{"id":1868,"date":"2025-05-23T15:27:31","date_gmt":"2025-05-23T07:27:31","guid":{"rendered":"https:\/\/www.vcro.com.tw\/cn\/?p=1868"},"modified":"2025-06-02T16:49:41","modified_gmt":"2025-06-02T08:49:41","slug":"%e7%be%8e%e5%9b%bdfda%e5%af%b9%e4%ba%8ehct-ps%e6%8d%90%e8%b5%a0%e8%80%85%e5%90%88%e9%80%82%e6%80%a7%e5%88%a4%e5%ae%9a%e5%9f%ba%e5%87%86%e7%9a%84%e6%8c%87%e5%bc%95%e6%9b%b4%e6%96%b0-part-1","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1868","title":{"rendered":"\u7f8e\u56fdFDA\u5bf9\u4e8eHCT\/Ps\u6350\u8d60\u8005\u5408\u9002\u6027\u5224\u5b9a\u57fa\u51c6\u7684\u6307\u5f15\u66f4\u65b0 (Part 1.)"},"content":{"rendered":"\n<p>\u7f8e\u56fd\u98df\u54c1\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u4e8e2025\u5e741\u6708\u53d1\u5e03\u516d\u7bc7\u4e0e\u4eba\u4f53\u7ec6\u80de\u3001\u7ec4\u7ec7\u53ca\u4ee5\u7ec6\u80de\u548c\u7ec4\u7ec7\u4e3a\u57fa\u7840\u7684\u4ea7\u54c1\uff08HCT\/Ps\uff09\u6350\u8d60\u8005\u5408\u9002\u6027\u5224\u5b9a\u76f8\u5173\u7684\u6307\u5f15\u4e0e\u8349\u6848\uff0c\u5ef6\u7eed2007\u5e74\u53d1\u5e03\u7684HCT\/Ps\u6350\u8d60\u8005\u5408\u9002\u6027\u5224\u5b9a\u6307\u5f15<sup>1<\/sup>\uff0c\u63d0\u4f9b\u6700\u65b0\u7b26\u5408\u7f8e\u56fd\u6cd5\u89c4Title 21 CFR Part 1271 Subpart C\u8981\u6c42\u7684\u5efa\u8bae\u3002\u672c\u6b21\u66f4\u65b0\u6db5\u76d6\u4e00\u7bc7\u603b\u6307\u5f15\uff08Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry<sup>2<\/sup>\uff09\u53ca\u4e94\u7bc7\u9488\u5bf9\u7279\u5b9a\u76f8\u5173\u4f20\u67d3\u6027\u75c5\u539f\u6216\u75be\u75c5\uff08RCDADs\uff09\u7684\u4e13\u95e8\u6307\u5f15\u3002FDA\u5728\u6307\u5f15\u4e2d\u63d0\u4f9b\u5176RCDADs\u7684\u98ce\u9669\u56e0\u5b50\u8bc4\u4f30\u3001\u4e34\u5e8a\u8bc1\u636e\u53ca\u8eab\u4f53\u68c0\u67e5\u5efa\u8bae\uff0c\u4ee5\u63d0\u9ad8\u5f00\u53d1\u5382\u5546\u9075\u5faa\u6027\u4e0e\u5b9e\u52a1\u64cd\u4f5c\u7684\u6e05\u6670\u5ea6\uff0c\u964d\u4f4e\u4f20\u64ad\u98ce\u9669\u3002<\/p>\n\n\n\n<p>\u76ee\u524d\uff0cFDA\u5df2\u53d1\u5e03\u4e94\u9879\u9488\u5bf9RCDADs\u7684\u4e13\u95e8\u6307\u5f15\uff0c\u6db5\u76d6\u4eba\u7c7b\u514d\u75ab\u7f3a\u4e4f\u75c5\u6bd2\uff08HIV\uff09\u3001B\u578b\u809d\u708e\u75c5\u6bd2\uff08HBV\uff09\u3001C\u578b\u809d\u708e\u75c5\u6bd2\uff08HCV\uff09\u3001\u8d25\u8840\u75c7\uff08Sepsis\uff09\u53ca\u7ed3\u6838\u5206\u679d\u6746\u83cc\uff08Mycobacterium tuberculosis\uff09\uff0c\u5176\u4e2d\u8d25\u8840\u75c7\u4e0e\u7ed3\u6838\u5206\u679d\u6746\u83cc\u6307\u5f15\u5df2\u6b63\u5f0f\u751f\u6548\uff0c\u5176\u4ed6RCDADs\u7684\u6307\u5f15\u5c06\u7531FDA\u9646\u7eed\u53d1\u5e03\u3002\u6b64\u5916FDA\u6b64\u6b21\u6574\u5408\u4e862007\u5e74\u81f32025\u5e74\u95f4\u5173\u4e8e\u6350\u8d60\u8005\u5408\u9002\u6027\u5224\u5b9a\u7684\u540e\u7eed\u6307\u5f15\uff0c\u5305\u542b\u6885\u6bd2\uff08Syphilis\uff09\u3001B\u578b\u809d\u708e\u75c5\u6bd2\uff08HBV\uff09\u53ca\u897f\u5c3c\u7f57\u75c5\u6bd2\uff08WNV\uff09\u7684\u68c0\u6d4b\u6280\u672f\u5efa\u8bae\u3002\u672c\u6b21\u66f4\u65b0\u6db5\u76d6\u591a\u4e2a\u65b9\u9762\uff0c\u5305\u62ecRCDADs\u8ba4\u5b9a\u3001RCDADs\u7b5b\u9009\u5efa\u8bae\u3001\u6350\u8d60\u8005\u7684\u75c5\u53f2\u8bbf\u8c08\u3001RCDADs\u68c0\u6d4b\u6280\u672f\u53d1\u5c55\u3002<\/p>\n\n\n\n<p><strong>1. RCDADs<\/strong><strong>\u8ba4\u5b9a\u66f4\u65b0<\/strong> RCDADs\u7684\u8ba4\u5b9a\u5c06\u5f71\u54cd\u6350\u8d60\u8005\u7684\u7b5b\u9009\u4e0e\u68c0\u6d4b\u9879\u76ee\u3002FDA\u5efa\u8bae\u6