我国创新药审评机制的挑战与优化路径OA

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.