{"id":1912,"date":"2025-08-04T16:33:32","date_gmt":"2025-08-04T08:33:32","guid":{"rendered":"https:\/\/www.vcro.com.tw\/cn\/?p=1912"},"modified":"2025-08-04T16:34:55","modified_gmt":"2025-08-04T08:34:55","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-2","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1912","title":{"rendered":"\u7f8e\u56fdFDA\u5bf9\u4e8eHCT\/Ps\u6350\u8d60\u8005\u5408\u9002\u6027\u5224\u5b9a\u57fa\u51c6\u7684\u6307\u5f15\u66f4\u65b0 (Part 2.)"},"content":{"rendered":"\n<p><strong>2. RCDADs\u7b5b\u9009\u6761\u4ef6\u66f4\u65b0<\/strong>\u00a0FDA\u4e8e\u5404RCDADs\u4e13\u95e8\u6307\u5f15\u4e2d\u8be6\u8ff0\u5176\u98ce\u9669\u56e0\u5b50\uff0c\u5176\u4e2dHIV\u3001HBV\u3001HCV\u7684\u7b5b\u9009\u6761\u4ef6\u6709\u91cd\u5927\u8c03\u6574\u3002\u98ce\u9669\u56e0\u5b50\u65f6\u9650\u7684\u7f29\u77ed\u5f97\u76ca\u4e8e\u68c0\u6d4b\u6280\u672f\u7684\u8fdb\u6b65\u53ca\u7f8e\u56fd\u3001\u82f1\u56fd\u3001\u52a0\u62ff\u5927\u7b49\u56fd\u7684\u5927\u578b\u8840\u6db2\u6350\u8d60\u8005\u7814\u7a76\u6210\u679c\u3002\u4f8b\u5982\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8fc7\u53bb\u4e94\u5e74\u5185\u66fe\u4ee5\u6027\u884c\u4e3a\u4ea4\u6613\u91d1\u94b1\u3001\u836f\u7269\u6216\u5176\u4ed6\u62a5\u916c\u7684\u7b5b\u9009\u65f6\u9650\uff0c\u7f29\u77ed\u4e3a\u8fc7\u53bb\u4e09\u4e2a\u6708\u3002<\/li>\n\n\n\n<li>\u8fc7\u53bb12\u4e2a\u6708\u5185\u66fe\u4ee5\u672a\u6d88\u6bd2\u65b9\u5f0f\u8fdb\u884c\u523a\u9752\u3001\u7a7f\u8033\u6d1e\u3001\u8eab\u4f53\u7a7f\u73af\u6216\u5171\u4eab\u672a\u6d88\u6bd2\u5668\u5177\u8005\uff0c\u5176\u7b5b\u9009\u65f6\u9650\u7f29\u77ed\u81f3\u4e09\u4e2a\u6708\u5185\u3002<\/li>\n\n\n\n<li>HIV\u7b5b\u9009\u65b0\u589e\u6570\u9879\u836f\u7269\u4f7f\u7528\u7b5b\u9009\u6761\u4ef6\uff0c\u5305\u62ec\u66fe\u63a5\u53d7HIV\u6cbb\u7597\u8005\u3001\u8fc7\u53bb\u4e24\u5e74\u5185\u66fe\u6ce8\u5c04\u9884\u9632HIV\u611f\u67d3\u7684\u836f\u7269\u8005\uff0c\u6216\u8fc7\u53bb\u4e09\u4e2a\u6708\u5185\u6709\u53e3\u670dHIV\u9884\u9632\u6027\u7528\u836f\u8005\uff0c\u4ee5\u964d\u4f4e\u56e0\u836f\u7269\u5e72\u6270\u5bfc\u81f4\u68c0\u6d4b\u7ed3\u679c\u5047\u9634\u6027\u7684\u98ce\u9669\u3002<\/li>\n<\/ul>\n\n\n\n<p><strong>3.&nbsp;<\/strong><strong>\u6350\u8d60\u8005\u7684\u75c5\u53f2\u8bbf\u8c08<\/strong>&nbsp;\u6350\u8d60\u8005\u7684\u75c5\u53f2\u8bbf\u8c08\u662f\u7b5b\u9009\u7a0b\u5e8f\u4e2d\u7684\u91cd\u8981\u73af\u8282\u3002FDA\u5efa\u8bae\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8bbf\u8c08\u5e94\u4ee5\u9762\u5bf9\u9762\u6216\u7535\u8bdd\u65b9\u5f0f\u6765\u8fdb\u884c\u5bf9\u8bdd\uff0c\u82e5\u91c7\u7528\u95ee\u5377\u65b9\u5f0f\uff0c\u5219\u5e94\u518d\u9010\u9879\u786e\u8ba4\u3002<\/li>\n\n\n\n<li>\u8bb0\u5f55\u65b9\u5f0f\u53ef\u5305\u62ec\u7eb8\u672c\u3001\u8bed\u