美国药品标准管理模式研究

Study on Mode of Drug Standard in America

目的为我国建立药品标准管理体系提供参考。方法通过研究美国药品标准的管理模式,探索其保证药品标准权威性、科学性、先进性的管理经验和特点,提出收获的几点启示。结果美国已基本形成完善的药品标准管理体系,健全的法律体系确保了USP-NF作为药品标准的权威性;独立专业的美国药典委员会对药品标准的科学管理、标准制定程序的公开透明、注重与公众的沟通及企业参与度等特点保证了药品标准的科学性;灵活的加速修订程序及各论更新计划调动各利益相关方参与标准的修订活动,保证了标准的先进性。结论我国应引入先进的标准管理理念,完善法律法规及标准的制定、修订程序,引入公众评议机制,逐渐强化企业在标准化活动中的主体地位,建立符合国情的药品标准管理体系。

Objective To provide references for establishing Chinese drug standard management system. Methods The 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. Results The 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. Gorlclusiori We 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.