创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

王宗敏, 丁桂蓉. 2018年江苏省药品注册分析报告[J]. 药学进展, 2019, 43(5): 355-360.
引用本文: 王宗敏, 丁桂蓉. 2018年江苏省药品注册分析报告[J]. 药学进展, 2019, 43(5): 355-360.
WANG Zongmin, LIU Yue. 2018 Annual Report on Drug Registration in Jiangsu Province[J]. Progress in Pharmaceutical Sciences, 2019, 43(5): 355-360.
Citation: WANG Zongmin, LIU Yue. 2018 Annual Report on Drug Registration in Jiangsu Province[J]. Progress in Pharmaceutical Sciences, 2019, 43(5): 355-360.

2018年江苏省药品注册分析报告

2018 Annual Report on Drug Registration in Jiangsu Province

  • 摘要: 2018年江苏省药品注册申报持续位居全国首位。药物创新成果凸显,生物制品实现零的突破,全国批准10个国产创新药上市,其中有6个品种落户江苏。仿制药质量和疗效一致性评价稳步推进,上市许可持有人试点工作逐渐深入,临床试验资源紧张局面有效缓解,医疗机构应用传统工艺配制制剂备案管理按时启动,江苏省中药饮片炮制规范修订和医疗机构制剂标准提高工作初见成效。

     

    Abstract: In 2018, Jiangsu province continued to rank first in the country in drug registration. Highlighted results were obtained from drug innovation, zero breakthrough was achieved in biological products, 6 of the 10 domestic innovative drugs approved for marketing nationwide were produced in Jiangsu. The consistency evaluation of the quality and efficacy of generic drugs was steadily advanced; the pilot project of Marketing Authorization Holders was gradually deepened; the shortage of clinical trial resources was effectively relieved. Recordation administration of the utilization of traditional techniques by medical institutions to prepare preparations was initiated on time. Revision of the specifications for processing prepared slices of Chinese crude drugs in Jiangsu province and the improvement of standards for preparations formulated by medical institutions had achieved initial success.

     

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