药学研究2026，Vol.45Issue(5)：531-535,586,6.DOI:10.13506/j.cnki.jpr.2026.05.008
我国创新药审评机制的挑战与优化路径
Challenges and optimized paths of China's innovative drug review mechanism
摘要
Abstract
Currently,China is in a critical period of transitioning from a major pharmaceutical country to a powerful pharmaceutical nation.The reform of the innovative drug evaluation mechanism has achieved remarkable results,with continuous improvement in regulations and policies,refinement of evaluation standards,and significant enhancement in evaluation efficiency.However,there are still challenges such as insufficient operability of some regulations,lagging evaluation standards in frontier fields,mismatch between team building and industrial development,and inadequate implementation of intelligent evaluation.This article delved into the current predicaments and proposes optimization paths from refining regulatory content,improving standards in frontier fields,strengthening team building,and deepening the integration of big data,artificial intelligence,and evaluation business.It aims to provide some theoretical references for the optimization of the innovative drug evaluation mechanism.关键词
创新药/审评机制/审评标准/审评队伍/智能审评Key words
Innovative drugs/Review mechanism/Review standards/Review team/Intelligent review分类
医药卫生引用本文复制引用
张宇,马韶青..我国创新药审评机制的挑战与优化路径[J].药学研究,2026,45(5):531-535,586,6.基金项目
北京中医药大学2025年度基本科研业务费项目(No.2025-JYB-PY-009) （No.2025-JYB-PY-009）
北京市法学会2025年市级法学研究专项课题[No.BLS(2025)B019] （2025）
