As a characteristic tumortherapy in China, Chinesemedicine (CM) plays an important position in comprehensive treatment of tumor. It's a critical issue of objective realization, analysis and evaluation of CM safety for scientific decision-making in tumor safe medication and it also is a pivotal issue which affects the international communication. The safety evaluation of CM includes three phases pre-clinical safety evaluation, clinical trials (micro-dose studies and traditional clinical trials) and post-marketing CM safety assessment. The key point of evaluation should be distinguished among different stages and various types of CM (such as classic formulas, Chineseherbal extracts, etc). Emphasis should be given to chronic toxicity when evaluating oral Chineseherbal , microdose studies and quality control must be underlined while injection is evaluated and more attention should be pay to the dose-effect relationship and time-effect relationship when turned to toxic Chinesemedicine , and so as for the toxicity grading study. Moreover, we should constantly improve CM safety assessment method in various stages of tumortreatment, such as introducing the concept of syndromeclassification theory, bringing in metabonomics and real-world researchmethod which are similar to the CM therapeutic concept. Most importantly, we must keep its own feature of CM theory when we learn the concept of safety evaluation from abroad. Actively exploring the anti-tumormedicinesafety evaluation methods and strategies is of great significance for clinical and experimental research, and it can provide supportability platform to CM's international communication.