人工智能在药品审评中的应用展望

Application Prospects of Artificial Intelligence in Drug Evaluation

近年来人工智能(artificial intelligence,AI)技术方兴未艾,特别是伴随着生成式AI技术的不断进步以及AI技术应用场景的不断拓展,AI已然成为经济增长的新引擎和赋能千行百业的新手段,并不断推动科技进步和产业升级。医药产业作为关乎国计民生的基础和战略性产业,如何借助AI技术提升药品审评质量和效率,缩短药品审评周期,加速新药上市,成为药品审评的新发展方向。目前,AI在药品智慧监管、药品审评中的应用尚处在探索期。本研究由AI的概念切入,在概述AI发展以及应用现状的基础上,结合我国药品审评的发展历程和实际现状,分析药品审评当前所面临的现实问题,探索和展望AI技术在药品审评中的应用场景和未来发展方向。本研究认为,未来随着AI应用的不断落地,将AI高效应用到药品审评过程,可有效提高药品审评质量和效率,进一步加快新药上市的步伐。AI的应用场景也将不断丰富,包括AI智能咨询机器人、智能化数据治理、AI辅助报告分析与解读、AI比对申报材料等,借助AI技术有效提升药品审评质量和效率,促进AI技术在药品审评中更多应用场景的落地,保障药品安全,同时激发整个产业链的发展。

In recent years,artificial intelligence(AI) technology has been in the ascendant,especially with the continuous progress of generative AI technology and the continuous expansion of AI technology application scenarios.AI has become a new engine for economic growth and a new means to empower thousands of industries,and it has continuously promoted technological progress and industrial upgrading.As a basic and strategic industry related to the national economy and people's livelihood,how to use AI technology to improve the quality and efficiency of drug evaluation,shorten the drug evaluation cycle,and accelerate the launch of new drugs has become a new development direction for drug evaluation.Currently,the application of AI in drug intelligent supervision and drug evaluation is still in the exploratory stage.This study starts from the concept of AI,summarizes the development and application status of AI,and combines the development history and actual status of drug evaluation in China to analyze the current practical problems faced by drug evaluation,explore and prospect the application scenarios and future development directions of AI technology in drug evaluation.This study believes that the efficient application of AI in the drug evaluation process can effectively improve the quality and efficiency of drug evaluation,further accelerate the pace of new drug launch,with the continuous implementation of AI applications in the future.The application scenarios of AI will also continue to be enriched,including AI intelligent consulting robots,intelligent data governance,AIassisted report analysis and interpretation,AI comparison of application materials,etc.With the help of AI technology,we can effectively improve the quality and efficiency of drug evaluation,promote the landing of more application scenarios of AI technology in drug evaluation,ensure drug safety,and stimulate the development of the entire industry chain.