我国2019年至2021年审评建议批准上市创新药的审评和临床试验现场核查情况分析
Analysis on the situation of the evaluation and clinical trials on-site inspection of the innovative drugs which are recommended approved between 2019 and 2021
班浩 1何辉 1刘艺迪 1周刚1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京,100076
- 折叠
摘要
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.
Abstract
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.
关键词
创新药/药品审评/临床试验/现场核查Key words
innovative drug/drug evaluation/clinical trial/on-site in-spection引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
维普
万方数据