【摘要】 我国药品质量风险监管不但面临着数量巨大的传统仿制药企业带来的风险，还面临很多新型挑战，比如集中采购后企业产能的爆发增长、药品上市许可持有人委托生产数量激增、新型生物技术药物上市等带来的风险。通过系统梳理美国食品药品监督管理局(FDA)药品质量风险监管的百年发展历程及发展趋势，从注重成品检验的事后监管，到注重生产过程的事中监管，再到注重前期设计的事前监管，然后再到注重质量文化的生产体系评估和激励，FDA的药品质量风险监管理念持续改进，监管效率不断提升。本文回顾性分析总结了FDA药品质量风险监管的重要发展节点，剖析了其发展理念和逻辑，并对我国药品质量监管体系的优化和完善提出了建议。更多还原

【Abstract】 China’s drug quality risk regulation faces challenges from a vast number of traditional generic drug manufacturers as well as emerging issues such as the explosive growth in production capacity following collective procurement,a surge in contract manufacturing by marketing authorization holders,and the introduction of new biotechnological drugs.This article systematically reviews the century-long development and trends in the U.S.Food and Drug Administration’s (FDA) approach to drug quality risk regulation.It traces the progression from a focus on post-market finished product testing to in-process production monitoring,followed by pre-market design considerations,and,most recently,the assessment and promotion of quality culture within production systems.The FDA’s drug quality risk management philosophy has continuously improved,significantly enhancing regulatory efficiency.Through retrospective analysis,this paper summarizes important milestones in the FDA’s regulatory evolution,explores its underlying principles and logic,and offers suggestions for optimizing and improving China’s drug quality regulatory framework.更多还原