Abstract: ObjectiveTo make suggestion to regulatory authorities on the management of the classification, by exploring the classification framework of prescription and non-prescription drugs in EU, and analyzing the main regulatory areas and the change of classification of a medicinal product. MethodsLiterature study was used to research the experience of EU's management, then use the comparative study to analyze the differences. ResultsEU has rounded classification system, brilliant supporting measures and strict supervision of major field, which are worth reference. ConclusionWe need further improvement in the regulatory system, labeling, advertisement, supporting measure and switching.

Key words: prescription drug, non-prescription drug, classification, switching