药审中心发布临床急需儿童用药优先审批评定原则及首批品种名单

2016-02-02 佚名 医谷

为贯彻落实国家食品药品监督管理总局《关于药品注册审评审批若干政策的公告》(2015年第230号)精神,药审中心组织制定了《临床急需儿童用药申请优先审评审批品种评定的基本原则》(以下简称“基本原则”)及根据“基本原则”拟定了优先审评审批的儿童用药注册申请品种目录,并于2015年12月21日至28日公开征求了社会意见并完善后,经国家食品药品监督管理总局同意。1月29日,药审中心将“基本原则”(附件

为贯彻落实国家食品药品监督管理总局《关于药品注册审评审批若干政策的公告》(2015年第230号)精神,药审中心组织制定了《临床急需儿童用药申请优先审评审批品种评定的基本原则》(以下简称“基本原则”)及根据“基本原则”拟定了优先审评审批的儿童用药注册申请品种目录,并于2015年12月21日至28日公开征求了社会意见并完善后,经国家食品药品监督管理总局同意。1月29日,药审中心将“基本原则”(附件1)和确定的首批优先审评审批的儿童用药品种目录(附件2)予以公告,确定的优先审评审批品种将列入审评计划优先审评。

附件1:临床急需儿童用药申请优先审评审批品种评定的基本原则

一、本原则适用于对临床急需儿童专用药品的优先审评审批品种评定

二、基本原则

(一)新增用于儿童人群品种:

此类品种,应满足以下任一条件。

1、针对严重威胁儿童生命或者影响儿童生长发育,且目前无有效治疗药物或治疗手段的疾病;2、相比现有的治疗药物,具有明显治疗优势。

(二)改剂型或新增规格品种:。

此类品种应同时满足以下两个条件。

1、国内现行药品说明书中包含有确定的“儿童用法用量”;。

2、现有剂型或规格均不适用于儿童,新增剂型或规格适合于儿童。

(三)仿制品种:

对于目前市场短缺的儿童用药品,实行优先审评。

上述(二)和(三)的品种,若申报厂家的数目为多家申请的,按照申请先后排队顺序,对排第一位的优先审评,若经审评不符合要求,则取消优先资格,后面的同品种申请可按序增补替代。

附件2:优先审评审批的儿童用药注册申请目录(第一批)

 

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    2016-02-16 mengli1984

    优先不能简化,需要更加严格

    0

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    2016-02-04 howi

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