集采常态化背景下保障药品质量安全的策略分析

Strategy Analysis of Ensuring Drug Quality and Safety under the Background ofNormalization of Centralized Procurement

目的:为药品监管部门科学制定监管措施提供技术支撑,为药品生产企业开展质量管理活动提供合理建议。方法:对2021年度山东省集采中选药品生产企业进行调研以及对集采中选药品专项监督检查结果进行分析。结果:药品生产企业在质量管理活动中存在GMP执行不到位、变更控制不严格等问题。部分企业创新能力不足,不能应对集采等带来的不可预期的变化。结论:在药品集中带量采购常态化的大形势下,建议药品生产企业重视药品质量安全,提升GMP执行能力,通过与药品监管部门沟通加强变更分类管理;监管部门通过信息化手段提升监管效能,综合利用抽检、检查等风险发现措施,确保人民群众用药安全。

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.