中国特殊医学用途配方食品行业现况及探索

Food for special medical purposes in China:status quo and future development

通过分析我国特殊医学用途配方食品(FSMP)的发展历程、行业现况及壁垒,提供可参考的探索性意见,为相关政策制定及产业发展趋势提供一定依据。企业生产方应及时了解并准确解读政策,强化基础研究,提升创新能力,满足具有中国特色的市场需求,关注效果反馈以优化产品设计。建立FSMP临床应用效果监测平台,形成逐级上报机制,以获得真实世界数据研究,生产出具有高质量的真实世界证据以支持上市后的质量监管体系。在患者及其家属中推广FSMP概念,加强宣传力度,拓展宣传途径,深化消费者对其临床效果的了解程度。以需求为导向,FSMP为当下多学科融合迈向产学研用协同发展提供了一种可行的模式。提升产品效能、患者满意度、企业利润率、降低个人、家庭、医疗机构乃至政府的负担是FSMP市场形成一定规模后的必经之路。

By analyzing the development history of food for special medical purposes(FSMP)in China,the current situation and barriers of the industry were analyzed,and some exploratory suggestions were provided for reference to provide a certain basis for relevant policy formulation and industrial development trend.The enterprise manufacturer should timely understand and accurately interpret the policy,strengthen basic research,enhance innovation ability,meet the market demand with Chinese characteristics,pay attention to the effect feedback to optimize product design.It is recommended to establish a system to monitor the effects of FSMPs in clinical application as well as a hierarchical reporting system,so as to obtain real-world research data through the regulating system for the clinical application of FSMP products,and to produce high-quality real-world evidence to improve the post-market quality regulation system.The concept of FSMP among patients and their families should be promoted,to strengthen the publicity efforts,expand the channels of publicity,and deepen the understanding of consumers on its clinical effects.With demand-oriented policies and systems,the industry of FSMP that integrates various disciplines might provide new insights into the coordinated development of industries,universities,research institutes and end-users.The industry of FSMP will have to form a model that integrates product efficiency,patients′satisfaction and enterprises′profitability,and reduce the burden on individuals,families,medical institutions and even the government.