疫苗临床试验质量管理研究进展

Research Progress of Vaccine Clinical Trial Qquality Management

目前,我国的疫苗临床试验尚处于发展阶段,与国际发达国家相比,我国在疫苗临床试验的管理理念、监查稽查制度、质量管理和控制手段、研究人员素质等方面都存在一定的差距。法规的修订和完善将有助于疫苗临床试验质量管理更高质量地发展。

At present,China’s vaccine clinical trial is still in the development stage.Compared with developed countries,there are certain gaps in the management philosophy,inspection and checking system,quality management and control means,and quality of researchers in vaccine trials.Regulatory changes and improvements will facilitate the development of better quality management of vaccine clinical trials。