注册分类改革视角下药品数据保护制度效应分析

Study on the Impact of Drug Data Protection Regime from the Perspective of Registration Classification Reform

在国际趋势的压力下,兼受跨太平洋伙伴关系协定(TPP)影响,我国实施药品数据保护制度已成大势所趋。鉴于药品数据保护与药品注册审批体系紧密相关,我国化学药注册分类改革后,药品数据保护对医药产业发展必然会带来不同影响。结合我国分类注册改革新标准,在理论上对数据保护制度实施效果进行研究,进而探讨新注册分类下数据保护的实施对1至4类药品及医药产业的影响。

Under the pressure of international tendency and the influence of TPP,the establishment of drug data protection regime in China has become an irresistible trend.Because of the connection between data protection and drug registration system,drug data protection will have different impact on pharmaceutical industry after the reform of registration classification.Based on the new standards adopted by the reformed registration system,this paper conducted theoretical analysis of the implementation of data protection regime and further investigated its impact on Class one to Class four drug and pharmaceutical industry.