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Effectiveness, safety and quality controllability are the three basic and most important premises for evaluating the quality of drugs. Having undergone clinical tests and been verified in thousands of years, the effectiveness and safety of compound prescription, the chief form of medication in TCM, have been proved reliable. Sometimes due to the lack of quality controllability, incorrect drug or method of preparing being used, so poor therapeutic effect can be seen, though diagnosis and prescription are correct. Quality uncontrollability is also one of the important reasons that causes difficulty for TCM preparation to enter intational market. In order to ensure the effectiveness and safety of TCM compound prescription and the entering of TCM preparation into intational market, strict quality control specifications should be defined. Although wide attention has been paid to this task, how to define the specifications is still under discussion.rn