我国儿童药品研发的政策支持及立项考虑

Policy Support and Project Considerations for Pediatric Drug Development in China

我国儿童用药现存问题突出,表现为儿童适宜品种少、适宜剂型和规格缺乏、超说明书用药。近年来,我国药品监管机构发布了多项儿童药物研发的支持政策和指导原则,企业研发热情逐渐增加。本文梳理了国内儿童药物研发的相关配套政策,并尝试从企业的角度提出儿童药物立项的方向,分析研发立项中需要关注的问题。

Objective:The current issues in children’s medication are prominent in China,characterized by a limited variety of suitable drugs,a lack of appropriate dosage forms and specifications for children,and off-label drug use.In recent years,drug regulatory authorities have issued multiple support policies and guiding principles for pediatric drug development in China,leading to an increasing enthusiasm for research and development among enterprises.This article reviews the relevant supporting policies for domestic pediatric drug development,attempts to propose directions for the initiation of pediatric drug projects from the perspective of enterprises,and analyzes the issues that need attention in research and development initiation.