浅谈数字化转型对我国制药行业和药品监管发展的影响

摘要/Abstract

摘要： 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。

关键词: font-size:medium, ">数字化转型；制药行业；智慧监管

Abstract: 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.

Key words: Digital transformation, Pharmaceutical industry, Intelligent supervision

中图分类号:

吴欣然, 于淼. 浅谈数字化转型对我国制药行业和药品监管发展的影响[J]. 中国医药导刊, 2022, 24(8): 750-753.

WU Xinran, YU Miao. The Impact of Digital Transformation on the Development of Pharmaceutical Industry and Drug Supervision in China[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2022, 24(8): 750-753.

参考文献

[1]陈世清. 对称经济学[M]. 中国时代经济出版社,2010.
     [2]饶宏.数字电网推动构建以新能源为主体的新型电力系统[J].电力设备管理,2021,(8):21-22.
     [3]周维富.以数字化制造引领制造业高质量发展[J].实践(思想理论版),2020,(5):59.
     [4]National Academies of Sciences, Engineering, and Medicine, Division on Earth and Life Studies, Board on Chemical Sciences and Technology, et al. Innovations in pharmaceutical manufacturing on the horizon: technical challenges, regulatory issues, and recommendations[M]. Washington (DC): National Academies Press (US):2021.
     [5]Junker B,Zablackis E,Verch T,et al.Quality-by-design:as related to analytical concepts, control and qualification. In Vaccine Analysis: Strategies, Principles, and Control[M]. Springer Berlin, 2015: 479-520.
     [6]王瑞峰,张晓明. 浅析“质量源于设计”在制药生产中的应用[J]. 机电信息, 2016,(2):23-25,51.
     [7]Lipsitz YY, Timmins NE, Zandstra PW. Quality cell therapy manufacturing by design[J].Nature Biotechnology,2016, 34(4):393-400.
     [8]王智民, 张启伟. 美国FDA产业指南:创新的药物开发、生产和质量保障框架体系——PAT[J]. 中国中药杂志, 2009, 34(24):3304-3309.
     [9]卞正岗. PAT过程分析技术及其它[J]. 可编程控制器与工厂自动化,2008,(11):30-34.
     [10]Holm P, Alles M, Bryder MC, et al. Q8 (R2) Pharmaceutical development. In ICH quality guidelines: an implementation guide[M]. John Wiley & Sons, 2017: 535-577.
     [11]Hu C, Testa CJ, Wu W, et al. An automated modular assembly line for drugs in a miniaturized plant[J]. Chemical Communications, 2020, 56(7): 1026-1029.
     [12]Hohmann L, Lbnitz L, Menke C, et al. Continuous downstream processing of amino acids in a modular miniplant[J]. Chemical Engineering & Technology, 2018, 41(6): 1152-1164.
     [13]制药网. 药企数字化转型势在必行，制药装备行业肩负着重大使命[EB/OL].(2020-11-10)[2022-02-13]. https://www.zyzhan.com/news/detail/79261.html
     [14]夏元. 智能制造助疫情防控生产提质增效数字化车间让药企生产效率提高近四成[EB/OL]. (2020-02-13)[2022-02-13]. https://app.cqrb.cn/topics/2020zycqxd/2020-02-13/125266_pc.html.
     [15]金旻矣.从“批次管理”到“单支管理” 国控生物全溯系统保障“针尖上的安全” [EB/OL]. (2021-08-20) [2022-02-13]. http://newsxmwb.xinmin.cn/chengsh/2021/08/20/32012449.html.
     [16]胡颖廉. 监管部门嵌入医药产业尚浅[J]. 中国医院院长, 2013,(9):89.
     [17]全面贯彻落实“四个最严”有效保障公众用药安全新修订《药品管理法》审议通过[J]. 中国制药信息, 2019, 35(10):7-9.
     [18]王立光,陈健. 全过程质量管理体系在药品监管中的应用[J]. 中文科技期刊数据库（文摘版）医药卫生，2016，(7):196.
     [19]林伟强,郭晓敏,周宗梁,等. 基于检验数据的药品质量风险预警模型研究[J]. 软件,2018,39(12):127-130.
     [20]任峰,梅蕾蕾,李存金,等. 药品检查过程中关于数据可靠性的研究与思考[J]. 中国药事,2021,35(3):243-249.
     [21]张菊芳. 多元统计分析方法中的降维方法及其应用[D]. 山东大学, 2004.

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