本文關(guān)鍵詞： 藥品生產(chǎn)企業(yè) 藥品上市后風(fēng)險(xiǎn)管理 政府規(guī)制　出處：《沈陽藥科大學(xué)》2014年博士論文　論文類型：學(xué)位論文

【摘要】：隨著我國經(jīng)濟(jì)的快速發(fā)展,公眾對生命和健康的重視程度不斷提升,藥品安全問題受到全社會的高度關(guān)注。2006年“魚腥草事件”、2007年“甲氨蝶呤事件”、2012年“羅氏事件”等藥品安全事件反映出來兩個問題,一是制藥企業(yè)對藥品上市后風(fēng)險(xiǎn)管理的意識不夠,沒有承擔(dān)起“藥品安全第一責(zé)任人”的這個責(zé)任。二是藥品監(jiān)管部門對生產(chǎn)企業(yè)藥品上市后風(fēng)險(xiǎn)管理的監(jiān)管不到位。有必要對生產(chǎn)企業(yè)藥品上市后風(fēng)險(xiǎn)管理政府規(guī)制模式進(jìn)行全面、深入的分析及研究,為我國藥品上市后安全監(jiān)管提供借鑒。 本文首先運(yùn)用了政府規(guī)制理論,采取了對比分析的方法對歐美等國與我國的制藥企業(yè)藥品上市后風(fēng)險(xiǎn)管理政府規(guī)制模式進(jìn)行了研究。運(yùn)用了調(diào)查分析法和專家咨詢法分別研究了制藥企業(yè)藥品上市后風(fēng)險(xiǎn)管理規(guī)制現(xiàn)狀和影響規(guī)制的相關(guān)因素。最后在經(jīng)濟(jì)學(xué)理論指導(dǎo)下,分析藥品上市后風(fēng)險(xiǎn)管理規(guī)制的適度性和高效性。 通過上述的研究主要得到以下研究結(jié)果：一是我國缺乏對生產(chǎn)企業(yè)藥品上市后風(fēng)險(xiǎn)管理的社會規(guī)制方式,例如建立檢查、資格認(rèn)證和信息公開等；二是生產(chǎn)企業(yè)對藥品不良反應(yīng)信息的收集與分析評價(jià)存在嚴(yán)重缺陷；三是政府規(guī)制的信息和規(guī)制相關(guān)的法律法規(guī)仍是影響規(guī)制效果的重要因素。四是對于制藥企業(yè)藥品上市后風(fēng)險(xiǎn)管理政府規(guī)制是存在適度性的；五是可采取激勵經(jīng)濟(jì)規(guī)制方式提高政府規(guī)制效率。 對于我國制藥企業(yè)藥品上市后風(fēng)險(xiǎn)規(guī)制的建議是首先完善社會規(guī)制措施：建立藥品安全性信息公開制度,制定藥品不良反應(yīng)報(bào)告和監(jiān)測工作檢查制度,明確企業(yè)的違規(guī)行為并加大處罰力度。對于行政規(guī)制應(yīng)建立監(jiān)管績效評估制度,做好監(jiān)管相關(guān)法規(guī)與技術(shù)指南的良好銜接,完善政府告知制度。經(jīng)濟(jì)規(guī)制方式可藥品監(jiān)管部門可與生產(chǎn)企業(yè)建立激勵契約,根據(jù)契約來對企業(yè)進(jìn)行激勵和處罰。實(shí)現(xiàn)高效低成本監(jiān)管。 制藥企業(yè)藥品上市后風(fēng)險(xiǎn)管理政府規(guī)制是一個長期的、不斷總結(jié)經(jīng)驗(yàn)、不斷更新探索的工作,希望通過本文的嘗試性的研究與探討,能為完善我國生產(chǎn)企業(yè)藥品上市后風(fēng)險(xiǎn)管理政府規(guī)制方式提供一些有益的參考。
[Abstract]:With the rapid economic development of our country, the public has been paying more and more attention to life and health. The drug safety problem is highly concerned by the whole society. The drug safety incidents such as the Houttuynia incident in 2006, the methotrexate incident in 2007, and the "Roche incident" in 2012 reflect two problems. First, the pharmaceutical enterprises are not aware of the risk management after the drug market. The second is that the supervision and control of the risk management after drug listing in the manufacturing enterprise is not in place. It is necessary to manage the risk after the drug listing in the manufacturing enterprise. The regulatory model is comprehensive, The deep analysis and research provide reference for the safety supervision after drug marketing in our country. Firstly, this paper applies the theory of government regulation. This paper adopts the method of comparative analysis to study the government regulation mode of the post-marketing risk management of pharmaceutical enterprises in Europe, America and China. The methods of investigation and analysis and expert consultation are used to study the pharmaceutical products in pharmaceutical enterprises. The present situation of post-market risk management regulation and the related factors affecting regulation. Finally, under the guidance of economic theory, This paper analyzes the appropriateness and efficiency of risk management regulation after drug marketing. The main results are as follows: first, there is a lack of social regulation on the risk management after the listing of pharmaceutical products in our country, such as establishing inspection, qualification certification, information disclosure and so on; Second, there are serious defects in the collection, analysis and evaluation of adverse drug reaction information in manufacturing enterprises; Third, the information of government regulation and the relevant laws and regulations are still the important factors that affect the effect of regulation. Fifth, incentive economic regulation can be adopted to improve the efficiency of government regulation. The suggestions for the risk regulation after drug marketing in Chinese pharmaceutical enterprises are as follows: first, to perfect the measures of social regulation: to establish the open system of drug safety information, to establish the system of adverse drug reaction reporting and monitoring work inspection. It is necessary to establish a regulatory performance evaluation system for administrative regulations, and make a good connection between relevant regulations and technical guidelines. Perfecting the government informing system. The economic regulation can establish the incentive contract with the production enterprise, according to the contract to encourage and punish the enterprise, and realize the high efficiency and low cost supervision. The government regulation of risk management after drug listing in pharmaceutical enterprises is a long-term, continuous summing up of experience, constantly updating and exploring work, hoping that through the trial research and discussion in this paper, It can provide some useful reference for perfecting the government regulation mode of risk management after drug listing in Chinese manufacturing enterprises.
【學(xué)位授予單位】：沈陽藥科大學(xué)
【學(xué)位級別】：博士
【學(xué)位授予年份】：2014
【分類號】：F426.72;R95

