药品安全论文：中国药品管制体制变迁研究

药品安全论文：中国药品管制体制变迁研究
【中文摘要】近年来,中国药品管制体制不断变迁,是最受关注和争议的领域之一。

研究首先运用管制经济学理论,构建一个药品管制的目标体系,为本项研究建立了基准点；其次,通过对美国药品管制体制现状及发展历程的研究,为本项研究确立一个规范模式。

在此基础上,对中国药品管制机构及其职能的变迁过程进行了剖析,分析其动因、成效及存在问题,对未来改革提出了建议。

公共管制因为市场缺陷的存在而建立,管制的供给受制于社会经济条件和政府的政策目标。

药品管制是政府管制在药品领域的运用,其核心是确保药品的安全性,但要兼顾可获得性、质量保证、合理使用等基本目标。

多重目标之间的优先顺序是不断发展变化的,并直接影响着管制制度的设计。

美国药品管制机构包括联邦和州政府两个部分,分别负责有着不同外部效应的管制领域。

美国药品管制体制是在一系列公共危机事件的压力下,通过法律修订逐步形成的,在新公共管理背景下,已经进入了以合作与开放为特征的现代化管制阶段。

中国药品管制机构是顺应经济体制转型、管制目标调整而建立的,通过制度设计,为药品安全监管提供了较为有效的保障。

但也存在着管制体制需增强法律保障、管制体制与管制领域不够匹配、管制制度需进一步完善、管制方式不适应形势需要等问题,影响了管制效能。

中国药品管制体制今后的改革应该贯彻“顶层设计”的理念。

首先要在决策层面协调各方利益,凝聚全社会的共识,制定符合社会经济发展水平的管制目标,以立法形
式为管制体制确立指南。

其次要完善公共管制评估制度,为管制制度的设计、改革提供依据。

在体制上应该厘清权责,建立垂直管理的中央部门和分级管理的地方部门两个系统,各施其职。

在向服务型、监管型政府转变的过程中,要引导、建设一个多元共治的机制,进一步探索信息监管、综合治理等新型监管手段的运用。

【英文摘要】In recent years, China’s drug regulation organization constantly change, it is one of the field that most be concerned and disputed. The first step to study is to build a target system of drug regulation, built benchmark for this study; Secondly, through the research to the status and development of American drug regulation organization, to establish a standard mode. On the basis, the change process of China’s drug regulation agency and its functions are analyzed, analyzes its causes, effectiveness and the existing problems, puts forward suggestions for future reform.Public regulation built up for the defect of market, the supply of regulation subject to social and economic conditions and the policy of the government targets. Drug regulation is the use of government regulation in pharmaceutical field, the core is to ensure the safety of drugs, but we should take other basic goals such as availability, quality assurance, reasonable use. The priority between multiple objectives is ever-changing, and affect the
design of regulation system directly.American drug regulation agency include federal and state two parts, which are responsible for the regulation of field with different external effects. Under the pressure of a series of public crisis, the drug regulation system of American formed gradually through legal procedures, and has entered to the modern stage with the characteristics of cooperation and openness, in the background of new public management. Follows transformation of economic system and adjustment of regulation target, China’s drug regulation agency establishes and provides a more effective safeguard for drug safety supervision through system design. But there are also more question affecting regulation effectiveness such as:the regulation system needs to improve legal protection, the regulation system not matching the regulation field, the regulation system need to be further perfected, the regulation mode not adapt to the needs.The next reform of China’s drug regulation system should implement the concept of “top design”. First, we should to coordinate the interests of all parties in decision-making level, build consensus of the whole society, formulate regulation goals that conform the level of social economic development, established guidelines for regulation system by legal. Secondly, should
perfect the evaluation of public regulation system, provides
the basis for design and reform of regulation system. In the system, establish the central authorities with vertical management and local authorities with Classification management, bearing different functions. in the process of transformation to service-oriented、regulatory government, should to guide、build a multiple co-government mechanism, to further explore the applying of new regulatory means,such as information supervision, general management.
【关键词】药品安全公共管制组织体制改革
【英文关键词】drug safety government regulation organizational system reform
【目录】中国药品管制体制变迁研究摘要
5-6Abstract6-7第一章导论8-11第一节研
究目的8第二节该问题研究现状8-10(一) 国外研究
现状8-9(二) 国内研究现状9-10第三节逻辑思路与
研究方法10-11第二章公共管制的理论依据11-15第
一节公共管制11-12第二节药品管制12-13第三节
建立政府管制体制的原则和模式13-15第三章美国药品管制
体制及其借鉴意义15-19第一节美国药品管制体制的现状
15-16(一) 美国食品药品管理局15-16(二) 州一级
的药品管制16第二节美国药品管制的发展历程
16-17第三节美国药品管制体制的借鉴意义17-19第四章中国药品管制体制的变迁历程19-29第一节管制机构的变迁19-23(一) 1998年之前的情况19-20(二) 1998年-2008年的情况20-22(三) 2008年以来中国药品管制机构改革进展22-23第二节管制职能的变迁23-29(一) 经济管制职能的逐渐弱化23-24(二) 市场准入职能的法制化24-25(三) 质量管理规范的强制推进25-26(四) 信息监管方式的引入26-27(五) 综合治理方式的制度化
27-28(六) 医疗机构的药品管理28-29第五章对中国药品管制体制的评估29-38第一节管制体制变迁的原因分析29-31第二节管制职能与管制机构的匹配31-33第三节中国药品管制体制存在的问题33-38(一) 管制体制需增强法律保障33-34(二) 管制体制与管制领域不够匹配
34-35(三) 管制制度需进一步完善35-36(四) 管制方式不适应形势需要36-38第六章结论与建议38-41
第一节结论38-39第二节建议39-41注释
41-45参考文献45-49后记49-50。