美国获批儿科药物及其在我国的研发现状

Pediatric Drugs Approved by US FDA and Their R&D Situation in China

儿科用药缺乏一直是世界性难题,究其原因,主要在于其临床试验难度大以及儿童专用剂型、儿童用药规格和儿科临床用药信息的缺乏。然而,在美国,有关儿童用药法规相对健全,且已有多个儿科药物获得FDA批准。概述并解析1996—2016年美国FDA批准的儿科药物以及这些药物在我国的上市和申报状况。

The lack of pediatric medications has been a worldwide problem, because it is difficult to conduct clinical trials in children, and there are less varieties of drugs or dosage forms for children and the information of clinical pediatric medications is defcient. However, legal and regulatory frameworks for pediatric medications have been well established in the US, where there are plenty of pediatric drugs approved by the FDA. In this paper, the pediatric drugs approved by the US FDA in 1996-2016 and their launching and filing situation in China were summarized and analyzed.