摘要
在国民健康水平逐渐成为经济增长重要推手的时代,国家政策、资金均逐渐倾斜向医疗及创新药研发领域,这一领域中,药品注册及合作研发都需要大量临床试验数据作为基础支撑。在我国数据合规法律体系下,临床试验数据不能被简单地划分为某一类被完整定义的数据,而应当根据处理主体、信息内容的不同进行分类讨论;在与境外特定国家间的数据传输过程中,由于不同法域法律规定层面的差异,如何保证传输的双边合规也有待进一步讨论。本文尝试在厘清境内临床试验数据合规体系的基础上,通过与境外法规的对比,分析数据在跨境传输中能满足双边国家法律要求的方式,管窥未来立法趋势,为医药企业提供数据跨境合规的思路参考。
In an era when national health has gradually become an important driver of economic growth, national policies and funds are gradually tilted towards the field of medical and innovative drug research and development, in which drug registration and cooperative research and development require a large number of clinical trial data as basic support. Under China’s data compliance legal system, clinical trial data cannot be simply divided into a certain type of data that is completely defined, but should be classified and discussed according to the different processing subjects and information content. In the process of data transfer with specific overseas countries, due to the differences in the legal requirements of different jurisdictions, how to ensure the bilateral compliance of the transfer also needs to be further discussed. On the basis of clarifying the compliance system of domestic clinical trial data, this paper attempts to analyze the ways in which data can meet the legal requirements of bilateral countries in cross-border transmission through comparison with overseas regulations, explore the future legislative trend, and provide a reference for pharmaceutical companies to achieve cross-border data compliance.
出处
《争议解决》
2024年第4期233-237,共5页
Dispute Settlement
