化学药品创新药Ⅲ期临床试验前会议的药学共性问题及审评考虑  

Pharmaceutical Common Issues and Evaluation Considerations in Pre-phaseⅢClinical Trial Meetings for Innovative Chemical Drugs

作　　者：徐立华 周浩辉 赵一飞 王亚敏[1] XU Li-hua;ZHOU Hao-hui;ZHAO Yi-fei;WANG Ya-min(Center for Drug Evaluation,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2023年第8期32-37,共6页China Food & Drug Administration Magazine

摘　　要：为鼓励创新,加快新药研发,国家药品监督管理局药品审评中心组织起草制定了《化学药品创新药Ⅲ期临床试验前会议药学共性问题及相关技术要求(试行)》,并正式发布。本文结合国内创新药Ⅲ期临床试验前药学方面沟通会议审评中发现的问题,对Ⅲ期临床试验前药学共性问题进行分析总结,帮助申请人更好地理解并运用该技术要求,提高创新药药学沟通交流的质量和效率。To encourage innovation and accelerate new drug development,the Center for Drug Evaluation has initiated the drafting and official release of the Pharmaceutical Common Issues and Related Technical Requirements in Pre-phase III Clinical Trial Meetings for Innovative Chemical Drugs(Trial).Drawing from issues identified in the review of pre-phaseⅢclinical trial meetings of pharmaceutical communication for innovative drugs in China,this paper analyzes and summarizes the recurring pharmaceutical common issues in such trials.The aim is to enhance applicants’understanding and utilization of these technical requirements,thereby improving the quality and efficiency of pharmaceutical communication concerning innovative drugs.

关 键 词：创新药 Ⅲ期临床试验 药学共性问题 技术要求 

分 类 号：R95[医药卫生—药学]