{"id":2016,"date":"2025-05-23T15:21:28","date_gmt":"2025-05-23T07:21:28","guid":{"rendered":"https:\/\/www.vcro.com.tw\/tw\/?p=2016"},"modified":"2025-06-17T13:03:47","modified_gmt":"2025-06-17T05:03:47","slug":"%e7%be%8e%e5%9c%8bfda%e5%b0%8d%e6%96%bchct-ps%e6%8d%90%e8%b4%88%e8%80%85%e5%90%88%e9%81%a9%e6%80%a7%e5%88%a4%e5%ae%9a%e5%9f%ba%e6%ba%96%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\/tw\/?p=2016","title":{"rendered":"\u7f8e\u570bFDA\u5c0d\u65bcHCT\/Ps\u6350\u8d08\u8005\u5408\u9069\u6027\u5224\u5b9a\u57fa\u6e96\u7684\u6307\u5f15\u66f4\u65b0 (Part 1.)"},"content":{"rendered":"\n<p>\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u65bc2025\u5e741\u6708\u767c\u5e03\u516d\u7bc7\u8207\u4eba\u9ad4\u7d30\u80de\u3001\u7d44\u7e54\u53ca\u4ee5\u7d30\u80de\u548c\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u7522\u54c1\uff08HCT\/Ps\uff09\u6350\u8d08\u8005\u5408\u9069\u6027\u5224\u5b9a\u76f8\u95dc\u7684\u6307\u5f15\u8207\u8349\u6848\uff0c\u5ef6\u7e8c2007\u5e74\u767c\u5e03\u7684HCT\/Ps\u6350\u8d08\u8005\u5408\u9069\u6027\u5224\u5b9a\u6307\u5f15<sup>1<\/sup>\uff0c\u63d0\u4f9b\u6700\u65b0\u7b26\u5408\u7f8e\u570b\u6cd5\u898fTitle 21 CFR Part 1271 Subpart C\u8981\u6c42\u7684\u5efa\u8b70\u3002\u672c\u6b21\u66f4\u65b0\u6db5\u84cb\u4e00\u7bc7\u7e3d\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for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry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\u91dd\u5c0d\u7279\u5b9a\u76f8\u95dc\u50b3\u67d3\u6027\u75c5\u539f\u6216\u75be\u75c5\uff08RCDADs\uff09\u7684\u5c08\u9580\u6307\u5f15\u3002FDA\u5728\u6307\u5f15\u4e2d\u63d0\u4f9b\u5176RCDADs\u7684\u98a8\u96aa\u56e0\u5b50\u8a55\u4f30\u3001\u81e8\u5e8a\u8b49\u64da\u53ca\u8eab\u9ad4\u6aa2\u67e5\u5efa\u8b70\uff0c\u4ee5\u63d0\u9ad8\u958b\u767c\u5ee0\u5546\u9075\u5faa\u6027\u8207\u5be6\u52d9\u64cd\u4f5c\u7684\u6e05\u6670\u5ea6\uff0c\u964d\u4f4e\u50b3\u64ad\u98a8\u96aa\u3002<\/p>\n\n\n\n<p>\u76ee\u524d\uff0cFDA\u5df2\u767c\u5e03\u4e94\u9805\u91dd\u5c0dRCDADs\u7684\u5c08\u9580\u6307\u5f15\uff0c\u6db5\u84cb\u4eba\u985e\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\u6557\u8840\u75c7\uff08Sepsis\uff09\u53ca\u7d50\u6838\u5206\u679d\u687f\u83cc\uff08Mycobacterium tuberculosis\uff09\uff0c\u5176\u4e2d\u6557\u8840\u75c7\u8207\u7d50\u6838\u5206\u679d\u687f\u83cc\u6307\u5f15\u5df2\u6b63\u5f0f\u751f\u6548\uff0c\u5176\u4ed6RCDADs\u7684\u6307\u5f15\u5c07\u7531FDA\u9678\u7e8c\u767c\u5e03\u3002\u6b64\u5916FDA\u6b64\u6b21\u6574\u5408\u4e862007\u5e74\u81f32025\u5e74\u9593\u95dc\u65bc\u6350\u8d08\u8005\u5408\u9069\u6027\u5224\u5b9a\u7684\u5f8c\u7e8c\u6307\u5f15\uff0c\u5305\u542b\u6885\u6bd2\uff08Syphilis\uff09\u3001B\u578b\u809d\u708e\u75c5\u6bd2\uff08HBV\uff09\u53ca\u897f\u5c3c\u7f85\u75c5\u6bd2\uff08WNV\uff09\u7684\u6aa2\u6e2c\u6280\u8853\u5efa\u8b70\u3002\u672c\u6b21\u66f4\u65b0\u6db5\u84cb\u591a\u500b\u65b9\u9762\uff0c\u5305\u62ecRCDADs\u8a8d\u5b9a\u3001RCDADs\u7be9\u9078\u5efa\u8b70\u3001\u6350\u8d08\u8005\u7684\u75c5\u53f2\u8a2a\u8ac7\u3001RCDADs\u6aa2\u6e2c\u6280\u8853\u767c\u5c55\u3002<\/p>\n\n\n\n<p><strong>1. RCDADs<\/strong><strong>\u8a8d\u5b9a\u66f4\u65b0<\/strong> RCDADs\u7684\u8a8d\u5b9a\u5c07\u5f71\u97ff\u6350\u8d08\