Ufficio Informazione e Comunicazione - Agenzia Italiana del Farmaco (AIFA), Via del Tritone, 181 - 00187 Roma, Italy.
Ital J Pediatr. 2010 Aug 17;36:56. doi: 10.1186/1824-7288-36-56.
The lack of availability of appropriate medicines for children is an extensive and well known problem. Paediatricians and Physicians who take care of the paediatric population are primarily exposed to cope with this negative situation very often as more than half of the children are prescribed off-label or unlicensed medicines.
Medicinal products used to treat this population should be subjected to ethical research of high quality and be explicitly authorized for use in children as it happens in adults. For that reason, and following the US experience, the European Paediatric Regulation has been amended in January 2007 by the European Commission. The objective of the Paediatric Regulation is to improve the development of high quality and ethically researched medicines for children aged 0 to 17 years, to facilitate the availability of information on the use of medicines for children, without subjecting children to unnecessary trials, or delaying the authorization of medicines for use in adults.
The Paediatric Regulation is dramatically changing the regulatory environment for paediatric medicines in Europe and is fuelling an increased number of clinical trials in the paediatric population. Nevertheless, there are some risks and pitfalls that need to be anticipated and controlled in order to ensure that children will ultimately benefit from this European initiative.
儿童适用药物的缺乏是一个广泛而众所周知的问题。照顾儿科患者的儿科医生和内科医生经常会遇到这种负面情况，因为超过一半的儿童开的是标签外用药或无许可证的药物。
用于治疗该人群的药品应接受高质量的伦理研究，并明确授权用于儿童，就像在成人中一样。出于这个原因，并效仿美国的经验，欧盟委员会于 2007 年 1 月修订了《欧洲儿科法规》。该法规的目标是改进针对 0 至 17 岁儿童的高质量和经过伦理研究的药物的开发，促进儿童用药信息的可用性，同时避免让儿童进行不必要的试验，或延迟成人用药的授权。
《儿科法规》正在彻底改变欧洲儿科药物的监管环境，并推动在儿科人群中开展更多的临床试验。然而，为了确保儿童最终能从这一欧洲倡议中受益，仍需要预见和控制一些风险和陷阱。
