我国药品包装材料行业发展及监管概况与发展趋势分析  

Analysis on the Development and Supervision of Pharmaceutical Packaging Materials Industry in China and its Development Trend

作　　者：谢兰桂[1] 肖新月[1] 赵霞[1] 孙会敏[1] 胡增峣 Xie Langui;Xiao Xinyue;Zhao Xia;Sun Huimin;Hu Zengyao(NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients,National Institutes for Food and Drug Control,Beijing 100050,China;Department of Drug Regulation of National Medical Products Administration,Beijing 100037,China)

机构地区：[1]国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京100050 [2]国家药品监督管理局药品监督管理司,北京100037

出　　处：《中国药事》2024年第10期1101-1107,共7页Chinese Pharmaceutical Affairs

基　　金：中国食品药品检定研究院学科带头人培养基金(编号2023X9)。

摘　　要：目的:总结回顾我国药品包装材料(简称药包材)行业的发展过程及监管概况,结合所处环境分析发展趋势,为行业的发展提供参考。方法:归类我国不同历史时期药包材的产品类型及工业生产特点发展概况,以及与之相适配实施的管理制度,结合行业的发展环境,阐述行业的发展趋势,展望药包材行业面临的挑战与机遇。结果:我国药包材行业历经70年的发展,特别是近20年的国家层面的监督管理和引导发展,行业由小到大,由弱到强,国民经济行业分类增设“药用辅料及包装材料制造”类别。药包材产品种类由简单到复杂,由单一到多元,产品功能由通用包装储存发展到个性化辅助便利给药,并达到适应经济高速发展和人们生活水平显著提高现状的安全性要求。在国家政策的扶持下,药包材行业展露出智能化、契合药品功能化、绿色化发展的趋势。结论:我国药包材行业经过70年的发展,从模仿借鉴走向自主研发的道路,已成为我国战略性产业中的重要组成部分,有助于支撑我国医药工业产业的高质量发展。Objective:To summarize and review the development trajectory and the supervision of China's pharmaceutical packaging industry,analyze the trends in conjunction with the prevailing environment,and to offer insights to inform the industry's growth.Methods:The analysis was anchored in the evolution of product types,the distinctive industrial production features of pharmaceutical packaging materials and the management system adapted across various historical periods in China.It integrated the broader development context of the industry to elucidate current trends and anticipate future challenges and opportunities.Results:Spanning seven decades,China's pharmaceutical packaging industry has experienced significant growth,particularly bolstered by national supervision and guidance over the past twenty years.The industry has transformed from nascent to robust,with the economic sector now formally recognizing"Pharmaceutical Excipients and Packaging Materials Manufacturing".The diversity and complexity of pharmaceutical packaging materials have expanded,evolving from rudimentary to sophisticated and from singular to a multitude of options.Their functionality has advanced from basic containment to personalized,convenient drug delivery solutions,aligning with the rigorous safety demands of a rapidly growing economy and elevated public health standards.Underpinned by state policies,the industry is gravitating towards intelligent,pharmaceutically compatible,and eco-friendly development.Conclusion:After seventy years of evolution,China's pharmaceutical packaging industry has transitioned from a phase of emulation to one of innovation.It has established itself as a vital component of the nation's strategic industries and stands poised to underpin the high-quality development of China's pharmaceutical sector.

关 键 词：药包材 包装容器 包装系统 行业发展 监督管理 发展历程 

分 类 号：R95[医药卫生—药学]