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Research On Vaccine Safety Supervision

Posted on:2018-06-04Degree:MasterType:Thesis
Country:ChinaCandidate:G B JianFull Text:PDF
GTID:2336330515979842Subject:Law
Abstract/Summary:PDF Full Text Request
Number of Vaccines Safety and quality safety are related to individual well-being,government image and social stability,But with the emergence of a series of vaccine safety events,Exposing the loopholes in the work of vaccine safety supervision.It is very important to establish the legal system of vaccine safety supervision to ensure the safety of vaccines in China.The article is divided into four parts,the first part of the vaccine safety supervision system for the basic introduction.Through the introduction of the concept of vaccine safety supervision and the main part of vaccine supervision,it is pointed out that vaccine safety supervision includes two aspects,One is the executive authority,including the laws and regulations authorized by the organization,the use of executive power of the vaccine production at all stages of long-term,effective vaccine quality supervision and management.The second is to supervise their own supervision and management,to prevent the breeding of corruption.The third part is to expound the current situation of vaccine safety supervision in our country,and use the theory of regulation to analyze the theoretical basis of vaccine safety supervision,and point out the necessity and legitimacy foundation of vaccine safety supervision.In the second part,the author points out the problems in the supervision of vaccine safety in China.The article explains from the four aspects of supervision system,supervision scope,supervision way and supervision procedure.First of all,the regulatory system problems are mainly unclear regulatory functions,procurement system is not in place supervision,storage and transportation management system is not perfect.Second,in view of the problems in the scope of supervision,the author from the research and development,approval,production,circulation and inoculation specific links for a specific analysis.Thirdly,the article points out the defects in administrative legislation,administrative license,administrative inspection and administrative punishment by analyzing the way of traditional vaccine safety supervision.Finally,the problems in the vaccine safety supervision procedures are introduced,mainly from two aspects,one is the government procurement of vaccine procedures,and the second is the vaccine safety information disclosure system.In the third part,the author makes a study on the legal system of vaccine supervision in foreign countries,hoping to get useful inspiration from the foreignsupervision mode and establish a vaccine safety supervision system suitable for our country.By summarizing,we can find that foreign countries pay great attention to the administration of vaccine safety guidance,through the administrative guidance to regulate the vaccine production enterprises.In addition,the Government attaches great importance to the field of vaccine regulation legislation,with a view to the adoption of legislative means to improve the regulatory aspects of the vaccine capacity.Second,the Government's financial support,improve the supporting infrastructure construction,including the construction of the laboratory and the construction of the vaccine database.Third,the government attaches great importance to the follow-up inspection of the vaccine information,the whole process of the implementation of regulation of the vaccine.At the same time,focus on strengthening the cooperation of various departments of vaccine information,focusing on the rational allocation of vaccine resources.Finally,pay attention to the vaccine-related system construction,including information disclosure system,vaccine damage compensation system,vaccination adverse reaction reporting system.The fourth part of the third part of the vaccine safety supervision for the problems,I propose to improve China's vaccine safety supervision of specific measures.the monitoring system construction,improve the vaccine safety supervision system.Second,the vaccine in all aspects of a reasonable definition of the scope of vaccine safety supervision.In regulating the administrative legislation,administrative licensing,administrative penalties and administrative inspection at the same time,the establishment of information regulation,credit regulation and administrative guidance of the regulatory means.Fourth,improve the vaccine safety supervision and control procedures,including the government's vaccine procurement procedures and vaccine safety information disclosure system.Finally,the article points out that only through the sound safety supervision of the legal system,regulatory system,regulatory scope and regulatory approach to ensure the safety and effectiveness of the vaccine.
Keywords/Search Tags:vaccine safety, supervision system, supervision mode, scope of supervision, regulatory procedures
PDF Full Text Request
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