Research On Policy Process Of The Consistency Evaluation For Generic Drug In China

China has become the largest producer of generic drug in the world,generic drug accounted for more than 90 percent of the approved drugs.It was not required to do the consistency evaluation in the previous time,which lead to a strong impact on safety of the drug quality and efficiency of drug using,laying hidden problems for the public health.Impromving the quality of generic drug in an all-round way was first put forward in the“12th Five-Year Plan” for Drug Safety in 2012.Then,in 2015,The State Council makes promoting the consistency evaluation of generic drugs as the essential task in the reform of the evaluation and approval system for drugs and medical devices.The official start of generic drug consistency evaluation launched in 2016,requiring all the generic drug approved before the reform of drug registration and classification to finish consistency evaluation by batching and sorting to reach the target of medical and biological equivalence between generic and original drug,substituting original drug in clinic gradually.Solid oral dosage forms take the lead of all generic drug forms,thereof,289 chemicals in the national essential drug list(2012 edition)need to be done in more restrict time limitation,in oder to ensure public acess to basic medicine and upgrate the quality and the international competitiveness of drugs in China.This thesis mainly adapts philological research,case analysis,interview and statistics data analysis as main research method.In terms of optimizing the policy process,enhancing scientificity and effectiveness of consistency evaluation,improving the quality of drug as the fundamental purpose,on the base of multi-source flow theory,progressive decision theory,progressive decision theory and stakeholders theory,combining with correlative policy and institution about the health care system reform and the reform of the review and approval system for drugs and medical devices,the article apply policy analysis framework as “problems construction” “target prediction” “policy implentmention” and“effect evaluation” to research and analysis the generic drug policy process.Becauce the policy is under implementation,the article emphasis on the formulation and implementation process,then evaluate policy effects and discuss the problems existing in the policy process,providing the suggestion to optimizing the policy process and advance the progress of genric drug consistency evaluation at last.We can conclude from the generic drug policy process analysis primarily about oral solid dosage forms that our country keeps adjusting and introducing policies via policy practices.At the present phase,the generic drug policy has already covered the full lifecycle of drugs,forming a dynamic and circular policy systems basically.But for the internal input feature in formulation process,lagging of information construction in policy implementation process,and the absense of formal systematic evaluation leading by public sector,which all have an influence on the scientificity,effectiveness,and democracy of generic drug related policy.Finally,based on the research results,this paper puts forward five optimized paths for generic drug policy process: the first one is promoting the legislative process of generic drug,constructing whole process quality management standard system,providing legal and technical suppor for long term operation of genric drug work.Besides,the public sector need to improve social participation mechanism,building communication channel among interest body,making policies represent multiple interest needs.The third,we call for the start of formal assessment to generic drug related polices,evaluating from more public,macroscopic,and systematic level to optimize operation of policy process model.In addition,on the basis of accelerating information construction,multiple subjects work in coordination to create the co-governance model between central and regional government.The last,the public sector should furthur clear the key role of implementation process,and change service concept,ensuring give full play to administrative effectiveness,meanwhile,taking seriously in cultivating consciousness of policy target group.