J9九游会AG

J9九游会(hui)AG
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关于规范申请人儿童用药申报信息备注的通知

发布时间:2022-07-12



为(wei)鼓(gu)励儿童(tong)(tong)用(yong)(yong)药(yao)的(de)(de)创新研发,优(you)化儿童(tong)(tong)用(yong)(yong)药(yao)沟通交流和受(shou)理审评效率(lv),完善儿童(tong)(tong)用(yong)(yong)药(yao)品种(zhong)(zhong)信(xin)息的(de)(de)记录(lu)与(yu)统(tong)计,现对(dui)涉及(ji)申报品种(zhong)(zhong)的(de)(de)儿童(tong)(tong)用(yong)(yong)药(yao)信(xin)息备注进行(xing)规(gui)范,具体要(yao)求如下(xia):


在提交临床试验申(shen)请(qing)和(he)(he)上市申(shen)请(qing)时,由申(shen)请(qing)人在药(yao)品注(zhu)(zhu)册申(shen)请(qing)表(biao)中“其他事项(xiang)”条目下(xia)备注(zhu)(zhu)(可备注(zhu)(zhu)多(duo)项(xiang)):申(shen)请(qing)儿童(tong)专(zhuan)用(yong)(yong)药(yao)、申(shen)请(qing)新增儿童(tong)应用(yong)(yong)(适应症和(he)(he)用(yong)(yong)法用(yong)(yong)量)、本品属于鼓励(li)研(yan)发申(shen)报儿童(tong)药(yao)品清单(写明批次和(he)(he)编号(hao))。


在提交补充申(shen)(shen)请时(shi),由申(shen)(shen)请人在药品注(zhu)册(ce)申(shen)(shen)请表中(zhong)“补充申(shen)(shen)请的内容(rong)”条目下备注(zhu)(可(ke)备注(zhu)多(duo)项(xiang)):申(shen)(shen)请新增儿童(tong)(tong)应(ying)用(yong)(适应(ying)症和用(yong)法用(yong)量)、申(shen)(shen)请修订儿童(tong)(tong)应(ying)用(yong)(适应(ying)症和用(yong)法用(yong)量)、申(shen)(shen)请增加儿童(tong)(tong)专用(yong)规格、申(shen)(shen)请修订说明书中(zhong)儿童(tong)(tong)应(ying)用(yong)信(xin)息、申(shen)(shen)请其他与儿童(tong)(tong)应(ying)用(yong)相关的事(shi)项(xiang)。


自通知发布之(zhi)日起施行。


特此通告。


国家药品(pin)监(jian)督管理局药品(pin)审评中心


2021年7月9日


(来源:国家药(yao)监局药(yao)品审评中(zhong)心)