我国药品安全监管体制存在的问题及对策研究

发布时间：2019-04-15 13:09

【摘要】：药品作为一种特殊的商品，既有治病救人的功能，也有致病害人的潜在风险。可以说，药品安全风险已然成为风险社会的主要构成因素。药害事件给人类的健康和生命带来了越来越大的威胁，尤其是近些年来，药害事件更是频繁发生，这些触目惊心的药害事件让我们不得不对药品安全监管体制进行反思。药品安全监管体制的建立健全对药品安全监管成效的取得有着巨大的影响力。然而，目前我国的药品安全监管体制还存在很到的不足，从药品安全监管体制的构成因素这一角度去分析，不难发现我国的药品安全监管体制还存在以下几个大的问题：一是药品安全监管理念落后；二是药品安全监管职能划分不合理；三是药品安全监管组织结构不优化；四是药品安全监管方式单一落后。为了完善我国药品安全监管体制建设，，我国可以通过总结欧美等国的优秀经验和做法来获得启示，例如完善的法制建设、强大的组织机构以及充实的社会力量支援等等，这些经验都应该为我们所借鉴。为此，完善我国药品安全监管体制建设，具体可以从以下几个方面着手：一是要创新药品安全监管理念；二是政府要充分发挥主导作用：首先要加强法制建设；其次是合理划分监管职能；再次是要优化组织结构；三是要创新监管方式。四是要充分发挥外部力量的支持作用：首先要强化企业的自律建设；其次要发挥社会组织的协助作用；再次是充分调动公众的参与热情；最后还要善于发挥社会媒体的监督作用。药品安全监管工作是一项涉及千万家庭和群众健康和安全的重要工程，需要全社会工作努力，不管是政府还是企业、社会组织和公民个人，都不应该袖手旁观，而是应该勇于承担责任和义务，争取在药品安全监管事业中贡献自己的一份力量，为贯彻落实科学发展观和构建社会主义和谐社会添砖加瓦，最终使全国人民过上安全放心的美好生活。
[Abstract]:As a special commodity, medicine not only has the function of cure and save people, but also has the potential risk of disease-causing person. It can be said that the risk of drug safety has become a major component of the risk society. Drug damage events have brought more and more threats to human health and life, especially in recent years, drug damage incidents occur more frequently, these shocking drug damage events make us have to reflect on the drug safety supervision system. The establishment and perfection of drug safety supervision system has great influence on the achievement of drug safety supervision. However, there are still some deficiencies in the drug safety supervision system in our country, which is analyzed from the perspective of the constituent factors of the drug safety supervision system. It is not difficult to find that the drug safety supervision system in China still has the following major problems: first, the concept of drug safety supervision is backward; Second, the division of drug safety supervision function is unreasonable; third, the organization structure of drug safety supervision is not optimized; the fourth is single backward drug safety supervision mode. In order to improve the system of drug safety supervision in China, China can draw inspiration by summarizing the excellent experiences and practices of Europe and the United States and other countries, such as perfect legal system construction, strong organization, and substantial social support, and so on. All these experiences should be used for reference. Therefore, to perfect the system construction of drug safety supervision in our country, we can proceed from the following aspects: first, to innovate the concept of drug safety supervision; second, to give full play to the leading role of the government: firstly, to strengthen the construction of the legal system; Secondly, the reasonable division of regulatory functions; the third is to optimize the organizational structure; third, to innovate the way of supervision. Fourth, it is necessary to give full play to the supporting role of external forces: first, we should strengthen the self-discipline construction of enterprises; secondly, we should give play to the assisting role of social organizations; thirdly, we should fully mobilize the enthusiasm of public participation; Finally, we should be good at giving play to the monitoring role of social media. Drug safety supervision is an important project involving the health and safety of millions of families and people, and requires full social work efforts. Neither government nor enterprises, social organizations and citizens should stand idly by. Instead, we should have the courage to shoulder our responsibilities and obligations, strive to contribute our part to the cause of drug safety supervision, and contribute to the implementation of the scientific concept of development and the building of a harmonious socialist society. In the end, the people of the whole country will live a good life of safety and peace of mind.
【学位授予单位】：湘潭大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F203;F426.82

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