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Time:2018-10-26 Source:root Read:1222

Recently, a wholly owned subsidiary Xiangcam TCM Research Centre Limited received notice from the MHRA, submitted to the MHRA that radix isatidis products used to treat cold and flu registration approved by the review, as the first declaration of traditional Chinese medicine according to requirements of the eu directive, XPH digital Chinese medicine formally entered the international market, is also a milestone in the development of Chinese traditional Chinese medicine internationalization. This product is the first Chinese medicine product to be registered and approved by MHRA in the UK for the treatment of colds.

该项目主要由技术支持中心负责,历时近5年,通过对原药材质量标准进行提高,对原药材产地与重金属、农残等共20多项指标进行控制,通过对产品工艺进行研究优化,对产品质量标准进行提高,增加100多个检测项目及指标,通过产品安全性研究验证、毒性学实验评价、与临床有效性数据、不良反应数据跟踪收集,完善质量管理体系,提高产品质量的有效性与安全性,获得欧盟GMP审计认可及MHRA审评,给予板蓝根颗粒批准许可。

项目团队成员:技术支持中心康志英、高金山、梁咏,朱燕宁、刘卫珍、区秋华、谭贵均、刘松标、李梦嘉、杨小红、产品研发中心周劲松、战略运营系统项目部陆思蕴等。

附:药品基本情况    1、产品名称:Phynova Cold and Flu Relief Powder for Oral Solution(凡诺华缓解感冒和流感颗粒剂)
    2、产品剂型:Powder for oralsolution(颗粒剂)
    3、产品规格:Each sachet contains 4.0g of powder【4g/袋】
    4、申请人:Xiangcam TCM Research Centre Ltd(香雪剑桥中药国际研究中心)
    5、申请事项:MHRA营销授权,英国上市许可
    6、销售许可证号:THR 44590/0001