\u5bf9\u6b64\u7c7b\u7814\u7a76\u7684\u76d1\u7ba1\u53d1\u5c55\uff0c\u662f\u4e00\u4e2a\u4ece<strong>\u201c\u6df7\u4e71\u65e0\u5e8f\u201d\u5230\u201c\u89c4\u8303\u521b\u65b0\u201d<\/strong>\u00a0\u7684\u6f14\u8fdb\u8fc7\u7a0b\uff0c\u6838\u5fc3\u4e3e\u63aa\u662f\u5efa\u7acb\u5e76\u5b8c\u5584\u4e86<strong>\u56fd\u5bb6\u975e\u4e34\u5e8a\u7814\u7a76\u6ce8\u518c\uff08NRCR\uff09\u4f53\u7cfb<\/strong>\u3002<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>\u95ee\u9898\u66b4\u9732\u4e0e\u76d1\u7ba1\u771f\u7a7a\u671f\uff082015\u5e74\u4e4b\u524d\uff09<\/strong><\/p>\n<ul>\n<li class=\"ds-markdown-paragraph\"><strong>\u80cc\u666f<\/strong>\uff1a\u7ec6\u80de\u7597\u6cd5\u6210\u4e3a\u5168\u7403\u70ed\u70b9\uff0c\u4f46\u76d1\u7ba1\u6846\u67b6\u5c1a\u672a\u5efa\u7acb\u3002<\/li>\n<li class=\"ds-markdown-paragraph\"><strong>\u4e71\u8c61<\/strong>\uff1a\u90e8\u5206\u533b\u7597\u673a\u6784\u5229\u7528\u201c\u4e34\u5e8a\u8bd5\u9a8c\u201d\u4e4b\u540d\uff0c\u884c<strong>\u5546\u4e1a\u5316\u6cbb\u7597<\/strong>\u4e4b\u5b9e\uff0c\u5938\u5927\u7597\u6548\uff0c\u5411\u60a3\u8005\u63d0\u4f9b\u672a\u7ecf\u6279\u51c6\u7684\u7597\u6cd5\uff0c\u5bfc\u81f4\u5e02\u573a\u6df7\u4e71\uff0c\u60a3\u8005\u6743\u76ca\u53d7\u635f\u3002<\/li>\n<li class=\"ds-markdown-paragraph\"><strong>\u9700\u6c42<\/strong>\uff1a\u4e00\u65b9\u9762\u9700\u8981<strong>\u904f\u5236\u6ee5\u7528<\/strong>\uff0c\u53e6\u4e00\u65b9\u9762\u53c8\u9700\u8981\u4e3a\u771f\u6b63\u7684<strong>\u63a2\u7d22\u6027\u4e34\u5e8a\u7814\u7a76<\/strong>\u63d0\u4f9b\u5408\u6cd5\u7a7a\u95f4\uff0c\u4ee5\u6536\u96c6\u521d\u6b65\u6570\u636e\u3002<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u5236\u5ea6\u521b\u65b0\u4e0e\u8bd5\u70b9\u5efa\u7acb\uff082015\u5e74\uff09<\/strong><\/p>\n<ul>\n<li class=\"ds-markdown-paragraph\"><strong>\u5173\u952e\u4e3e\u63aa<\/strong>\uff1a\u9488\u5bf9\u95ee\u9898\u6700\u7a81\u51fa\u7684\u5e72\u7ec6\u80de\u9886\u57df\uff0c\u56fd\u5bb6\u536b\u751f\u8ba1\u751f\u59d4\u548c\u98df\u836f\u76d1\u603b\u5c40\u8054\u5408\u53d1\u5e03\u00a0<strong>\u300a\u5e72\u7ec6\u80de\u4e34\u5e8a\u7814\u7a76\u7ba1\u7406\u529e\u6cd5\uff08\u8bd5\u884c\uff09\u300b<\/strong>\u00a0\u53ca\u914d\u5957\u6307\u5357\u3002<\/li>\n<li class=\"ds-markdown-paragraph\"><strong>\u6838\u5fc3\u521b\u65b0<\/strong>\uff1a\u5f15\u5165\u4e86<strong>\u5e72\u7ec6\u80deNRCR\u4f53\u7cfb<\/strong>\u4f5c\u4e3a\u8bd5\u70b9\u3002\u8fd9\u4e00\u5236\u5ea6\u5c06\u76d1\u7ba1\u5173\u53e3\u524d\u79fb\uff0c<strong>\u6307\u5b9a\u7b26\u5408\u6761\u4ef6\u7684\u533b\u7597\u673a\u6784\u4f5c\u4e3a\u8d23\u4efb\u4e3b\u4f53<\/strong>\uff0c\u5bf9\u5728\u5176\u5185\u90e8\u5f00\u5c55\u7684\u5e72\u7ec6\u80de\u4e34\u5e8a\u7814\u7a76\u8fdb\u884c\u7ba1\u7406\u548c\u76d1\u7763\u3002<\/li>\n<\/ul>\n<p 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aria-describedby=\"caption-attachment-20276\" class=\"wp-image-20276 