中、日、美、欧盟保健产品监管比较分析

目的:为进一步完善我国保健产品监管法律体系提供借鉴。方法:对中国、日本、美国、欧盟保健产品的概念、上市监管情况等进行比较和分析。结果与结论:各国和地区保健产品的概念不尽相同,但对于保健产品本质的认识观点还是相对一致的。各国和地区保健产品上市监管模式可分为注册审批制(如中国)和备案制(如美国)2类。我国目前缺乏对上市后产品的有力监管,导致国内保健产品市场仍存在产品质量低、标签使用随意、宣传行为混乱等问题。建议我国应学习日本、美国,制定一部比较全面的规范保健产品生产、经营、流通行为并保障产品质量的法规,使企业的市场行为和政府的监管行为都能有章可循。同时,应及时对相关法规进行更新,避免出现矛盾或脱节的现象,保证市场活动和执法行为的顺利进行。

Comparison and Analysis of the Health Products Supervisions in China,Japan,USA and EU

OBJECTIVE:To provide reference for further improvement of law and regulation system of health products in China.METHODS:The differences of the concepts and the market supervisions of health products in the China,Japan,USA and EU were compared and analyzed.RESULTS & CONCLUSIONS:The concepts of health products in the countries and areas differ from each other.Those countries and areas’ opinions are in agreement about health products.The supervision models can be summarized into the approval system(China) and the recording system(USA).Our country lack of strong supervision of listed products,which result in low quality of health products,abuse of label and confuse propaganda behavior,etc.It is suggested to learn from Japan and USA to formulate comprehensive regulation on the production,operation,circulation of health products and their qualities.There are rules to go by in market behavior of enterprise and supervision behavior of government.At the same time,smooth development of market behavior and supervision behavior can be guaranteed by updating related regulations timely and avoiding contradictions and disjointing.