Dempsey E M, Connolly K
Neonatal Intensive Care Unit, Department of Pediatrics and Child Health, University College Cork, Wilton, Cork, Ireland,
Eur J Pediatr. 2014 Feb;173(2):233-5. doi: 10.1007/s00431-013-2096-2. Epub 2013 Aug 8.
In January 2007, the Paediatric Regulation entered into force and established the Paediatric Committee (PDCO) within the European Medicines Agency. The goal of the PDCO is to improve the health of the children of Europe by increasing high-quality research for medicinal products and promoting the development and authorization of such medicines at the EU level. A major function of the PDCO is to formulate and authorize Paediatric Investigation Plans and Paediatric Use Marketing Authorisations. The EU's Seventh Framework Programme for Research has facilitated the establishment of consortia whose ultimate goal is to answer important clinical questions involving medicines commonly used "off-label", in children. The benefits of these consortia include enhanced collaboration amongst paediatricians, scientists and small to medium enterprises whose ultimate goal is to obtain an authorization for a new indication or formulation for use in the paediatric population. It will be interesting in a number of years time to measure the success of this very important European initiative.
2007年1月，《儿科法规》生效，并在欧洲药品管理局内设立了儿科委员会（PDCO）。PDCO的目标是通过增加对医药产品的高质量研究以及促进此类药物在欧盟层面的开发和授权，来改善欧洲儿童的健康状况。PDCO的一项主要职能是制定和批准儿科研究计划及儿科用药上市许可。欧盟第七框架研究计划推动了联盟的建立，其最终目标是解答涉及儿童“超说明书”常用药物的重要临床问题。这些联盟的好处包括加强了儿科医生、科学家和中小企业之间的合作，其最终目标是获得用于儿科人群的新适应症或新剂型的授权。若干年后衡量这项非常重要的欧洲举措的成效将会很有意思。