size-full\" src=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_174158_612.png\" alt=\"\u56fe3\uff1a\u5e72\u7ec6\u80de\u548c\u4f53\u7ec6\u80de\u4ea7\u54c1\u975e\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76\uff08NRCR\uff09\u7533\u8bf7\u6d41\u7a0b\u3002\u865a\u7ebf\u6846\u5185\u7684\u90e8\u5206\u4ee3\u8868NRCR\u4e2d\u5e72\u7ec6\u80de\u548c\u4f53\u7ec6\u80de\u7684\u901a\u7528\u6d41\u7a0b\uff0c\u865a\u7ebf\u6846\u5916\u7684\u90e8\u5206\u5219\u5c55\u793a\u4e86NRCR\u6d41\u7a0b\u4e2d\u5e72\u7ec6\u80de\u548c\u4f53\u7ec6\u80de\u7684\u5dee\u5f02\u3002*PMPA\u548cNMPA\u4e0d\u53c2\u4e0e\u4f53\u7ec6\u80deNRCR\u7533\u8bf7\u6d41\u7a0b\u3002\" width=\"685\" height=\"1000\" title=\"\" srcset=\"https:\/\/www.hjtdsm.cn\/wp-content\/uploads\/2025\/11\/\u5fae\u4fe1\u56fe\u7247_2025-11-03_174158_612.png 685w, 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class=\"ds-markdown-paragraph\"><strong>\u6210\u6548\u663e\u73b0\u4e0e\u4f53\u7cfb\u5b8c\u5584\uff08\u5f53\u524d\uff09<\/strong><\/p>\n<ul>\n<li class=\"ds-markdown-paragraph\"><strong>\u6570\u636e\u8bc1\u660e<\/strong>\uff1a\u81ea2017\u5e74\u9996\u6279\u9879\u76ee\u548c\u673a\u6784\u83b7\u6279\u4ee5\u6765\uff0cNRCR\u4f53\u7cfb\u53d1\u5c55\u8fc5\u901f\uff08\u622a\u81f32024\u5e7410\u6708\uff1a141\u5bb6\u673a\u6784\uff0c168\u4e2a\u9879\u76ee\uff09\u3002<\/li>\n<li class=\"ds-markdown-paragraph\"><strong>\u8f6c\u5316\u4fc3\u8fdb<\/strong>\uff1a\u6700\u5173\u952e\u7684\u662f\uff0c\u7ea6<strong>90%<\/strong>\u00a0\u7684NRCR\u9879\u76ee\u7814\u7a76\u8005\u5728\u4e4b\u540e\u63d0\u4ea4\u4e86IND\u7533\u8bf7\uff0c\u8bc1\u660e\u4e86\u8be5\u4f53\u7cfb\u80fd\u6709\u6548<strong>\u4fc3\u8fdb\u7814\u7a76\u6210\u679c\u5411\u6b63\u5f0f\u836f\u7269\u7814\u53d1\u8f6c\u5316<\/strong>\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E5%85%B3%E9%94%AE%E8%A6%81%E7%B4%A0%E5%88%86%E6%9E%90\"><\/span><strong>\u5173\u952e\u8981\u7d20\u5206\u6790<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p class=\"ds-markdown-paragraph\">\u8fd9\u4e00\u76d1\u7ba1\u4f53\u7cfb\u7684\u6210\u529f\u6784\u5efa\u548c\u6709\u6548\u8fd0\u884c\uff0c\u4f9d\u8d56\u4e8e\u4ee5\u4e0b\u51e0\u4e2a\u5173\u952e\u8981\u7d20\uff1a<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>\u660e\u786e\u7684\u5b9a\u4f4d\uff1a\u4e25\u683c\u533a\u5206\u201c\u4e34\u5e8a\u7814\u7a76\u201d\u4e0e\u201c\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u201d<\/strong><\/p>\n<ul>\n<li class=\"ds-markdown-paragraph\">NRCR\u7684\u672c\u8d28\u662f<strong>\u7814\u7a76\u8005\u53d1\u8d77\u7684\u63a2\u7d22\u6027\u4e34\u5e8a\u7814\u7a76<\/strong>\uff0c\u5176<strong>\u6838\u5fc3\u76ee\u6807\u975e\u5546\u4e1a\u5316<\/strong>\uff0c\u800c\u662f\u89e3\u7b54\u79d1\u5b66\u95ee\u9898\u3001\u9a8c\u8bc1\u5047\u8bbe\u3002<\/li>\n<li class=\"ds-markdown-paragraph\"><strong>\u4e25\u7981\u5411\u60a3\u8005\u6536\u8d39<\/strong>\uff0c\u4ece\u6839\u672c\u4e0a\u675c\u7edd\u4e86\u4ee5\u7814\u7a76\u4e3a\u540d\u7684\u5546\u4e1a\u7092\u4f5c\u548c\u6ee5\u7528\u3002<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u6e05\u6670\u7684\u8d23\u4efb\u4e3b\u4f53\uff1a\u533b\u7597\u673a\u6784\u8d1f\u8d23\u5236<\/strong><\/p>\n<ul>\n<li