u8005\u7684\u7be9\u9078\u8207\u6aa2\u6e2c\u9805\u76ee\u3002FDA\u5efa\u8b70\u6240\u6709HCT\/Ps\u6350\u8d08\u8005\u7686\u61c9\u63a5\u53d7\u4ee5\u4e0bRCDADs\u7be9\u9078\u8207\u6aa2\u6e2c\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4eba\u985e\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\u985e\u50b3\u67d3\u6027\u6d77\u7dbf\u6a23\u8166\u75c7\uff08TSE\uff09<\/li>\n\n\n\n<li>\u897f\u5c3c\u7f85\u75c5\u6bd2\uff08WNV\uff09<\/li>\n\n\n\n<li>\u75d8\u82d7\u75c5\u6bd2\uff08Vaccinia\uff09<\/li>\n\n\n\n<li>\u6557\u8840\u75c7\uff08Sepsis\uff09<\/li>\n\n\n\n<li>\u7d50\u6838\u5206\u679d\u687f\u83cc\uff08Mycobacterium tuberculosis\uff09<\/li>\n\n\n\n<li>\u7570\u7a2e\u79fb\u690d\u76f8\u95dc\u611f\u67d3\u98a8\u96aa\u75c5\u539f<\/li>\n<\/ul>\n\n\n\n<p>\u5c0d\u65bc\u5bcc\u542b\u767d\u8840\u7403\u7684HCT\/Ps\u6350\u8d08\u8005\uff0cRCDADs\u7bc4\u570d\u4ea6\u5305\u542b\u4eba\u985e\u55dcT\u6dcb\u5df4\u7403\u75c5\u6bd2\uff08HTLV-1\u3001HTLV-2\uff09\u3001\u5de8\u7d30\u80de\u75c5\u6bd2\uff08CMV\uff09\u3002<\/p>\n\n\n\n<p>\u91dd\u5c0d\u751f\u6b96\u76f8\u95dcHCT\/Ps\u6350\u8d08\u8005\uff0c\u62ab\u8863\u83cc\uff08Chlamydia trachomatis\uff09\u53ca\u6dcb\u75c5\u5948\u745f\u83cc\uff08Neisseria gonorrhoeae\uff09\u88ab\u8a8d\u5b9a\u70baRCDADs\u3002 \u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u8332\u5361\u75c5\u6bd2\uff08Zika virus\uff09\u65bc2016\u5e74\u66fe\u88ab\u5217\u70baRCDADs\uff0c\u4f46\u56e0\u5176\u767c\u751f\u7387\u548c\u6d41\u884c\u7387\u4e0b\u964d\uff0cFDA\u65bc2024\u5e74\u5df2\u516c\u544a\u8a72\u75c5\u6bd2\u4e0d\u518d\u88ab\u8a8d\u5b9a\u70baRCDADs\u3002<\/p>\n\n\n\n<p>\u5ef6\u4f38\u95b1\u8b80\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-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" data-id=\"2017\" src=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2025\/05\/image.png\" alt=\"\" class=\"wp-image-2017\" srcset=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2025\/05\/image.png 1024w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2025\/05\/image-300x300.png 300w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2025\/05\/image-150x150.png 150w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/figure>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u65bc2025\u5e741\u6708\u767c\u5e03\u516d\u7bc7\u8207\u4eba\u9ad4\u7d30\u80de\u3001\u7d44\u7e54\u53ca\u4ee5\u7d30\u80de\u548c\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u7522\u54c1\uff08HCT\/Ps\uff09 [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2017,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[185,187,23,182,183,184,186,188],"class_list":["post-2016","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-11","tag-b","tag-c","tag-fda","tag-hct-ps","tag-rcdads","tag-184","tag-186","tag-188"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>\u7f8e\u570bFDA\u5c0d\u65bcHCT\/Ps\u6350\u8d08\u8005\u5408\u9069\u6027\u5224\u5b9a\u57fa\u6e96\u7684\u6307\u5f15\u66f4\u65b0 (Part 1.) - VCRO<\/title>\r\n<meta name=\"description\" content=\"\u7f8e\u570bFDA\u5c0d\u65bcHCT\/Ps\u6350\u8d08\u8005\u5408\u9069\u6027\u5224\u5b9a\u57fa\u6e96\u7684\u6307\u5f15\u66f4\u65b0 (Part 1.) 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