非注册类临床试验用于药品注册审评的几点思考

Several thoughts on accepting non-registered clinical trials in IND registration evaluation

近年来,我国细胞治疗技术发展迅速,临床试验的数量和规模呈爆发式增长,很多研究机构或企业通过第三类医疗技术相关的非注册类临床试验积累了大量的人体研究数据。如何在提交新药研究申请(IND)时充分利用这些临床研究数据,是临床试验监管部门和制药企业共同关注的问题。在本文中我们从工艺稳定性、临床试验的合规性、试验数据质量等角度,讨论上述非注册类临床试验的研究数据在用于新药上市审评时应注意的问题,以期为规范和完善细胞治疗产品的申报注册和管理模式提供参考。

In recent years,cell therapy has been developed rapidly in China,and the number and scale of clinical trials have increased dramatically. Many research institutions and companies have accumulated lots of human research data through non-registered clinical trials which related class Ⅲ medical technology. How to make full use of these clinical data at the time of submitting the investigational new drug（ IND） application has become a great concern which clinical trial regulatory authorities and pharmaceutical companies focus. In this paper,we discuss the problems that should be paid attention to when using non-registered clinical trial data in the evaluation of IND from several aspects,including process stability,compliance of clinical trials and quality management of non-registered clinical trials data,in order to provide advice for standardizing and improving the registration and management of cell therapy products.