class=\"ds-markdown-paragraph\">\u76d1\u7ba1\u673a\u6784\uff08\u536b\u5065\u59d4\u548c\u836f\u76d1\u90e8\u95e8\uff09\u8d1f\u8d23\u5236\u5b9a\u89c4\u5219\u548c\u51c6\u5165\u5ba1\u6279\u3002<\/li>\n<li class=\"ds-markdown-paragraph\">\u5c06<strong>\u533b\u7597\u673a\u6784<\/strong>\u786e\u7acb\u4e3aNRCR\u7684<strong>\u4e3b\u8981\u8d23\u4efb\u4e3b\u4f53<\/strong>\uff0c\u8981\u6c42\u5176\u5177\u5907\u76f8\u5e94\u7684\u8d44\u8d28\u3001\u80fd\u529b\u548c\u7ba1\u7406\u4f53\u7cfb\uff0c\u5b9e\u73b0\u4e86\u7814\u7a76\u8fc7\u7a0b\u7684\u8d34\u8eab\u5316\u548c\u5e38\u6001\u5316\u76d1\u7ba1\u3002<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u4e25\u683c\u7684\u8d28\u91cf\u95e8\u69db\uff1a\u524d\u7f6e\u8d28\u91cf\u63a7\u5236\u4e0e\u4e34\u5e8a\u524d\u7814\u7a76<\/strong><\/p>\n<ul>\n<li class=\"ds-markdown-paragraph\">\u6240\u6709\u7533\u8bf7NRCR\u7684\u7ec6\u80de\u4ea7\u54c1\uff0c\u5fc5\u987b<strong>\u4e8b\u5148\u6ee1\u8db3<\/strong>\u300a\u5e72\u7ec6\u80de\u5236\u5242\u8d28\u91cf\u63a7\u5236\u548c\u4e34\u5e8a\u524d\u7814\u7a76\u6307\u5357\u300b\u7b49\u6587\u4ef6\u7684\u8981\u6c42\u3002<\/li>\n<li class=\"ds-markdown-paragraph\">\u8fd9\u786e\u4fdd\u4e86\u5373\u4f7f\u662f\u65e9\u671f\u63a2\u7d22\u6027\u7814\u7a76\uff0c\u4e5f\u5efa\u7acb\u5728<strong>\u521d\u6b65\u8bc1\u660e\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027<\/strong>\u57fa\u7840\u4e4b\u4e0a\uff0c\u4fdd\u969c\u4e86\u53d7\u8bd5\u8005\u5b89\u5168\u3002<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u7075\u6d3b\u7684\u8854\u63a5\u8def\u5f84\uff1a\u4e0eIND\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8054\u52a8<\/strong><\/p>\n<ul>\n<li class=\"ds-markdown-paragraph\"><strong>\u975e\u5f3a\u5236\u524d\u7f6e<\/strong>\uff1aNRCR\u4e0d\u662f\u63d0\u4ea4IND\u7684\u5fc5\u8981\u524d\u63d0\uff0c\u4e3a\u7814\u53d1\u63d0\u4f9b\u4e86\u7075\u6d3b\u6027\u3002<\/li>\n<li class=\"ds-markdown-paragraph\"><strong>\u6570\u636e\u652f\u6491<\/strong>\uff1aNRCR\u9636\u6bb5\u4ea7\u751f\u7684\u6570\u636e<strong>\u53ef\u4f5c\u4e3a\u8f85\u52a9\u6280\u672f\u6750\u6599<\/strong>\u63d0\u4ea4\uff0c\u652f\u6301IND\u7684\u8bc4\u4f30\u548c\u5ba1\u6279\u3002<\/li>\n<li class=\"ds-markdown-paragraph\"><strong>\u52a0\u901f\u901a\u9053<\/strong>\uff1a\u5bf9\u4e8e\u5728NRCR\u4e2d\u8868\u73b0\u51fa\u9ad8\u5ea6\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u4ea7\u54c1\uff0c\u7ecf\u4e25\u683c\u8bc4\u4f30\u540e\uff0c<strong>\u53ef\u80fd\u8df3\u8fc7I\u671f\u4e34\u5e8a\u76f4\u63a5\u8fdb\u5165II\u671f<\/strong>\uff0c\u8fd9\u6781\u5927\u5730\u6fc0\u52b1\u4e86\u7814\u7a76\u8005\u5e76\u52a0\u901f\u4e86\u7597\u6cd5\u5f00\u53d1\u3002<\/li>\n<\/ul>\n<p class=\"ds-markdown-paragraph\"><strong>\u7edf\u4e00\u7684\u76d1\u7ba1\u6846\u67b6\uff1a\u6f84\u6e05\u201c\u53cc\u8f68\u5236\u201d\u8bef\u89e3<\/strong><\/p>\n<ul>\n<li class=\"ds-markdown-paragraph\">\u5b98\u65b9\u660e\u786e\u5426\u8ba4\u5b58\u5728\u6240\u8c13\u7684\u201c\u53cc\u8f68\u5236\u201d\uff08\u4e00\u8f68\u7528\u4e8e\u7814\u7a76\uff0c\u4e00\u8f68\u7528\u4e8e\u5546\u4e1a\u5316\u5e94\u7528\uff09\u3002<\/li>\n<li