我国中成药与美国植物药、日本汉方药在非处方药管理方面的比较研究

发布时间：2018-07-08 19:31

本文选题：比较研究 + 非处方药　；参考：《北京中医药大学》2017年硕士论文

【摘要】：自上世纪50年代起,由于"磺酰胺剂"、"反应停"等国际性药害事件的发生,引发世界对药品安全性的关注,各国开始重视用药安全和对毒性、成瘾性药品销售使用的监督管理。美国、日本等国家相继建立了处方药与非处方药分类管理制度,以保证国民用药的安全、有效、便捷、经济。我国于2000年开始施行药品分类管理制度,随着我国社会科技的进步、医疗体制改革的深入,使用非处方药已成为国民自我药疗、健康保健的普遍方式。中成药非处方药占据了我国非处方药品的主体位置,约占非处方药品的80%,并在公众基本医疗、慢性病预防中发挥着不可替代的作用,具有广阔的市场前景。我国药品分类管理制度起步较晚,仍有许多亟待完善的部分,应与时俱进,积极吸取国外优秀的管理经验,促进我国中成药非处方药的发展。研究目的:美国FDA是全球药品管理的标杆,也是最早建立处方药与非处方药分类管理制度的国家;日本汉方药与我国中药同根异流,关系密切。本文旨以美国植物药和日本汉方药非处方药的管理为研究对象,以期能从中发现非处方药管理的逻辑和参考点,对现阶段我国中成药非处方药管理提供政策建议,为调整我国中成药非处方药管理方向提供思路。研究方法:本研究采用文献研究法、比较分析法及问卷调查法。首先通过文献研究梳理美国植物药、日本汉方药非处方药管理的相关政策,然后与我国中成药非处方药管理政策进行比较研究,总结归纳可用于我国中成药非处方管理的经验。最后通过问卷调查法,收集药品监管部门和药品生产企业对中成药非处方药现状和相关政策建议的看法,并提出完善我国中成药非处方药管理的政策建议。研究结果:美国和日本药品分类管理制度建立较早,非处方药管理的相关政策比较成熟,在非处方药注册程序、转换要求、配套管理措施上均有可借鉴的经验。此外,问卷调查结果显示药品监管部门和药品生产企业认为我国中成药非处方药现状良好,但仍存在一些亟待完善的部分。我国应结合国情,合理地吸纳美、日非处方药管理经验,建立具有中医药特色的中成药非处方药管理体系。研究结论:本研究在对美国植物药、日本汉方药非处方药相关管理政策研究的基础上,结合问卷调查结果,提出以下完善中成药非处方药管理的政策建议:健全处方药与非处方药分类管理法律体系;建立我国的中成药非处方药专论;对非处方药目录药品再评价;改进非处方药转换要求;增强非处方药审评的公开性和透明性;规范销售环节,健全药学服务;加强自我药疗相关知识的宣传教育。
[Abstract]:Since the 1950s, due to the occurrence of "sulfonamide", "reaction stop" and other international drug damage events, the world began to pay attention to drug safety, drug safety and toxicity, drug sales and use of the supervision and management. The United States, Japan and other countries have established the classified management system of prescription drugs and over-the-counter drugs in order to ensure the safety, efficiency, convenience and economy of national drug use. With the progress of social science and technology and the deepening of medical system reform, the use of over-the-counter drugs has become a universal way of national self-medication and health care. The over-the-counter Chinese patent medicine occupies the main position of the over-the-counter drugs in our country, about 80% of the over-the-counter drugs, and plays an irreplaceable role in the public basic medical treatment and the prevention of chronic diseases, and has a broad market prospect. The classification management system of Chinese drugs started late, and there are still many parts to be improved. We should keep pace with the times, actively absorb foreign excellent management experience, and promote the development of over-the-counter Chinese patent medicine in China. Objective: FDA is the benchmark of global drug management and the earliest country to establish the classification management system of prescription and over-the-counter drugs. The purpose of this paper is to study the management of over-the-counter drugs in the United States and Japanese Chinese prescription drugs, in order to find out the logic and reference points of over-the-counter drug management, and to provide policy recommendations for the management of over-the-counter Chinese patent medicines in China at the present stage. In order to adjust the management direction of Chinese patent medicine over-the-counter drugs. Methods: literature research, comparative analysis and questionnaire survey were used in this study. In this paper, the author firstly combs the relative policies of American herbal medicine and Japanese Chinese prescription over-the-counter drug management, then compares them with the Chinese patent medicine over-the-counter drug management policy, and summarizes the experience that can be used in the over-the-counter management of Chinese patent medicine. Finally, through the method of questionnaire, the author collects the opinions of drug supervision department and drug manufacturing enterprises on the current situation and relevant policy suggestions of over-the-counter Chinese patent medicine, and puts forward some policy suggestions to improve the management of over-the-counter Chinese patent medicine. The results showed that the drug classification management system was established earlier in the United States and Japan, and the relative policies of over-the-counter drug management were relatively mature. There were some experiences in the registration procedure, conversion requirements and supporting management measures for over-the-counter drugs. In addition, the results of the questionnaire survey show that the drug regulatory authorities and drug manufacturers think that the status quo of over-the-counter Chinese patent drugs in China is good, but there are still some parts that need to be improved. According to the situation of our country, we should reasonably absorb the management experience of American and Japanese over-the-counter drugs, and establish the management system of over-the-counter Chinese patent medicines with the characteristics of traditional Chinese medicine. Conclusion: this study is based on the research of the relative management policy of American and Japanese Chinese prescription drugs, combined with the results of questionnaire. The following policy suggestions are put forward to perfect the management of over-the-counter Chinese patent drugs: to perfect the legal system of classified management of prescription drugs and over-the-counter drugs; to establish a monograph on over-the-counter Chinese patent medicines; to re-evaluate the over-the-counter drugs; To improve the requirements of over-the-counter drug conversion; to enhance the openness and transparency of over-the-counter drug review; to standardize sales links and improve pharmaceutical services; to strengthen the publicity and education of self-medication related knowledge.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R288

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