CDE发布《基因治疗产品药学研究与评价技术指导原则(征求意见稿)》

2020-09-15 CDE CDE

继今年7、8两月相继发布《免疫细胞治疗产品临床试验技术指导原则(征求意见稿)》、《溶瘤病毒类药物临床试验设计指导原则(征求意见稿)》、《人源性干细胞及其衍生细胞治疗产品临床试验技术指导原则》等指导原则

继今年7、8两月相继发布《免疫细胞治疗产品临床试验技术指导原则(征求意见稿)》、《溶瘤病毒类药物临床试验设计指导原则(征求意见稿)》、《人源性干细胞及其衍生细胞治疗产品临床试验技术指导原则》等指导原则意见稿后,日前,CDE发布了针对基因治疗的《基因治疗产品药学研究与评价技术指导原则(征求意见稿)》。

意见稿中指出,该指导原则不包括溶瘤病毒类产品和CAR-T 细胞等离体基因修饰细胞治疗类产品,但此类产品的部分相关研究,如病毒载体的制备等,适当条件下可以综合借鉴参考。同时,意见稿对基因治疗产品在生产用材料、制备工艺、质量控制、稳定性研究等方面进行了指导规范。

为了规范基因治疗产品的药学研究,统一评价标准,引导基因治疗产品的研究与申报,我中心在借鉴国内外基因治疗产品监管标准的基础上,通过前期调研、文件撰写、专家咨询以及部门技术委员会讨论,形成了《基因治疗产品药学研究与评价技术指导原则(征求意见稿)》。现通过中心网站(www.cde.org.cn)向社会公开征求意见,欢迎各界提出宝贵意见和建议。

如您有任何进一步完善或补充的意见和建议,请在征求意见反馈表填写具体信息,并通过邮件反馈我们。感谢您的参与和支持!

联系人:徐隆昌, Email:xulch@cde.org.cn;

韦 薇, Email:weiw@cde.org.cn;

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    2020-09-17 huagfeg
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    2020-09-16 14818eb4m67暂无昵称

    学习

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