Analysis of related policies in China and abroad on pediatric off-label drug use / 中国小儿急救医学

ABSTRACT

The problem of off-label drug use is particularly prominent among children. The main rea-son is that children are not routinely tested in drug clinical trials and lack of medication information in chil-dren′s instructions. In view of this,a number of countries have formulated relevant policies to promote the clinical research of children′s drugs,to improve the information of children′s medication in the instructions, and to standardize the pediatric off-label uses. There are no current laws and regulations related on paediatric off-label drug uses in China,we should learn from the experience of other countries,make laws and regula-tions for pediatrics, implement pediatric drug policy,promote pediatric clinical research data to improve, to guide pediatric drug information more scientificly and sufficiently. Only multi-department cooperation can en-sure children′s safety,rational drug use,and promote the healthy growth of children.