Objective To assess the quality of budget impact analysis in China and Canada. Methods We searched databases including PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP from inception to 1st November, 2016, to collect studies about budget impact analysis. Two reviewers independently screened literatures, extracted data and assessed the quality of included studies. Results 27 literatures were included. The mean grades of Chinese and Canadian literatures were 3.8 and 5.5, respectively. Some Chinese studies did not explicitly clarify the research perspective. Few studies in China were conducted according to budget holders’ perspective and with a short time horizon, or examined the results using sensitivity analyses responsive to the uncertainty surrounding future market developments, or compared between current and comparator scenarios. These deficiencies were not conducive to scientific and rational decision-making. Conclusion The quality of budget impact analysis is relatively low in China. It is needed to establish uniform budget impact analysis guideline to improve quality to guide decision making.