团体标准驱动生物医药产业高质量发展路径研究  

Study on high-quality development path of biomedical industry driven by group standards

作　　者：廖萍 吴耀卫 曹萌 张景辰 LIAO Ping;WU Yaowei;CAO Meng;ZHANG Jingchen(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201210,China;Shanghai Pharmaceutical Profession Association,Shanghai 200003,China;Yangtze River Center for Drug Evaluation and Inspection of National Medical Products Administration,Shanghai 201210,China)

机构地区：[1]上海药品审评核查中心,上海201210 [2]上海医药行业协会,上海200003 [3]国家药品监督管理局长三角药品审评检查分中心,上海201210

出　　处：《上海医药》2023年第21期42-46,65,共6页Shanghai Medical & Pharmaceutical Journal

摘　　要：团体标准由市场主体遵循市场规律自主制定,能快速反映市场需求,具有制定灵活、创新性强和指标领先等特点,可以发挥重要的标准补充供给作用,近几年发展迅速。但是团体标准在生物医药产业的应用还不广泛,影响力较弱。本文对团体标准的发展现状、在生物医药产业的应用情况进行了调研,对团体标准在生物医药产业发展较缓慢的原因进行了分析,并通过解读上海实践中的成功案例提出发展好团体标准,从而驱动生物医药产业高质量发展的有效路径。The group standard is independently formulated by the market subject in accordance with the law of the market,can quickly reflect the market demand,has the characteristics of flexible development,strong innovation and leading indicators,can play an important role in the supply of standards,and has made rapid development in recent years.However,the application of group standards in the biomedical industry is not widespread,and the influence is weak.In this article,the development status of group standards and their application in the biomedical industry were investigated,the reasons for the slow development of group standards in the biomedical industry were analyzed,and the effective path of the development of group standards to drive the high-quality development of the biomedical industry was proposed by interpreting successful cases in Shanghai practice.

关 键 词：生物医药产业 团体标准 高质量发展 路径研究 

分 类 号：R951[医药卫生—药学]