本文選題：疫苗安全 + 監(jiān)管體系�。� 參考：《安徽大學(xué)》2017年碩士論文

【摘要】：疫苗的質(zhì)量安全關(guān)系到個(gè)人的福祉、政府的形象和社會(huì)的穩(wěn)定,隨著一系列疫苗安全事件的出現(xiàn),暴露出我國(guó)疫苗安全監(jiān)管工作中存在的漏洞。完善疫苗安全監(jiān)管制度對(duì)保障疫苗安全顯得尤為的重要。文章主要分為四個(gè)部分,第一部分對(duì)疫苗安全監(jiān)管制度進(jìn)行了基本的介紹。通過(guò)對(duì)疫苗安全監(jiān)管的概念、疫苗監(jiān)管的主要環(huán)節(jié)的介紹,指出了疫苗安全監(jiān)管包括兩方面,其一是行政機(jī)關(guān)包括法律、法規(guī)授權(quán)的組織,運(yùn)用行政權(quán)對(duì)疫苗生產(chǎn)的各個(gè)階段進(jìn)行長(zhǎng)期、有效的疫苗質(zhì)量監(jiān)督管理。其二是對(duì)監(jiān)督者自身進(jìn)行監(jiān)督管理,防止滋生腐敗。其三是闡述了我國(guó)疫苗安全監(jiān)管的現(xiàn)狀,并運(yùn)用規(guī)制理論分析了疫苗安全監(jiān)管的理論基礎(chǔ),指出了疫苗安全監(jiān)管的必要性和合法性。第二部分通過(guò)分析指出了我國(guó)疫苗安全監(jiān)管中存在的問(wèn)題,文章從監(jiān)管體系、監(jiān)管范圍、監(jiān)管方式和監(jiān)管程序四個(gè)方面進(jìn)行了闡釋。首先,監(jiān)管體系中存在的問(wèn)題主要有監(jiān)管職能不清晰,購(gòu)銷體系監(jiān)管不到位,儲(chǔ)存運(yùn)輸管理體系不健全。第二,針對(duì)監(jiān)管范圍中存在的問(wèn)題,筆者從研發(fā)、審批、生產(chǎn)、流通和接種的各個(gè)環(huán)節(jié)進(jìn)行了具體的分析。第三,文章通過(guò)分析傳統(tǒng)疫苗安全監(jiān)管的方式,指出了行政立法、行政許可、行政檢查和行政處罰中存在的弊端。最后,對(duì)疫苗安全監(jiān)管程序中存在的問(wèn)題進(jìn)行了介紹,主要從兩個(gè)方面展開(kāi),其一是政府采購(gòu)疫苗程序,其二是疫苗安全信息公開(kāi)制度。第三部分文章對(duì)國(guó)外的疫苗監(jiān)管法律制度進(jìn)行了研究,希望能夠從國(guó)外的監(jiān)管模式中得到有益的啟示,建立適合我國(guó)國(guó)情的疫苗安全監(jiān)管制度。通過(guò)總結(jié)歸納,我們可以發(fā)現(xiàn)國(guó)外十分注重對(duì)疫苗安全監(jiān)管的行政指導(dǎo),通過(guò)行政指導(dǎo)來(lái)對(duì)疫苗生產(chǎn)企業(yè)加以規(guī)范。此外,政府十分注重對(duì)疫苗監(jiān)管領(lǐng)域的立法,以期通過(guò)立法的手段,提高對(duì)疫苗各個(gè)環(huán)節(jié)的監(jiān)管能力。其次,政府的財(cái)政支持力度大,完善相關(guān)配套基礎(chǔ)設(shè)施的建設(shè),包括實(shí)驗(yàn)室的建設(shè)和疫苗數(shù)據(jù)庫(kù)的建設(shè)。再次,政府十分注重疫苗信息的跟蹤檢查,對(duì)疫苗的全過(guò)程實(shí)行監(jiān)管。同時(shí),注重加強(qiáng)各個(gè)部門疫苗信息的合作,注重疫苗資源的合理配置。最后,注重疫苗相關(guān)各種制度的建設(shè),包括信息公開(kāi)制度,疫苗損害賠償制度,預(yù)防接種不良反應(yīng)報(bào)告制度等。第四部分針對(duì)第三部分提出的疫苗安全監(jiān)管中存在的問(wèn)題,筆者提出了完善我國(guó)疫苗安全監(jiān)管的具體措施。主要從以下四個(gè)方面展開(kāi),第一,加強(qiáng)疫苗監(jiān)管組織、監(jiān)測(cè)體系的建設(shè),完善疫苗安全監(jiān)管體系。第二,在疫苗的各個(gè)環(huán)節(jié)合理界定疫苗安全監(jiān)管的范圍。第三,在完善傳統(tǒng)疫苗安全監(jiān)管方法的同時(shí),引入新的疫苗安全監(jiān)管方法。在規(guī)范行政立法、行政許可、行政處罰和行政檢查的同時(shí),建立起信息規(guī)制、信用規(guī)制和行政指導(dǎo)的監(jiān)管手段。第四,健全疫苗安全監(jiān)管的程序,包括政府的疫苗采購(gòu)程序和疫苗安全信息公開(kāi)制度。最后,文章對(duì)提出的觀點(diǎn)進(jìn)行了總結(jié),指出只有通過(guò)健全疫苗安全監(jiān)管的法制、監(jiān)管體系、監(jiān)管范圍和監(jiān)管方式,才能保障疫苗的安全、有效。
[Abstract]:The quality and safety of the vaccine is related to the well-being of the individual, the image of the government and the stability of the society. With the emergence of a series of vaccine safety incidents, the loopholes in the safety supervision of the vaccine in China are exposed. It is particularly important to improve the safety supervision system of the vaccine. The article is divided into four parts, the first part The basic introduction of the vaccine safety supervision system is made. Through the introduction of the concept of vaccine safety supervision and the main link of vaccine supervision, it is pointed out that the vaccine safety supervision includes two aspects, one is that the administrative organs include the law, the organization authorized by the laws and regulations, and the use of administrative power for the long-term and effective vaccine of the vaccine production. Quality supervision and management. The second is to supervise and manage the supervisors themselves to prevent corruption. Thirdly, the present situation of vaccine safety supervision in China is expounded, and the theoretical basis of vaccine safety supervision is analyzed with the theory of regulation, and the necessity and legitimacy of the vaccine safety supervision are pointed out. The second part points out the vaccine of our country through analysis. The problems existing in the safety supervision are explained in four aspects: the supervision system, the scope of supervision, the mode of supervision