Research On The Consistency Evaluation Of Quality And Efficacy Of Generic Drugs In China

Generic drug is a huge social public wealth.Comparing with the original drug,it has good economic and social benefits,such as improving the medical service level,reducing the medical expenditure,maintenance of a wider public health,lower price and so on.Although the development of generic drug starts late,China has become the world's largest producer of generic drug due to the rapid development.As generic drug consistency evaluation is not required by law from the early approval,there are gaps in the efficacy between some generic drugs and original drug.Under this background,generic drug consistency evaluation was required as one of the important parts of the national drug safety “12th Five-Year Plan”,which is one of the most important tasks in the reform of China's medical device evaluation system by the Sate Council.In this paper,the significance and value of the consistency evaluation of generic drug are defined base on the analysis of background,procedures,technical requirement,resource support,implementation process and so on.It will provide methods,ideas and suggestions for the consistency evaluation of generic drugs.The statistics data analysis and literature analysis are in this paper.Research Content: analysis based on the background of the China's generic drug consistency evaluation,including the status of generic drug market,the generic drug management strategies all over the world,the introduction and the implementation;how they implement,including the procedures and requirements;the processes and resources.The results show that: China has basically established a consistent evaluation programs,such as methods,procedures,departmental functions and requirements,which make the evaluation process have rules to follow.Through the research,we believe that the consistency evaluation method of generic drugs is still to be improved.The current policy in the management method of generic consistency evaluation will lead to the risk of drug market.It is suggests that regulators reduce the intensity of state compulsory intervention,provide more optimized encouragement policies,and give more options to the market.The task of generic drug consistency evaluation in China is very difficult and no time to lose,including 289 chemicals in the national essential drug list(2012 edition).It is difficult for pharmaceutical companies to choose the evaluation of varieties due to the shortage of clinical resources.As the subject units,it is suggested that the drug manufacturers should fully understand the significance and function of the generic drug consistency evaluation,then accurately select the evaluation varieties according to adequate resource analysis and market research.The consistency evaluation of generic drugs in China is a missed history lesson,as well as many countries have experienced the same course.The market capacity of generic drugs is huge,and the market value of drugs can be greatly improved through consistency evaluation.It is of great significance to carry out the evaluation by pharmaceutical enterprises.