【摘要】：實(shí)施藥品電子監(jiān)管系統(tǒng)的主要目的是我國(guó)在藥品監(jiān)督和管理層次上的進(jìn)一步提高,隨時(shí)監(jiān)控藥品在生產(chǎn)、流通、銷售等各個(gè)環(huán)節(jié)中的實(shí)時(shí)狀態(tài),可以隨時(shí)追溯及召回有問題的藥品,使藥品監(jiān)督管理部門的監(jiān)督效果和保障藥品生產(chǎn)企業(yè)的合法利益方面得到了很大的提升。國(guó)家食品藥品監(jiān)督管理局規(guī)定,從2011年4月起我國(guó)將所有基本藥物目錄的品種入網(wǎng)至中國(guó)藥品電子監(jiān)管網(wǎng)。藥品電子監(jiān)管政策實(shí)施至今,對(duì)于政策實(shí)施狀況,社會(huì)各界專家們的關(guān)注一直沒有中斷過,也提出過各種假設(shè)性問題,但是,對(duì)于藥品電子監(jiān)管政策確切實(shí)施后所分析其政策的發(fā)展性及可行性研究的主題卻少之又少,因此,本論文在延邊州實(shí)施政策以來所呈現(xiàn)出的各種優(yōu)點(diǎn)和缺點(diǎn)來對(duì)比分析,并且探討其政策的長(zhǎng)期發(fā)展性及政策實(shí)施的必要性。 本文通過延邊州藥品電子監(jiān)管實(shí)施實(shí)際效果情況,從以下三個(gè)方面研究分析政策是否具有長(zhǎng)期可行性及必要性。 第一,通過比較我國(guó)與其他國(guó)家醫(yī)藥行業(yè)的監(jiān)督管理體制和藥品的質(zhì)量保障和用藥的安全保障而制定的有關(guān)政策、措施以及法律法規(guī),分析結(jié)果發(fā)現(xiàn),許多發(fā)達(dá)國(guó)家的藥品監(jiān)督管理機(jī)制和針對(duì)于藥品用藥安全管理的相關(guān)政策及法律法規(guī)都比我國(guó)先進(jìn)、完善。 第二,全面的說明了關(guān)于我國(guó)藥品電子監(jiān)管政策實(shí)行至今的情況,政策的優(yōu)越性和不足點(diǎn)。藥品電子監(jiān)管政策確實(shí)具有許多優(yōu)點(diǎn),例如,防偽功能、方便追溯、隨時(shí)召回和信息查詢等等,但同時(shí)也存在著不可忽視的缺點(diǎn),比如,企業(yè)成本投入過高、藥品電子監(jiān)管網(wǎng)絡(luò)不穩(wěn)定、相關(guān)法律法規(guī)不健全等等。 第三,通過分析了解延邊州實(shí)施政策以來所呈現(xiàn)出的效果,認(rèn)識(shí)我國(guó)實(shí)施藥品電子監(jiān)管政策將給我國(guó)醫(yī)藥生產(chǎn)企業(yè)、運(yùn)輸企業(yè)、銷售企業(yè)所帶來的改革及變化。結(jié)果表明,對(duì)于生產(chǎn)低價(jià)位基本藥物生產(chǎn)企業(yè),藥品電子監(jiān)管政策的實(shí)施的確帶來了較高的成本壓力,但總體來講,政策的實(shí)施效果較好,還有待提高,相關(guān)部門監(jiān)管力度還有待加強(qiáng),政策的可行性較高,并提出部分相關(guān)政策及措施能進(jìn)一步改進(jìn)的建議,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.
【學(xué)位授予單位】：延邊大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R95

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 徐徠;趙艷蛟;李t，

本文編號(hào)：2361749