《药品管理法》发展视角下药品生产质量管理规范实施演进与趋势展望  

Evolution and Trend of Implementing Drug Manufacturing Quality Management Practices from the Perspective of the Development of the Drug Administration Law

作　　者：杨淑迪 张晶晶[1] 蒋蓉[1] 邵蓉[1] YANG Shu-Di;ZHANG Jing-jing;JIANG Rong;SHAO Rong(Institute of Regulatory Science,China Pharmaceutical University)

机构地区：[1]中国药科大学药品监管科学研究院

出　　处：《中国食品药品监管》2024年第12期24-29,共6页China Food & Drug Administration Magazine

摘　　要：目的:分析《药品管理法》颁布40周年以来,我国《药品生产质量管理规范》(GMP)的演进、变革特点和发展趋势,为有效实施药品GMP提供参考。方法:通过文献研究法和收集整理药品生产企业GMP认证数据,梳理我国药品GMP的演进历程、分析药品GMP监管方式与执行成效的变化,阐释药品GMP发展趋势。结果:我国药品GMP经历3次修订,历经监管面向从“法规约束”到“事前认证”再到“动态监管”的辩证发展,以及执行面向从“效益权衡”到“强制改造”再到“持续合规”的递进演变,不断推动我国药品生产质量管理水平的提升。结论:为强化药品GMP持续合规的动态监管,提高药品GMP实施能力和水平,我国将持续完善药品GMP实施检查体系,推动药品GMP监管国际化。Objective:This study analyzes the evolution,reform characteristics,and development trends of pharmaceutical Good Manufacturing Practices(GMP)in China over the 40 years since the promulgation of the Drug Administration Law,providing a reference for the effective implementation of pharmaceutical GMP.Methods:Using literature research and data collection on pharmaceutical GMP certification by enterprises,this study outlines the historical evolution of GMP in China,analyzes changes in regulatory approaches and implementation outcomes,and interprets the development trends of pharmaceutical GMP.Results:China's pharmaceutical GMP has undergone three major revisions,reflecting a shift in regulatory focus from'legal constraints'to'prior certification'and,ultimately,to'dynamic supervision'.Similarly,implementation has evolved progressively,moving from'benefit balancing'to'mandatory transformation'and,finally,to'sustained compliance'.These changes have constantly driven the improvement of China's drug manufacturing quality management standards.Conclusion:In order to strengthen the dynamic supervision of pharmaceutical GMP compliance and improve implementation capabilities and standards,China will continue to improve its GMP inspection system and promote the internationalization of pharmaceutical GMP supervision.

关 键 词：药品管理法 药品生产质量管理规范 认证 演进 质量管理 

分 类 号：R95[医药卫生—药学]