97f3\u6216\u5f55\u50cf\uff0c\u5e76\u5e94\u4ee5\u51c6\u786e\u3001\u6e05\u6670\u548c\u4e0d\u6613\u78e8\u706d\u7684\u65b9\u5f0f\u4fdd\u5b58\u3002<\/li>\n\n\n\n<li>\u82e5\u7ec6\u80de\u6216\u7ec4\u7ec7\u6536\u53d6\u65f6\u95f4\u4e0e\u8bbf\u8c08\u65f6\u95f4\u6709\u5dee\u8ddd\uff0c\u5e94\u8be2\u95ee\u5e76\u8bb0\u5f55\u8bbf\u8c08\u540e\u53ef\u80fd\u51fa\u73b0\u7684\u75c5\u53f2\u53d8\u5316\uff0c\u4ee5\u964d\u4f4e\u98ce\u9669\u3002<\/li>\n<\/ul>\n\n\n\n<p><strong>4. RCDADs<\/strong><strong>\u68c0\u6d4b\u6280\u672f\u53d1\u5c55<\/strong>&nbsp;\u968f\u7740\u6838\u9178\u68c0\u6d4b\u6280\u672f\uff08NAT\uff09\u7684\u8fdb\u6b65\uff0cFDA\u5efa\u8bae\u5bf9\u591a\u6570RCDADs\u6267\u884cNAT\u68c0\u6d4b\uff0c\u4ee5\u964d\u4f4e\u4f20\u64ad\u98ce\u9669\u3002\u4f8b\u5982\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9488\u5bf9HBV\u68c0\u6d4b\uff0c\u9700\u540c\u65f6\u8fdb\u884c\u8868\u9762\u6297\u539f\u3001\u6297\u4f53\u53ca\u6838\u9178\u68c0\u6d4b\uff0c\u4e09\u9879\u5747\u987b\u901a\u8fc7\u624d\u53ef\u5224\u5b9a\u5408\u9002\u3002<\/li>\n\n\n\n<li>HIV\u68c0\u6d4b\u6280\u672f\u5df2\u53ef\u4fa6\u6d4bHIV-1 group O\uff0c\u56e0\u6b64\u4e0d\u518d\u4ee5\u7b5b\u9009\u6350\u8d60\u8005\u4e8e1977\u5e74\u540e\u51fa\u751f\u6216\u5c45\u4f4f\u7279\u5b9a\u975e\u6d32\u56fd\u5bb6\u6216\u662f\u66fe\u5728\u7279\u5b9a\u56fd\u5bb6\u63a5\u53d7\u8840\u6db2\u76f8\u5173\u6cbb\u7597\u4f5c\u4e3a\u98ce\u9669\u5224\u5b9a\u6807\u51c6\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u66f4\u591a\u5173\u4e8eRCDADs\u98ce\u9669\u8bc4\u4f30\u53ca\u68c0\u6d4b\u9879\u76ee\u7684\u66f4\u65b0\u5185\u5bb9\uff0c\u8bf7\u53c2\u9605FDA\u53d1\u5e03\u7684\u5404\u4e13\u95e8\u6307\u5f15<sup>3-7<\/sup>\u3002<\/p>\n\n\n\n<p>\u672c\u6b21\u66f4\u65b0\u63d0\u4f9b\u5f00\u53d1\u5382\u5546\u66f4\u660e\u786e\u7684\u7b5b\u9009\u53ca\u68c0\u6d4b\u6807\u51c6\u7684\u5efa\u8bae\uff0c\u4ee5\u63d0\u9ad8HCT\/Ps\u6350\u8d60\u8005\u5408\u9002\u6027\u5224\u5b9a\u7684\u5408\u89c4\u6027\u548c\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u3002<\/p>\n\n\n\n<p>\u5ef6\u4f38\u9605\u8bfb\uff1a<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV)by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT\/Ps): Draft Guidance for Industry 2025<\/li>\n\n\n\n<li>Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT\/Ps): Draft Guidance for Industry 2025<\/li>\n\n\n\n<li>Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT\/Ps): Draft Guidance for Industry 2025<\/li>\n\n\n\n<li>Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT\/Ps): Guidance for Industry 2025<\/li>\n\n\n\n<li>Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT\/Ps): Guidance for Industry 2025<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>2. 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