试验数据保护是鼓励创新、平衡创新与仿制的重要措施，各国监管机构均制定了相关管理制度。通过对美欧日韩等国家生物制品数据保护制度进行对比研究，提炼管理要素；结合我国数据保护制度的现状、设计问卷、开展调研和专家研讨；综合对比研究、调研和研讨，提出完善我国生物制品数据保护制度的建议。

Experimental data protection is an important measure to encourage innovation and balance innovation and imitation. A comparative study on the biological product data protection systems in the United States, Europe, Japan, and Korea is made to extract the management elements in this paper. The status quo of China's data protection system, questionnaire design, research, and expert discussion are combined. Based on the comprehensive comparative study, investigation, and discussion, some suggestions to improve the data protection system of biological products in China are put forward in this paper.