class=\"ds-markdown-paragraph\">\u5f3a\u8c03<strong>\u65e0\u8bba\u662f\u7814\u7a76\u8fd8\u662f\u6700\u7ec8\u4e34\u5e8a\u5e94\u7528\uff0c\u90fd\u5fc5\u987b\u9075\u5faa\u4e25\u683c\u7684\u76d1\u7ba1\u8981\u6c42<\/strong>\u3002NRCR\u662f\u836f\u7269\u4e0a\u5e02\u524d\u4e34\u5e8a\u7814\u7a76\u9636\u6bb5\u7684\u4e00\u4e2a<strong>\u7279\u6b8a\u4e14\u53d7\u76d1\u7ba1\u7684\u73af\u8282<\/strong>\uff0c\u6700\u7ec8\u6240\u6709\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u90fd\u5fc5\u987b\u83b7\u5f97NMPA\u6279\u51c6\u624d\u80fd\u4e0a\u5e02\uff0c\u786e\u4fdd\u4e86\u76d1\u7ba1\u7684\u4e25\u8083\u6027\u548c\u4e00\u81f4\u6027\u3002<\/li>\n<\/ul>\n<p><strong>\u5c0f\u7ed3\uff1a<\/strong>\u4e2d\u56fd\u901a\u8fc7\u521b\u5efaNRCR\u4f53\u7cfb\uff0c\u6210\u529f\u5730\u8d70\u51fa\u4e86\u4e00\u6761\u00a0<strong>\u201c\u5728\u4e25\u76d1\u7ba1\u4e0b\u4fc3\u521b\u65b0\u201d<\/strong>\u00a0\u7684\u9053\u8def\u3002\u8be5\u4f53\u7cfb\u901a\u8fc7<strong>\u660e\u786e\u7814\u7a76\u5c5e\u6027\u3001\u843d\u5b9e\u673a\u6784\u8d23\u4efb\u3001\u8bbe\u5b9a\u8d28\u91cf\u5e95\u7ebf\u3001\u6253\u901a\u8f6c\u5316\u8def\u5f84<\/strong>\u7b49\u5173\u952e\u8981\u7d20\uff0c\u6709\u6548\u5730\u5c06\u6b64\u524d\u65e0\u5e8f\u7684\u201c\u672a\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76\u201d\u7eb3\u5165\u4e86\u89c4\u8303\u5316\u7ba1\u7406\u7684\u8f68\u9053\uff0c\u65e2\u4fdd\u62a4\u4e86\u60a3\u8005\u6743\u76ca\uff0c\u53c8\u4e3a\u771f\u6b63\u7684\u79d1\u5b66\u521b\u65b0\u63d0\u4f9b\u4e86\u5b9d\u8d35\u7684\u8bd5\u9a8c\u7a7a\u95f4\u548c\u6570\u636e\u652f\u6301\uff0c\u6700\u7ec8\u6709\u529b\u5730\u4fc3\u8fdb\u4e86\u7ec6\u80de\u6cbb\u7597\u9886\u57df\u7684\u5065\u5eb7\u53d1\u5c55\u3002<\/p>\n<h2 id=\"Sec7\" class=\"c-article-section__title js-section-title js-c-reading-companion-sections-item\"><span class=\"ez-toc-section\" id=\"6%E3%80%81%E5%AE%8C%E5%96%84%E5%9B%BD%E5%AE%B6CTP%E8%B4%A8%E9%87%8F%E6%8E%A7%E5%88%B6%E4%BD%93%E7%B3%BB%E7%9A%84%E6%96%B9%E6%B3%95%E6%9C%89%E5%93%AA%E4%BA%9B%EF%BC%9F\"><\/span><span class=\"c-article-section__title-number\"><span dir=\"auto\">6\u3001\u5b8c\u5584\u56fd\u5bb6CTP\u8d28\u91cf\u63a7\u5236\u4f53\u7cfb\u7684\u65b9\u6cd5\u6709\u54ea\u4e9b\uff1f<\/span><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div id=\"Sec7-content\" class=\"c-article-section__content\">\n<p><span dir=\"auto\">\u4e0e\u6240\u6709\u836f\u54c1\u4e00\u6837\uff0c\u7ec6\u80de\u7597\u6cd5\u4e5f\u628a\u8d28\u91cf\u7f6e\u4e8e\u7814\u53d1\u548c\u5e94\u7528\u7684\u9996\u4f4d\u3002\u4ece\u7ec6\u80de\u7597\u6cd5\u7814\u53d1\u7684\u521d\u671f\u9636\u6bb5\u5230\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08IND\uff09\u548c\u6ce8\u518c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u6bcf\u4e00\u6b65\u90fd\u9700\u8fdb\u884c\u4e25\u683c\u7684\u8d28\u91cf\u8bc4\u4f30\uff0c\u4ee5\u786e\u4fdd\u7ec6\u80de\u7597\u6cd5\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/span><\/p>\n<p><span