关键词: 药品标准, 药品标准管理体系

Abstract: ObjectiveTo provide references for establishing Chinese drug standard management system. MethodsThe mode of drug standard in America was briefly introduced. The managerial experience and features of maintaining the authority, scientificity and progressiveness of drug standard were explored and some revelations were put forward. ResultsThe USA has basically developed the perfect drug standard management system. The robust legal system defines USP-NF as the authority of drug standard. The scientific management by United States Pharmacopeial Convention, transparency and communication with the public and participation of enterprises ensure the scientificity of standard. Flexible Accelerated Revision Processes and USP Monograph Update Program involve stakeholders to join in the revision activities of drug standard, thus ensuring the progressiveness of drug standard. ConclusionWe should bring in advanced management concept, improve related laws and regulations, drug standard establishment and revision process and introduce public review mechanism as well as intensify the main position of enterprises in standardization activities, thus establishing drug standard management system which conforms to national conditions.

Key words: drug standard, drug standard management system