Objective To introduce the development process and present situation of the chemistry drug registration management system in our country. Methods The development process of the chemical drug registration management system in our country was retrospected by adopting the research method of literature review and its present situation was analyzed. Results and Conclusion Although the chemical drug registration management system in our country already possesses a certain scientificity and systematicness and also dis-plays the systematic supervision ability,but compared with the development trend of current international pharmaceutical industry and the drug research,many problems still exist and need to be improved.%目的：介绍我国化学药品注册管理体系的发展过程及现状。方法利用文献综述的研究方法进行回顾性分析。结果与结论我国化学药品注册管理体系虽已具备了一定的科学性和系统性，也显示出了系统的监管功能，但与当前国际制药工业和药品研发的发展态势和现状相比，尚存在诸多问题有待改进。
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