The European paediatric initiative: 1 year of experience.
The European Regulation on medicines for pediatric use entered into force on 26 January 2007. It changes dramatically the way medicines are developed for children. This regulation will increase availability of and information on pediatric medicines through high quality, ethical research.
Saint-Raymond
Agnès
A
Scientific Advice, Paediatrics, and Orphan Drugs Sector, European Medicines Agency, London, UK. paediatrics@emea.europa.eu
Seigneuret
Nathalie
N
D002648:Child; D002662:Child Health Services; D002675:Child, Preschool; D017277:Drug Approval; D004339:Drug Compounding / Q000592:standards; D004341:Drug Evaluation / Q000941:ethics; D011307:Drug Prescriptions / Q000592:standards; D004992:Ethics, Medical; D005060:Europe; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007880:Legislation, Drug; D010372:Pediatrics