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 尹海員;李忠民;;中國證券市場監(jiān)管均衡與適度性分析[J];重慶大學(xué)學(xué)報(bào)(社會科學(xué)版);2011年03期

2 肖興志;王鈉;;轉(zhuǎn)型期中國煤礦安全規(guī)制機(jī)制研究——基于激勵相容的視角[J];產(chǎn)業(yè)經(jīng)濟(jì)評論;2007年01期

3 吳冬妮;;藥品不良反應(yīng)報(bào)告主體需加強(qiáng)上報(bào)意識[J];國際醫(yī)藥衛(wèi)生導(dǎo)報(bào);2006年03期

4 王光躍;趙海;王樂羊;;羅氏被指瞞1.5萬人死亡報(bào)告,涉事部分藥物在華有售[J];中國醫(yī)藥科學(xué);2012年15期

5 柯洪;周付彥;;工程項(xiàng)目交易方式選擇的影響因素指標(biāo)體系構(gòu)建研究[J];工程管理學(xué)報(bào);2012年02期

6 陳思;羅云波;江樹人;;激勵相容:我國食品安全監(jiān)管的現(xiàn)實(shí)選擇[J];中國農(nóng)業(yè)大學(xué)學(xué)報(bào)(社會科學(xué)版);2010年03期

7 汪會霞;;我國藥品不良反應(yīng)報(bào)告制度的研究[J];科技與企業(yè);2013年05期

8 韓東平 ,袁知柱;不對稱信息條件下企業(yè)生產(chǎn)成本契約的設(shè)計(jì)研究[J];會計(jì)之友;2004年10期

9 劉有貴;蔣年云;;委托代理理論述評[J];學(xué)術(shù)界;2006年01期

10 李芳健;王家驥;王培席;周志衡;張立威;曹杰;;我國全科醫(yī)學(xué)教育的PEST分析及策略選擇[J];中國全科醫(yī)學(xué);2013年01期

相關(guān)博士學(xué)位論文 前1條

1 石磊;中國藥品政府管制法律問題研究[D];中國政法大學(xué);2008年

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