Ramet José
Paediatric Intensive Care Unit, Academisch Ziekenhuis, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium.
Eur J Pediatr. 2005 May;164(5):263-5. doi: 10.1007/s00431-005-1633-z. Epub 2005 Feb 22.
Most parents and many paediatricians are not aware that medicines for children are often not tested, labelled, or approved for their prescribed use. In 1997, the Food and Drug Administration developed incentives for pharmaceutical companies to perform paediatric research in medications. The European Commission brought out its proposal for paediatric incentives after in-depth internal reflection. Now it should be adapted quickly to boost pharmaceutical paediatric research in the EU as soon as possible.
The proposal must be balanced and aware that both incentives and requirements are mandatory in order to maintain and stimulate paediatric research on medicines in Europe.
大多数家长和许多儿科医生并未意识到，儿童用药往往未针对其规定用途进行测试、标注或获批。1997年，美国食品药品监督管理局制定激励措施，促使制药公司开展儿科药物研究。欧盟委员会在深入内部反思后提出了儿科激励措施提案。现在应尽快对其进行调整，以尽快推动欧盟的儿科药物研究。
该提案必须保持平衡，并认识到激励措施和要求都是强制性的，以便在欧洲维持和促进儿科药物研究。
