Practice of incentives for orphan drug research and development in the united states and enlightenment for China:based on the perspective of drug life cycle
To provide reference for the construction and improvement of the incentive system of orphan drug research and development in China,this article reviewed the incentive policies of orphan drug research and development in the United States.After collecting and sorting out the incentive policies and practical experience of orphan drug research and development in the United States,the incentive measures of each link were analyzed and summarized from the perspective of the whole life cycle of drugs.Based on the current policy situation in China,this paper provided reference and suggestions for the construction and improvement of the incentive policy system for the research and development of orphan drugs from the aspects of defining standards,basic research,clinical research and development,marketing approval,market incentive and medical security.A complete incentive policy system for the research and development of orphan drugs is a strong driving force and an important guarantee to promote the innovation and development of orphan drugs.As the first country to legislate for orphan drugs,the United States has set relatively perfect incentive measures for research and development in all aspects of the drug life cycle,and has a relatively perfect policy system and rich practical experience.It is suggested that in the process of building the incentive policy for the research and development of orphan drugs in China,on the basis of improving the identification of rare diseases and orphan drugs,a"1+n"incentive policy system for the research and development of orphan drugs covering the whole life cycle of drugs should be gradually formed,and the construction of the ecological environment for the innovation of orphan drugs should be continuously promoted to promote the continuous development of China's rare disease security.
orphan drugdrug research and developmentincentive policydrug life cyclethe United States
NETL
NSTL
万方数据
