Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
European Medicines Agency, London, UK.
Arch Dis Child. 2018 Jun;103(6):557-564. doi: 10.1136/archdischild-2017-313309. Epub 2018 Feb 28.
This paper focuses on the authorisation of new medicines, new indications and new pharmaceutical forms or strengths for use in children and also on the availability of paediatric information in the product information of centrally authorised medicinal products following the enforcement of the Paediatric Regulation on 26 January 2007.
To investigate whether the Paediatric Regulation has led to more medicines available for children in the European Union (EU) and if more information on paediatric use is now available in the product information of medicines authorised via the centralised procedure.
We retrospectively analysed the centrally authorised medicinal products in the EU that had an approval for an initial marketing authorisation, a type II variation, or a line extension during the years 2004-2006 and 2012-2014. Medicinal products not subjected to the obligations of the Paediatric Regulation were excluded.
In 2004-2006, 20 new medicines and 10 new indications were centrally authorised for paediatric use compared with 26 new medicines and 37 new indications in 2012-2014. The number of medicines with a new pharmaceutical form or strength for use in children was eight in 2004-2006 and seven in 2012-2014. There was a huge increase in the number of products with changes of paediatric relevance in the summary of product characteristics in 2012-2014 compared with 2004-2006.
The entry into force of the Paediatric Regulation has had a positive impact on paediatric drug development with more medicines available for children in the EU and substantially more information available for clinicians on paediatric use in the product information.
本文重点关注新药品、新适应证、新儿童适用剂型或新儿童适用规格的批准，以及 2007 年 1 月 26 日《儿科药物规例》生效后，集中批准药物的产品信息中儿童用药信息的可用性。
调查《儿科药物规例》是否导致欧盟（EU）有更多儿童适用药物，并了解更多关于通过集中程序批准的药物的儿童使用信息是否现在可在产品信息中获得。
我们回顾性分析了 2004-2006 年和 2012-2014 年期间获得初始营销授权、II 类变更或产品线扩展的集中批准药物。未受《儿科药物规例》义务约束的药物被排除在外。
2004-2006 年，有 20 种新药品和 10 种新适应证获得儿科使用的集中批准，而 2012-2014 年有 26 种新药品和 37 种新适应证。2004-2006 年有 8 种儿童适用新剂型或新规格的药物，2012-2014 年有 7 种。2012-2014 年与 2004-2006 年相比，产品特性摘要中与儿科相关的变更产品数量大幅增加。
《儿科药物规例》的生效对儿科药物开发产生了积极影响，欧盟有更多儿童适用药物，产品信息中为临床医生提供了更多儿童用药信息。
