摘要
本文以截至2023年3月1日美国所有通过加速批准程序上市的抗肿瘤药为研究样本,将其分为已转常规、验证中和已撤回3种情况,对美国加速批准程序的运行效果进行分析.结果显示美国加速批准程序的运行具有完整性、灵活性和科学性3个特点,并从完善我国附条件批准法律法规的相关内容、构建更加全面的附条件批准程序技术指导原则体系、提高我国附条件批准程序的灵活性、加强我国附条件批准程序的证据体系建设、鼓励开展随机对照试验和优化我国抗肿瘤药物附条件批准转常规批准的路径6个方面对我国附条件批准程序的完善提出建议.
Abstract
This article took all antitumor drugs approved through the accelerated approval process in the United States by March 1,2023 as research samples,and analyzed the operation effect of the accelerated approval process in the United States by dividing them into three scenarios:verified,ongoing and withdrawn.The results showed that the operation of the accelerated approval process in the United States had three characteristics:completeness,flexibility,and scientificity.This paper proposed suggestions for the improvement of China's conditional approval procedures from six aspects:perfecting the relevant contents of the laws and regulations,constructing a more comprehensive guidance system,improving the flexibility of the review procedures,strengthening the evidence system construction,encouraging the conduct of randomized controlled trials and optimizing the transition path of conditional approval to routine approval of anti-tumor drugs.
基金项目
辽宁省社会科学规划基金(2021)(L21BGL054)
沈阳药科大学中青年教师事业发展支持计划(2023)(ZQN202307)
辽宁省教育厅基本科研项目(2022)(LJKFR-20220260)
中国药品监督管理研究会研究课题(2023)(2023-Y-Y-010)
NETL
NSTL
万方数据