浅谈数字化转型对我国制药行业和药品监管发展的影响

The Impact of Digital Transformation on the Development ofPharmaceutical Industry and Drug Supervision in China

随着数字技术的蓬勃发展,数字经济正深刻改变着人们的生产生活方式。加快推进数字化转型,为各个行业的发展提供了新机遇。我国“十四五”规划明确提出,加快数字化发展,建设数字中国。《“十四五”医药工业发展规划》进一步提出推动医药产业数字化转型升级的要求,以及促进新兴产业快速发展的目标。推进制药行业的数字化转型,不仅有利于提升制药企业自身竞争力,也有利于药品智慧监管的发展完善。本研究介绍了制造业数字化转型的背景和概念、制药行业数字化转型的发展,结合国外制药行业数字化转型经验,分析了制药行业数字化转型对药品监管理念的影响及其面临的挑战和风险,为我国制药行业数字化转型和促进药品智慧监管发展提供参考。

With the vigorous development of digital technology,digital economy is profoundly changing human production mode and life-style.Accelerating the digital transformation has provided new opportunities for the development of various industries.The outline of the 14th Five Year Plan for China′s national economic and social development clearly proposes to accelerate digital development and build“digital China”.The 14th Five Year Plan for the development of pharmaceutical industry further puts forward the requirements for promoting the digital transformation and upgrading of pharmaceutical industry,as well as the goal of promoting the rapid development of emerging industries.Promoting the digital transformation of the pharmaceutical industry is not only conducive to improving the competitiveness of pharmaceutical enterprises,but also conducive to the development and improvement of drug smart regulation.This paper introduces the background and concept of digital transformation of manufacturing industry and the development of digital transformation of pharmaceutical industry.Combined with the experience of the digital transformation of foreign pharmaceutical industry,this paper analyzes the impact of the digital transformation of pharmaceutical industry on the concept of intelligent supervision and the challenges and risks it faces,so as to provide reference for the digital transformation of pharmaceutical industry in China and promoting the development of drug intelligent supervision.