dir=\"auto\">\u4e0e\u5316\u5b66\u836f\u54c1\u6210\u719f\u7684\u8d28\u91cf\u8bc4\u4ef7\u6807\u51c6\u76f8\u6bd4\uff0c\u5c3d\u7ba1\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\u7269\uff08CTP\uff09\u7684IND\u7533\u8bf7\u6570\u91cf\u5df2\u8d85\u8fc7100\u4efd\u4e14\u6301\u7eed\u589e\u957f\uff0c\u4f46CTP\u7684\u8d28\u91cf\u8bc4\u4ef7\u4ecd\u5904\u4e8e\u8d77\u6b65\u9636\u6bb5\u3002\u6b64\u5916\uff0cCTP\u7684\u76d1\u7ba1\u73af\u5883\u5f80\u5f80\u6ede\u540e\u4e8e\u7814\u53d1\u7684\u6b65\u4f10\u3002\u7ec6\u80de\u6cbb\u7597\u9886\u57df\u6b63\u7ecf\u5386\u7740\u5feb\u901f\u53d1\u5c55\uff0c\u8fd9\u5f97\u76ca\u4e8e\u7a81\u7834\u6027\u53d1\u73b0\u3001\u4ea7\u4e1a\u5316\u521d\u671f\u9636\u6bb5\u4ee5\u53ca\u65b0\u578b\u4ea7\u54c1\u7c7b\u578b\u3001\u751f\u4ea7\u5de5\u827a\u548c\u6280\u672f\u8fdb\u6b65\u7684\u4e0d\u65ad\u6d8c\u73b0\u3002\u5728\u6b64\u80cc\u666f\u4e0b\uff0c\u4f5c\u4e3a\u552f\u4e00\u8d1f\u8d23CTP\u8d28\u91cf\u8bc4\u4ef7\u7684\u56fd\u5bb6\u7ea7\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\uff08NCL\uff09\uff0c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NIFDC\uff09\u5728CTP\u8d28\u91cf\u8bc4\u4ef7\u7814\u7a76\u9886\u57df\u5f00\u5c55\u4e86\u5e7f\u6cdb\u7684\u57fa\u7840\u6027\u3001\u5f00\u521b\u6027\u548c\u521b\u65b0\u6027\u5de5\u4f5c\uff0c\u6781\u5927\u5730\u4fc3\u8fdb\u4e86\u884c\u4e1a\u53d1\u5c55\u548c\u76f8\u5173\u4ea7\u54c1\u7684\u76d1\u7ba1\u3002<\/span><\/p>\n<p><span dir=\"auto\">\u8fd1\u5e74\u6765\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\uff08CTP\uff09\u7814\u7a76\u9886\u57df\u6d8c\u73b0\u51fa\u4f17\u591a\u521b\u65b0\u6210\u679c\uff0c\u5305\u62ec\u65b0\u578b\u4ea7\u54c1\u3001\u7814\u7a76\u6280\u672f\u548c\u6cbb\u7597\u5e94\u7528\u3002\u5982\u4f55\u8c03\u6574\u76d1\u7ba1\u653f\u7b56\u548c\u6280\u672f\u4ee5\u8ddf\u4e0a\u8fd9\u4e00\u5feb\u901f\u53d1\u5c55\u7684\u884c\u4e1a\u6b65\u4f10\uff0c\u540c\u65f6\u4fc3\u8fdb\u5176\u589e\u957f\u5e76\u7ef4\u6301\u9002\u5f53\u7684\u4ea7\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u6027\uff0c\u662f\u4e00\u9879\u91cd\u5927\u6311\u6218\u3002\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NIFDC\uff09\u5df2\u6295\u5165\u5927\u91cf\u7cbe\u529b\u5f00\u53d1\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269\u7684\u76d1\u7ba1\u6280\u672f\uff0c\u4e3a\u52a0\u5f3a\u76d1\u7ba1\u505a\u51fa\u4e86\u91cd\u8981\u8d21\u732e\u3002\u4e3a\u5e94\u5bf9\u8fd9\u4e9b\u6311\u6218\uff0cNIFDC\u5b9e\u65bd\u4e86\u591a\u9879\u6218\u7565\u3002<\/span><\/p>\n<section data-title=\"Improvement of the National Quality Control System for CTPs\">\n<div id=\"Sec7-section\" class=\"c-article-section\">\n<div id=\"Sec7-content\" class=\"c-article-section__content\">\n<p