A comparative study of the application of real real-world evidence to support drug approval in China and US
The purpose of this paper is to provide a reference for promoting the application of real-world evidence in drug approval in China and the system establishment.We adopt the literature research to sort out the technical guidelines on real-world evidence supporting drug approval in China and US,and compare the successful cases of its application in some drugs and biologics in the United States,and in some imported chemicals and new Chinese medicines in China.Compared with the US,gap still exists in China's system related to the use of real-world evidence in drug approvals,the percentage of approvals,the degree of application,and the quality of real-world data.The indications for drugs that are approved based on real-world evidence in the two countries are usually rare diseases with unmet needs.In order to promote the use of real-world evidence for drug approval in China,our country should improve the system facilitating the use of real-world evidence in drug approval,increase the proportion of real-world evidence used in drug approval,clarify the core objectives of using real-world evidence to support drug approval,follow up the international practice,comb useful experiences,and improve the quality and standardization of the data.
real world datareal world studyreal world evidencedrug approvalcomparative study
NETL
NSTL
万方数据
