政策动向 国家药监局器审中心发布多项注册审查指导原则 近日，国家药监局器审中心组织修订了《癌症筛查体外诊断试剂临床评价注册审查指导原则》、《结直肠癌筛查体外诊断试剂临床评价注册审查指导原则》、《高危型人乳头瘤病毒（HPV）核酸检测及基因分型试剂注册审查指导原则（2025年修订稿）》、《人类嗜T淋巴细胞病毒抗体检测试剂注册审查指导原则》，以进一步规范癌症筛查体外诊断试剂等产品的管理。 药械审批 ...
Source Link政策动向 国家药监局器审中心发布多项注册审查指导原则 近日，国家药监局器审中心组织修订了《癌症筛查体外诊断试剂临床评价注册审查指导原则》、《结直肠癌筛查体外诊断试剂临床评价注册审查指导原则》、《高危型人乳头瘤病毒（HPV）核酸检测及基因分型试剂注册审查指导原则（2025年修订稿）》、《人类嗜T淋巴细胞病毒抗体检测试剂注册审查指导原则》，以进一步规范癌症筛查体外诊断试剂等产品的管理。 药械审批 ...
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