class=\"ds-markdown-paragraph\"><strong>\u7b2c\u4e00\uff0c\u4f9d\u6258\u56fd\u5bb6\u7ea7\u79d1\u7814\u9879\u76ee\uff0c\u7cfb\u7edf\u6027\u5730\u5f00\u5c55\u8d28\u91cf\u8bc4\u4ef7\u7814\u7a76\u3002<\/strong> \u56fd\u5bb6\u673a\u6784\uff08\u5982NIFDC\uff09\u901a\u8fc7\u79ef\u6781\u4e89\u53d6\u5e76\u627f\u62c5\u56fd\u5bb6\u201c\u5341\u4e8c\u4e94\u201d\u3001\u201c\u5341\u56db\u4e94\u201d\u7b49\u91cd\u5927\u79d1\u6280\u4e13\u9879\uff08\u5982\u201c\u5e72\u7ec6\u80de\u4e0e\u8f6c\u5316\u7814\u7a76\u201d\u3001\u201c\u5e72\u7ec6\u80de\u4e0e\u5668\u5b98\u4fee\u590d\u7814\u7a76\u201d\uff09\uff0c\u83b7\u5f97\u4e86\u7a33\u5b9a\u7684\u8d44\u91d1\u652f\u6301\u3002\u8fd9\u4e9b\u9879\u76ee\u65e8\u5728\u5efa\u7acb\u548c\u592f\u5b9eCTP\u8d28\u91cf\u8bc4\u4ef7\u7684\u6280\u672f\u57fa\u7840\uff0c\u6210\u529f\u5f00\u53d1\u51fa\u9488\u5bf9\u4eba\u7c7b\u80da\u80ce\u5e72\u7ec6\u80de\u3001\u95f4\u5145\u8d28\u5e72\u7ec6\u80de\u7b49\u7684\u57fa\u7840\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8bc4\u4f30\u6280\u672f\uff0c<span dir=\"auto\">\u8fd9\u4e9b\u76d1\u7ba1\u6280\u672f\u65b9\u6848\u6709\u6548\u5730\u652f\u6301\u4e86\u4e34\u5e8a\u7814\u7a76\u7684\u76d1\u7763\uff0c\u5e76\u786e\u4fdd\u4e86\u7ec6\u80de\u8d28\u91cf\uff0c\u4e16\u754c\u4e0a\u9996\u4f8b\u5229\u7528\u80da\u80ce\u5e72\u7ec6\u80de\u884d\u751f\u7684\u795e\u7ecf\u524d\u4f53\u7ec6\u80de\u6cbb\u7597\u4eba\u7c7b\u5e15\u91d1\u68ee\u75c5\u7684\u6848\u4f8b[\u00a0<\/span><a id=\"ref-link-section-d65886511e2027\" title=\"Cyranoski D. \u4e2d\u56fd\u5373\u5c06\u542f\u52a8\u80da\u80ce\u5e72\u7ec6\u80de\u8bd5\u9a8c\u3002\u81ea\u7136\u30022017;546(7656):15\u20136\u3002https:\/\/doi.org\/10.1038\/546015a\u3002\" href=\"https:\/\/springer.z.scidown.top\/chapter\/10.1007\/978-3-031-97297-3_5#ref-CR39\" data-track=\"click\" data-track-action=\"reference anchor\" data-track-label=\"link\" data-test=\"citation-ref\" aria-label=\"\u53c2\u8003\u6587\u732e39\" rel=\"nofollow noopener\" target=\"_blank\"><span dir=\"auto\">39<\/span><\/a><span dir=\"auto\">\u00a0]\u4fbf\u8bc1\u660e\u4e86\u8fd9\u4e00\u70b9\u3002<\/span><\/p>\n<p class=\"ds-markdown-paragraph\"><strong>\u7b2c\u4e8c\uff0c\u4e3b\u52a8\u542f\u52a8\u76d1\u7ba1\u79d1\u5b66\u9879\u76ee\uff0c\u6784\u5efa\u534f\u540c\u7814\u7a76\u7f51\u7edc\u3002<\/strong>\u00a0\u9664\u4e86\u627f\u63a5\u56fd\u5bb6\u9879\u76ee\uff0cNIFDC\u8fd8\u4f5c\u4e3a\u91cd\u70b9\u53c2\u4e0e\u65b9\u79ef\u6781\u63a8\u52a8\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u79d1\u5b66\u91cd\u70b9\u5b9e\u9a8c\u5ba4\u7684\u5efa\u8bbe\uff0c\u5e76\u81ea\u4e3b\u542f\u52a8\u591a\u4e2a\u4e13\u6ce8\u4e8e\u65b0\u836f\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8bc4\u4ef7\u7684\u7814\u7a76\u9879\u76ee\u3002\u8fd9\u4e9b\u9879\u76ee\u65e8\u5728\u7814\u53d1\u521b\u65b0\u7684\u8bc4\u4ef7\u6280\u672f\u3001\u65b9\u6cd5\u548c\u6807\u51c6\uff0c\u5e76\u901a\u8fc7\u4e0e\u56fd\u5bb6\u7ea7\u5b9e\u9a8c\u5ba4\u3001\u4e34\u5e8a\u4e2d\u5fc3\u3001\u9ad8\u6821\u7b49\u673a\u6784\u5408\u4f5c\uff0c\u5f62\u6210\u4e00\u4e2a\u9ad8\u6548\u7684\u76d1\u7ba1\u79d1\u5b66\u7f51\u7edc\u4f53\u7cfb\uff0c\u5171\u540c\u63a8\u8fdb\u521b\u65b0\u6280\u672f\u7684\u8f6c\u5316\u4e0e\u5e94\u7528\u3002<\/p>\n<p