儿童用药可及已经成为一个全球性问题，儿童用药短缺、超说明书用药等情况十分严重。中国儿童用药适宜品种少、适宜剂型和规格缺乏、药物临床试验基础薄弱、不规范处方行为和不合理用药等问题比较突出。儿童用药可及需要各方面通力合作，在国家宏观调控、政策支持、企业参与和医疗机构配合等多方面共同努力，建立切实可行的方案和目标，解决儿童用药问题。本文将通过研究中国儿童用药现状，对比国外儿童用药监管措施和政策，找出存在的问题和缺陷，给出相应的建议，为推进中国儿童用药发展提供借鉴和参考。%Pediatric drug accessibility has become a global problem,pediatric drug shortages and off-label uses are very seri⁃ous. In China,lack of suitable varieties,appropriate dosage forms and specifications,weak foundations on clinical trials,irregular prescribing behavior and irrational drug use and other issues on pediatric drugs are still outstanding. To improve pediatric drug accessi⁃bility,it may need all aspects work together,that is,cooperation of the national macro-policy support,participation of enterprises and medical institutions,to establish realistic goals and programs to address pediatric drug problem. This paper studies the foreign pediat⁃ric regulation measures and policies and by comparing foreign policies to China′s current situation,we can find out the problems and defects,give appropriate advice,in order to provide advice and reference to promote the development of pediatric drug.
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