药品加快上市程序在儿童用药注册体系中的作用与思考

袁利佳, 王丽卿, 汪小燕, 张宁

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主办:上海医药工业研究院
   中国药学会
   中国化学制药工业协会
ISSN 1001-8255   CN 31-1243/R   ZYGZEA
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中国医药工业杂志 ›› 2022, Vol. 53 ›› Issue (11) : 1529-1538. DOI: 10.16522/j.cnki.cjph.2022.11.001
专论与综述

药品加快上市程序在儿童用药注册体系中的作用与思考

  • 袁利佳,王丽卿,汪小燕,张宁
作者信息 +

The Role and Consideration of Accelerated Approval Process in Pediatric Drug Registration System

  • YUAN Lijia, WANG Liqing, WANG Xiaoyan, ZHANG Ning
Author information +
History +

摘要

儿童用药研发困难是全世界面临的难题。由于儿童用药研发难度大、研发成本高、周期长,同时儿童用药服药周 期较短,与成人用药的市场相比,市场回报较低,加剧了企业对儿童用药研发不活跃的状况。为了鼓励儿童用药研发, 各个国家或地区通过诸多措施鼓励儿童用药的研发。文章对美、欧、日、中等国家及地区为加快儿童用药上市而制定的 特殊政策、发布的相关技术指南进行了归纳、汇总并分析,为中国儿童用药研发者及后续的政府法规政策制定提供借鉴 及参考。

Abstract

Difficulty in research and development(R&D) of pediatric drugs is a global problem. The high difficulty of R&D, high costs and long cycle of pediatric drugs, as well as the low market returns compared with the adult medicines because of the short medication cycle, aggravate the inactive R&D situation of pediatric drugs. In order to encourage the R&D of pediatric drugs in China, various countries have adopted many measures to acclerate the R&D of pediatric drugs. This paper summarizes and analyzes the special policies and related technical guidelines issued by US, EU, Japan and China to accelerate the review and approval of pediatric drugs, which will serve as a referance for Chinese pediatric drugs developers and the follow-up government regulation and policy makers.

关键词

儿童用药 / 药品注册 / 加快程序

Key words

pediatric drug / drug regisration / accelerated system

引用本文

导出引用
袁利佳, 王丽卿, 汪小燕, 张宁. 药品加快上市程序在儿童用药注册体系中的作用与思考. 中国医药工业杂志. 2022, 53(11): 1529-1538 https://doi.org/10.16522/j.cnki.cjph.2022.11.001
YUAN Lijia, WANG Liqing, WANG Xiaoyan, ZHANG Ning. The Role and Consideration of Accelerated Approval Process in Pediatric Drug Registration System. Chinese Journal of Pharmaceuticals. 2022, 53(11): 1529-1538 https://doi.org/10.16522/j.cnki.cjph.2022.11.001

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