美国联邦政府食品药物管制的公共政策分析  

An Analysis of the Public Policy of the Federal Government of USA on the Regulation of Food and Drug

作　　者：张国庆[1] 李丹阳[1] 

机构地区：[1]北京大学政府管理学院,北京100871

出　　处：《中山大学学报（社会科学版）》2003年第6期55-61,共7页Journal of Sun Yat-sen University(Social Science Edition)

摘　　要：美国近百年来关于食品药物管制的公共政策 ,经历了一个从以刚性规则和具有封闭性的FDA单一管制为特点的传统管制范式 ,向以合作、开放、信息共享、信息服务为特点的现代化—信息化管制范式转变的过程。这一过程可以分为管制的建立、管制的加强、管制的强化、管制的放松、管制的现代化—信息化五个阶段。其价值取向主要表现为优化管制方式、改变管制结构、加强管制责任、提高管制效率、注重信息开发和共享、强调提供全方位和高品质的公共信息服务 ,其政策措施则集中在转换管制范式、尝试间接管制、倡导自我管制、推行第三方管制与认证、开放管制程序、推进国际管制的和谐化趋势等方面。In the last century, the public policy of the Federal Government of USA on the regulation of food and drug has transformed from the traditional paradigm characterized by rigid rule and single closed FDA regulation to the paradigm of modernization-information characterized by cooperation, openness, information-sharing and information-service. This process can be divided into five phases: the setting-up of regulation, the enhancement of regulation, the reinforcement of regulation, the relief of regulation and the modernization and information of regulation. In the latest phase, the value-orientation is to optimize the regulatory mode, to change the regulatory structure, to strengthen the regulatory responsibility, to improve the regulatory efficiency, to pay attention to developing and sharing information, and to emphasize the supply of omni-directionally public information of high quality; and the policies and measures focus on the shift of the regulatory paradigm, the attempt of indirect regulation, the guidance for self-regulation, the practice of the regulation and certification by the third party, the open of regulatory process, and the harmonization of international regulation.

关 键 词：美国 食品药物管制 FDA 公共政策 

分 类 号：F171.2[经济管理—世界经济]