class=\"ds-markdown-paragraph\"><strong>\u7b2c\u4e09\uff0c\u79ef\u6781\u6574\u5408\u524d\u6cbf\u6280\u672f\uff0c\u63d0\u5347\u8d28\u91cf\u8bc4\u4ef7\u7684\u7cbe\u51c6\u5ea6\u548c\u6df1\u5ea6\u3002<\/strong>\u00a0\u76d1\u7ba1\u673a\u6784\u5c06\u5355\u7ec6\u80de\u6d4b\u5e8f\u3001\u591a\u7ec4\u5b66\u5206\u6790\u548c\u673a\u5668\u5b66\u4e60\u7b49\u6700\u65b0\u6280\u672f\u6574\u5408\u5230\u76d1\u7ba1\u6d41\u7a0b\u4e2d\u3002\u8fd9\u4e9b\u6280\u672f\u7684\u5e94\u7528\u80fd\u591f\u66f4\u5168\u9762\u5730\u6355\u6349\u4ea7\u54c1\u7684\u8d28\u91cf\u5c5e\u6027\uff0c\u4e3a\u5f00\u53d1\u7597\u6548\u548c\u5b89\u5168\u6027\u751f\u7269\u6807\u5fd7\u7269\u63d0\u4f9b\u4e86\u65b0\u9014\u5f84\u3002\u4f8b\u5982\uff0cNIFDC\u5f00\u53d1\u5e76\u9a8c\u8bc1\u4e86\u5229\u7528\u673a\u5668\u5b66\u4e60\u7b97\u6cd5\u7cbe\u51c6\u8bc6\u522b\u95f4\u5145\u8d28\u5e72\u7ec6\u80de\u7ec4\u7ec7\u6765\u6e90\u7684\u65b9\u6cd5\u3002\u540c\u65f6\uff0c\u901a\u8fc7\u4e0e\u9876\u5c16\u5b66\u672f\u4e13\u5bb6\u5408\u4f5c\uff0c\u786e\u4fdd\u80fd\u51c6\u786e\u4e86\u89e3\u65b0\u5174\u4ea7\u54c1\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff0c\u5e76\u9009\u62e9\u6700\u4f73\u7684\u8bc4\u4f30\u5de5\u5177\u3002<\/p>\n<p 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24603\uff09\u7684\u53d1\u5e03\u3002<\/p>\n<p 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class=\"ds-markdown-paragraph\"><strong>\u7b2c\u516d\uff0c\u901a\u8fc7\u4f53\u7cfb\u5316\u5efa\u8bbe\u53d6\u5f97\u663e\u8457\u6210\u6548\uff0c\u9a8c\u8bc1\u5e76\u6301\u7eed\u4f18\u5316\u8d28\u91cf\u63a7\u5236\u4f53\u7cfb\u3002<\/strong>\u00a0\u5b8c\u5584\u7684\u8d28\u91cf\u63a7\u5236\u4f53\u7cfb\u76f4\u63a5\u4fc3\u8fdb\u4e86CTP\u884c\u4e1a\u7684\u84ec\u52c3\u53d1\u5c55\u3002\u7ecfNIFDC\u8bc4\u4f30\u7684CTP\u6570\u91cf\u4ece2018\u5e74\u7684\u7ea640\u4e2a\u5927\u5e45\u589e\u957f\u81f32023\u5e74\u7684\u8fd1200\u4e2a\uff0c\u6db5\u76d6\u4e86\u5927\u90e8\u5206IND\u548cNRCR\u7533\u8bf7\u3002\u8be5\u4f53\u7cfb\u79ef\u7d2f\u7684\u4e13\u4e1a\u77e5\u8bc6\u548c\u6280\u672f\u4e5f\u6210\u529f\u652f\u6301\u4e86\u4ea7\u54c1\u7684\u4e0a\u5e02\u5ba1\u6279\uff0c\u4f8b\u5982\u5df2\u5bf9\u4e2d\u56fd\u83b7\u6279\u7684\u516d\u79cdCAR-T\u7ec6\u80de\u7597\u6cd5\u8fdb\u884c\u4e86\u4e0a\u5e02\u524d\u6388\u6743\u6d4b\u8bd5\uff0c\u5e76\u5c31\u4ea7\u54c1\u8d28\u91cf\u6807\u51c6\u63d0\u4f9b\u53cd\u9988\uff0c\u5e2e\u52a9\u4f01\u4e1a\u6539\u8fdb\u65b9\u6cd5\u3001\u7a33\u5b9a\u4ea7\u54c1\u8d28\u91cf\uff0c\u6700\u7ec8\u6210\u529f\u63a8\u5411\u5e02\u573a\u3002<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section data-title=\"Conclusion\">\n<div id=\"Sec14-section\" class=\"c-article-section\">\n<h2 id=\"Sec14\" class=\"c-article-section__title js-section-title js-c-reading-companion-sections-item\"><span class=\"ez-toc-section\" id=\"7%E3%80%81%E7%BB%93%E8%AE%BA\"><\/span><span class=\"c-article-section__title-number\"><span dir=\"auto\">7\u3001<\/span><\/span><span dir=\"auto\">\u7ed3\u8bba<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div id=\"Sec14-content\" class=\"c-article-section__content\">\n<p><span