对美欧日韩等国家及我国生物类似药法规体系框架包括职能体系、注册分类及程序进行了对比研究，提炼关键要素；针对我国现状、设计问卷、开展调研及专家研讨；结合对比研究、调研和研讨，提出建立完善我国生物类似药法规体系的总体建议，以及完善生物类似药定义、生物类似药注册审评程序的建议及建议的考量。

The regulatory framework of bio-similar drugs in the United States, European Union, Japan, Korea, and China, including the functional system, registration classification and procedures is made a comparative study in this paper, and the key elements are extracted. In view of the present situation, the questionnaire is designed, and the investigation and the expert discussion are carried on. Combined with comparative research, investigation, and discussion, general suggestions for establishing and improving the regulatory system of bio-similar drugs in China, as well as suggestions and considerations for improving the definition of bio-similar drugs and the registration and evaluation procedures of bio-similar drugs are put forward in this paper.