随着药品审评和审批改革的推进，完善药品注册分类、修订GCP、开展临床试验数据核查、强化临床试验数据管理等一系列新举措不断推出，中药新药临床试验面临着新的机遇与挑战。首先，中药新药的研制一定要以满足临床需求为目的，必须清楚地回答解决哪些临床问题。其次，中药新药的疗效是可以测量的，关键问题是要掌握科学合理的研究方法。另外，中药新药临床试验要注重临床试验的研究逻辑，更加注重临床试验数据的质量，真正做到中药新药的疗效通过来自于人体的临床数据加以证实。从发展趋势来看，中药新药品种将继续以中药复方为主，研发人员应当切实提高中药复方新药临床试验的整体水平。

With the reform of drug evaluation and approval in advance,a series of new initiatives have be launched，including improving the drug registration classification,revision of GCP and carrying out clinical trial data verification,strengthening clinical trial data management etc.Clinical trials of traditional Chinese medicines are facing new opportunities and challenges.The development of new traditional Chinese medicines should meet the clinical needs and clearly answer the clinical problems.The effectiveness of traditional Chinese medicines can be measured,and the key is to grasp scientific and reasonable research methods.Clinical trials of traditional Chinese medicines should pay attention to the research logic of clinical trials,and pay more attention to the quality of clinical trial data.The efficacy of traditional Chinese medicines is indeed based on clinical data.Viewed from its tendency, new Traditional Chinese Medicines are based on compound prescription.Therefore,researchers should effectively improve the overall research quality of the clincal trials on the new medicines of traditional Chinese medical compounds.