't Jong G W, Stricker B H Ch, Choonar I, van den Anker J N
Department of Paediatrics, Sophia Children's Hospital, Erasmus Medical Centre Rotterdam, The Netherlands.
Acta Paediatr. 2002;91(11):1233-8. doi: 10.1080/080352502320777487.
To evaluate the registration for paediatric use of new chemical entities (NCEs) granted a marketing authorization (product licence).
European Public Assessment Reports (EPARs) published on the Internet from January 1995 to May 2001 were analysed.
Of 120 new substances licensed since January 1995, 70 (58%) were of potential use in children. Of these, only 17 were licensed for all paediatric uses, and 15 for some paediatric age groups. Hence, the majority (54%) of these substances were probably not tested in paediatric age groups.
Many of the new drugs granted marketing authorization lack sufficient paediatric labelling. The proportion of drugs for which full labelling was available has not increased in recent years. The European Medicines Evaluation Agency should make an effort to improve this situation.
评估已获得上市许可（产品许可证）的新化学实体（NCEs）在儿科使用方面的注册情况。
分析了1995年1月至2001年5月在互联网上发布的欧洲公共评估报告（EPARs）。
自1995年1月以来获得许可的120种新物质中，70种（58%）可能对儿童有用。其中，只有17种获得了所有儿科用途的许可，15种获得了某些儿科年龄组的许可。因此，这些物质中的大多数（54%）可能未在儿科年龄组中进行测试。
许多获得上市许可的新药缺乏足够的儿科标签。近年来，有完整标签的药物比例并未增加。欧洲药品评估局应努力改善这种情况。
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