本文選題：比較研究 + 非處方藥��； 參考：《北京中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：自上世紀(jì)50年代起,由于"磺酰胺劑"、"反應(yīng)停"等國際性藥害事件的發(fā)生,引發(fā)世界對藥品安全性的關(guān)注,各國開始重視用藥安全和對毒性、成癮性藥品銷售使用的監(jiān)督管理。美國、日本等國家相繼建立了處方藥與非處方藥分類管理制度,以保證國民用藥的安全、有效、便捷、經(jīng)濟。我國于2000年開始施行藥品分類管理制度,隨著我國社會科技的進步、醫(yī)療體制改革的深入,使用非處方藥已成為國民自我藥療、健康保健的普遍方式。中成藥非處方藥占據(jù)了我國非處方藥品的主體位置,約占非處方藥品的80%,并在公眾基本醫(yī)療、慢性病預(yù)防中發(fā)揮著不可替代的作用,具有廣闊的市場前景。我國藥品分類管理制度起步較晚,仍有許多亟待完善的部分,應(yīng)與時俱進,積極吸取國外優(yōu)秀的管理經(jīng)驗,促進我國中成藥非處方藥的發(fā)展。研究目的:美國FDA是全球藥品管理的標(biāo)桿,也是最早建立處方藥與非處方藥分類管理制度的國家;日本漢方藥與我國中藥同根異流,關(guān)系密切。本文旨以美國植物藥和日本漢方藥非處方藥的管理為研究對象,以期能從中發(fā)現(xiàn)非處方藥管理的邏輯和參考點,對現(xiàn)階段我國中成藥非處方藥管理提供政策建議,為調(diào)整我國中成藥非處方藥管理方向提供思路。研究方法:本研究采用文獻研究法、比較分析法及問卷調(diào)查法。首先通過文獻研究梳理美國植物藥、日本漢方藥非處方藥管理的相關(guān)政策,然后與我國中成藥非處方藥管理政策進行比較研究,總結(jié)歸納可用于我國中成藥非處方管理的經(jīng)驗。最后通過問卷調(diào)查法,收集藥品監(jiān)管部門和藥品生產(chǎn)企業(yè)對中成藥非處方藥現(xiàn)狀和相關(guān)政策建議的看法,并提出完善我國中成藥非處方藥管理的政策建議。研究結(jié)果:美國和日本藥品分類管理制度建立較早,非處方藥管理的相關(guān)政策比較成熟,在非處方藥注冊程序、轉(zhuǎn)換要求、配套管理措施上均有可借鑒的經(jīng)驗。此外,問卷調(diào)查結(jié)果顯示藥品監(jiān)管部門和藥品生產(chǎn)企業(yè)認(rèn)為我國中成藥非處方藥現(xiàn)狀良好,但仍存在一些亟待完善的部分。我國應(yīng)結(jié)合國情,合理地吸納美、日非處方藥管理經(jīng)驗,建立具有中醫(yī)藥特色的中成藥非處方藥管理體系。研究結(jié)論:本研究在對美國植物藥、日本漢方藥非處方藥相關(guān)管理政策研究的基礎(chǔ)上,結(jié)合問卷調(diào)查結(jié)果,提出以下完善中成藥非處方藥管理的政策建議:健全處方藥與非處方藥分類管理法律體系;建立我國的中成藥非處方藥專論;對非處方藥目錄藥品再評價;改進非處方藥轉(zhuǎn)換要求;增強非處方藥審評的公開性和透明性;規(guī)范銷售環(huán)節(jié),健全藥學(xué)服務(wù);加強自我藥療相關(guān)知識的宣傳教育。
[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.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R288

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