制药企业药品上市后风险管理政府规制研究

发布时间：2018-02-24 07:48

本文关键词： 药品生产企业药品上市后风险管理政府规制　出处：《沈阳药科大学》2014年博士论文　论文类型：学位论文

【摘要】：随着我国经济的快速发展,公众对生命和健康的重视程度不断提升,药品安全问题受到全社会的高度关注。2006年“鱼腥草事件”、2007年“甲氨蝶呤事件”、2012年“罗氏事件”等药品安全事件反映出来两个问题,一是制药企业对药品上市后风险管理的意识不够,没有承担起“药品安全第一责任人”的这个责任。二是药品监管部门对生产企业药品上市后风险管理的监管不到位。有必要对生产企业药品上市后风险管理政府规制模式进行全面、深入的分析及研究,为我国药品上市后安全监管提供借鉴。本文首先运用了政府规制理论,采取了对比分析的方法对欧美等国与我国的制药企业药品上市后风险管理政府规制模式进行了研究。运用了调查分析法和专家咨询法分别研究了制药企业药品上市后风险管理规制现状和影响规制的相关因素。最后在经济学理论指导下,分析药品上市后风险管理规制的适度性和高效性。通过上述的研究主要得到以下研究结果：一是我国缺乏对生产企业药品上市后风险管理的社会规制方式,例如建立检查、资格认证和信息公开等；二是生产企业对药品不良反应信息的收集与分析评价存在严重缺陷；三是政府规制的信息和规制相关的法律法规仍是影响规制效果的重要因素。四是对于制药企业药品上市后风险管理政府规制是存在适度性的；五是可采取激励经济规制方式提高政府规制效率。对于我国制药企业药品上市后风险规制的建议是首先完善社会规制措施：建立药品安全性信息公开制度,制定药品不良反应报告和监测工作检查制度,明确企业的违规行为并加大处罚力度。对于行政规制应建立监管绩效评估制度,做好监管相关法规与技术指南的良好衔接,完善政府告知制度。经济规制方式可药品监管部门可与生产企业建立激励契约,根据契约来对企业进行激励和处罚。实现高效低成本监管。制药企业药品上市后风险管理政府规制是一个长期的、不断总结经验、不断更新探索的工作,希望通过本文的尝试性的研究与探讨,能为完善我国生产企业药品上市后风险管理政府规制方式提供一些有益的参考。
[Abstract]:With the rapid economic development of our country, the public has been paying more and more attention to life and health. The drug safety problem is highly concerned by the whole society. The drug safety incidents such as the Houttuynia incident in 2006, the methotrexate incident in 2007, and the "Roche incident" in 2012 reflect two problems. First, the pharmaceutical enterprises are not aware of the risk management after the drug market. The second is that the supervision and control of the risk management after drug listing in the manufacturing enterprise is not in place. It is necessary to manage the risk after the drug listing in the manufacturing enterprise. The regulatory model is comprehensive, The deep analysis and research provide reference for the safety supervision after drug marketing in our country. Firstly, this paper applies the theory of government regulation. This paper adopts the method of comparative analysis to study the government regulation mode of the post-marketing risk management of pharmaceutical enterprises in Europe, America and China. The methods of investigation and analysis and expert consultation are used to study the pharmaceutical products in pharmaceutical enterprises. The present situation of post-market risk management regulation and the related factors affecting regulation. Finally, under the guidance of economic theory, This paper analyzes the appropriateness and efficiency of risk management regulation after drug marketing. The main results are as follows: first, there is a lack of social regulation on the risk management after the listing of pharmaceutical products in our country, such as establishing inspection, qualification certification, information disclosure and so on; Second, there are serious defects in the collection, analysis and evaluation of adverse drug reaction information in manufacturing enterprises; Third, the information of government regulation and the relevant laws and regulations are still the important factors that affect the effect of regulation. Fifth, incentive economic regulation can be adopted to improve the efficiency of government regulation. The suggestions for the risk regulation after drug marketing in Chinese pharmaceutical enterprises are as follows: first, to perfect the measures of social regulation: to establish the open system of drug safety information, to establish the system of adverse drug reaction reporting and monitoring work inspection. It is necessary to establish a regulatory performance evaluation system for administrative regulations, and make a good connection between relevant regulations and technical guidelines. Perfecting the government informing system. The economic regulation can establish the incentive contract with the production enterprise, according to the contract to encourage and punish the enterprise, and realize the high efficiency and low cost supervision. The government regulation of risk management after drug listing in pharmaceutical enterprises is a long-term, continuous summing up of experience, constantly updating and exploring work, hoping that through the trial research and discussion in this paper, It can provide some useful reference for perfecting the government regulation mode of risk management after drug listing in Chinese manufacturing enterprises.
【学位授予单位】：沈阳药科大学
【学位级别】：博士
【学位授予年份】：2014
【分类号】：F426.72;R95

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