欧洲药品评估局批准的新药儿科用药情况。
Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use.
作者信息
Impicciatore P, Choonara I
机构信息
Academic Division of Child Health, (University of Nottingham), Derbyshire Children's Hospital, Derby, UK.
出版信息
Br J Clin Pharmacol. 1999 Jul;48(1):15-8. doi: 10.1046/j.1365-2125.1999.00981.x.
AIMS
To evaluate the activity of the European Medicines Evaluation Agency with regard to the registration for paediatric use of new medicines granted a marketing authorization.
METHODS
European Public Assessment Reports published on the Internet from January 95 until April 98 have been analysed using the browser Microsoft Explorer and the software Adobe Acrobat Reader.
RESULTS
Of the 45 new substances licensed since January 95, 29 (64%) were of possible use in children but only 10 were licensed for paediatric use. For the 19 drugs of possible use in children, but not approved for such a use, in nine instances (47%) their summary of product characteristics reported that their use in children has not been established.
CONCLUSIONS
A change of practice by pharmaceutical companies and regulatory authorities is imperative so that children are not precluded from having the same rights to medicines as adults.
目的
评估欧洲药品评估机构在授予上市许可的新药儿科用药注册方面的活动。
方法
使用微软浏览器和Adobe Acrobat Reader软件，对1995年1月至1998年4月在互联网上发布的欧洲公共评估报告进行了分析。
结果
自1995年1月以来获得许可的45种新物质中，有29种（64%）可能用于儿童，但只有10种获得了儿科用药许可。对于19种可能用于儿童但未获批准用于该用途的药物，在9例（47%）中，其产品特征摘要报告称其在儿童中的使用尚未确立。
结论
制药公司和监管机构必须改变做法，以使儿童在用药方面享有与成人相同的权利。
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