| Drug quality standard is the state of drug quality, specifications and test methods for the technical requirements, is to follow the common legal basis includes drug production, supply, use, inspection and administration department. Reform and opening-up over the past30years," Drug Administration Law" and relevant laws and regulations constantly revised and improved, to a certain extent, ensure the public safety. With the aim at improving the drug standards in China and ensuring the safety in application of drugs,this article gave a brief analysis of the current status of drug quality standards in China on the basis of relevant literatures and examples, and addressed the importance of the establishment of reevaluation system of drug standards. At present, our country built in" Chinese Pharmacopoeia" as the core of the drug standard system. However, throughout the chinese medicine, social and economic regulation system, laws and regulations system development, there is, as many of the legislature and the related laws the contents of the amendments to lag behind other problems.Based on theoretical research and practical research, this article from the research carried out in six parts:(1) Basic Overview, mainly on the background and significance of this study, research status, research ideas and methods, innovations elaborated;(2) Chapter2of the drug standard management theory research. From the pharmaceutical standards of management theory, drug standard regulatory content, regulation of actors and relationships, regulation game behavior analysis, four aspects described for this study lay the theoretical foundation;(3) The third chapter in the former chapters based on the research, focus Based on theory of regulation, our pharmaceutical standards on the status of a series of regulatory analysis.(4) The fourth chapter is on drug problems in the management standards and practices for analysis.(5) The fifth chapter, for the fourth chapter questions, make relevant recommendations.(6) Finally, on the basis of this study, a summary and outlook.Based on the above analysis, the sound management of the reality of China’s drug standard path that started from the following:a pharmaceutical standards to improve the management of economic regulation; two standard drugs to improve the management of social regulation; three drugs to improve safety regulatory system; four drugs to speed up the standardization of information technology; five to deepen the medical and health system, to ensure regulatory quality. |