dir=\"auto\">\u8fd1\u5e74\u6765\uff0c\u7ec6\u80de\u6cbb\u7597\uff08CTP\uff09\u7684\u84ec\u52c3\u53d1\u5c55\u4fc3\u4f7f\u76d1\u7ba1\u4f53\u7cfb\u52a0\u5feb\u5b8c\u5584\uff0c\u4ee5\u9002\u5e94\u8be5\u884c\u4e1a\u7684\u5feb\u901f\u589e\u957f\u548c\u4e2d\u56fd\u65e5\u76ca\u589e\u957f\u7684\u65b0\u836f\u7533\u8bf7\u9700\u6c42\u3002\u4e3a\u6ee1\u8db3\u7ec6\u80de\u6cbb\u7597\u884c\u4e1a\u7684\u9700\u6c42\uff0c\u56fd\u5bb6\u548c\u5730\u65b9\u653f\u5e9c\u542f\u52a8\u4e86\u4f17\u591a\u9879\u76ee\uff0c\u652f\u6301\u4ea7\u54c1\u7814\u53d1\u548c\u76d1\u7ba1\u6280\u672f\u7684\u53d1\u5c55\u3002\u76d1\u7ba1\u673a\u6784\u4e5f\u79ef\u6781\u4e0e\u4f01\u4e1a\u5408\u4f5c\uff0c\u63d0\u4f9b\u66f4\u7cbe\u51c6\u7684\u653f\u7b56\u548c\u6280\u672f\u652f\u6301\uff0c\u4fc3\u8fdb\u7ec6\u80de\u6cbb\u7597\u7684\u4e34\u5e8a\u8f6c\u5316\u5065\u5eb7\u3001\u53ca\u65f6\u5730\u8fdb\u884c\u3002\u76ee\u524d\uff0c\u76d1\u7ba1\u673a\u6784\u5df2\u5efa\u7acb\u8d77\u6e05\u6670\u7684\u7ec6\u80de\u6cbb\u7597\u76f8\u5173\u65b0\u836f\u7533\u8bf7\u76d1\u7ba1\u8def\u5f84\u3002\u901a\u8fc7\u6c9f\u901a\u4e0e\u5408\u4f5c\uff0c\u5df2\u5f62\u6210\u4e00\u5957\u9488\u5bf9\u65b0\u5174\u4ea7\u54c1\u548c\u6280\u672f\u7684\u6709\u6548\u8fd0\u884c\u673a\u5236\u3002\u4e2d\u56fd\u76d1\u7ba1\u673a\u6784\u5df2\u4e3a\u7ec6\u80de\u6cbb\u7597\u65f6\u4ee3\u505a\u597d\u5145\u5206\u51c6\u5907\u3002<\/span><\/p>\n<blockquote><p><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">\u53c2\u8003\u8d44\u6599\uff1a[1] Na, T.\u00a0<\/span><\/span><i><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">\u7b49<\/span><\/span><\/i><span dir=\"auto\" style=\"vertical-align: inherit;\"><span dir=\"auto\" style=\"vertical-align: inherit;\">\u00a0(2025). \u4e2d\u56fd\u7ec6\u80de\u7597\u6cd5\u76d1\u7ba1\u4e0e\u653f\u7b56\u53d1\u5c55\u3002\u8f7d\u4e8e\uff1aStacey, GN, Zhao, T. (\u7f16) \u7ec6\u80de\u7597\u6cd5\u5236\u9020\u3002\u5b9e\u9a8c\u533b\u5b66\u4e0e\u751f\u7269\u5b66\u8fdb\u5c55\uff0c\u7b2c1486\u5377\u3002Springer\uff0cCham\u3002https:\/\/doi.org\/10.1007\/978-3-031-97297-3_5<\/span><\/span><\/p><\/blockquote>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff08CTPs\uff09\u5df2\u6210\u4e3a\u4e2d\u56fd\u518d\u751f\u533b\u5b66\u7814\u7a76\u9886\u57df\u4e2d\u6781\u5177\u53d1\u5c55\u524d\u666f\u7684\u65b9\u5411\u3002\u8fd1\u5e74\u6765\uff0c\u4e0e\u8fd9\u4e9b\u521b\u65b0\u4ea7\u54c1\u76f8\u5173\u7684\u65b0\u836f\u7533\u8bf7\u9700 [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[87],"tags":[184],"_links":{"self":[{"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/posts\/20274"}],"collection":[{"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/comments?post=20274"}],"version-history":[{"count":4,"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/posts\/20274\/revisions"}],"predecessor-version":[{"id":20283,"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/posts\/20274\/revisions\/20283"}],"wp:attachment":[{"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/media?parent=20274"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/categories?post=20274"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hjtdsm.cn\/ar\/wp-json\/wp\/v2\/tags?post=20274"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}