Priority medicines for children: Background Paper 7.1. Update on 2004 Background Paper.

Children are entitled to safe, efficacious, and age-appropriate medicines. However, the provision of optimal medicines for children is limited by the lack of commercial incentives, a dearth of clinical trials on paediatric medicines, delays in licensing medicines for children, and the absence of suitable formulations for children. Children are not small adults, but rather a vulnerable population with specific needs resulting from their changing physiology, who make up a heterogeneous patient group with a scope of diseases different than those of adults, and for whom there is a scarcity of data on appropriate medicines delivery and use. Therefore, these needs are discussed in detail in this background paper; the challenges and opportunities for improvement and further research are also identified. (aut.ref.)