美国处方药付费法案的演变特点及对我国新药审评的启示

Evolutionary characteristics of the US’s Prescription Drug User Fee Act(PDUFA)and its implications to China’s new drug review system

目的:为完善我国新药审评制度提供参考。方法:分析美国《处方药付费法案》各阶段侧重点、监管措施及实施成效,进而针对我国新药审评实际提出相关建议。结果:PDUFA在显著缩短新药审评时间、改善研制效率、提高首轮审评通过率和助力极具创新性药物产出方面发挥了重要作用。结论:建议我国在确保药品安全有效前提下,通过加强新药研发指导、优化上市申请审评过程管理以及加快药品监管科学发展与应用等进一步完善新药审评制度。

Objective:To provide references for China s new drug review system. Methods:This paper analyzes the focus and regulatory measures of PDUFA I to PDUFA VI policies and their performance, in order to puts forward some suggestions regarding the status quo of new drugs review in China. Results:The PDUFA has played an important role in shortening the review time, improving R&D efficiency, enhancing first-cycle approval rate, and supporting the output of the most innovative drugs. Conclusion:This paper suggests that, under ensuring drug safety, China can still improve its new drug review system by strengthening R&D guidance, optimizing the review process management, and accelerating the scientific development and implementation of drug regulation policies.