Based on the study of EU drug registration regulations and standards,to establish the evaluation index system of the EU simplified registration of compound Chinese patent medicine and the fuzzy comprehensive evaluation model,aiming to provide references for the variety choice of the EU simplified registration of compound Chinese patent medicine.Methods:Delphi expert consultation method was applied to establish the evaluation index system of the EU simplified registration of compound Chinese patent medicine,and the fuzzy comprehensive evaluation method was used to establish the fuzzy comprehensive evaluation model.Results:A total of 2 first grade indexes,3 second grade indexes,18 third grade indexes and their weights were obtained.After evaluating 113 varieties of the compound Chinese patent medicine in enterprise A,61 varieties are not suitable for the EU simplified registration.Conclusion:The evaluation index system and the fuzzy comprehensive evaluation model established by the fuzzy comprehensive evaluation method can be effectively used in the evaluation of registered varieties,and have reference significance in the EU simplified registration of compound Chinese patent medicine.