国家基本药物电子监管政策及其在延边州实际应用效果分析
发布时间：2018-11-27 19:04
【摘要】：实施药品电子监管系统的主要目的是我国在药品监督和管理层次上的进一步提高,随时监控药品在生产、流通、销售等各个环节中的实时状态,可以随时追溯及召回有问题的药品,使药品监督管理部门的监督效果和保障药品生产企业的合法利益方面得到了很大的提升。国家食品药品监督管理局规定,从2011年4月起我国将所有基本药物目录的品种入网至中国药品电子监管网。药品电子监管政策实施至今,对于政策实施状况,社会各界专家们的关注一直没有中断过,也提出过各种假设性问题,但是,对于药品电子监管政策确切实施后所分析其政策的发展性及可行性研究的主题却少之又少,因此,本论文在延边州实施政策以来所呈现出的各种优点和缺点来对比分析,并且探讨其政策的长期发展性及政策实施的必要性。 本文通过延边州药品电子监管实施实际效果情况,从以下三个方面研究分析政策是否具有长期可行性及必要性。 第一,通过比较我国与其他国家医药行业的监督管理体制和药品的质量保障和用药的安全保障而制定的有关政策、措施以及法律法规,分析结果发现,许多发达国家的药品监督管理机制和针对于药品用药安全管理的相关政策及法律法规都比我国先进、完善。 第二,全面的说明了关于我国药品电子监管政策实行至今的情况,政策的优越性和不足点。药品电子监管政策确实具有许多优点,例如,防伪功能、方便追溯、随时召回和信息查询等等,但同时也存在着不可忽视的缺点,比如,企业成本投入过高、药品电子监管网络不稳定、相关法律法规不健全等等。 第三,通过分析了解延边州实施政策以来所呈现出的效果,认识我国实施药品电子监管政策将给我国医药生产企业、运输企业、销售企业所带来的改革及变化。结果表明,对于生产低价位基本药物生产企业,药品电子监管政策的实施的确带来了较高的成本压力,但总体来讲,政策的实施效果较好,还有待提高,相关部门监管力度还有待加强,政策的可行性较高,并提出部分相关政策及措施能进一步改进的建议,最后做出展望。
[Abstract]:The main purpose of implementing the electronic drug supervision system is to further improve the level of drug supervision and management in our country, and to monitor the real-time status of drugs in production, circulation, sale and other links at any time. The problem of drugs can be traced back and recalled at any time, which makes the supervision effect of drug supervision and administration department and the protection of the legitimate interests of drug manufacturing enterprises greatly improved. The State Food and Drug Administration (SDA) has stipulated that from April 2011, China will put all kinds of essential drugs on the Internet to the Electronic Drug Regulatory Network of China. Since the implementation of the electronic drug regulatory policy, experts from all walks of life have not stopped paying attention to the implementation of the policy, and have also raised various hypothetical issues, but, After the implementation of electronic drug regulatory policy, there are few topics for the development and feasibility study of the policy, therefore, this paper presents a variety of advantages and disadvantages in Yanbian Prefecture since the implementation of the policy to compare and analyze. It also discusses the long-term development of its policy and the necessity of its implementation. Based on the actual effect of electronic drug supervision in Yanbian Prefecture, this paper analyzes the long-term feasibility and necessity of the policy from the following three aspects. First, by comparing the supervision and management system of the pharmaceutical industry between China and other countries and the quality assurance of drugs and the safety assurance of drugs, the relevant policies, measures, laws and regulations are drawn up, and the results of the analysis show that, The mechanism of drug supervision and management in many developed countries and the related policies and laws and regulations for the safety management of drug use are more advanced and perfect than in China. Secondly, it explains the situation, superiority and deficiency of the electronic drug supervision policy in our country. Electronic drug regulatory policy does have many advantages, such as anti-counterfeiting function, convenient traceability, recall at any time and information query, etc., but at the same time, it also has some shortcomings that can not be ignored. For example, the cost of enterprise is too high. Drug electronic regulatory network instability, related laws and regulations are not perfect and so on. Thirdly, by analyzing the effect of Yanbian state's implementation of the policy, we know that the implementation of electronic drug supervision policy will bring about the reform and change of pharmaceutical production enterprises, transportation enterprises and sales enterprises in our country. The results show that the implementation of electronic drug regulatory policy does bring higher cost pressure to the enterprises that produce low-cost essential drugs, but on the whole, the effect of the policy is better, and it still needs to be improved. The supervision of relevant departments needs to be strengthened, the feasibility of the policy is high, and some suggestions for further improvement of relevant policies and measures are put forward, and finally the prospect is made.
【学位授予单位】：延边大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95
[Abstract]:The main purpose of implementing the electronic drug supervision system is to further improve the level of drug supervision and management in our country, and to monitor the real-time status of drugs in production, circulation, sale and other links at any time. The problem of drugs can be traced back and recalled at any time, which makes the supervision effect of drug supervision and administration department and the protection of the legitimate interests of drug manufacturing enterprises greatly improved. The State Food and Drug Administration (SDA) has stipulated that from April 2011, China will put all kinds of essential drugs on the Internet to the Electronic Drug Regulatory Network of China. Since the implementation of the electronic drug regulatory policy, experts from all walks of life have not stopped paying attention to the implementation of the policy, and have also raised various hypothetical issues, but, After the implementation of electronic drug regulatory policy, there are few topics for the development and feasibility study of the policy, therefore, this paper presents a variety of advantages and disadvantages in Yanbian Prefecture since the implementation of the policy to compare and analyze. It also discusses the long-term development of its policy and the necessity of its implementation. Based on the actual effect of electronic drug supervision in Yanbian Prefecture, this paper analyzes the long-term feasibility and necessity of the policy from the following three aspects. First, by comparing the supervision and management system of the pharmaceutical industry between China and other countries and the quality assurance of drugs and the safety assurance of drugs, the relevant policies, measures, laws and regulations are drawn up, and the results of the analysis show that, The mechanism of drug supervision and management in many developed countries and the related policies and laws and regulations for the safety management of drug use are more advanced and perfect than in China. Secondly, it explains the situation, superiority and deficiency of the electronic drug supervision policy in our country. Electronic drug regulatory policy does have many advantages, such as anti-counterfeiting function, convenient traceability, recall at any time and information query, etc., but at the same time, it also has some shortcomings that can not be ignored. For example, the cost of enterprise is too high. Drug electronic regulatory network instability, related laws and regulations are not perfect and so on. Thirdly, by analyzing the effect of Yanbian state's implementation of the policy, we know that the implementation of electronic drug supervision policy will bring about the reform and change of pharmaceutical production enterprises, transportation enterprises and sales enterprises in our country. The results show that the implementation of electronic drug regulatory policy does bring higher cost pressure to the enterprises that produce low-cost essential drugs, but on the whole, the effect of the policy is better, and it still needs to be improved. The supervision of relevant departments needs to be strengthened, the feasibility of the policy is high, and some suggestions for further improvement of relevant policies and measures are put forward, and finally the prospect is made.
【学位授予单位】：延边大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95
【参考文献】
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1 徐徕;赵艳蛟;李t，
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