and the supervision procedure. First, the main problems in the supervision system are unclear supervision function, lack of supervision of the purchase and marketing system, and the imperfect storage and transportation management system. Second. A specific analysis was made from the aspects of R & D, approval, production, circulation and inoculation. Third, the article pointed out the drawbacks of the administrative legislation, administrative license, administrative inspection and administrative punishment through the analysis of the traditional vaccine safety regulation. Finally, the problems in the vaccine safety supervision procedure were introduced, mainly from the problems. Two aspects, one is the government purchasing the vaccine program, the other is the vaccine safety information disclosure system. The third part of the article makes a study on the legal system of foreign vaccine supervision, hoping to get useful inspiration from the foreign regulatory model and establish a vaccine safety supervision system suitable for our country. We can find that foreign countries pay great attention to the administration guidance of vaccine safety supervision and regulate vaccine production enterprises through administrative guidance. In addition, the government pays great attention to the legislation in the field of vaccine supervision so as to improve the supervision ability of every link of the vaccine through legislative means. Secondly, the government's financial support is great and perfect. The construction of the supporting infrastructure, including the construction of the laboratory and the construction of the vaccine database. Again, the government pays great attention to the tracking and inspection of the vaccine information and the supervision of the whole process of the vaccine. At the same time, we should pay more attention to the cooperation of the vaccine information in various departments and pay attention to the rational allocation of vaccine resources. Finally, pay attention to the various systems related to the vaccine. Construction, including information disclosure system, vaccine damage compensation system, prevention of adverse reaction reporting system. The fourth part of the third part of the vaccine safety supervision of the existing problems, the author put forward to improve the specific measures of vaccine safety supervision in China, mainly from the next four aspects, the first, strengthen the vaccine regulatory organization The construction of the monitoring system and the improvement of the vaccine safety supervision system. Second, the scope of the safety supervision of the vaccine is rationally defined in every link of the vaccine. Third, while improving the traditional vaccine safety supervision and supervision methods, the new method of vaccine safety supervision is introduced. It is established at the same time, while standardizing administrative legislation, administrative license, administrative punishment and administrative inspection. Information regulation, credit regulation and administrative guidance supervision means. Fourth, improve the procedures of vaccine safety supervision, including the government's vaccine procurement procedures and the system for the disclosure of vaccine safety information. Finally, the article summarizes the views put forward, and points out that the legal system, supervision system, regulatory scope and supervision are only through the sound supervision of the vaccine security. In order to ensure the safety and effectiveness of the vaccine.

【學(xué)位授予單位】：安徽大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：D922.16;R186

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