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“中国14may18_XXXXXLmedjyf”-环球时报

中国官方:32个中国14may18_XXXXXLmedjyf儿童药品获批上市 其中半数为罕见病用药

来源: 上海证券报
2024-12-07 06:36:52

最佳回答

“中国14may18_XXXXXLmedjyf”中国官方:32个中国14may18_XXXXXLmedjyf儿童药品获批上市 其中半数为罕见病用药

  中新中国14may18_XXXXXLmedjyf社北京12月6日电 (记者 李中国14may18_XXXXXLmedjyf纯)中国国家卫生健康委员会药政司副司长王雪涛6日在北京介绍说,2016年以来,国家卫健委会同相关部门,先后制定并发布了5批共144个药品的《鼓励研发申报儿童药品清单》,目前已有32个药品获批上市,其中有16个是罕见病用药。

  当天,中国国家卫健委在北京举行新闻发布会,介绍医药领域科技创新有关情况。王雪涛在会上表示,近年来,国家卫健委注重临床用药需求评估,主要通过制定鼓励研发申报儿童药品清单和鼓励仿制药品目录,强化部门间药物政策协同,引导和支持药品的研发创新和生产供应,更好满足临床急需适宜的药品需求。

  王雪涛表示,在鼓励儿童药品研发申报方面,按照加强儿童用药工作的要求,不断丰富儿童适用药品的品种、剂型、规格,满足儿科临床用药需求。

  据他介绍,2016年以来,国家卫健委会同相关部门,先后制定并发布了5批共144个药品的鼓励研发申报儿童药品清单。目前已有32个药品获批上市,其中有16个是罕见病用药,包括用于罕见难治性癫痫患儿治疗的氯巴占片等。

  王雪涛表示,在提升仿制药品供应保障能力方面,国家卫健委联合相关部门组织专家,对国内药品专利情况及临床供应短缺、研发生产动力不足的药品进行梳理遴选和论证,先后制定发布3批鼓励仿制中国14may18_XXXXXLmedjyf药品目录,共有89个品种。

  “目前已经有33个品种获批上市,其中有10个品种填补了国内治疗空白;有5个品种填补了国产空白,比如治疗和预防侵袭性曲霉病的泊沙康唑注射液。”王雪涛说。

  他还表示,在完善鼓励研发药物政策方面,国家卫健委注重强化部门协同,建立跨部门信息共享、沟通会商和协同创新机制,将以上清单和目录中的品种纳入国家重大专项优先支持、实施优先审评审批、按程序优先纳入国家基本药物目录和国家基本医疗保险药品目录等,更好地引导企业以临床需求为导向进行研发申报。

  王雪涛还说:“同时,我们每年对这两个清单目录进行动态评估,推进鼓励研发和仿制药品药物政策的协调衔接。”(完)

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