目的：分析我国2021年药品监督抽检质量情况。方法：以检验报告书为依据，对2021年药品监督抽验的结果进行统计分析。结果：药品质量情况总体良好，基本药物质量稳定，药品不合格率整体呈逐年下降趋势。2021年不合格批次共70批，总体不合格率为0.39%。按抽检类别分，国家基本药物质量状况较好，不合格批次主要集中在其他监督抽检中；按抽样环节分，不合格批次主要集中在经营和使用环节中；按药品类别分，不合格批次以中药饮片居多。结论：各级药品监管部门应继续加大监管力度，加强对基层药学专业人员的培训力度，科学布局药品抽验工作，加大后续处罚力度，确保百姓用药安全。

Objective: To analyze the quality of drug supervision sampling in China of 2021. Methods: Based on the inspection report, the results of the drug supervision sampling in 2021 were analyzed statistically. Results: The quality of the drug was good in general, and the overall drug unqualifi ed rate was decreasing year by year, the quality of essential drugs was stable. In 2021, a total of 70 batches were unqualifi ed, and the overall unqualifi ed rate was 0.39%. The quality of national essential medicines was relatively good according to the sampling category, and the unqualifi ed batches were mainly concentrated in other supervision sampling inspections; the unqualified batches were mainly concentrated in the supply and use links according to the sampling link, and the unqualified batches were mostly divided into traditional Chinese medicine slices. Conclusion: The drug regulatory departments at all levels should continue to strengthen the supervision, strengthen the training of basic professionals of pharmacy, arrange drug sampling inspections scientifi cally, and increase follow-up penalties to ensure the safety of drug use of people.