美國(guó)藥品安全監(jiān)管機(jī)制研究及啟示
發(fā)布時(shí)間:2018-05-26 18:38
本文選題:藥品安全 + 監(jiān)管機(jī)制 ; 參考:《中國(guó)藥房》2017年04期
【摘要】:目的:為我國(guó)藥品安全監(jiān)管機(jī)制的完善提供參考。方法:基于市場(chǎng)失靈、合約失靈和政府失靈理論,選取美國(guó)具有代表性的藥品安全監(jiān)管機(jī)制進(jìn)行分析和評(píng)價(jià)。結(jié)果與結(jié)論:美國(guó)在藥品安全監(jiān)管機(jī)制的實(shí)施和運(yùn)用方面取得的成效顯著,其具有代表性的藥品安全監(jiān)管機(jī)制有處方藥申報(bào)者付費(fèi)機(jī)制、藥品安全信息溝通機(jī)制、懲罰與激勵(lì)機(jī)制、公私合作伙伴機(jī)制以及被動(dòng)監(jiān)測(cè)和主動(dòng)監(jiān)測(cè)相結(jié)合機(jī)制,這些機(jī)制緩解了FDA的政府失靈,在一定程度上破解了市場(chǎng)失靈和合約失靈的難題。我國(guó)在完善藥品安全監(jiān)管機(jī)制時(shí)應(yīng)細(xì)化法律保障、充分調(diào)動(dòng)外部力量、吸收利用現(xiàn)代信息技術(shù)、預(yù)防與處置并重、注重不同機(jī)制之間的協(xié)調(diào)、力求過(guò)程公開(kāi)和結(jié)果透明。
[Abstract]:Objective: to provide reference for the perfection of drug safety supervision mechanism in China. Methods: based on the theories of market failure, contract failure and government failure, the representative drug safety regulatory mechanism in the United States was analyzed and evaluated. Results & conclusion: the United States has achieved remarkable results in the implementation and application of drug safety regulatory mechanisms. The representative drug safety regulatory mechanisms include the payment mechanism for prescription drug registrants and the communication mechanism for drug safety information. Punishment and incentive mechanism, public-private partnership mechanism and passive monitoring and active monitoring mechanism, these mechanisms alleviate the government failure of FDA, and to some extent solve the problem of market failure and contract failure. In perfecting the mechanism of drug safety supervision, our country should refine the legal guarantee, fully mobilize external forces, absorb and utilize modern information technology, pay equal attention to prevention and disposal, pay attention to the coordination among different mechanisms, and strive for openness of the process and transparency of the results.
【作者單位】: 沈陽(yáng)藥科大學(xué)工商管理學(xué)院;
【基金】:國(guó)家社會(huì)科學(xué)基金資助項(xiàng)目(No.13CFX086) 遼寧省教育廳科學(xué)研究一般項(xiàng)目(No.W2014119) 沈陽(yáng)藥科大學(xué)中青年教師事業(yè)發(fā)展支持計(jì)劃
【分類號(hào)】:R95
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