本文通过收集2019年至2021年度药品审评中心建议批准上市的68个创新药的审评情况,分析创新药研发趋势以及审评审批制度改革对创新药带来的影响.同时,通过对药物临床试验数据核查审核报告梳理,分析创新药临床现场核查情况,总结现场核查发现的常见问题,为后续创新药申报及高质量开展药物临床试验提供参考和建议.
The 68 Center for Drug Evaluation recommend approved innovative drugs between 2019 and 2021 evaluation situation was summarized in this article,to analyzes the innovative drugs research and development trend and the influence of the drug evaluation and approval system reform.Meanwhile,after sorting out the clinical trials inspection report,to analyze the clinical trials on-site inspection of innovative drugs,and summarized the common defects,hope to provide reference and suggestions for subsequent innovative drug application and high-quality drug clinical trials.
班浩;何辉;刘艺迪;周刚
国家药品监督管理局药品审评中心,北京,100076
药学
创新药;药品审评;临床试验;现场核查
innovative drug;drug evaluation;clinical trial;on-site in-spection
《中国临床药理学杂志》 2024 (001)
144-149 / 6
10.13699/j.cnki.1001-6821.2024.01.030
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