PERSPECTIVES
Children's medicines
"Bonne Année", "Gutes Neues Jahr"? Will 2007 be a "Happy New Year" for children’s medicines in Europe?
Correspondence to:
Correspondence to:
Professor Terence Stephenson
Centre for Reproduction and Early Life, Academic Division of Child Health, School of Human Development, Queen’s Medical Centre, Nottingham NG7 2UH, UK; terence.stephenson@nottingham.ac.uk
Accepted 16 April 2007
New European legislation has the potential to have an enormous impact on how paediatric medicines are studied and used
Keywords: European Union; unlicensed medicines; medicines for children research network
| The first 150 words of the full text of this article appear below. |
New European Union (EU) paediatric regulations to encourage more research on children’s medicines became law on 26 January 2007.1 The main proposals are as follows. First, there will be incentives to encourage the pharmaceutical industry to test products for use in children. Secondly, the European Agency for the Evaluation of Medicinal Products (EMEA) will host an expert paediatric committee to oversee and assess paediatric investigation plans for developing medicines for children. Thirdly, a European clinical trials network will be set up to foster collaboration on paediatric studies throughout the EU. Fourthly, medicines licensed for paediatric use should be sold with a special label indicating that fact.
This legislation has the potential to have an enormous impact on how paediatric medicines, both old and new, are studied and used. Is this good news for Europe’s 140 million children?
Evidence-based prescribing for children is compromised by lack of sufficient data
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Arch. Dis. Child. 2007 92: e8.[Extract] [Full Text] [PDF]
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