美国药品即时审评制度分析及对我国的启示

Analysis of Real-Time Review of Drug Applications in the United States and Its Enlightenment to China

目的分析美国药品即时审评制度实施方式,为我国药品注册审评制度改革提供参考。方法通过文献与案例研究,全面分析美国食品和药物管理局药品即时审评制度的框架、实施流程和实施效果。结果美国药品即时审评制度包括实时肿瘤学评估和评估支持两个项目,前者通过标准化数据分析过程和"预提交"、"预分析"步骤,后者通过标准化申报资料模板,加快审评速度。截止2019年底,已有27个项目通过该制度获批。结论在我国药品审评制度改革不断深化过程中,建议加强政策顶层设计、探索多样化的加快审评方式、积极推进数据标准化,从而提高审评效率、加快具有临床价值的药品上市。

OBJECTIVE To analyze the implementation of the real-time review of drug application system in the United States and provide a reference for the reform of the drug registration review system in China. METHODS Through the literature and case studies, the article analyzed the framework, implementation process, and effectiveness of the FDA′s real-time review of drug application system. RESULTS It is found that the system includes real-time oncology review(RTOR) and assessment aid(AAid). RTOR provides a standardized data analysis process and the steps of "pre-submission" and "pre-analysis", while AAid is based on the FDA multidisciplinary review template. By the end of 2019, 27 projects have been approved through the system. CONCLUSION Druing the reforming process of drug review system in China, it is recommended to strengthen the top-level design of policies, explore diversified special review methods, and actively promote data standardization and communication and interaction, so as to improve the review efficiency and accelerate the marketing of medicines with clinical value.