[Discussion on clinical problems about bases of new drug of traditional Chinese medicine development].

In view of the industry lacking of sufficient analyses on the bases of project establishment about the new drugs of traditional Chinese medicine(TCM) during their applying for the clinical research, from the perspective of clinical evaluation, this paper reviewed and analyzed the present situation and development paths of new drugs of TCM in recent years. Through the analyses of the rationality of formulations, human use experiences and clinical studies, the paper puts forward the countermeasures to solve these difficulties during the technical evaluation of new drugs of TCM in order to improve the new drugs' clinical research.