240\u6709HCT\/Ps\u6350\u8d60\u8005\u7686\u5e94\u63a5\u53d7\u4ee5\u4e0bRCDADs\u7b5b\u9009\u4e0e\u68c0\u6d4b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4eba\u7c7b\u514d\u75ab\u7f3a\u4e4f\u75c5\u6bd2\u7b2c\u4e00\u578b\u3001\u7b2c\u4e8c\u578b\uff08HIV-1\u3001HIV-2\uff09<\/li>\n\n\n\n<li>\uff22\u578b\u809d\u708e\u75c5\u6bd2\uff08HBV\uff09\u3001\uff23\u578b\u809d\u708e\u75c5\u6bd2\uff08HCV\uff09<\/li>\n\n\n\n<li>\u6885\u6bd2\uff08Syphilis\uff09<\/li>\n\n\n\n<li>\u4eba\u7c7b\u4f20\u67d3\u6027\u6d77\u7ef5\u6837\u8111\u75c7\uff08TSE\uff09<\/li>\n\n\n\n<li>\u897f\u5c3c\u7f57\u75c5\u6bd2\uff08WNV\uff09<\/li>\n\n\n\n<li>\u75d8\u82d7\u75c5\u6bd2\uff08Vaccinia\uff09<\/li>\n\n\n\n<li>\u8d25\u8840\u75c7\uff08Sepsis\uff09<\/li>\n\n\n\n<li>\u7ed3\u6838\u5206\u679d\u6746\u83cc\uff08Mycobacterium tuberculosis\uff09<\/li>\n\n\n\n<li>\u5f02\u79cd\u79fb\u690d\u76f8\u5173\u611f\u67d3\u98ce\u9669\u75c5\u539f<\/li>\n<\/ul>\n\n\n\n<p>\u5bf9\u4e8e\u5bcc\u542b\u767d\u8840\u7403\u7684HCT\/Ps\u6350\u8d60\u8005\uff0cRCDADs\u8303\u56f4\u4ea6\u5305\u542b\u4eba\u7c7b\u55dcT\u6dcb\u5df4\u7403\u75c5\u6bd2\uff08HTLV-1\u3001HTLV-2\uff09\u3001\u5de8\u7ec6\u80de\u75c5\u6bd2\uff08CMV\uff09\u3002<\/p>\n\n\n\n<p>\u9488\u5bf9\u751f\u6b96\u76f8\u5173HCT\/Ps\u6350\u8d60\u8005\uff0c\u62ab\u8863\u83cc\uff08Chlamydia trachomatis\uff09\u53ca\u6dcb\u75c5\u5948\u745f\u83cc\uff08Neisseria gonorrhoeae\uff09\u88ab\u8ba4\u5b9a\u4e3aRCDADs\u3002 \u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u5179\u5361\u75c5\u6bd2\uff08Zika virus\uff09\u4e8e2016\u5e74\u66fe\u88ab\u5217\u4e3aRCDADs\uff0c\u4f46\u56e0\u5176\u53d1\u751f\u7387\u548c\u6d41\u884c\u7387\u4e0b\u964d\uff0cFDA\u4e8e2024\u5e74\u5df2\u516c\u544a\u8be5\u75c5\u6bd2\u4e0d\u518d\u88ab\u8ba4\u5b9a\u4e3aRCDADs\u3002<\/p>\n\n\n\n<p>\u5ef6\u4f38\u9605\u8bfb\uff1a<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT\/Ps): Guidance for Industry 2007<\/li>\n\n\n\n<li>Recommendations for determining donor eligibility of donors of human cells, tissues and cellular and tissue-based products: Draft Guidance for Industry 2025<\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/05\/ChatGPT-Image-2025\u5e745\u670823\u65e5-\u4e0b\u534803_16_29.png\" alt=\"\" class=\"wp-image-1869\" srcset=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/05\/ChatGPT-Image-2025\u5e745\u670823\u65e5-\u4e0b\u534803_16_29.png 1024w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/05\/ChatGPT-Image-2025\u5e745\u670823\u65e5-\u4e0b\u534803_16_29-300x300.png 300w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/05\/ChatGPT-Image-2025\u5e745\u670823\u65e5-\u4e0b\u534803_16_29-150x150.png 150w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd\u98df\u54c1\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u4e8e2025\u5e741\u6708\u53d1\u5e03\u516d\u7bc7\u4e0e\u4eba\u4f53\u7ec6\u80de\u3001\u7ec4\u7ec7\u53ca\u4ee5\u7ec6\u80de\u548c\u7ec4\u7ec7\u4e3a\u57fa\u7840\u7684\u4ea7\u54c1\uff08HCT\/Ps\uff09 [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1869,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[53,159,160,163,162,161,165,164],"class_list":["post-1868","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-11","tag-fda","tag-hct-ps","tag-rcdads","tag-163","tag-162","tag-161","tag-165","tag-164"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - 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