关键词: font-size:medium, ">集采中选药品；药品质量安全；缺陷项目；提升建议

Abstract: Objective：To provide technical support for drug regulatory authorities to formulate scientific regulatory measures， and to provide reasonable suggestions for pharmaceutical manufacturers to carry out quality management activities. Methods： To investigate the production enterprises of drugs selected in centralized procurement in Shandong Province in 2021 and analyze the results of investigate and survey and special supervision and inspection of drugs selected in centralized procurement. Results: There were some problems in the quality management activities of some pharmaceutical manufacturers， such as inadequate GMP implementation and not strict change control. Some enterprises lack the ability to innovate and cannot cope with the unpredictable changes brought about by centralized procurement. Conclusion： Under the situation of normalization of centralized purchasing of drugs， it is suggested that enterprises should pay attention to the quality and safety of drugs， improve the implementation ability of GMP， and strengthen the management of change classification through communication with drug regulatory authorities. Regulatory authorities should improve the effectiveness of supervision through information technology， and comprehensively use random inspection， inspection and other risk discovery measures to ensure drug safety for the public.

Key words: font-size:medium, ">Drugs selected in centralized procurement； Drug quality and safety； Defective items； Suggestions for improvement