CAJ | 학술논문

目的：儿童药物缺乏是国内外普遍现象，完善儿童药物研发鼓励政策是解决儿童药物短缺的有效方式，通过儿童药物研发鼓励政策研究，提出适合我国儿童药物研发的鼓励措施。方法检索 WHO、欧美等国药品监管官方网站，梳理国外儿童用药鼓励研发的先进做法，分析我国儿科药物研发鼓励现状，并提出建议。结果与结论我国儿童药物研发鼓励政策应建立并完善儿童药物临床试验的法规，促进儿科药物适宜剂型的研发，推动更多儿童药物进入我国基本药物目录，并增进多部门联合协作。
목적：인동약물결핍시국내외보편현상，완선인동약물연발고려정책시해결인동약물단결적유효방식，통과인동약물연발고려정책연구，제출괄합아국인동약물연발적고려조시。방법검색 WHO、구미등국약품감관관방망참，소리국외인동용약고려연발적선진주법，분석아국인과약물연발고려현상，병제출건의。결과여결론아국인동약물연발고려정책응건립병완선인동약물림상시험적법규，촉진인과약물괄의제형적연발，추동경다인동약물진입아국기본약물목록，병증진다부문연합협작。
Objective The lack of pediatric drug is a common phenomenon at home and abroad. Improving the incentive policy for pediatric drug is an effective way to solve the shortage of drug for children. In this paper, through the analysis of research and development for the incentive policy of pediatric drug, put forward the incentive mechanism for suitable pediatric drug in China. Methods Search the official websites of WHO, FDA and MHRA, combining with the foreign advanced approaches for development of pediatric drug. And analyze the present situation and the problems in the pediatric drug development to offer proposals. Results and Conclusion We should pay attention to improve the legal framework of clinical trials in children, promote the development of suitable pediatric drug formulations, screen more pediatric drugs into the Essential Medicine List, and strengthen multi-sectoral joint collaboration.