儿童不是缩小版的成人，从新生儿到青春期整个过程中，组织器官和功能发生有很大的变化。儿科药物研发 和临床试验是儿童用药安全的重要保障，但儿科药物研发和临床试验开展困难亦是全球性的问题。本文综述欧美及国内 儿科药物临床试验的政策法规、临床试验现状，以期为我国儿科药物研发和临床试验开展提供参考。

　Children are not smaller-sized adults, their tissues, organs and functions change dramatically from newborn to adolescence. Pediatric drug development and clinical trials are important safeguards for children's drug safety. However, pharmaceutical research and clinical trials are difficult to perform in children, which is a universal problem in the world. This article reviews the policies, regulations, and clinical trials of pediatric drugs in Europe, America, and China, which intends to provide references for the future development of pediatric drug clinical trials in China.