从中美两国药品质量标准现状看我国药品标准管理存在的问题

目的 比较中美两国药品标准形成历史、法律地位、法定标准的管理机构和审评流程,分析我国标准管理现状和存在的问题,为完善我国药品标准体系提出合理化建议.方法 查阅近年来相关文献资料,通过归纳总结、对比分析进行评述.结果 我国药品标准与《美国药典》(USP)相比在水平和管理上均存在一定差距,希望能够通过建立完善药品标准配套机制,推动我国药品标准水平的提高.结论 美国已经建立了一套完整严格的药品质量标准审评机制,对我国药品标准体系的建立和完善具有借鉴意义.

Study the Existing Problems in Drug Standard Management in China According to the Current Status of Drug Quality Standard between China and America

Objective Comparing drug standard formation history,legal status,management and review process between China and America.Analyzing the standard management situation and existing problems,so as to provide rational suggestions for improvement of our drug standard system.Methods Consulting literatures in recent years and making reviews through summary and comparative analysis.Results There are certain gaps between our drug standards and USP in terms of level and management.We hope that drug standard level in China can be promoted through the establishment of drug standards supporting mechanism.Conclusion America has established a complete and strict mechanism for drug quality standards review,which can be used as references for establishment and improvement of the drug standard system in China.