Research About Retardation Fators And Countermeasures During Promotion Process Of GMP In Yuxi

Medicine is the indispensable part of human life, is the most basic living needs. Based on Maslow’s hierarchy, medicine belongs to the basic human physiology, which is the foundation of other high-level demand. In the development of human society, to ensure the medicine safety, is one of the most basic and important proposition. In recent years, China has happened a series of medicine-events. How to effectively promote GMP implementation, emphasis on the supervision for the source of pharmaceutical production, is becoming the primary task of pharmaceutical supervisory and administrative departments.This dissertation researches the implementation of Yunnan province pharmaceutical GMP, based on public management and public policy implementation related theory. This dissertation analyzes the actuality of the Yuxi’s GMP, also analyzes the existing retardation factors, in the foundation of research about GMP development and current situation of USA, the European Union and China, related to the actual situation in Yuxi, put forward the effective implementation GMP countermeasures and suggestions in Yuxi.This dissertation is divided into four chapters--Chapter1:introduces the background, purpose, ideas and status of this research.Chapter2:summarizes the basic theory of GMP, expounds the significance of carrying out pharmaceutical GMP implementation, the GMP development process, regulatory agencies and regulatory system, GMP inspector selection and management of USA, the European Union and China.Chapter3:adopt survey method to collect and organize a plenty of background information about recent years pharmaceutical producing enterprises in Yuxi. Analyzes implementation plan and the existing problems about2010edition GMP, investigate the selection and management situation of medicine GMP inspector in Yuxi, analyzes the actual situation of inspection to enterprise by Yuxi Food and Drug Supervision&Administration department. Using the public policy theory to analyzes retardation factors on GMP promoting process, such as imperfect implementation system, the difficulty for small and medium sized enterprises to implement medicine GMP, the problems of GMP inspector and inspection ways.Chapter4:reference to the experiences from USA, the European Union and other developed countries and regions, carry out the countermeasure and suggestion to promote the2010edition GMP in Yuxi, one is to complete GMP system, the second is to encourage small and medium sized pharmaceutical production enterprise to acquisition and restructuring, introduce vaccines varieties which with high added value by use Yuxi’s advantages; the third one is to complete the GMP inspector selection, assessment, rewards and punishment and training system, the forth one is to explore deep, particular, targeted and effective ways of the GMP inspection.