基于《鼓励研发申报儿童药品清单》中精神神经类化学药品的药学研究探讨  

Discussion on Pharmaceutical Research Based on Chemical Psychotropic and Neuropsychiatric Drugs in“the Encourage Pediatric Drugs Catalogues”

作　　者：司晓菲 刘彦 李艳杰 孙亮 姜典卓 SI Xiaofei;LIU Yan;LI Yanjie;SUN Liang;JIANG Dianzhuo(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国医药工业杂志》2022年第11期1593-1598,共6页Chinese Journal of Pharmaceuticals

摘　　要：为促进儿童用药研发,国家卫生健康委员会等发布了3批《鼓励研发申报儿童药品清单》。该研究检索整理了清单中精神神经类化学药品的适应证、国内已上市剂型、参比制剂等信息,结合具体实例和国外审评报告等文献资料,从审评角度对研发中可能涉及的药学研究问题进行分析并提出一些考虑,以期为纳入品种的相关研究提供科学参考。推荐考虑临床需求,结合给药剂型、原料药性质、质量控制等多方面进行深入药学研究,以促进国内儿童用药开发。“Encourage pediatric drugs catalogue(batches 1-3)”have been issued by National Health Commission to facilitate the development and accessibility of paediatric medicines.The indications,approval dosage form and reference list drug(RLD)of chemical psychotropic and neuropsychiatric drugs in this catalogue are sorted out.Based on the analysis of specific cases and relevant review reports,some key points of the drug research and development are discussed,and some considerations about pharmaceutical studies are put forward in order to provide certain references for the selected pediatric drugs.It’s recommended to take clinical needs into account and conduct further in-depth pharmaceutical studies on dosage form,drug substance and quality control,so as to improve the development of pediatric drugs.

关 键 词：儿童药品 精神系统用药 神经系统用药 化学药品 药学研究 

分 类 号：R985[医药卫生—药品]